Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=70
{ "count": 4829, "next": "http://api.gregory-ms.com/trials/?format=api&page=71", "previous": "http://api.gregory-ms.com/trials/?format=api&page=69", "results": [ { "trial_id": 3656, "title": "An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis", "summary": null, "published_date": "2008-04-28T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.234099Z", "link": "https://clinicaltrials.gov/show/NCT00670449", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00670449" }, "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": "6489908", "last_refreshed_on": "2017-10-19", "scientific_title": "An Extension of the 6-month, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study Comparing Efficacy and Safety of FTY720 0.5 mg and 1.25 mg Administered Orally Once Daily in Patients With Relapsing Multiple Sclerosis", "primary_sponsor": "Novartis", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "60 Years", "inclusion_gender": "All", "date_enrollement": "2008-04-19", "target_size": "143", "study_type": "Interventional", "study_design": null, "phase": "Phase 2", "countries": "Japan;Japan;Japan;Japan", "contact_firstname": "; ; ;", "contact_lastname": "Novartis Pharmaceuticals, Japan;Novartis Pharmaceuticals, Japan;Novartis Pharmaceuticals, Japan;Novartis Pharmaceuticals, Japan", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "81-3-3797-8748;81-3-3797-8748;81-3-3797-8748;81-3-3797-8748", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Patients who completed 6 months of treatment with the study drug and the Month 6 visit\r<br> in the core study NCT00537082.\r<br>\r<br> - Females of childbearing potential who have a negative pregnancy test in the core study\r<br> NCT00537082.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients who permanently discontinued study drug treatment prior to the Month 6 visit\r<br> in the core study NCT00537082.\r<br>\r<br> Other protocol-defined inclusion/exclusion criteria applied to the study.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Patients who completed 6 months of treatment with the study drug and the Month 6 visit\r<br> in the core study NCT00537082.\r<br>\r<br> - Females of childbearing potential who have a negative pregnancy test in the core study\r<br> NCT00537082.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients who permanently discontinued study drug treatment prior to the Month 6 visit\r<br> in the core study NCT00537082.\r<br>\r<br> Other protocol-defined inclusion/exclusion criteria applied to the study.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Patients who completed 6 months of treatment with the study drug and the Month 6 visit\r<br> in the core study NCT00537082.\r<br>\r<br> - Females of childbearing potential who have a negative pregnancy test in the core study\r<br> NCT00537082.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients who permanently discontinued study drug treatment prior to the Month 6 visit\r<br> in the core study NCT00537082.\r<br>\r<br> Other protocol-defined inclusion/exclusion criteria applied to the study.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Patients who completed 6 months of treatment with the study drug and the Month 6 visit\r<br> in the core study NCT00537082.\r<br>\r<br> - Females of childbearing potential who have a negative pregnancy test in the core study\r<br> NCT00537082.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Patients who permanently discontinued study drug treatment prior to the Month 6 visit\r<br> in the core study NCT00537082.\r<br>\r<br> Other protocol-defined inclusion/exclusion criteria applied to the study.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis;Multiple Sclerosis", "intervention": "Drug: Fingolimod;Drug: Fingolimod;Drug: Fingolimod;Drug: Fingolimod", "primary_outcome": "Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions;Percentage of Patients Free of Gd-enhanced T1 Weighted Magnetic Resonance Imaging (MRI) Lesions", "secondary_outcome": "Percentage of Patients Free of New or Newly Enlarged T2 Weighted MRI Lesions;Aggregate Annualized Relapse Rate (ARR) Based on Confirmed Relapses;Percentage of Patients Relapse-free at the End of the Study;Percentage of Patients Free From 3-month and 6-month Confirmed Disability Progression at Their Last Expanded Disability Status Scale (EDSS) Assessment;Change From Core Study Baseline in the Expanded Disability Status Scale (EDSS) Score", "secondary_id": "CFTY720D1201E1", "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": 3655, "title": "Effectiveness of a Structured Information interview in people with newly-diagnosed Multiple Sclerosis", "summary": null, "published_date": "2008-04-30T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.212792Z", "link": "http://isrctn.com/ISRCTN81072971", "source": "WHO XML import", "relevant": null, "identifiers": { "isrctn": "ISRCTN81072971" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4529060", "last_refreshed_on": "2015-01-13", "scientific_title": "", "primary_sponsor": "Neurological Institute \"C. Besta\" Foundation IRCCS (Italy)", "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": "2008-03-18", "target_size": "120", "study_type": "Interventional", "study_design": "Multi-centre randomised controlled trial (Treatment)", "phase": null, "countries": "Italy", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: Subjects are eligible for recruitment if all the following criteria are satisfied: <br>1. Diagnostic workup to confirm/exclude MS diagnosis<br>2. Age 18 years and above, either sex<br>3. Signed informed consent (pre-diagnostically)<br> <br>Consenting subjects will be randomised at the end of the diagnostic workup, provided that all the following criteria apply:<br>1. Diagnosis of MS confirmed<br>2. Interval between informed consent and MS diagnosis within seven months", "exclusion_criteria": "Exclusion criteria: Subjects will be excluded from the study if one or more of the following criteria apply: <br>1. Previous MS diagnosis<br>2. Presence of definite cognitive compromise, psychiatric disease, or substance abuse", "condition": "Multiple sclerosis (MS) <br>Nervous System Diseases <br>Multiple sclerosis", "intervention": "At least 120 patients will be recruited from eight Italian centres and randomly assigned to receive the study intervention (add-on information aids, n = 60) or control (no add-on information aids, n = 60).