Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=71
{ "count": 4829, "next": "http://api.gregory-ms.com/trials/?format=api&page=72", "previous": "http://api.gregory-ms.com/trials/?format=api&page=70", "results": [ { "trial_id": 3646, "title": "Effects of a cognitive-behavioural mindfulness intervention upon quality of life, depression and fatigue among multiple sclerosis (MS) patients", "summary": null, "published_date": "2008-05-16T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.013608Z", "link": "http://isrctn.com/ISRCTN21643919", "source": "WHO XML import", "relevant": null, "identifiers": { "isrctn": "ISRCTN21643919" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "8184452", "last_refreshed_on": "2019-07-01", "scientific_title": "Effects of a cognitive-behavioural mindfulness intervention upon quality of life, depression and fatigue among multiple sclerosis (MS) patients", "primary_sponsor": "University Hospital Basel (Switzerland)", "retrospective_flag": "No", "date_registration": null, "source_register": "ISRCTN", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "Both", "date_enrollement": "2007-01-04", "target_size": "140", "study_type": "Interventional", "study_design": "Single-centre, randomised controlled trial (Treatment)", "phase": "Not Specified", "countries": "Germany;Switzerland", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br> 1. Both males and females, aged 18 - 70 years<br> 2. Verified diagnosis of MS with an expanded disability status scale score of less than or equal to 6.0 (from no disability to moderately severe disability MS) and no more than one step increase within the last year. We include patients with the followng types of disease:<br> 2.1. Relapsing-remitting MS and no more than two exacerbations within the last year, with at least three months since start of last relapse; or<br> 2.2. Secondary progressive disease<br> 3. Patients who have not initiated or changed treatment with a disease-modifying drug within the past three months<br> 4. Patients who have not been treated with corticosteroids within the previous 30 days<br> 5. Time since onset of disease will be evaluated and considered in statistical analyses but will not form a criterion for enrolment into the study<br>", "exclusion_criteria": "Exclusion criteria: <br> 1. Serious psychological disorders other than depression and anxiety syndromes, such as psychotic disorders, bipolar disorders, borderline personality disorders or active substance abuse disorders<br> 2. Evidence of dementia as indicated by testing below the fifth percentile in at least three of six dimensions of neuropsychological functioning (i.e. attention and concentration, processing speed, executive function, verbal memory, and verbal processing)<br> 3. Suicidality<br> 4. Other life-threatening or severely disabling physical disorders<br> 5. Current MS exacerbation<br> 6. Other disorders of the central nervous system (CNS) besides MS<br> 7. Symptomatic medication has been altered within the past three months<br> 8. Pregnancy<br> 9. Inability to understand written and spoken German<br>", "condition": "Multiple sclerosis <br>Nervous System Diseases <br>Multiple sclerosis", "intervention": "<br> Intervention:<br> Mindfulness-based stress reduction. 8-week group (10 - 15 participants) intervention, 2.5 hours per week with one additional whole-day session and optimal conventional medical care.<br><br> Control:<br> Optimal conventional medical care alone.<br>", "primary_outcome": "<br> 1. Quality of life: Hamburg Quality of Life Questionnaire in Multiple Sclerosis and Profile Quality of Life in Chronic Disorder<br> 2. Modified Fatigue Impact Scale<br> 3. Center for Epidemiological Studies Depression Scale<br><br> Timepoints of assessment: pre-Intervention, post-intervention and 6-month post-intervention.<br>", "secondary_outcome": "<br> 1. Multiple Sclerosis Inventory of Cognition<br> 2. Personal Goal Attainment Scale<br> 3. Visual Analogue Quality of Life Scale<br> 4. Spielberger Trait Anxiety Scale<br> 5. Expanded Disability Status Scale<br> 6. 25-foot walk test<br><br> Timepoints of assessment: pre-Intervention, post-intervention and 6-month post-intervention.<br>", "secondary_id": "3200B0-112604", "source_support": "Swiss National Science Foundation (ref: 3200B0-112604) (Switzerland), St. Johnson Foundation (Switzerland), Swiss MS Society (Switzerland), Merck Serono (Switzerland), Sanofi Aventis (France), Biogen Dompe (Switzerland)", "ethics_review_status": null, "ethics_review_approval_date": "1990-01-01", "ethics_review_contact_name": null, "ethics_review_contact_address": "Ethics approval received from the Ethics Committee of Basel (EKBB) on the 21st March 2007 (ref: 32/07)", "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": "2009-06-30", "results_url_link": null }, { "trial_id": 3645, "title": "Cannabis for Spasticity in Multiple Sclerosis", "summary": null, "published_date": "2005-11-30T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.988338Z", "link": "http://clinicaltrials.gov/show/NCT00260741", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00260741" }, "categories": [ { "category_id": 18, "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs", "category_name": "Physical therapy and Telerehabilitation", "category_slug": "physical-therapy-and-telerehabilitation", "category_terms": [ "telerehabilitation", "physical therapy", "virtual reality", "gamification", "neurostimulation", "cognitive training", "spasticity", "motor control" ], "article_count": 175 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4610045", "last_refreshed_on": "2015-02-19", "scientific_title": "Cannabis for Spasticity in Multiple Sclerosis: A Placebo-Controlled Study", "primary_sponsor": "Center for Medicinal Cannabis Research", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "21 Years", "inclusion_agemax": "N/A", "inclusion_gender": "Both", "date_enrollement": "2003-03-19", "target_size": "60", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment", "phase": "Phase 1/Phase 2", "countries": "United States", "contact_firstname": "", "contact_lastname": "Mark Agius, M.D.", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "University of California, Davis", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Diagnosis of clinically definite multiple sclerosis as defined by Poser criteria\r<br>\r<br> - Primary or secondary disease course\r<br>\r<br> - Moderate or severe spasticity\r<br>\r<br> - Age 21 or older\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Preexisting pulmonary conditions, including poorly controlled asthma, chronic\r<br> bronchitis, emphysema, bronchiectasis, and other significant pulmonary disorders\r<br>\r<br> - Preexisting cardiac conditions, including ischemic heart disease, congestive heart\r<br> failure, and other significant cardiac disorders\r<br>\r<br> - Inability to abstain from tobacco or marijuana smoking, or use of alcohol or sedative\r<br> or hypnotic medications during the duration of the study\r<br>\r<br> - Past history of abuse of recreational drugs, including marijuana and alcohol in the\r<br> last 12 months\r<br>\r<br> - History of or currently meets DSM-IV criteria for dependence on cannabis\r<br>\r<br> - Use of cannabis, marijuana, or THC in the last two weeks\r<br>\r<br> - Preexisting dementia, mania, depression, or schizophrenia or other poorly controlled\r<br> psychiatric illness\r<br>\r<br> - Exacerbation of MS within 30 days prior to screenin visit\r<br>\r<br> - Current use of cyclophosphamide, mitoxanthrone, or cladribine\r<br>\r<br> - Arthritis, bony and soft tissue disorders interfering with spasticity measures\r<br>\r<br> - Inability to provide informed consent\r<br>\r<br> - Recent cannabis use of more than twice per week one month prior to study entry\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: Smoked Cannabis", "primary_outcome": "Change in an objective measurement of spasticity between the pretreatment assessment and the 4- and 8-week assessments.", "secondary_outcome": "Differences between active agent and placebo in the changes in Ashworth Scale, Functional System Score, Expanded Disability Status Score, Ambulation Index, Functional Composite Score, and Quality of Life Inventory.", "secondary_id": "200311404-4;C00-DA-112", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3644, "title": "A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)", "summary": null, "published_date": "2008-05-19T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.967221Z", "link": "https://clinicaltrials.gov/show/NCT00681538", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00681538" }, "categories": [ { "category_id": 18, "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs", "category_name": "Physical therapy and Telerehabilitation", "category_slug": "physical-therapy-and-telerehabilitation", "category_terms": [ "telerehabilitation", "physical therapy", "virtual reality", "gamification", "neurostimulation", "cognitive training", "spasticity", "motor control" ], "article_count": 175 }, { "category_id": 45, "category_description": "Sativex", "category_name": "Sativex", "category_slug": "sativex", "category_terms": [ "nabiximols", "sativex" ], "article_count": 27 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6490108", "last_refreshed_on": "2017-10-19", "scientific_title": "A Two-phase, Phase 3 Study of the Safety and Efficacy of Sativex, in the Symptomatic Relief of Spasticity in Subjects With Spasticity Due to Multiple Sclerosis: Phase A - Single-blind Response Assessment; Phase B - Double-blind, Randomised, Placebo Controlled, Parallel Group Study.", "primary_sponsor": "GW Pharmaceuticals Ltd.", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2008-01-19", "target_size": "572", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "United Kingdom;United Kingdom;United Kingdom;United Kingdom", "contact_firstname": "; ; ;", "contact_lastname": "Paul Davies, MRCP, FRCP;Paul Davies, MRCP, FRCP;Paul Davies, MRCP, FRCP;Paul Davies, MRCP, FRCP", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Department of Neurology;Department of Neurology;Department of Neurology;Department of Neurology", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give written informed consent for participation in the study.\r<br>\r<br> - Male or female, aged 18 years or above.\r<br>\r<br> - Subject is able (in the investigator's opinion) and willing to comply with all study\r<br> requirements.\r<br>\r<br> - Diagnosed with any disease sub-type of MS of at least six months duration.\r<br>\r<br> - Spasticity due to MS of at least three months duration, which is not wholly relieved\r<br> with current anti-spasticity therapy, and which is expected to remain stable for the\r<br> duration of the study.\r<br>\r<br> - Subject fulfils at least one of the two criteria below. Subject must be either:\r<br> Currently established on a regular dose of anti-spasticity therapy or Previously tried\r<br> and failed, or could not tolerate suitable anti-spasticity therapy.\r<br>\r<br> - Subject is currently receiving a stable regimen (for at least 30 days prior to study\r<br> entry) of all medications that may have an effect on spasticity; and willing to\r<br> maintain this for the duration of the study. If the subject is currently taking\r<br> disease-modifying medication, this must be at a stable dose for at least three months\r<br> prior to the screening visit; the dose must also remain stable for the duration of the\r<br> study.\r<br>\r<br> - Willing for his or her name to be notified to his or her primary care physician, and\r<br> consultant and the responsible authorities for participation in this study, as\r<br> applicable.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any concomitant disease or disorder that has spasticity-like symptoms or that may\r<br> influence the subject's level of spasticity.\r<br>\r<br> - Subject's medical history suggests that relapse/remission is likely to occur during\r<br> the study (over the next 19 weeks) which, in the opinion of the investigator, is\r<br> expected to influence the subject's spasticity.\r<br>\r<br> - Currently receiving a prohibited medication and unwilling to stop for the stated\r<br> period prior to the screening visit and for the duration of the study.\r<br>\r<br> - Any known or suspected history of: schizophrenia or other psychotic illness;diagnosed\r<br> dependence disorder;poorly controlled epilepsy or recurrent seizures;hypersensitivity\r<br> to cannabinoids.\r<br>\r<br> - Significant cardiac, renal or hepatic disease.\r<br>\r<br> - Female subjects of child bearing potential and male subjects whose partner is of child\r<br> bearing potential, unless willing to ensure that they or their partner use effective\r<br> contraception during the study and for three months thereafter.\r<br>\r<br> - Female subject who is pregnant, lactating or planning pregnancy during the course of\r<br> the study or for three months thereafter.\r<br>\r<br> - Subjects who have received an IMP within the 12 weeks before Visit 1.\r<br>\r<br> - Any other significant disease or disorder which, in the opinion of the investigator,\r<br> may either put the subject at risk because of participation in the study, or may\r<br> influence the result of the study, or the subject's ability to participate in the\r<br> study.\r<br>\r<br> - Following a physical examination, the subject has any abnormalities that, in the\r<br> opinion of the investigator, would prevent them from safely participating in the\r<br> study.\r<br>\r<br> - Unwilling to abstain from donation of blood during the study.\r<br>\r<br> - Travel outside the country of residence planned during the study.\r<br>\r<br> - Subjects previously randomised into this study.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give written informed consent for participation in the study.\r<br>\r<br> - Male or female, aged 18 years or above.\r<br>\r<br> - Subject is able (in the investigator's opinion) and willing to comply with all study\r<br> requirements.\r<br>\r<br> - Diagnosed with any disease sub-type of MS of at least six months duration.\r<br>\r<br> - Spasticity due to MS of at least three months duration, which is not wholly relieved\r<br> with current anti-spasticity therapy, and which is expected to remain stable for the\r<br> duration of the study.\r<br>\r<br> - Subject fulfils at least one of the two criteria below. Subject must be either:\r<br> Currently established on a regular dose of anti-spasticity therapy or Previously tried\r<br> and failed, or could not tolerate suitable anti-spasticity therapy.\r<br>\r<br> - Subject is currently receiving a stable regimen (for at least 30 days prior to study\r<br> entry) of all medications that may have an effect on spasticity; and willing to\r<br> maintain this for the duration of the study. If the subject is currently taking\r<br> disease-modifying medication, this must be at a stable dose for at least three months\r<br> prior to the screening visit; the dose must also remain stable for the duration of the\r<br> study.\r<br>\r<br> - Willing for his or her name to be notified to his or her primary care physician, and\r<br> consultant and the responsible authorities for participation in this study, as\r<br> applicable.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any concomitant disease or disorder that has spasticity-like symptoms or that may\r<br> influence the subject's level of spasticity.\r<br>\r<br> - Subject's medical history suggests that relapse/remission is likely to occur during\r<br> the study (over the next 19 weeks) which, in the opinion of the investigator, is\r<br> expected to influence the subject's spasticity.\r<br>\r<br> - Currently receiving a prohibited medication and unwilling to stop for the stated\r<br> period prior to the screening visit and for the duration of the study.\r<br>\r<br> - Any known or suspected history of: schizophrenia or other psychotic illness;diagnosed\r<br> dependence disorder;poorly controlled epilepsy or recurrent seizures;hypersensitivity\r<br> to cannabinoids.\r<br>\r<br> - Significant cardiac, renal or hepatic disease.\r<br>\r<br> - Female subjects of child bearing potential and male subjects whose partner is of child\r<br> bearing potential, unless willing to ensure that they or their partner use effective\r<br> contraception during the study and for three months thereafter.\r<br>\r<br> - Female subject who is pregnant, lactating or planning pregnancy during the course of\r<br> the study or for three months thereafter.\r<br>\r<br> - Subjects who have received an IMP within the 12 weeks before Visit 1.\r<br>\r<br> - Any other significant disease or disorder which, in the opinion of the investigator,\r<br> may either put the subject at risk because of participation in the study, or may\r<br> influence the result of the study, or the subject's ability to participate in the\r<br> study.\r<br>\r<br> - Following a physical examination, the subject has any abnormalities that, in the\r<br> opinion of the investigator, would prevent them from safely participating in the\r<br> study.