Trial List
List all clinical trials by discovery date. Accepts regular expressions in search.
GET /trials/?format=api&page=68
{ "count": 4842, "next": "http://api.gregory-ms.com/trials/?format=api&page=69", "previous": "http://api.gregory-ms.com/trials/?format=api&page=67", "results": [ { "trial_id": 3689, "title": "12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients", "summary": null, "published_date": "2008-04-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:23.015824Z", "link": "http://clinicaltrials.gov/show/NCT00616733", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00616733" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "4636772", "last_refreshed_on": "2015-02-19", "scientific_title": "An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis", "primary_sponsor": "Daiichi Sankyo Inc.", "retrospective_flag": "Yes", "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": "2008-03-27", "target_size": "25", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 1", "countries": "United States", "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> - Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on\r<br> Poser or McDonald criteria (may include patients with secondary progressive disease)\r<br>\r<br> - Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain\r<br> MRI scan within the past 12 months\r<br>\r<br> - Baseline EDSS score of 0 - 6.5\r<br>\r<br> - Female subjects who are sexually active, unless sterile or post-menopausal for at\r<br> least 1 year, must be willing to use double-barrier contraception\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Primary progressive MS\r<br>\r<br> - Any medical condition that predisposes to immunocompromise\r<br>\r<br> - History of malignancy, tuberculosis, invasive fungal infections, herpes zoster\r<br> infection (or shingles), or other opportunistic infection, or any current active\r<br> infection\r<br>\r<br> - Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or\r<br> lupus)\r<br>\r<br> - Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation\r<br>\r<br> - Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant\r<br> within 3 months of study initiation\r<br>\r<br> - Treatment with interferon beta or glatiramer acetate within 2 months of study\r<br> initiation\r<br>\r<br> - Prior treatment with natalizumab or rituximab\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: CS-0777 tablets;Drug: CS-0777 tablets;Drug: CS-0777 tablets", "primary_outcome": "Safety and tolerability.", "secondary_outcome": "Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions)", "secondary_id": "IND 77,409;CS0777-A-U102", "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": 3688, "title": "AT RISK FOR MS - Clinical Conversion of Female Monozygotic Twins Discordant for CIS/MS", "summary": null, "published_date": "2008-05-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.993903Z", "link": "https://clinicaltrials.gov/show/NCT00617383", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00617383" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "6610846", "last_refreshed_on": "2017-12-16", "scientific_title": "Determine if the Presence of Characteristic MS-like Lesion(s) on Baseline MRI Predisposes to CIS/MS in Female MZ Twins Discordant for CIS/MS.", "primary_sponsor": "The University of Texas Health Science Center, Houston", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "10 Years", "inclusion_agemax": "45 Years", "inclusion_gender": "Female", "date_enrollement": "2008-02-27", "target_size": "3", "study_type": "Observational", "study_design": null, "phase": "N/A", "countries": "United States;United States;United States;United States;United States", "contact_firstname": "; ; ; ;", "contact_lastname": "Staley A Brod, MD;Staley A Brod, MD;Staley A Brod, MD;Staley A Brod, MD;Staley A Brod, MD", "contact_address": null, "contact_email": ";;;;", "contact_tel": ";;;;", "contact_affiliation": "University of Texas;University of Texas;University of Texas;University of Texas;University of Texas", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - 'at risk' individuals for MS - female co-twins discordant for CIS/MS.\r<br>\r<br> - 'at risk' individuals for MS who at the time of randomization have not converted to MS\r<br> or CIS.\r<br>\r<br> - 'at risk' individuals will be treatment-naïve for immunomodulatory/suppressive\r<br> medications.\r<br>\r<br> - < 46 years old.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Individuals diagnosed with MS or CIS.