<br><br>The add-on interview is conducted by trained neurologists (approximately one hour in length), during which information about MS is presented with the aid of a specifically designed compact disc (CD). The information is tailored to individual needs; the patient is also given a booklet containing all the information provided. <br><br>The \"Sapere Migliora\" CD:<br>\"Sapere Migliora\" can be approximately rendered as \"knowledge helps\"; it works in Italian because the initials of the condition are SM ? sclerosi multipla. The CD contains an introduction followed by a menu of the headings: <br>1. MS insights:<br>1.1. Central nervous system<br>1.2. The myelin and the axon<br>1.3. Myelin and axon's damage<br>1.4. Mechanisms of damage<br>2. The diagnosis:<br>2.1. Relapses<br>2.2. Most common symptoms at disease onset<br>2.3. Clinical examination<br>2.4. Laboratory examinations<br>3. What happens after diagnosis:<br>3.1. MS course<br>3.2. Scheduled visits<br>4. Therapies:<br>4.1. Research at basis of therapies<br>4.2. Treatment for relapses<br>4.3. Disease-modifying drugs<br>5. Emotions:<br>5.1. Common emotional reactions<br>5.2. Reactions due to neurological damage<br>5.3. Depression<br>6. Having a child:<br>6.1. Motherhood<br>6.2. Fatherhood<br>7. Frequently asked questions (FAQs):<br>7.1. General questions<br>7.2. Questions on pregnancy<br>8. Glossary<br><br>Animations and intuitively-obvious aids are used extensively throughout the CD. A voice in the background illustrates the entire presentation. Emotions are also presented as a movie lasting eight minutes.<br><br>At the beginning of the interview, the \"Sapere Migliora\" CD is started and an opening menu appears. The patient indicates to the \"informing neurologist\" at which point on the program he/she wants to start. The \"informing neurologist\" navigates through the program guided by the patient's preferences, spending as m", "primary_outcome": "Primary endpoints, assessed one and six months after diagnosis disclosure, are knowledge and satisfaction with diagnosis communication as determined by the MS Knowledge Questionnaire (MSKQ) and the instrument \"Comunicazione medico-paziente nella Sclerosi Multipla\" (revised) (CoSM-R):<br>1. MSKQ: no widely-accepted measure of patient knowledge on MS is currently available. The MSKQ, specifically devised for this study, consists of 25 multiple-choice items, is self-administered, and designed to be applicable to a wide range of people with MS. The total score is the number of correct responses (range 0 - 25).<br>2. CoSM-R: this MS-specific scale was recently devised for this study. CoSM-R is self-administered and consists of multiple-choice questions about the moment of MS diagnosis communication (9 items), and about the period immediately following diagnosis communication (16 items).", "secondary_outcome": "Secondary endpoints are changes at one and six months in:<br>1. The Hospital Anxiety and Depression Scale (HADS)<br>2. The Control Preference Scale (CPS). The CPS was translated and cross-culturally adapted into Italian from the original English version. <br><br>Other endpoints measured over the study period:<br>3. Attrition<br>4. Number of consultations<br>5. Number of visits to the MS centre", "secondary_id": "2007/R/19", "source_support": "The Italian Multiple Sclerosis Society (Italy)", "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": 3654, "title": "A double-blind, placebo controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with relapsing remitting multiple sclerosis.", "summary": null, "published_date": "2008-01-05T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.190734Z", "link": "https://anzctr.org.au/ACTRN12608000226303.aspx", "source": "WHO XML import", "relevant": null, "identifiers": { "actrn": "ACTRN12608000226303" }, "categories": [], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13852406", "last_refreshed_on": "2024-04-08", "scientific_title": "A double-blind, placebo controlled, randomised trial to prove the therapeutic concept and to determine the pharmacokinetic profile of ATL1102 (VLA-4 antisense oligonucleotide) by subcutaneous injections in patients with multiple sclerosis.", "primary_sponsor": "Antisense Therapeutics Limited", "retrospective_flag": "No", "date_registration": null, "source_register": "ANZCTR", "recruitment_status": "Not Recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "Both males and females", "date_enrollement": "2005-02-19", "target_size": "80", "study_type": "Interventional", "study_design": "Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy;", "phase": "Phase 2", "countries": "Slovakia;Poland;Czech Republic;Romania;Bulgaria;Germany", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: Males and females aged 18 to 55 years\r<br>Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS)\r<br>At least 9 T2 lesions or at least 4 if one is gadolinium-enhancing\r<br>Last relapse in the previous 12 months\r<br>No relapse in the previous four weeks\r<br>Score of EDSS 0 to 6.0\r<br>Reliable contraception (e.g. surgical sterilisation, oral contraceptives) \r<br>Written informed consent to participate in the study by signature on the Patients Consent Form", "exclusion_criteria": "Exclusion criteria: Administration of any investigational drug within the previous 2 months before enrolment (4 months if the previous drug was a new chemical entity).\r<br>Progressive disease.\r<br>Concomitant clinically relevant other findings on MRI that may interfere with outcome assessment.\r<br>Previous treatment with VLA-4 antibodies, anti-CD4 antibodies, or other monoclonal antibodies.\r<br>Total lymphoid irradiation at any time.\r<br>Treatment with immune-modulating drugs in the previous two months or treatment with immune-suppressive drugs in the previous six months.