\r<br>\r<br> - Unwilling to abstain from donation of blood during the study.\r<br>\r<br> - Travel outside the country of residence planned during the study.\r<br>\r<br> - Subjects previously randomised into this study.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give written informed consent for participation in the study.\r<br>\r<br> - Male or female, aged 18 years or above.\r<br>\r<br> - Subject is able (in the investigator's opinion) and willing to comply with all study\r<br> requirements.\r<br>\r<br> - Diagnosed with any disease sub-type of MS of at least six months duration.\r<br>\r<br> - Spasticity due to MS of at least three months duration, which is not wholly relieved\r<br> with current anti-spasticity therapy, and which is expected to remain stable for the\r<br> duration of the study.\r<br>\r<br> - Subject fulfils at least one of the two criteria below. Subject must be either:\r<br> Currently established on a regular dose of anti-spasticity therapy or Previously tried\r<br> and failed, or could not tolerate suitable anti-spasticity therapy.\r<br>\r<br> - Subject is currently receiving a stable regimen (for at least 30 days prior to study\r<br> entry) of all medications that may have an effect on spasticity; and willing to\r<br> maintain this for the duration of the study. If the subject is currently taking\r<br> disease-modifying medication, this must be at a stable dose for at least three months\r<br> prior to the screening visit; the dose must also remain stable for the duration of the\r<br> study.\r<br>\r<br> - Willing for his or her name to be notified to his or her primary care physician, and\r<br> consultant and the responsible authorities for participation in this study, as\r<br> applicable.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any concomitant disease or disorder that has spasticity-like symptoms or that may\r<br> influence the subject's level of spasticity.\r<br>\r<br> - Subject's medical history suggests that relapse/remission is likely to occur during\r<br> the study (over the next 19 weeks) which, in the opinion of the investigator, is\r<br> expected to influence the subject's spasticity.\r<br>\r<br> - Currently receiving a prohibited medication and unwilling to stop for the stated\r<br> period prior to the screening visit and for the duration of the study.\r<br>\r<br> - Any known or suspected history of: schizophrenia or other psychotic illness;diagnosed\r<br> dependence disorder;poorly controlled epilepsy or recurrent seizures;hypersensitivity\r<br> to cannabinoids.\r<br>\r<br> - Significant cardiac, renal or hepatic disease.\r<br>\r<br> - Female subjects of child bearing potential and male subjects whose partner is of child\r<br> bearing potential, unless willing to ensure that they or their partner use effective\r<br> contraception during the study and for three months thereafter.\r<br>\r<br> - Female subject who is pregnant, lactating or planning pregnancy during the course of\r<br> the study or for three months thereafter.\r<br>\r<br> - Subjects who have received an IMP within the 12 weeks before Visit 1.\r<br>\r<br> - Any other significant disease or disorder which, in the opinion of the investigator,\r<br> may either put the subject at risk because of participation in the study, or may\r<br> influence the result of the study, or the subject's ability to participate in the\r<br> study.\r<br>\r<br> - Following a physical examination, the subject has any abnormalities that, in the\r<br> opinion of the investigator, would prevent them from safely participating in the\r<br> study.\r<br>\r<br> - Unwilling to abstain from donation of blood during the study.\r<br>\r<br> - Travel outside the country of residence planned during the study.\r<br>\r<br> - Subjects previously randomised into this study.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give written informed consent for participation in the study.\r<br>\r<br> - Male or female, aged 18 years or above.\r<br>\r<br> - Subject is able (in the investigator's opinion) and willing to comply with all study\r<br> requirements.\r<br>\r<br> - Diagnosed with any disease sub-type of MS of at least six months duration.\r<br>\r<br> - Spasticity due to MS of at least three months duration, which is not wholly relieved\r<br> with current anti-spasticity therapy, and which is expected to remain stable for the\r<br> duration of the study.\r<br>\r<br> - Subject fulfils at least one of the two criteria below. Subject must be either:\r<br> Currently established on a regular dose of anti-spasticity therapy or Previously tried\r<br> and failed, or could not tolerate suitable anti-spasticity therapy.\r<br>\r<br> - Subject is currently receiving a stable regimen (for at least 30 days prior to study\r<br> entry) of all medications that may have an effect on spasticity; and willing to\r<br> maintain this for the duration of the study. If the subject is currently taking\r<br> disease-modifying medication, this must be at a stable dose for at least three months\r<br> prior to the screening visit; the dose must also remain stable for the duration of the\r<br> study.\r<br>\r<br> - Willing for his or her name to be notified to his or her primary care physician, and\r<br> consultant and the responsible authorities for participation in this study, as\r<br> applicable.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any concomitant disease or disorder that has spasticity-like symptoms or that may\r<br> influence the subject's level of spasticity.\r<br>\r<br> - Subject's medical history suggests that relapse/remission is likely to occur during\r<br> the study (over the next 19 weeks) which, in the opinion of the investigator, is\r<br> expected to influence the subject's spasticity.\r<br>\r<br> - Currently receiving a prohibited medication and unwilling to stop for the stated\r<br> period prior to the screening visit and for the duration of the study.\r<br>\r<br> - Any known or suspected history of: schizophrenia or other psychotic illness;diagnosed\r<br> dependence disorder;poorly controlled epilepsy or recurrent seizures;hypersensitivity\r<br> to cannabinoids.\r<br>\r<br> - Significant cardiac, renal or hepatic disease.\r<br>\r<br> - Female subjects of child bearing potential and male subjects whose partner is of child\r<br> bearing potential, unless willing to ensure that they or their partner use effective\r<br> contraception during the study and for three months thereafter.\r<br>\r<br> - Female subject who is pregnant, lactating or planning pregnancy during the course of\r<br> the study or for three months thereafter.\r<br>\r<br> - Subjects who have received an IMP within the 12 weeks before Visit 1.\r<br>\r<br> - Any other significant disease or disorder which, in the opinion of the investigator,\r<br> may either put the subject at risk because of participation in the study, or may\r<br> influence the result of the study, or the subject's ability to participate in the\r<br> study.\r<br>\r<br> - Following a physical examination, the subject has any abnormalities that, in the\r<br> opinion of the investigator, would prevent them from safely participating in the\r<br> study.\r<br>\r<br> - Unwilling to abstain from donation of blood during the study.\r<br>\r<br> - Travel outside the country of residence planned during the study.\r<br>\r<br> - Subjects previously randomised into this study.