Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=70
{ "count": 4828, "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": 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": 224 } ], "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 }, { "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 } ] }