\r<br>HIV positive patients.\r<br>Detectable levels of JC Virus in the blood measured by quantitative PCR.\r<br>Patients with renal impairment with serum creatinine greater than or equal to 2,0 mg/dl.\r<br>History of clinically relevant gastrointestinal, hepatic, renal, endocrine, haematological, metabolic, neurologic (other than multiple sclerosis (MS)) and psychiatric disease.\r<br>Patients with infections (lymphocytes greater than 3000/microL).\r<br>History of any bleeding.\r<br>History of coagulation abnormalities.\r<br>Concomitant medication acetyl salicylic acid (greater than 300 mg/day) and phenprocoumon.\r<br>Clinically relevant abnormalities in physical findings at screening examination if interfering with the study objective.\r<br>Pregnant or breast-feeding women.\r<br>History of drug or alcohol abuse.\r<br>Epileptics.\r<br>Suicidal subjects.\r<br>History of drug allergy and/or known drug hypersensitivity.\r<br>Inability to communicate or cooperate with the Investigator due to language problem, poor mental development or impaired cerebral function.\r<br>Any medical condition which, in the judgement of the Investigator, might interfere with the objectives of the study.\r<br>Repeated participation in this study.\r<br>Contraindication for application of study drug.\r<br>Corticoid-treatment in the previous six weeks and during the study period, exceptions are corticoid-treatment before the study period (not in the previous six weeks) and of relapses during the study period: Relapses are characterised by the occurrence of neurological dysfunction symptoms, appearing after a 30-day period of stability or improvement and lasting for more than 24 hours (no infection, no fever). \r<br>A 5-day methylprednisolone treatment 1000 mg intravenous (i.v) is allowed in this case followed by a reducing procedure.\r<br>Corticoid-treatment if applied locally (e.g. inhaled products) is allowed.\r<br>Additionally MRI exclusion criteria: Metal residing in the body (e.g. implants), Cardiac pacemaker, valves, cochlear implants, CNS vascular clips.\r<br>Contrast medium allergy Gadolinium Diethylenetriamine Penta-Acetic Acid (Gd-DTPA).\r<br>No MRI exclusion criteria but caution is advised in case of: Cardiovascular disease including coronary heart disease, Immune deficiency, Haematologic disorder.", "condition": "Multiple Sclerosis; <br>Multiple Sclerosis;Neurological - Multiple sclerosis", "intervention": "Patients receive 200 mg ATL1102 (VLA-4 antisense oligonucleotide) by subcutaneous injection three times in the first week, then twice weekly for the next seven weeks. The patients are monitored for a further eight weeks following completion of dosing.", "primary_outcome": "Cumulative number of new active lesions on Magnetic Resonance Imaging (MRI), corrected for the number of enhancing lesions at baseline.[ At 4, 8 and 12 weeks after intervention commencement.]", "secondary_outcome": "Cumulative volume of gadolinium-enhancing lesions on MRI, corrected for the volume of enhancing lesions at baseline.[ At 4, 8 and 12 weeks after intervention commencement.]", "secondary_id": "Nil", "source_support": "Antisense Therapeutics Limited", "ethics_review_status": "Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved;Approved", "ethics_review_approval_date": null, "ethics_review_contact_name": ";;;;;;;;;;;;;;;;;;;;;;", "ethics_review_contact_address": "Ethics Committee of the Faculty of Medicine, University of Duisburg-Essen, University Clinic Essen;Ethics Committee of the State Chamber of Physicians of the Federal State of Hessen;Ethics Committee of the Chamber of Physicians of the Federal State of Lower Saxony, Corporation under Public Law;Ethics Committee of the Chamber of Physicians of the Federal State of Mecklenburg-West Pomerania at the University of Rostock, Institute of Forensic Medicine;Ethics Committee of the State Chamber of Physicians of Thuringia, Corporation under Public Law;Ethics Committee of the Chamber of Physicians of Berlin, Corporation under Public Law;Ethics Committee of the Medical University of Hannover;Ethics Committee of the State Chamber of Physicians of Rhineland-Palatinate, Corporation under Public Law;Ethics Committee of the Chamber of Physicians of Hamburg, Corporation under Public Law;Ethics Committee of the Faculty of Medicine, University of Witten/Herdecke;MHAT \"Tzaritza Ioanna\" Ltd Local Ethics Committee;Local Ethics Committee at SHATNP \"Sv. Naum;Local Ethics Committee at SHATCVD;MHAT \"St. Marina\" Ltd. Varna Local Ethics Committee;Ethics Committee FN Olomouc;Ethics Committee of Slezska Nemocnice Opava;Ethics Commitee of FNKV;Ethics Committee of District Hospital Pardubice;Ethics Committee at FNsP Bratislava Ruzinov Facility;Ethics Committee at FNsP BratislavaSt.cyril and Method Hospital pracovisko Petrzalka;Ethics committee at University Hospital Nitra;Bioethical Committee of Medical University of Lodz;Ministry of Health National Ethics Committee", "ethics_review_contact_phone": ";;;;;;;;;;;;;;;;;;;;;;", "ethics_review_contact_email": ";;;;;;;;;;;;;;;;;;;;;;", "results_date_completed": "2008-04-17", "results_url_link": null }, { "trial_id": 3653, "title": "Far Infrared Irradiation for Managing and Treating Multiple Sclerosis (MS)", "summary": null, "published_date": "2008-06-05T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.169916Z", "link": "http://clinicaltrials.gov/show/NCT00674934", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00674934" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4641199", "last_refreshed_on": "2015-02-19", "scientific_title": "Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Multiple Sclerosis.", "primary_sponsor": "GAAD Medical Research Institute Inc.", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "N/A", "inclusion_agemax": "N/A", "inclusion_gender": "Both", "date_enrollement": "2008-05-19", "target_size": "5", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 1", "countries": "Canada", "contact_firstname": "", "contact_lastname": "Ken Nedd, M.D.", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "GAAD Medical Research Institute Inc.", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Patients