\r<br>", "exclusion_criteria": null, "condition": "Spasticity;Multiple Sclerosis;Spasticity;Multiple Sclerosis;Spasticity;Multiple Sclerosis;Spasticity;Multiple Sclerosis", "intervention": "Drug: Sativex®;Drug: Placebo;Drug: Sativex®;Drug: Placebo;Drug: Sativex®;Drug: Placebo;Drug: Sativex®;Drug: Placebo", "primary_outcome": "The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).;The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).", "secondary_outcome": "Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline.;Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B).;Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B).;Change in Spasticity as Measured Using the Modified Ashworth Scale From Baseline to End of Treatment (Phase B).;Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs.;Change in Timed 10-metre Walk From Baseline to End of Treatment (Phase B).;Subject Global Impressions of Change at End of Treatment (Phase B).;Carer Global Impressions of Change at of Treatment (Phase B).;Carer Ease of Transfer Global Impressions of Change at End of Treatment (Phase B).;Physician Global Impressions of Change at End of Treatment (Phase B).;Change EuroQoL Quality of Life Questionnaire (EQ-5D)From Baseline to End of Treatment (Phase B);Mood Assessment: Change in Beck Depression Inventory - II (BDI-II)From Baseline to End of Treatment (Phase B)", "secondary_id": "GWSP0604", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3643, "title": "Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)", "summary": null, "published_date": "2008-05-30T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.946003Z", "link": "http://clinicaltrials.gov/show/NCT00688948", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00688948" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4642264", "last_refreshed_on": "2015-02-19", "scientific_title": "A Pilot Study Looking At The Use Of Alfuzosin In The Treatment Of Bladder Dysfunction In Patients With Multiple Sclerosis", "primary_sponsor": "Capital District Health Authority, Canada", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "Both", "date_enrollement": "2007-11-19", "target_size": "20", "study_type": "Interventional", "study_design": "Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 2/Phase 3", "countries": "Canada", "contact_firstname": "", "contact_lastname": "Jerzy B Gajewski, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "QEII Health Science Centre", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Participant should be eighteen years of age or older.\r<br>\r<br> 2. Participant should have LUTS secondary to Multiple Sclerosis as defined below.\r<br>\r<br> 3. Participant should have frequency = 8/day and/or incontinence and/or nocturia =\r<br> 2/night and/or urgency and/or urinary retention.\r<br>\r<br> 4. Participant should be able to understand, speak and read English.\r<br>\r<br> 5. Participant 's urine culture should not show any evidence of urinary tract infection.\r<br>\r<br> 6. Participant should be willing to take part in the study and sign the consent form.\r<br>\r<br> 7. Female participants consents to use a medically acceptable method of birth control\r<br> throughout the entire study period and for four weeks after the study is completed.\r<br> Medically acceptable methods of contraception that may be used by the study\r<br> participants and/or their partner includes abstinence, birth control pills or\r<br> patches, diaphragm with spermicide, IUD, condom and vaginal spermicide, surgical\r<br> sterilization, vasectomy, progestin implants or injections.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Participant with known hypersensitivity to Alfuzosin.\r<br>\r<br> 2. Participant with history of postural hypotension and/or syncope.\r<br>\r<br> 3. Participant has used another alpha blocker within the last 30 days.\r<br>\r<br> 4. Participant has active urethral stricture disease.\r<br>\r<br> 5. Participant has a history of prostate cancer within the preceding five years.\r<br>\r<br> 6. Participant has hepatic dysfunction.\r<br>\r<br> 7. Participant has renal dysfunction.\r<br>\r<br> 8. Participant has unstable angina pectoris.\r<br>\r<br> 9. Participant has a positive pregnancy test at the time of screening.\r<br>\r<br> 10. Participant has a history of serious social, mental or medical conditions that would\r<br> stop patient from taking part in the study.\r<br>\r<br> 11. Participant has a history of alcohol or drug abuse within the last five years.\r<br>\r<br> 12. Participant who is currently being treated for chronic bacterial prostatitis or\r<br> painful bladder syndrome/interstitial cystitis.\r<br>\r<br> 13. Participant has a significant medical problem which the investigator considers a\r<br> serious risk for the patient to be part of the study.\r<br>\r<br> 14. Use of any investigational drug or device within the last 6 months.\r<br>\r<br> 15. Participant who is unwilling or unable to abide by the requirements of study.\r<br>\r<br> 16. Participant has a bladder infection proven by urine culture.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Bladder Dysfunction", "intervention": "Drug: Alfuzosin", "primary_outcome": "The primary efficacy measures will be the ICIQ-LUTSqol questionnaire, the IPSS questionnaire, uroflow/PVR and the voiding diaries.", "secondary_outcome": null, "secondary_id": "JBGMS01;CDHA-RS/2007-035", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3642, "title": "Constraint-Induced (CI) Movement Therapy for Progressive Multiple Sclerosis (MS)", "summary": null, "published_date": "2008-09-06T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.926235Z", "link": "http://clinicaltrials.gov/show/NCT00695084", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00695084" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4642733", "last_refreshed_on": "2015-02-19", "scientific_title": "Constraint-Induced Movement Therapy Trial for Progressive Multiple Sclerosis", "primary_sponsor": "National Multiple Sclerosis Society", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "21 Years", "inclusion_agemax": "80 Years", "inclusion_gender": "Both", "date_enrollement": "2007-03-19", "target_size": "7", "study_type": "Interventional", "study_design": "Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 1", "countries": "United States", "contact_firstname": "", "contact_lastname": "Victor W Mark, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "University of Alabama at Birmingham", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Chronic upper extremity motor deficit due to multiple sclerosis\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Relapse within 3 months of planned enrollment.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Behavioral: Constraint-Induced Movement Therapy", "primary_outcome": "Improvement on the Motor Activity Log", "secondary_outcome": "Improvement on the Wolf Motor Function Test", "secondary_id": "PP1395;CIMSTrial", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3641, "title": "Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis", "summary": null, "published_date": "2008-06-19T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.901993Z", "link": "https://clinicaltrials.gov/show/NCT00702468", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00702468" }, "categories": [ { "category_id": 18, "category_description": "Search terms: telerehabilitation, physical therapy, virtual reality, gamification, neurostimulation, cognitive training, spasticity, motor control.\n\nSuggested by Alejandro Carrabs", "category_name": "Physical therapy and Telerehabilitation", "category_slug": "physical-therapy-and-telerehabilitation", "category_terms": [ "telerehabilitation", "physical therapy", "virtual reality", "gamification", "neurostimulation", "cognitive training", "spasticity", "motor control" ], "article_count": 175 }, { "category_id": 45, "category_description": "Sativex", "category_name": "Sativex", "category_slug": "sativex", "category_terms": [ "nabiximols", "sativex" ], "article_count": 27 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6490467", "last_refreshed_on": "2017-10-19", "scientific_title": "A Placebo Controlled, Parallel Group, Randomised Withdrawal Study of Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Who Are Receiving Long-term Sativex®.", "primary_sponsor": "GW Pharmaceuticals Ltd.", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2007-11-19", "target_size": "36", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "United Kingdom;United Kingdom;United Kingdom;United Kingdom", "contact_firstname": "; ; ;", "contact_lastname": "William Notcutt, MB ChB, FRCA;William Notcutt, MB ChB, FRCA;William Notcutt, MB ChB, FRCA;William Notcutt, MB ChB, FRCA", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "James Paget University Hospital NHS Foundation Trust;James Paget University Hospital NHS Foundation Trust;James Paget University Hospital NHS Foundation Trust;James Paget University Hospital NHS Foundation Trust", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give written informed consent for participation in the study.\r<br>\r<br> - Male or female, aged 18 years or above.\r<br>\r<br> - Subject is able (in the investigator's opinion) and willing to comply with all study\r<br> requirements.\r<br>\r<br> - Diagnosed with MS.\r<br>\r<br> - Received Sativex for the relief of spasticity for at least 12 weeks prior to screening\r<br> and willing to stop dosing with their own supply for the duration of the study.\r<br>\r<br> - Judged to have been receiving benefit from and shown tolerability to Sativex, in the\r<br> investigators' and subjects' opinion.