\r<br>\r<br> - Other 'at risk' individuals who do not conform to the specific 'at risk' groups\r<br> outlined above e.g., 1st degree, 2nd degree and 3rd degree relative of MS index cases.\r<br>\r<br> - Subjects over 45.\r<br>\r<br> - Use of immunomodulatory medications such as azathioprine, gold, sulfasalazine,\r<br> minocycline, statins, and MTX or prednisone > 7.5 mg/day within 30 days of\r<br> randomization for any reason.\r<br>\r<br> - Active drug use or dependence that, in the opinion of the site investigator, would\r<br> interfere with adherence to study requirements or a psychiatric disorder that is\r<br> unstable or would preclude reliable participation in the study.\r<br>\r<br> - Serious illness (requiring systemic treatment and/or hospitalization) such as diabetes\r<br> mellitus, renal, cardiac, or pulmonary disease. Subjects with a history of alcoholism,\r<br> or in whom intellectual functioning is impaired sufficiently to interfere with the\r<br> understanding of the protocol, or participation in the treatment and evaluation\r<br> program.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - 'at risk' individuals for MS - female co-twins discordant for CIS/MS.\r<br>\r<br> - 'at risk' individuals for MS who at the time of randomization have not converted to MS\r<br> or CIS.\r<br>\r<br> - 'at risk' individuals will be treatment-naïve for immunomodulatory/suppressive\r<br> medications.\r<br>\r<br> - < 46 years old.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Individuals diagnosed with MS or CIS.\r<br>\r<br> - Other 'at risk' individuals who do not conform to the specific 'at risk' groups\r<br> outlined above e.g., 1st degree, 2nd degree and 3rd degree relative of MS index cases.\r<br>\r<br> - Subjects over 45.\r<br>\r<br> - Use of immunomodulatory medications such as azathioprine, gold, sulfasalazine,\r<br> minocycline, statins, and MTX or prednisone > 7.5 mg/day within 30 days of\r<br> randomization for any reason.\r<br>\r<br> - Active drug use or dependence that, in the opinion of the site investigator, would\r<br> interfere with adherence to study requirements or a psychiatric disorder that is\r<br> unstable or would preclude reliable participation in the study.\r<br>\r<br> - Serious illness (requiring systemic treatment and/or hospitalization) such as diabetes\r<br> mellitus, renal, cardiac, or pulmonary disease. Subjects with a history of alcoholism,\r<br> or in whom intellectual functioning is impaired sufficiently to interfere with the\r<br> understanding of the protocol, or participation in the treatment and evaluation\r<br> program.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - 'at risk' individuals for MS - female co-twins discordant for CIS/MS.\r<br>\r<br> - 'at risk' individuals for MS who at the time of randomization have not converted to MS\r<br> or CIS.\r<br>\r<br> - 'at risk' individuals will be treatment-naïve for immunomodulatory/suppressive\r<br> medications.\r<br>\r<br> - < 46 years old.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Individuals diagnosed with MS or CIS.\r<br>\r<br> - Other 'at risk' individuals who do not conform to the specific 'at risk' groups\r<br> outlined above e.g., 1st degree, 2nd degree and 3rd degree relative of MS index cases.\r<br>\r<br> - Subjects over 45.\r<br>\r<br> - Use of immunomodulatory medications such as azathioprine, gold, sulfasalazine,\r<br> minocycline, statins, and MTX or prednisone > 7.5 mg/day within 30 days of\r<br> randomization for any reason.\r<br>\r<br> - Active drug use or dependence that, in the opinion of the site investigator, would\r<br> interfere with adherence to study requirements or a psychiatric disorder that is\r<br> unstable or would preclude reliable participation in the study.\r<br>\r<br> - Serious illness (requiring systemic treatment and/or hospitalization) such as diabetes\r<br> mellitus, renal, cardiac, or pulmonary disease. Subjects with a history of alcoholism,\r<br> or in whom intellectual functioning is impaired sufficiently to interfere with the\r<br> understanding of the protocol, or participation in the treatment and evaluation\r<br> program.\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - 'at risk' individuals for MS - female co-twins discordant for CIS/MS.\r<br>\r<br> - 'at risk' individuals for MS who at the time of randomization have not converted to MS\r<br> or CIS.\r<br>\r<br> - 'at risk' individuals will be treatment-naïve for immunomodulatory/suppressive\r<br> medications.