with MS\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - None\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Radiation: Far Infrared Radiation (5µm to 20µm wavelength)", "primary_outcome": "Treatment of MS", "secondary_outcome": "Rehabilitation of MS Patients", "secondary_id": "GAAD-MS-CTP1", "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": 3652, "title": "A Study of the Pharmacokinetics and Immunologic Effects of Lipoic Acid in Multiple Sclerosis", "summary": null, "published_date": "2008-07-05T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.145918Z", "link": "http://clinicaltrials.gov/show/NCT00676156", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00676156" }, "categories": [ { "category_id": 43, "category_description": "Lipoic Acid", "category_name": "Lipoic Acid", "category_slug": "lipoic-acid", "category_terms": [ "Lipoic acid" ], "article_count": 7 } ], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4641292", "last_refreshed_on": "2015-02-19", "scientific_title": "A Pilot Trial to Study the Pharmacokinetics of Oral Lipoic Acid (LA) and Immunological Effects of LA in Multiple Sclerosis", "primary_sponsor": "Oregon Health and Science University", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "80 Years", "inclusion_gender": "Both", "date_enrollement": "2005-12-19", "target_size": "40", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 1", "countries": "United States", "contact_firstname": "", "contact_lastname": "Vijayshree Yadav, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Oregon Health and Science University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Definite MS by McDonald's or Poser's criteria\r<br>\r<br> - EDSS = 7.5\r<br>\r<br> - Age 18 to 80\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - No clinically significant MS exacerbation within 30 days of the screening\r<br>\r<br> - No systemically administered corticosteroids within 30 days of study entry\r<br>\r<br> - Patient not pregnant or breast feeding\r<br>\r<br> - No LA in previous 2 weeks\r<br>\r<br> - Not on anti-coagulants such as heparin, coumadin, or aspirin during study\r<br>\r<br> - No other significant health problem (e.g. active coronary heart disease, liver\r<br> disease, pulmonary disease, diabetes mellitus) that might increase risk of patient\r<br> experiencing adverse events\r<br>\r<br> - Inability to give informed consent\r<br>\r<br> - Any condition which would make the patient, in the opinion of the investigator,\r<br> unsuitable for the study\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: oral lipoic acid (LA);Drug: lipoic acid (LA) with fish oil and LA without fish oil;Drug: R lipoic acid", "primary_outcome": "To determine the pharmacokinetics of orally administered LA 1200 mg. This will assess the variability in bioavailability of LA and the feasibility of conducting a more focused PK assessment in future studies with LA.", "secondary_outcome": "To study salivary LA concentrations corresponding to the serum levels.", "secondary_id": "NCCAM 1K23 AT003258-01;OHSU IRB00001305", "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": 3651, "title": "COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS", "summary": null, "published_date": "2008-08-05T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.124084Z", "link": "http://clinicaltrials.gov/show/NCT00675883", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00675883" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4641271", "last_refreshed_on": "2015-02-19", "scientific_title": "COMPliance With Avonex® PS in Patients With Relapsing-Remitting MS", "primary_sponsor": "Biogen Idec", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "65 Years", "inclusion_gender": "Both", "date_enrollement": "2008-05-19", "target_size": "1000", "study_type": "Observational", "study_design": "N/A", "phase": "N/A", "countries": "Canada", "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> - Diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS)\r<br>\r<br> - Prescription of AVONEX® PS (prefilled syringes)\r<br>\r<br> - Enrolment in the MS AllianceTM program\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Relapsing-Remitting", "intervention": null, "primary_outcome": "Compliance with therapy in the prospective arm;Persistence on therapy between prospective and retrospective arms", "secondary_outcome": "Patients' satisfaction with new MSA program", "secondary_id": "AVX-CAN-0703", "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": 3650, "title": "A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis", "summary": null, "published_date": "2008-09-05T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.103192Z", "link": "https://clinicaltrials.gov/ct2/show/NCT00676715", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00676715" }, "categories": [ { "category_id": 8, "category_description": "", "category_name": "Ocrelizumab", "category_slug": "ocrelizumab", "category_terms": [ "ocrelizumab", "ocrevus" ], "article_count": 225 } ], "export_date": "2024-04-15T00:00:00Z", "internal_number": "13701425", "last_refreshed_on": "2024-02-27", "scientific_title": "Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS", "primary_sponsor": "Genentech, Inc.", "retrospective_flag": "Yes", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "55 Years", "inclusion_gender": "All", "date_enrollement": "2008-07-17", "target_size": "220", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).", "phase": "Phase 2", "countries": "United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Italy;Mexico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Italy;Mexico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;United States;Czech Republic;Finland;Netherlands", "contact_firstname": "", "contact_lastname": "Clinical Trials", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Genentech, Inc.", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Ability to provide written informed consent and to be compliant with the schedule of\r<br> protocol assessments\r<br>\r<br> - Relapsing-remitting multiple sclerosis (MS)\r<br>\r<br> - Ages 