\r<br>\r<br> - Takes a minimum dose of Sativex of two sprays per day.\r<br>\r<br> - If receiving disease-modifying medications, these must have been at a stable dose for\r<br> at least three months prior to screening, and willing to maintain this for the\r<br> duration of the study.\r<br>\r<br> - Has had a stable regimen for at least 30 days prior to study entry, for all\r<br> medications and non-pharmacological therapies that may have an affect on spasticity;\r<br> and willing to maintain this for the duration of the study (N.B. This should be three\r<br> months prior to study entry, in the case of Interferon therapy).\r<br>\r<br> - Willing to allow his or her general practitioner and consultant, if appropriate, to be\r<br> notified of participation in the study.\r<br>\r<br> - Willing for his or her name to be notified to the responsible authorities for\r<br> participation in this study\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Has any concomitant disease or disorder that has symptoms of spasticity or that may\r<br> influence the subject's level of spasticity.\r<br>\r<br> - Unable to rate their level of spasticity or distinguish it from other MS symptoms.\r<br>\r<br> - Currently receiving a prohibited medication (Botulinum Toxin, or Acomplia\r<br> (Rimonabant), and unwilling to stop or comply for the duration of the study or had\r<br> received said medication/ therapy within three months prior to the screening visit.\r<br>\r<br> - Unwilling to stop their own Sativex treatment for the duration of the study.\r<br>\r<br> - Any known or suspected immediate family history of schizophrenia, other psychotic\r<br> illness, severe personality disorder or other significant psychiatric disorder other\r<br> than depression associated with their underlying condition.\r<br>\r<br> - Has evidence of cardiomyopathy.\r<br>\r<br> - Has experienced myocardial infarction or clinically relevant cardiac dysfunction\r<br> within the last 12 months or has a cardiac disorder that, in the opinion of the\r<br> investigator would put the subject at risk of a clinically relevant arrhythmia or\r<br> myocardial infarction.\r<br>\r<br> - Has a QT interval of > 450 ms (males) or > 470 ms (females) at Visit 1.\r<br>\r<br> - Has a secondary or tertiary atrioventricular (AV) block or sinus bradycardia (HR\r<br> <50bpm unless physiological) or sinus tachycardia (HR>110bpm) at Visit 1.\r<br>\r<br> - Has a diastolic blood pressure of <50 mmHg or >105 mmHg (when measured in a sitting\r<br> position at rest for five minutes) prior to randomisation\r<br>\r<br> - Has impaired renal function e.g. creatinine clearance is lower than 50ml/min at Visit\r<br> 1 and is indicative of renal impairment.\r<br>\r<br> - Has significantly impaired hepatic function, at Visit 1, in the investigator's\r<br> opinion.\r<br>\r<br> - Female subjects of child bearing potential and male subjects whose partner is of child\r<br> bearing potential, unless willing to ensure that they or their partner use effective\r<br> contraception during the study and for three months thereafter.\r<br>\r<br> - Female subject who is pregnant, lactating or planning pregnancy during the course of\r<br> the study and for three months thereafter.\r<br>\r<br> - Subjects who have received any IMP within the 12 weeks before Visit 1.\r<br>\r<br> - Any other significant disease or disorder which, in the opinion of the investigator,\r<br> may either put the subject at risk because of participation in the study, may\r<br> influence the result of the study, or the subject's ability to participate in the\r<br> study.\r<br>\r<br> - Following a physical examination, the subject has any abnormalities that, in the\r<br> opinion of the investigator, would prevent them from safely participating in the\r<br> study.\r<br>\r<br> - Travel outside the UK planned during the study.\r<br>\r<br> - Unwilling to abstain from donation of blood during the study.\r<br>\r<br> - Subjects previously randomised into this study.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give written informed consent for participation in the study.\r<br>\r<br> - Male or female, aged 18 years or above.\r<br>\r<br> - Subject is able (in the investigator's opinion) and willing to comply with all study\r<br> requirements.\r<br>\r<br> - Diagnosed with MS.\r<br>\r<br> - Received Sativex for the relief of spasticity for at least 12 weeks prior to screening\r<br> and willing to stop dosing with their own supply for the duration of the study.\r<br>\r<br> - Judged to have been receiving benefit from and shown tolerability to Sativex, in the\r<br> investigators' and subjects' opinion.\r<br>\r<br> - Takes a minimum dose of Sativex of two sprays per day.\r<br>\r<br> - If receiving disease-modifying medications, these must have been at a stable dose for\r<br> at least three months prior to screening, and willing to maintain this for the\r<br> duration of the study.\r<br>\r<br> - Has had a stable regimen for at least 30 days prior to study entry, for all\r<br> medications and non-pharmacological therapies that may have an affect on spasticity;\r<br> and willing to maintain this for the duration of the study (N.B. This should be three\r<br> months prior to study entry, in the case of Interferon therapy).\r<br>\r<br> - Willing to allow his or her general practitioner and consultant, if appropriate, to be\r<br> notified of participation in the study.\r<br>\r<br> - Willing for his or her name to be notified to the responsible authorities for\r<br> participation in this study\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Has any concomitant disease or disorder that has symptoms of spasticity or that may\r<br> influence the subject's level of spasticity.\r<br>\r<br> - Unable to rate their level of spasticity or distinguish it from other MS symptoms.\r<br>\r<br> - Currently receiving a prohibited medication (Botulinum Toxin, or Acomplia\r<br> (Rimonabant), and unwilling to stop or comply for the duration of the study or had\r<br> received said medication/ therapy within three months prior to the screening visit.\r<br>\r<br> - Unwilling to stop their own Sativex treatment for the duration of the study.\r<br>\r<br> - Any known or suspected immediate family history of schizophrenia, other psychotic\r<br> illness, severe personality disorder or other significant psychiatric disorder other\r<br> than depression associated with their underlying condition.\r<br>\r<br> - Has evidence of cardiomyopathy.\r<br>\r<br> - Has experienced myocardial infarction or clinically relevant cardiac dysfunction\r<br> within the last 12 months or has a cardiac disorder that, in the opinion of the\r<br> investigator would put the subject at risk of a clinically relevant arrhythmia or\r<br> myocardial infarction.\r<br>\r<br> - Has a QT interval of > 450 ms (males) or > 470 ms (females) at Visit 1.\r<br>\r<br> - Has a secondary or tertiary atrioventricular (AV) block or sinus bradycardia (HR\r<br> <50bpm unless physiological) or sinus tachycardia (HR>110bpm) at Visit 1.\r<br>\r<br> - Has a diastolic blood pressure of <50 mmHg or >105 mmHg (when measured in a sitting\r<br> position at rest for five minutes) prior to randomisation\r<br>\r<br> - Has impaired renal function e.g. creatinine clearance is lower than 50ml/min at Visit\r<br> 1 and is indicative of renal impairment.\r<br>\r<br> - Has significantly impaired hepatic function, at Visit 1, in the investigator's\r<br> opinion.\r<br>\r<br> - Female subjects of child bearing potential and male subjects whose partner is of child\r<br> bearing potential, unless willing to ensure that they or their partner use effective\r<br> contraception during the study and for three months thereafter.\r<br>\r<br> - Female subject who is pregnant, lactating or planning pregnancy during the course of\r<br> the study and for three months thereafter.\r<br>\r<br> - Subjects who have received any IMP within the 12 weeks before Visit 1.\r<br>\r<br> - Any other significant disease or disorder which, in the opinion of the investigator,\r<br> may either put the subject at risk because of participation in the study, may\r<br> influence the result of the study, or the subject's ability to participate in the\r<br> study.\r<br>\r<br> - Following a physical examination, the subject has any abnormalities that, in the\r<br> opinion of the investigator, would prevent them from safely participating in the\r<br> study.\r<br>\r<br> - Travel outside the UK planned during the study.\r<br>\r<br> - Unwilling to abstain from donation of blood during the study.