\r<br>\r<br> - < 46 years old.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Individuals diagnosed with MS or CIS.\r<br>\r<br> - Other 'at risk' individuals who do not conform to the specific 'at risk' groups\r<br> outlined above e.g., 1st degree, 2nd degree and 3rd degree relative of MS index cases.\r<br>\r<br> - Subjects over 45.\r<br>\r<br> - Use of immunomodulatory medications such as azathioprine, gold, sulfasalazine,\r<br> minocycline, statins, and MTX or prednisone > 7.5 mg/day within 30 days of\r<br> randomization for any reason.\r<br>\r<br> - Active drug use or dependence that, in the opinion of the site investigator, would\r<br> interfere with adherence to study requirements or a psychiatric disorder that is\r<br> unstable or would preclude reliable participation in the study.\r<br>\r<br> - Serious illness (requiring systemic treatment and/or hospitalization) such as diabetes\r<br> mellitus, renal, cardiac, or pulmonary disease. Subjects with a history of alcoholism,\r<br> or in whom intellectual functioning is impaired sufficiently to interfere with the\r<br> understanding of the protocol, or participation in the treatment and evaluation\r<br> program.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Clinically Isolated Syndrome;Multiple Sclerosis;Clinically Isolated Syndrome;Multiple Sclerosis;Clinically Isolated Syndrome;Multiple Sclerosis;Clinically Isolated Syndrome", "intervention": null, "primary_outcome": "Determine if the presence of characteristic MS-like lesion(s) on baseline MRI predisposes to CIS/MS in female MZ twins discordant for CIS/MS.;Determine if the presence of characteristic MS-like lesion(s) on baseline MRI predisposes to CIS/MS in female MZ twins discordant for CIS/MS.;Determine if the presence of characteristic MS-like lesion(s) on baseline MRI predisposes to CIS/MS in female MZ twins discordant for CIS/MS.", "secondary_outcome": "Define the protein and microarray gene expression profile predictive of conversion to MS/CIS in female MZ twins discordant for CIS/MS.", "secondary_id": "NMSS Pilot grant PP1464;HSC-MS-07-0327", "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": 3687, "title": "Atorvastatin in Relapsing-Remitting Multiple Sclerosis", "summary": null, "published_date": "2008-05-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.972879Z", "link": "https://clinicaltrials.gov/show/NCT00616187", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00616187" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "10204420", "last_refreshed_on": "2020-12-12", "scientific_title": "Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis", "primary_sponsor": "Charite University, Berlin, Germany", "retrospective_flag": "No", "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": "2003-10-27", "target_size": "41", "study_type": "Interventional", "study_design": "Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).", "phase": "Phase 2", "countries": null, "contact_firstname": "", "contact_lastname": "Frauke Zipp, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Cecilie Vogt Clinic for Neurology, Charite, Berlin", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - 18 - 55 years old\r<br>\r<br> - MS diagnosis according McDonald criteria\r<br>\r<br> - Relapsing-remitting MS\r<br>\r<br> - EDSS 0 - 6\r<br>\r<br> - Disease activity as occurrence of CEL in brain MRI\r<br>\r<br> - IFN-beta therapy for at least 6 months\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Primary chronic progressive MS\r<br>\r<br> - Symptoms and signs of clinical disease conditions similar to MS\r<br>\r<br> - Conditions that can disturb MRI measurements\r<br>\r<br> - Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus\r<br> pepticum\r<br>\r<br> - Clinically relevant lung, heart, CNS, infectious disease\r<br>\r<br> - Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific\r<br> clinical chemistry values)\r<br>\r<br> - Allergies towards Gd-DTPA\r<br>\r<br> - Allergies towards constituents of the therapeutic agent\r<br>\r<br> - Recruitment to other clinical trials within 6 months prior to or during this study\r<br>\r<br> - Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte\r<br> populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A,\r<br> human antibodies, all immunomodulatory or immunosuppressive agents including\r<br> recombinant cytokines or other potential experimental MS therapies (6 months prior to\r<br> study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start)\r<br> pregnancy or lactation\r<br>\r<br> - Alcohol or drug abuse\r<br>\r<br> - Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole\r<br> antimycotics).