18-55 years inclusive\r<br>\r<br> - For sexually active female and male participants of reproductive potential, use of\r<br> reliable means of contraception\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Secondary or primary progressive multiple sclerosis at screening\r<br>\r<br> - Incompatibility with MRI\r<br>\r<br> - Contra-indications to or intolerance of oral or IV corticosteroids\r<br>\r<br> - Known presence of other neurologic disorders\r<br>\r<br> - Pregnancy or lactation\r<br>\r<br> - Lack of peripheral venous access\r<br>\r<br> - History of severe allergic or anaphylactic reactions to humanized or murine monoclonal\r<br> antibodies\r<br>\r<br> - Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic,\r<br> endocrine or gastrointestinal\r<br>\r<br> - Congestive heart failure\r<br>\r<br> - Known active bacterial, viral, fungal, mycobacterial infection or other infection or\r<br> any major episode of infection requiring hospitalization or treatment with IV\r<br> antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior\r<br> to screening\r<br>\r<br> - History or known presence of recurrent or chronic infection\r<br>\r<br> - History of cancer, including solid tumors and hematological malignancies (except basal\r<br> cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the\r<br> cervix of the uterus that have been excised and resolved)\r<br>\r<br> - History of alcohol or drug abuse within 24 weeks prior to randomization\r<br>\r<br> - History of or currently active primary or secondary immunodeficiency\r<br>\r<br> - History of coagulation disorders\r<br>\r<br> - Treatment with any investigational agent within 4 weeks of screening\r<br>\r<br> - Receipt of a live vaccine within 6 weeks prior to randomization\r<br>\r<br> - Incompatibility with Avonex use\r<br>\r<br> - Previous treatment with rituximab\r<br>\r<br> - Previous treatment with lymphocyte-depleting therapies except mitoxantrone\r<br>\r<br> - Treatment with lymphocyte trafficking blockers within 24 weeks prior to randomization\r<br>\r<br> - Treatment with beta interferons, glatiramer acetate, IV immunoglobulin,\r<br> plasmapheresis, or immunosuppressive therapies within 12 weeks prior to randomization\r<br>\r<br> - Systemic corticosteroid therapy within 4 weeks prior to randomization\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis, Relapsing-Remitting", "intervention": "Drug: Placebo;Drug: Ocrelizumab;Drug: Avonex", "primary_outcome": "Total Number of Gadolinium-Enhancing T1 Lesions Observed on MRI Scans of the Brain", "secondary_outcome": "Annualized Protocol Defined Relapse Rate at Week 24;Percentage of Participants Who Remained Relapse Free at Week 24;Change From Baseline in Total Volume of T2 Lesions on MRI Scans of the Brain at Week 24;Total Number of New Gadolinium-Enhancing T1 Lesions Observed by MRI Scans of the Brain;Total Number of Gadolinium-Enhancing T1 Lesions at Weeks", "secondary_id": "2007-006338-32;WA21493;ACT4422g", "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": 3649, "title": "International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS", "summary": null, "published_date": "2008-05-13T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.079781Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000499-25", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2008-000499-25-DE" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "2644820", "last_refreshed_on": "2012-06-26", "scientific_title": "International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS", "primary_sponsor": "Merck Serono International S.A.", "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": null, "target_size": "100", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: no\nRandomised: no\nOpen: yes\nSingle blind: no\nDouble blind: no\nParallel group: no\nCross over: no\nOther: no\nIf controlled, specify comparator, Other Medicinial Product: \nPlacebo: \nOther:", "phase": null, "countries": "Germany;Spain;Italy;Sweden", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>•\tMales and females between 18 and 65 years of age<br>•\tFemale subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either:<br>-\tPost-menopausal or surgically sterile, or<br>-\tUsing a highly effective method of contraception for the duration of the study. This is defined as a method that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner. <br>•\tHave RMS according to the revised McDonald Criteria 2005<br>•\tHave disease duration for at least 3 months<br>•\tAre currently receiving RNF 44mcg sc by Rebiject IITM (RII) tiw and have been consistently on therapy for a minimum of 6 weeks prior to Screening<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>•\tHave any disease other than MS that could better explain his/her signs and symptoms<br>•\tReceive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the patient’s MS or the patient’s RNF therapy (e.g., influenza or pneumococcus vaccination) will be acceptable<br>•\tReceive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug [DMD]s: immunomodulatory, immunosuppressive agents or combination therapy) within 12 months prior to study enrolment or at any time during the study <br>•\tReceive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days prior to SD1<br>•\tHave inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2 x ULN if associated with any elevation of ALT or alkaline phosphatase<br>•\tHave inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal<br>•\tHave moderate to severe renal impairment<br>•\tHistory of any chronic pain syndrome<br>•\tAny visual or physical impairment that precludes the subject self-injecting the treatment using the RebiSmartTM<br><br>", "condition": "Relapsing forms of Multiple Sclerosis (RMS) <br>MedDRA version: 9.1\nLevel: PT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis", "intervention": "<br>Product Name: Rebif New Formulation 44mcg multidose cartridge<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: INTERFERON BETA-1A<br>CAS Number: NA<br>Concentration unit: µg/ml microgram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 88-<br><br>", "primary_outcome": "Main