\r<br>\r<br> - Subjects previously randomised into this study.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give written informed consent for participation in the study.\r<br>\r<br> - Male or female, aged 18 years or above.\r<br>\r<br> - Subject is able (in the investigator's opinion) and willing to comply with all study\r<br> requirements.\r<br>\r<br> - Diagnosed with MS.\r<br>\r<br> - Received Sativex for the relief of spasticity for at least 12 weeks prior to screening\r<br> and willing to stop dosing with their own supply for the duration of the study.\r<br>\r<br> - Judged to have been receiving benefit from and shown tolerability to Sativex, in the\r<br> investigators' and subjects' opinion.\r<br>\r<br> - Takes a minimum dose of Sativex of two sprays per day.\r<br>\r<br> - If receiving disease-modifying medications, these must have been at a stable dose for\r<br> at least three months prior to screening, and willing to maintain this for the\r<br> duration of the study.\r<br>\r<br> - Has had a stable regimen for at least 30 days prior to study entry, for all\r<br> medications and non-pharmacological therapies that may have an affect on spasticity;\r<br> and willing to maintain this for the duration of the study (N.B. This should be three\r<br> months prior to study entry, in the case of Interferon therapy).\r<br>\r<br> - Willing to allow his or her general practitioner and consultant, if appropriate, to be\r<br> notified of participation in the study.\r<br>\r<br> - Willing for his or her name to be notified to the responsible authorities for\r<br> participation in this study\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Has any concomitant disease or disorder that has symptoms of spasticity or that may\r<br> influence the subject's level of spasticity.\r<br>\r<br> - Unable to rate their level of spasticity or distinguish it from other MS symptoms.\r<br>\r<br> - Currently receiving a prohibited medication (Botulinum Toxin, or Acomplia\r<br> (Rimonabant), and unwilling to stop or comply for the duration of the study or had\r<br> received said medication/ therapy within three months prior to the screening visit.\r<br>\r<br> - Unwilling to stop their own Sativex treatment for the duration of the study.\r<br>\r<br> - Any known or suspected immediate family history of schizophrenia, other psychotic\r<br> illness, severe personality disorder or other significant psychiatric disorder other\r<br> than depression associated with their underlying condition.\r<br>\r<br> - Has evidence of cardiomyopathy.\r<br>\r<br> - Has experienced myocardial infarction or clinically relevant cardiac dysfunction\r<br> within the last 12 months or has a cardiac disorder that, in the opinion of the\r<br> investigator would put the subject at risk of a clinically relevant arrhythmia or\r<br> myocardial infarction.\r<br>\r<br> - Has a QT interval of > 450 ms (males) or > 470 ms (females) at Visit 1.\r<br>\r<br> - Has a secondary or tertiary atrioventricular (AV) block or sinus bradycardia (HR\r<br> <50bpm unless physiological) or sinus tachycardia (HR>110bpm) at Visit 1.\r<br>\r<br> - Has a diastolic blood pressure of <50 mmHg or >105 mmHg (when measured in a sitting\r<br> position at rest for five minutes) prior to randomisation\r<br>\r<br> - Has impaired renal function e.g. creatinine clearance is lower than 50ml/min at Visit\r<br> 1 and is indicative of renal impairment.\r<br>\r<br> - Has significantly impaired hepatic function, at Visit 1, in the investigator's\r<br> opinion.\r<br>\r<br> - Female subjects of child bearing potential and male subjects whose partner is of child\r<br> bearing potential, unless willing to ensure that they or their partner use effective\r<br> contraception during the study and for three months thereafter.\r<br>\r<br> - Female subject who is pregnant, lactating or planning pregnancy during the course of\r<br> the study and for three months thereafter.\r<br>\r<br> - Subjects who have received any IMP within the 12 weeks before Visit 1.\r<br>\r<br> - Any other significant disease or disorder which, in the opinion of the investigator,\r<br> may either put the subject at risk because of participation in the study, may\r<br> influence the result of the study, or the subject's ability to participate in the\r<br> study.\r<br>\r<br> - Following a physical examination, the subject has any abnormalities that, in the\r<br> opinion of the investigator, would prevent them from safely participating in the\r<br> study.\r<br>\r<br> - Travel outside the UK planned during the study.\r<br>\r<br> - Unwilling to abstain from donation of blood during the study.\r<br>\r<br> - Subjects previously randomised into this study.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give written informed consent for participation in the study.\r<br>\r<br> - Male or female, aged 18 years or above.\r<br>\r<br> - Subject is able (in the investigator's opinion) and willing to comply with all study\r<br> requirements.\r<br>\r<br> - Diagnosed with MS.\r<br>\r<br> - Received Sativex for the relief of spasticity for at least 12 weeks prior to screening\r<br> and willing to stop dosing with their own supply for the duration of the study.\r<br>\r<br> - Judged to have been receiving benefit from and shown tolerability to Sativex, in the\r<br> investigators' and subjects' opinion.\r<br>\r<br> - Takes a minimum dose of Sativex of two sprays per day.\r<br>\r<br> - If receiving disease-modifying medications, these must have been at a stable dose for\r<br> at least three months prior to screening, and willing to maintain this for the\r<br> duration of the study.\r<br>\r<br> - Has had a stable regimen for at least 30 days prior to study entry, for all\r<br> medications and non-pharmacological therapies that may have an affect on spasticity;\r<br> and willing to maintain this for the duration of the study (N.B. This should be three\r<br> months prior to study entry, in the case of Interferon therapy).\r<br>\r<br> - Willing to allow his or her general practitioner and consultant, if appropriate, to be\r<br> notified of participation in the study.\r<br>\r<br> - Willing for his or her name to be notified to the responsible authorities for\r<br> participation in this study\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Has any concomitant disease or disorder that has symptoms of spasticity or that may\r<br> influence the subject's level of spasticity.\r<br>\r<br> - Unable to rate their level of spasticity or distinguish it from other MS symptoms.\r<br>\r<br> - Currently receiving a prohibited medication (Botulinum Toxin, or Acomplia\r<br> (Rimonabant), and unwilling to stop or comply for the duration of the study or had\r<br> received said medication/ therapy within three months prior to the screening visit.\r<br>\r<br> - Unwilling to stop their own Sativex treatment for the duration of the study.\r<br>\r<br> - Any known or suspected immediate family history of schizophrenia, other psychotic\r<br> illness, severe personality disorder or other significant psychiatric disorder other\r<br> than depression associated with their underlying condition.\r<br>\r<br> - Has evidence of cardiomyopathy.\r<br>\r<br> - Has experienced myocardial infarction or clinically relevant cardiac dysfunction\r<br> within the last 12 months or has a cardiac disorder that, in the opinion of the\r<br> investigator would put the subject at risk of a clinically relevant arrhythmia or\r<br> myocardial infarction.\r<br>\r<br> - Has a QT interval of > 450 ms (males) or > 470 ms (females) at Visit 1.\r<br>\r<br> - Has a secondary or tertiary atrioventricular (AV) block or sinus bradycardia (HR\r<br> <50bpm unless physiological) or sinus tachycardia (HR>110bpm) at Visit 1.\r<br>\r<br> - Has a diastolic blood pressure of <50 mmHg or >105 mmHg (when measured in a sitting\r<br> position at rest for five minutes) prior to randomisation\r<br>\r<br> - Has impaired renal function e.g. creatinine clearance is lower than 50ml/min at Visit\r<br> 1 and is indicative of renal impairment.\r<br>\r<br> - Has significantly impaired hepatic function, at Visit 1, in the investigator's\r<br> opinion.\r<br>\r<br> - Female subjects of child bearing potential and male subjects whose partner is of child\r<br> bearing potential, unless willing to ensure that they or their partner use effective\r<br> contraception during the study and for three months thereafter.\r<br>\r<br> - Female subject who is pregnant, lactating or planning pregnancy during the course of\r<br> the study and for three months thereafter.