\r<br>\r<br> - Medical or psychological conditions that could hamper with the patients capacity to\r<br> understand patient information, to give the informed consent, to adhere to the\r<br> protocol of the study and to be able to complete the study\r<br>", "exclusion_criteria": null, "condition": "Relapsing Remitting Multiple Sclerosis", "intervention": "Drug: interferon beta treatment to add-on atorvastatin treatment;Drug: untreated to atorvastatin treatment", "primary_outcome": "number of MRI contrast enhancing lesions", "secondary_outcome": "other MRI-based parameters (CEL volume, T2-lesion load, T1-hypointense lesion volume, whole brain magnetization transfer ratio, and apparent diffusion coefficient of normal appearing white matter)", "secondary_id": "ATV-D-03-007G;1931/Si.270 am 8.5.03", "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": 3686, "title": "Motor Imagery Practice in Neurological Rehabilitation", "summary": null, "published_date": "2008-05-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.948364Z", "link": "http://clinicaltrials.gov/show/NCT00618085", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00618085" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "4636875", "last_refreshed_on": "2015-02-19", "scientific_title": "An Integrated Motor Imagery Program in Rehabilitation - a RCT", "primary_sponsor": "Nuffield Orthopaedic Centre NHS Trust", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "Both", "date_enrollement": "2008-02-27", "target_size": "50", "study_type": "Interventional", "study_design": "Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment", "phase": "Phase 2", "countries": "United Kingdom", "contact_firstname": ";", "contact_lastname": "Thamar J Bovend'Eerdt, MSc;Derick T Wade, MD", "contact_address": null, "contact_email": ";", "contact_tel": ";", "contact_affiliation": "Oxford Centre for Enablement;Oxford Centre for Enablement", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Participating in a rehabilitation program for problems arising secondary to disease\r<br> or damage affecting the central nervous system (usually stroke, brain injury,\r<br> multiple sclerosis)\r<br>\r<br> - Over 18 years of age\r<br>\r<br> - Have sufficient language and memory skills to undertake the intervention (i.e. score\r<br> positive on the first three items of the Sheffield screening test)\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any co-morbidity that would interfere with the ability to perform imagery as judged\r<br> by the clinician or from the medical notes (e.g., schizophrenia)\r<br>", "exclusion_criteria": null, "condition": "Stroke;Brain Injury;Multiple Sclerosis", "intervention": "Behavioral: Motor imagery practice;Other: Standard physiotherapy and occupational therapy", "primary_outcome": "Goal Attainment Scaling", "secondary_outcome": "Motor imagery questionnaire;Timed up and go;Action research arm test", "secondary_id": "07/H0605/84;07/H0605/84NOC", "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": 3685, "title": "Combination Therapy Using Cellcept and Rebif in RRMS", "summary": null, "published_date": "2008-06-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.924681Z", "link": "http://clinicaltrials.gov/show/NCT00618527", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00618527" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "4636907", "last_refreshed_on": "2015-02-19", "scientific_title": "Combination Therapy Using Mycophenolate Mofetil (CellCept) and Human Interferon beta1a (Rebif) in Early Treatment of Multiple Sclerosis", "primary_sponsor": "Aaron Boster", "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": "2006-08-27", "target_size": "31", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment", "phase": "Phase 0", "countries": "United States", "contact_firstname": "", "contact_lastname": "Aaron L Boster, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Ohio State University", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - diagnosed with relapsing remitting multiple sclerosis\r<br>\r<br> - eligible to initiate interferon therapy\r<br>\r<br> - between he ages of 18-65, inclusive\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - have received corticosteroids within 30 