Objective: The primary objective is to evaluate the suitability of RebiSmartTM for self-injection in the treatment of relapsing multiple sclerosis (RMS) subjects with Rebif® New Formulation (RNF) by a Patient User Trial Questionnaire;Secondary Objective: •\tEvaluate the occurrence of Injection Site Reactions (ISR) following drug administration with RebiSmartTM<br>•\tEvaluate overall subject satisfaction of RebiSmartTM use regarding the occurrence of adverse events and pain perception at the injection site by the Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ)<br>•\tAssess subject’s and trainer’s evaluation of specific characteristics of RebiSmartTM by a User Trial Questionnaire<br>;Primary end point(s): The primary endpoint is the proportion of RMS subjects rating the suitability of RebiSmartTM at the end of 12-week treatment period as “very suitable” or “suitable” for self-injecting Rebif® New Formulation (RNF)", "secondary_outcome": null, "secondary_id": "28733", "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": 3648, "title": "A Parallel Group Study to Compare Sativex® With Placebo in the Treatment of Detrusor Overactivity in Patients With Multiple Sclerosis", "summary": null, "published_date": "2008-05-14T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.058530Z", "link": "https://clinicaltrials.gov/show/NCT00678795", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00678795" }, "categories": [ { "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": "6490060", "last_refreshed_on": "2017-10-19", "scientific_title": "A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis.", "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": "2002-08-19", "target_size": "135", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "United Kingdom;United Kingdom;United Kingdom;United Kingdom", "contact_firstname": "; ; ;", "contact_lastname": "Cris Constantinescu, MD PhD;Cris Constantinescu, MD PhD;Cris Constantinescu, MD PhD;Cris Constantinescu, MD PhD", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Division of Clinical Neurology, Queen's Medical Centre;Division of Clinical Neurology, Queen's Medical Centre;Division of Clinical Neurology, Queen's Medical Centre;Division of Clinical Neurology, Queen's Medical Centre", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give informed consent.\r<br>\r<br> - Male or female, aged 18 years or over.\r<br>\r<br> - Diagnosed with MS and with detrusor overactivity not wholly relieved by current\r<br> therapy.\r<br>\r<br> - At least three incontinence episodes within five consecutive days during the baseline\r<br> period\r<br>\r<br> - Stable dose of anticholinergic medication for at least 14 days leading to study entry.\r<br>\r<br> - Agreement, if female and of child bearing potential or if male with a partner of child\r<br> bearing potential, to ensure that effective contraception is used during the study and\r<br> for three months thereafter.\r<br>\r<br> - Has not used cannabinoids (including cannabis, Marinol® or nabilone) for at least\r<br> seven days before Visit 1 and willing to abstain from any use of cannabinoids during\r<br> the study.\r<br>\r<br> - Agreement for the UK Home Office, their general practitioner, and their consultant if\r<br> appropriate, to be notified of their participation in the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - A symptomatic UTI or any cause of detrusor overactivity other than neurogenic causes\r<br> due to MS.\r<br>\r<br> - Using ISC.\r<br>\r<br> - A history of schizophrenia, other psychotic illness, severe personality disorder or\r<br> other significant psychiatric disorder other than depression associated with their\r<br> underlying condition.\r<br>\r<br> - A history of alcohol or substance abuse.\r<br>\r<br> - A severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other\r<br> than well controlled atrial fibrillation), poorly controlled hypertension or severe\r<br> heart failure.\r<br>\r<br> - A history of epilepsy.\r<br>\r<br> - If female, are pregnant of lactating, or are planning a pregnancy to occur during the\r<br> course of the study.\r<br>\r<br> - Significant renal or hepatic impairment.\r<br>\r<br> - Elective surgery or other procedures requiring general anesthesia scheduled to occur\r<br> during the study.\r<br>\r<br> - Terminal illness or any other significant disease or disorder which, in the opinion of\r<br> the investigator, may either put the subject at risk because of participation in the\r<br> study or influence the result of the study, or the subjects ability to participate in\r<br> the study.\r<br>\r<br> - Regular levodopa (Sinement®, Sinement Plus®, Levodopa, L-dopa, Madopar®, Benserazide)\r<br> within the seven days leading up to study entry.\r<br>\r<br> - Receiving and unwilling to stop fentanyl for the duration of the study.\r<br>\r<br> - Known or suspected hypersensitivity to cannabinoids or any of the excipients of the\r<br> study medications.\r<br>\r<br> - Intention to travel internationally or to donate blood during the study.\r<br>\r<br> - Participation in another research study in the 12 weeks leading up to study entry.\r<br>\r<br> - Previous randomization in to this study\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give informed consent.\r<br>\r<br> - Male or female, aged 18 years or over.\r<br>\r<br> - Diagnosed with MS and with detrusor overactivity not wholly relieved by current\r<br> therapy.\r<br>\r<br> - At least three incontinence episodes within five consecutive days during the baseline\r<br> period\r<br>\r<br> - Stable dose of anticholinergic medication for at least 14 days leading to study entry.\r<br>\r<br> - Agreement, if female and of child bearing potential or if male with a partner of child\r<br> bearing potential, to ensure that effective contraception is used during the study and\r<br> for three months thereafter.\r<br>\r<br> - Has not used cannabinoids (including cannabis, Marinol® or nabilone) for at least\r<br> seven days before Visit 1 and willing to abstain from any use of cannabinoids during\r<br> the study.