\r<br>\r<br> - Subjects who have received any IMP within the 12 weeks before Visit 1.\r<br>\r<br> - Any other significant disease or disorder which, in the opinion of the investigator,\r<br> may either put the subject at risk because of participation in the study, may\r<br> influence the result of the study, or the subject's ability to participate in the\r<br> study.\r<br>\r<br> - Following a physical examination, the subject has any abnormalities that, in the\r<br> opinion of the investigator, would prevent them from safely participating in the\r<br> study.\r<br>\r<br> - Travel outside the UK planned during the study.\r<br>\r<br> - Unwilling to abstain from donation of blood during the study.\r<br>\r<br> - Subjects previously randomised into this study.\r<br>", "exclusion_criteria": null, "condition": "Spasticity;Multiple Sclerosis;Spasticity;Multiple Sclerosis;Spasticity;Multiple Sclerosis;Spasticity;Multiple Sclerosis", "intervention": "Drug: Sativex;Drug: Placebo;Drug: Sativex;Drug: Placebo;Drug: Sativex;Drug: Placebo;Drug: Sativex;Drug: Placebo", "primary_outcome": "Number of Subjects Who Experience Treatment Failure.;Number of Subjects Who Experience Treatment Failure.", "secondary_outcome": "Change in Mean Daily Spasticity Severity as Measured on a Spasticity Severity 0-10 Numerical Rating Scale (NRS).;Change in Modified Ashworth Scale.;Change in Motricity Index;Timed 10-metre Walk.;Daily Sleep Disruption NRS;Subject Global Impressions of Change.;Carer Global Impressions of Change for Functional Ability;Carer Global Impressions of Change for Ease of Transfer", "secondary_id": "GWSP0702", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3640, "title": "A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment", "summary": null, "published_date": "2008-06-19T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.878852Z", "link": "http://clinicaltrials.gov/show/NCT00702065", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00702065" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4643258", "last_refreshed_on": "2015-02-19", "scientific_title": "A Multi-center, Multi-regional Observational Study to Test the Responsiveness of the Validated MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Instrument to EDSS Status Changes in Any Form of Multiple Sclerosis (MS) in Patients With or Without Treatment", "primary_sponsor": "EMD Serono", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "Both", "date_enrollement": "2007-11-19", "target_size": "599", "study_type": "Observational", "study_design": "Time Perspective: Prospective", "phase": "N/A", "countries": "United States;Argentina;Australia;Austria;France;Germany;Israel;Italy;Norway;Spain;Turkey;United Kingdom;United States;Argentina;Australia;Austria;France;Germany;Israel;Italy;Norway;Spain;Turkey;United Kingdom", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Patient has any form of MS (confirmed by McDonald and/or Poser criteria)\r<br>\r<br> 2. Patient is 18 years old or more (inclusive, at time of informed consent).\r<br>\r<br> 3. Patient has an EDSS score lower than 7.0 (inclusive, at time of informed consent)\r<br>\r<br> 4. Patient can be with or without treatment\r<br>\r<br> 5. Patient has read, understood, signed and dated informed consent form\r<br>\r<br> 6. Patient is able to fill in the questionnaire by him/herself\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. CIS Patient (MS not confirmed by Mc Donald and /or Poser criteria)\r<br>\r<br> 2. Patient receives or is planned to receive during the course of this study any\r<br> investigational drug or experimental procedure\r<br>\r<br> 3. Patient suffers from dementia in the opinion of the investigator\r<br>\r<br> 4. Patient suffers of major medical or psychiatric illness in the opinion of the\r<br> investigator\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": null, "primary_outcome": "MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) Score", "secondary_outcome": null, "secondary_id": "27904", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3639, "title": "Gene Expression Profiles in Multiple Sclerosis (MS)", "summary": null, "published_date": "2008-06-23T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.845309Z", "link": "https://clinicaltrials.gov/show/NCT00704834", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00704834" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "10205424", "last_refreshed_on": "2020-12-12", "scientific_title": "Gene Expression Profiles in Patients With Multiple Sclerosis", "primary_sponsor": "University of California, Davis", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "70 Years", "inclusion_gender": "All", "date_enrollement": "2006-03-19", "target_size": "46", "study_type": "Observational", "study_design": null, "phase": null, "countries": "United States", "contact_firstname": "", "contact_lastname": "Michelle Apperson, MD, PhD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "University of California, Davis", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - males and females\r<br>\r<br> - any race\r<br>\r<br> - Between the ages of 18 and 70 years\r<br>\r<br> - Diagnosed with a clinically isolated syndrome or the diagnosis of multiple sclerosis\r<br> using the widely established Macdonald criteria. A 'clinically isolated syndrome'\r<br> refers to an isolated attack of optic neuritis, transverse myelitis, or brain\r<br> demyelination. Relapsing-remitting MS is characterized by acute relapses that are\r<br> followed by some degree of recovery without worsening of disability between relapses.\r<br> Chronic progressive MS is defined as sustained progression of physical disability,\r<br> occurring separately from relapses, in patients with MS.\r<br>\r<br> - Control subjects will be male or female, between the ages 18 to 70 years, of any race,\r<br> with no symptoms of MS.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Children are excluded from the study because MS is generally a disease of young adult\r<br> onset and is rare in children.\r<br>\r<br> - Evidence of infection or communicable disease, cancer or other known systemic disease,\r<br> anti-coagulation, known bleeding disorder, illicit drug abuse, or change in\r<br> medications in the last 30 days (including treatment with steroids).\r<br>\r<br> - Patients receiving any other immune modulating medications (steroids,\r<br> cyclophosphamide, mitoxantrone, methotrexate, mycophenolate mofetil, azathioprine,\r<br> IVIG or rituximab) in the prior thirty days will be excluded from the study\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Other: Blood Draw", "primary_outcome": "Determine MS-specific peripheral blood gene expression patterns;Determine differences in peripheral blood gene expression patterns between subgroups of MS patients;Determine whether there are specific SNPs correlated with altered gene expression profiles in multiple sclerosis;Determine MS-specific peripheral blood inflammatory marker profiles", "secondary_outcome": null, "secondary_id": "291796", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3638, "title": "A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A", "summary": null, "published_date": "2008-06-25T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.824205Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002096-27", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-002096-27-PL" }, "categories": [ { "category_id": 1, "category_description": "Fingolimod, also known as Gilenya is a type of medicine known as a ‘disease-modifying therapy’ that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells. ‘Relapsing-remitting’ means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). Gilenya is used when the disease remains active despite appropriate treatment with at least one other disease-modifying therapy, or is severe and getting worse rapidly.