days prior to study start\r<br>\r<br> - have ever received cyclophosphamide or mitoxantrone\r<br>\r<br> - have received Imuran or methotrexate in the last 3 months\r<br>\r<br> - females that are pregnant or breastfeeding are excluded\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": "Drug: mycophenolate mofetil (Cellcept);Drug: human interferon beta 1a (Rebif)", "primary_outcome": "mRNA for MxA gene levels", "secondary_outcome": null, "secondary_id": "2006H0039", "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": 3684, "title": "Transition to Rebif New Formulation", "summary": null, "published_date": "2008-08-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.890328Z", "link": "https://clinicaltrials.gov/show/NCT00619307", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00619307" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "6489095", "last_refreshed_on": "2017-10-19", "scientific_title": "A Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as Prophylaxis", "primary_sponsor": "Merck KGaA", "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": "2007-07-27", "target_size": "117", "study_type": "Interventional", "study_design": null, "phase": "Phase 3", "countries": "France;Germany;France;Germany;France;Germany;France;Germany;France;Germany;France;Germany;France;Germany;France;Germany", "contact_firstname": "; ; ;", "contact_lastname": "Sabine Latour, MD;Sabine Latour, MD;Sabine Latour, MD;Sabine Latour, MD", "contact_address": null, "contact_email": ";;;", "contact_tel": ";;;", "contact_affiliation": "Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany;Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany;Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany;Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Subject with relapsing forms of Multiple Sclerosis (MS)\r<br>\r<br> - Expanded disability status scale (EDSS) score < 5.5 at study entry\r<br>\r<br> - Subjects who have been administering Rebif 44 mcg three times a week for at least 6\r<br> months prior to study enrolment\r<br>\r<br> - Subject currently using Rebiject II and who will use their own Rebiject II for the\r<br> Rebif New Formulation injections\r<br>\r<br> - Subject is between 18 and 60 years old inclusive\r<br>\r<br> - Female subjects must be neither pregnant nor breast-feeding and must lack childbearing\r<br> potential, as defined by either: post-menopausal or surgically sterile, or use a\r<br> highly effective method of contraception.\r<br>\r<br> - Subject is willing to follow study procedures\r<br>\r<br> - Subject is willing and must not present any contra-indication to taking ibuprofen\r<br> during 4 weeks of the study\r<br>\r<br> - Subject has given written informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Secondary Progressive Multiple Sclerosis without superimposed attacks\r<br>\r<br> - Use of any other injectible medications during the week prior to the screening period,\r<br> during the screening or treatment periods\r<br>\r<br> - Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3\r<br> months prior to study enrolment or at any time during study protocol\r<br>\r<br> - History of any chronic pain syndrome\r<br>\r<br> - Subjects that use any investigational drug or experimental procedure within 12 weeks\r<br> of visit\r<br>\r<br> - Subject received corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days\r<br> of visit 1\r<br>\r<br> - Subject with flu-like symptoms (FLS) associated with any cause (i.e. no current flu\r<br> and no FLS related to Interferon in the week prior to baseline)\r<br>\r<br> - Subject has abnormal liver function, defined by a total bilirubin > 1.5 times the\r<br> upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase\r<br> (ALT) > 2.5 times the upper limit of the normal values.\r<br>\r<br> - Subject has inadequate bone marrow reserve, defined as a total white blood cell count\r<br> < 3.0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.