\r<br>\r<br> - Agreement for the UK Home Office, their general practitioner, and their consultant if\r<br> appropriate, to be notified of their participation in the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - A symptomatic UTI or any cause of detrusor overactivity other than neurogenic causes\r<br> due to MS.\r<br>\r<br> - Using ISC.\r<br>\r<br> - A history of schizophrenia, other psychotic illness, severe personality disorder or\r<br> other significant psychiatric disorder other than depression associated with their\r<br> underlying condition.\r<br>\r<br> - A history of alcohol or substance abuse.\r<br>\r<br> - A severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other\r<br> than well controlled atrial fibrillation), poorly controlled hypertension or severe\r<br> heart failure.\r<br>\r<br> - A history of epilepsy.\r<br>\r<br> - If female, are pregnant of lactating, or are planning a pregnancy to occur during the\r<br> course of the study.\r<br>\r<br> - Significant renal or hepatic impairment.\r<br>\r<br> - Elective surgery or other procedures requiring general anesthesia scheduled to occur\r<br> during the study.\r<br>\r<br> - Terminal illness or any other significant disease or disorder which, in the opinion of\r<br> the investigator, may either put the subject at risk because of participation in the\r<br> study or influence the result of the study, or the subjects ability to participate in\r<br> the study.\r<br>\r<br> - Regular levodopa (Sinement®, Sinement Plus®, Levodopa, L-dopa, Madopar®, Benserazide)\r<br> within the seven days leading up to study entry.\r<br>\r<br> - Receiving and unwilling to stop fentanyl for the duration of the study.\r<br>\r<br> - Known or suspected hypersensitivity to cannabinoids or any of the excipients of the\r<br> study medications.\r<br>\r<br> - Intention to travel internationally or to donate blood during the study.\r<br>\r<br> - Participation in another research study in the 12 weeks leading up to study entry.\r<br>\r<br> - Previous randomization in to this study\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give informed consent.\r<br>\r<br> - Male or female, aged 18 years or over.\r<br>\r<br> - Diagnosed with MS and with detrusor overactivity not wholly relieved by current\r<br> therapy.\r<br>\r<br> - At least three incontinence episodes within five consecutive days during the baseline\r<br> period\r<br>\r<br> - Stable dose of anticholinergic medication for at least 14 days leading to study entry.\r<br>\r<br> - Agreement, if female and of child bearing potential or if male with a partner of child\r<br> bearing potential, to ensure that effective contraception is used during the study and\r<br> for three months thereafter.\r<br>\r<br> - Has not used cannabinoids (including cannabis, Marinol® or nabilone) for at least\r<br> seven days before Visit 1 and willing to abstain from any use of cannabinoids during\r<br> the study.\r<br>\r<br> - Agreement for the UK Home Office, their general practitioner, and their consultant if\r<br> appropriate, to be notified of their participation in the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - A symptomatic UTI or any cause of detrusor overactivity other than neurogenic causes\r<br> due to MS.\r<br>\r<br> - Using ISC.\r<br>\r<br> - A history of schizophrenia, other psychotic illness, severe personality disorder or\r<br> other significant psychiatric disorder other than depression associated with their\r<br> underlying condition.\r<br>\r<br> - A history of alcohol or substance abuse.\r<br>\r<br> - A severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other\r<br> than well controlled atrial fibrillation), poorly controlled hypertension or severe\r<br> heart failure.\r<br>\r<br> - A history of epilepsy.\r<br>\r<br> - If female, are pregnant of lactating, or are planning a pregnancy to occur during the\r<br> course of the study.\r<br>\r<br> - Significant renal or hepatic impairment.\r<br>\r<br> - Elective surgery or other procedures requiring general anesthesia scheduled to occur\r<br> during the study.\r<br>\r<br> - Terminal illness or any other significant disease or disorder which, in the opinion of\r<br> the investigator, may either put the subject at risk because of participation in the\r<br> study or influence the result of the study, or the subjects ability to participate in\r<br> the study.\r<br>\r<br> - Regular levodopa (Sinement®, Sinement Plus®, Levodopa, L-dopa, Madopar®, Benserazide)\r<br> within the seven days leading up to study entry.\r<br>\r<br> - Receiving and unwilling to stop fentanyl for the duration of the study.\r<br>\r<br> - Known or suspected hypersensitivity to cannabinoids or any of the excipients of the\r<br> study medications.\r<br>\r<br> - Intention to travel internationally or to donate blood during the study.\r<br>\r<br> - Participation in another research study in the 12 weeks leading up to study entry.\r<br>\r<br> - Previous randomization in to this study\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Willing and able to give informed consent.\r<br>\r<br> - Male or female, aged 18 years or over.\r<br>\r<br> - Diagnosed with MS and with detrusor overactivity not wholly relieved by current\r<br> therapy.\r<br>\r<br> - At least three incontinence episodes within five consecutive days during the baseline\r<br> period\r<br>\r<br> - Stable dose of anticholinergic medication for at least 14 days leading to study entry.\r<br>\r<br> - Agreement, if female and of child bearing potential or if male with a partner of child\r<br> bearing potential, to ensure that effective contraception is used during the study and\r<br> for three months thereafter.\r<br>\r<br> - Has not used cannabinoids (including cannabis, Marinol® or nabilone) for at least\r<br> seven days before Visit 1 and willing to abstain from any use of cannabinoids during\r<br> the study.\r<br>\r<br> - Agreement for the UK Home Office, their general practitioner, and their consultant if\r<br> appropriate, to be notified of their participation in the study.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - A symptomatic UTI or any cause of detrusor overactivity other than neurogenic causes\r<br> due to MS.