\r\n\r\nhttps://www.ema.europa.eu/en/medicines/human/EPAR/gilenya", "category_name": "Fingolimod", "category_slug": "fingolimod", "category_terms": [ "fingolimod", "gilenya" ], "article_count": 259 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "2483843", "last_refreshed_on": "2012-03-19", "scientific_title": "A 24-month double-blind, randomized, multicenter, placebocontrolled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis. - N/A", "primary_sponsor": "Novartis Pharma Services AG", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "Yes", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2008-10-09", "target_size": "1080", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes\nRandomised: yes\nOpen: no\nSingle blind: no\nDouble blind: yes\nParallel group: yes\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: no\nPlacebo: yes\nOther: no", "phase": null, "countries": "United Kingdom;Austria;Poland;Lithuania", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>General: <br>1. male or female females of childbearing potential must:<br>• have a negative pregnancy tests at Baseline prior to entry into the Double-Blind<br>Treatment Phase<br>• use simultaneously two forms of effective contraception (either partner) during the<br>treatment and for 3 months after discontinuation of the study medication females who are either post-menopausal for 12 months prior to Randomization or surgically sterile (through hysterectomy or bilateral oophorectomy) (if documented), are not required to use birth control. <br>2. 18 through 55 years of age inclusive<br>3. sign written informed consent prior to participating in the study <br><br>Multiple sclerosis:<br>4. diagnosis of multiple sclerosis as defined by 2005 revised McDonald criteria<br>5. a relapsing-remitting course with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years; prior to randomization<br>6. an Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive<br>7. neurologically stable with no evidence of relapse or corticosteroid treatment within 30 days prior to randomization<br>8. Patients who explicitly decline initiation or continuation of treatment with available disease modifying drugs for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>1. a manifestation of MS other than RRMS<br>2. a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome<br>3. a history or presence of malignancy (except for successfully treated basal or squamous cell carcinoma of skin)<br>4. a known or ‘new’ diagnosis of diabetes mellitus (if screening blood glucose is suspicious for diabetes [=126 mg/dL or =7 mmol/L if fasting; =200 mg/dL or 11.1 mmol/L if random testing] a patient should be further evaluated for diabetes mellitus)<br>5. a diagnosis of macular edema during Pre-randomization Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic screening visit).<br>6. active systemic bacterial, viral or fungal infections, or diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively<br>7. have received total lymphoid irradiation or bone marrow transplantation<br>8. have been treated with: (*)<br>9. any medically unstable condition, as assessed by the primary treating physician<br>10. any of the following cardiovascular conditions: (*)<br>11. any of the following pulmonary conditions: (*)<br>12. any of the following hepatic conditions: (*)<br>13. any of the following abnormal laboratory values: (*)<br>14. any of the following neurologic/psychiatric disorders: (*)<br>15. unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA<br>16. participation in any clinical research study evaluating another investigational drug or therapy within 6 months prior to randomization<br>17. history of fingolimod therapy<br><br>(*) Please see enclosed protocol section 5.1 for all details.<br><br>", "condition": "Relapsing-remitting multiple sclerosis. <br>MedDRA version: 13.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis\nSystem Organ Class: 10029205 - Nervous system disorders", "intervention": "<br>Product Name: Fingolimod<br>Product Code: FTY720D<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: Fingolimod<br>CAS Number: 162359-56-0<br>Current Sponsor code: FTY720D<br>Other descriptive name: FTY720<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.5-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>Product Name: Fingolimod<br>Product Code: FTY720D<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: Fingolimod<br>CAS Number: 162359-56-0<br>Current Sponsor code: FTY720D<br>Other descriptive name: FTY720<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.5-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br>", "primary_outcome": "Main Objective: The primary objective is to demonstrate that fingolimod 0.5 mg/day is superior to placebo as assessed by the annualized relapse rate (ARR) in patients with RRMS treated for up to 24 months.;Secondary Objective: 1. To evaluate the effect of fingolimod 0.5 mg/day relative to placebo on the percent change from baseline in brain atrophy in patients with RRMS treated for up to 24 months.<br>2. To evaluate the effect of fingolimod 0.5 mg/day relative to placebo on disability rogression as measured by the time to 3-month confirmed disability progression as measured by EDSS in patients with RRMS treated for up to 24 months.<br><br>Details of other secondary objectives see protocol track change.;Primary end point(s): The primary endpoint will be the annualized relapse rate (ARR), which is defined as the number of relapses in a year.", "secondary_outcome": null, "secondary_id": "CFTY720D2309", "source_support": null, "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null }, { "trial_id": 3637, "title": "Lido Workset Study", "summary": null, "published_date": "2008-02-07T00:00:00Z", "discovery_date": "2023-12-06T18:18:21.804710Z", "link": "https://clinicaltrials.gov/show/NCT00710645", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00710645" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "6611865", "last_refreshed_on": "2017-12-16", "scientific_title": "Assessment of Spasticity in MS Patients Using a Lido Workset", "primary_sponsor": "University of California, Davis", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "All", "date_enrollement": "2003-04-19", "target_size": "31", "study_type": "Observational", "study_design": null, "phase": "N/A", "countries": "United States;United States;United States;United States;United States", "contact_firstname": "; ; ; ;", "contact_lastname": "Mark Agius, MD;Mark Agius, MD;Mark Agius, MD;Mark Agius, MD;Mark Agius, MD", "contact_address": null, "contact_email": ";;;;", "contact_tel": ";;;;", "contact_affiliation": "University of California, Davis;University of California, Davis;University of California, Davis;University of California, Davis;University of California, Davis", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Must have a diagnosis of multiple sclerosis and\r<br>\r<br> - Must have some degree of spasticity or\r<br>\r<br> - Must be a healthy control subject\r<br>\r<br> - Ability to give informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients with any life-threatening or unstable clinically significant disease\r<br>\r<br> - Patients with other causes of reduced range of motion of the knee or wrist\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Must have a diagnosis of multiple sclerosis and\r<br>\r<br> - Must have some degree of spasticity or\r<br>\r<br> - Must be a healthy control subject\r<br>\r<br> - Ability to give informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients with any life-threatening or unstable clinically significant disease\r<br>\r<br> - Patients with other causes of reduced range of motion of the knee or wrist\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Must have a diagnosis of multiple sclerosis and\r<br>\r<br> - Must have some degree of spasticity or\r<br>\r<br> - Must be a healthy control subject\r<br>\r<br> - Ability to give informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients with any life-threatening or unstable clinically significant disease\r<br>\r<br> - Patients with other causes of reduced range of motion of the knee or wrist\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Must have a diagnosis of multiple sclerosis and\r<br>\r<br> - Must have some degree of spasticity or\r<br>\r<br> - Must be a healthy control subject\r<br>\r<br> - Ability to give informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients with any life-threatening or unstable clinically significant disease\r<br>\r<br> - Patients with other causes of reduced range of motion of the knee or wrist\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Device: Lido Workset;Device: Lido Workset;Device: Lido Workset;Device: Lido Workset", "primary_outcome": "Assess measure of spasticity;Assess measure of spasticity;Assess measure of spasticity", "secondary_outcome": null, "secondary_id": "200310977", "source_support": "Please refer to primary and secondary sponsors", "ethics_review_status": null, "ethics_review_approval_date": null, "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": null, "results_url_link": null } ] }