\r<br>\r<br> - Subject suffers from an active autoimmune disease other than MS\r<br>\r<br> - Subject suffers from major medical or psychiatric illness\r<br>\r<br> - Subject has seizures history or is currently experiencing seizures not adequately\r<br> controlled by anti-epileptics\r<br>\r<br> - Subject is pregnant or attempting to conceive\r<br>\r<br> - Visual or physical impairment that precludes completion of diaries and questionnaires\r<br> by himself/herself\r<br>\r<br> - Contraindication to ibuprofen:known hypersensitivity to the active ingredient\r<br> ibuprofen\r<br>\r<br> - Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to\r<br> asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding,\r<br> cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe\r<br> kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Subject with relapsing forms of Multiple Sclerosis (MS)\r<br>\r<br> - Expanded disability status scale (EDSS) score < 5.5 at study entry\r<br>\r<br> - Subjects who have been administering Rebif 44 mcg three times a week for at least 6\r<br> months prior to study enrolment\r<br>\r<br> - Subject currently using Rebiject II and who will use their own Rebiject II for the\r<br> Rebif New Formulation injections\r<br>\r<br> - Subject is between 18 and 60 years old inclusive\r<br>\r<br> - Female subjects must be neither pregnant nor breast-feeding and must lack childbearing\r<br> potential, as defined by either: post-menopausal or surgically sterile, or use a\r<br> highly effective method of contraception.\r<br>\r<br> - Subject is willing to follow study procedures\r<br>\r<br> - Subject is willing and must not present any contra-indication to taking ibuprofen\r<br> during 4 weeks of the study\r<br>\r<br> - Subject has given written informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Secondary Progressive Multiple Sclerosis without superimposed attacks\r<br>\r<br> - Use of any other injectible medications during the week prior to the screening period,\r<br> during the screening or treatment periods\r<br>\r<br> - Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3\r<br> months prior to study enrolment or at any time during study protocol\r<br>\r<br> - History of any chronic pain syndrome\r<br>\r<br> - Subjects that use any investigational drug or experimental procedure within 12 weeks\r<br> of visit\r<br>\r<br> - Subject received corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days\r<br> of visit 1\r<br>\r<br> - Subject with flu-like symptoms (FLS) associated with any cause (i.e. no current flu\r<br> and no FLS related to Interferon in the week prior to baseline)\r<br>\r<br> - Subject has abnormal liver function, defined by a total bilirubin > 1.5 times the\r<br> upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase\r<br> (ALT) > 2.5 times the upper limit of the normal values.\r<br>\r<br> - Subject has inadequate bone marrow reserve, defined as a total white blood cell count\r<br> < 3.0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.\r<br>\r<br> - Subject suffers from an active autoimmune disease other than MS\r<br>\r<br> - Subject suffers from major medical or psychiatric illness\r<br>\r<br> - Subject has seizures history or is currently experiencing seizures not adequately\r<br> controlled by anti-epileptics\r<br>\r<br> - Subject is pregnant or attempting to conceive\r<br>\r<br> - Visual or physical impairment that precludes completion of diaries and questionnaires\r<br> by himself/herself\r<br>\r<br> - Contraindication to ibuprofen:known hypersensitivity to the active ingredient\r<br> ibuprofen\r<br>\r<br> - Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to\r<br> asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding,\r<br> cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe\r<br> kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Subject with relapsing forms of Multiple Sclerosis (MS)\r<br>\r<br> - Expanded disability status scale (EDSS) score < 5.5 at study entry\r<br>\r<br> - Subjects who have been administering Rebif 44 mcg three times a week for at least 6\r<br> months prior to study enrolment\r<br>\r<br> - Subject currently using Rebiject II and who will use their own Rebiject II for the\r<br> Rebif New Formulation injections\r<br>\r<br> - Subject is between 18 and 60 years old inclusive\r<br>\r<br> - Female subjects must be neither pregnant nor breast-feeding and must lack childbearing\r<br> potential, as defined by either: post-menopausal or surgically sterile, or use a\r<br> highly effective method of contraception.