\r<br>\r<br> - Using ISC.\r<br>\r<br> - A history of schizophrenia, other psychotic illness, severe personality disorder or\r<br> other significant psychiatric disorder other than depression associated with their\r<br> underlying condition.\r<br>\r<br> - A history of alcohol or substance abuse.\r<br>\r<br> - A severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other\r<br> than well controlled atrial fibrillation), poorly controlled hypertension or severe\r<br> heart failure.\r<br>\r<br> - A history of epilepsy.\r<br>\r<br> - If female, are pregnant of lactating, or are planning a pregnancy to occur during the\r<br> course of the study.\r<br>\r<br> - Significant renal or hepatic impairment.\r<br>\r<br> - Elective surgery or other procedures requiring general anesthesia scheduled to occur\r<br> during the study.\r<br>\r<br> - Terminal illness or any other significant disease or disorder which, in the opinion of\r<br> the investigator, may either put the subject at risk because of participation in the\r<br> study or influence the result of the study, or the subjects ability to participate in\r<br> the study.\r<br>\r<br> - Regular levodopa (Sinement®, Sinement Plus®, Levodopa, L-dopa, Madopar®, Benserazide)\r<br> within the seven days leading up to study entry.\r<br>\r<br> - Receiving and unwilling to stop fentanyl for the duration of the study.\r<br>\r<br> - Known or suspected hypersensitivity to cannabinoids or any of the excipients of the\r<br> study medications.\r<br>\r<br> - Intention to travel internationally or to donate blood during the study.\r<br>\r<br> - Participation in another research study in the 12 weeks leading up to study entry.\r<br>\r<br> - Previous randomization in to this study\r<br>", "exclusion_criteria": null, "condition": "Detrusor Overactivity;Multiple Sclerosis;Detrusor Overactivity;Multiple Sclerosis;Detrusor Overactivity;Multiple Sclerosis;Detrusor Overactivity;Multiple Sclerosis", "intervention": "Drug: Sativex®;Drug: Placebo;Drug: Sativex®;Drug: Placebo;Drug: Sativex®;Drug: Placebo;Drug: Sativex®;Drug: Placebo", "primary_outcome": "Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment;Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment", "secondary_outcome": "Change From Baseline in the Mean Daily Episodes of Urgency at the End of Treatment;Change From Baseline in the Mean Daily Episodes of Nocturia at the End of Treatment;Change From Baseline in the Mean Daily Number of Incontinence Pads Used at the End of Treatment;Change From Baseline in Mean Total Incontinence Quality of Life (I-QOL) Questionnaire Score at the End of Treatment (Completion or Withdrawal);Change From Baseline in Mean Overall Bladder Condition 0-10 Numerical Rating Scale Score at the End of Treatment;Patient's Global Impression of Change;Change From Baseline in the Mean Number of Daily Voids at the End of Treatment", "secondary_id": "GWMS0208", "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": 3647, "title": "Cognitive Behavioural Therapy Software for the Treatment of Depression in People With Multiple Sclerosis", "summary": null, "published_date": "2008-05-14T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.035354Z", "link": "http://clinicaltrials.gov/show/NCT00678496", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00678496" }, "categories": [], "export_date": "2024-04-19T00:00:00Z", "internal_number": "4641471", "last_refreshed_on": "2015-02-19", "scientific_title": "Computerised Cognitive Behavioural Therapy for Treatment of Depression in MS (CoSMoS): Clinical Trial Pilot Study", "primary_sponsor": "University of Sheffield", "retrospective_flag": "Yes", "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": "2008-10-19", "target_size": "24", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 2", "countries": "United Kingdom", "contact_firstname": ";", "contact_lastname": "Cindy L Cooper, PhD;Glenys D Parry, PhD", "contact_address": null, "contact_email": ";", "contact_tel": ";", "contact_affiliation": "University of Sheffield;University of Sheffield", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Aged 18+\r<br>\r<br> - Diagnosis of MS confirmed by neurologist\r<br>\r<br> - Beck Depression Inventory-II score of at least 14 on two consecutive occasions\r<br>\r<br> - Not currently or within past three months receiving any treatment from a\r<br> psychologist, psychotherapist or psychiatrist.\r<br>\r<br> - Willingness to be randomised to CCBT, at home or primary care facility or treatment\r<br> as usual.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Unable to read or write English\r<br>\r<br> - Beck Depression Inventory score of at least 29 on two consecutive occasions\r<br>\r<br> - Active suicidal ideas\r<br>\r<br> - Current or life-time diagnosis of any of the following:\r<br>\r<br> - psychosis\r<br>\r<br> - organic mental disorder;\r<br>\r<br> - alcohol or drug dependency\r<br>\r<br> - Kurtzke Expanded Disability Status Scale (EDSS) score of 8.5 or above\r<br>\r<br> - Unable to use the CCBT package due to physical disability\r<br>\r<br> - Unable to use the CCBT package due to cognitive symptoms (mini-mental state of 20\r<br> below or if, in the opinion of the study psychologist, the individual would be\r<br> unlikely to benefit from CCBT)\r<br>", "exclusion_criteria": null, "condition": "Depression;Multiple Sclerosis", "intervention": "Other: CBT Software;Other: Treatment as usual", "primary_outcome": "Change in self-reported symptoms of depression (the difference between mean change scores of CCBT and standard care, as measured on the Beck Depression Inventory - Second Edition (BDI-II) 21-item self report instrument.", "secondary_outcome": "Depression as measured on the Patient Health Questionnaire-9 item (PHQ-9);Anxiety measured on the Generalised Anxiety Disorder-7 item (GAD-7);Disease-specific quality of life, measured on the Multiple Sclerosis Impact Scale-29 item (MSIS-29);Generic health-related quality of life, measured on the Short Form-36 item (SF-36)", "secondary_id": "EudraCT number: 2008-001039-37;MS Society: 845/06;112276", "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 } ] }