\r<br>\r<br> - Subject is willing to follow study procedures\r<br>\r<br> - Subject is willing and must not present any contra-indication to taking ibuprofen\r<br> during 4 weeks of the study\r<br>\r<br> - Subject has given written informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Secondary Progressive Multiple Sclerosis without superimposed attacks\r<br>\r<br> - Use of any other injectible medications during the week prior to the screening period,\r<br> during the screening or treatment periods\r<br>\r<br> - Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3\r<br> months prior to study enrolment or at any time during study protocol\r<br>\r<br> - History of any chronic pain syndrome\r<br>\r<br> - Subjects that use any investigational drug or experimental procedure within 12 weeks\r<br> of visit\r<br>\r<br> - Subject received corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days\r<br> of visit 1\r<br>\r<br> - Subject with flu-like symptoms (FLS) associated with any cause (i.e. no current flu\r<br> and no FLS related to Interferon in the week prior to baseline)\r<br>\r<br> - Subject has abnormal liver function, defined by a total bilirubin > 1.5 times the\r<br> upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase\r<br> (ALT) > 2.5 times the upper limit of the normal values.\r<br>\r<br> - Subject has inadequate bone marrow reserve, defined as a total white blood cell count\r<br> < 3.0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.\r<br>\r<br> - Subject suffers from an active autoimmune disease other than MS\r<br>\r<br> - Subject suffers from major medical or psychiatric illness\r<br>\r<br> - Subject has seizures history or is currently experiencing seizures not adequately\r<br> controlled by anti-epileptics\r<br>\r<br> - Subject is pregnant or attempting to conceive\r<br>\r<br> - Visual or physical impairment that precludes completion of diaries and questionnaires\r<br> by himself/herself\r<br>\r<br> - Contraindication to ibuprofen:known hypersensitivity to the active ingredient\r<br> ibuprofen\r<br>\r<br> - Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to\r<br> asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding,\r<br> cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe\r<br> kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus\r<br> ;\r<br> Inclusion Criteria:\r<br>\r<br> - Subject with relapsing forms of Multiple Sclerosis (MS)\r<br>\r<br> - Expanded disability status scale (EDSS) score < 5.5 at study entry\r<br>\r<br> - Subjects who have been administering Rebif 44 mcg three times a week for at least 6\r<br> months prior to study enrolment\r<br>\r<br> - Subject currently using Rebiject II and who will use their own Rebiject II for the\r<br> Rebif New Formulation injections\r<br>\r<br> - Subject is between 18 and 60 years old inclusive\r<br>\r<br> - Female subjects must be neither pregnant nor breast-feeding and must lack childbearing\r<br> potential, as defined by either: post-menopausal or surgically sterile, or use a\r<br> highly effective method of contraception.\r<br>\r<br> - Subject is willing to follow study procedures\r<br>\r<br> - Subject is willing and must not present any contra-indication to taking ibuprofen\r<br> during 4 weeks of the study\r<br>\r<br> - Subject has given written informed consent\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Secondary Progressive Multiple Sclerosis without superimposed attacks\r<br>\r<br> - Use of any other injectible medications during the week prior to the screening period,\r<br> during the screening or treatment periods\r<br>\r<br> - Subject receiving MS therapy in addition (i.e. combination therapy) to Rebif within 3\r<br> months prior to study enrolment or at any time during study protocol\r<br>\r<br> - History of any chronic pain syndrome\r<br>\r<br> - Subjects that use any investigational drug or experimental procedure within 12 weeks\r<br> of visit\r<br>\r<br> - Subject received corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days\r<br> of visit 1\r<br>\r<br> - Subject with flu-like symptoms (FLS) associated with any cause (i.e. no current flu\r<br> and no FLS related to Interferon in the week prior to baseline)\r<br>\r<br> - Subject has abnormal liver function, defined by a total bilirubin > 1.5 times the\r<br> upper limit of normal, aspartate aminotransferase (AST) or alanine aminotransferase\r<br> (ALT) > 2.5 times the upper limit of the normal values.\r<br>\r<br> - Subject has inadequate bone marrow reserve, defined as a total white blood cell count\r<br> < 3.0 x 109/L, platelet count < 75 x 109/L, haemoglobin < 100 g/L.\r<br>\r<br> - Subject suffers from an active autoimmune disease other than MS\r<br>\r<br> - Subject suffers from major medical or psychiatric illness\r<br>\r<br> - Subject has seizures history or is currently experiencing seizures not adequately\r<br> controlled by anti-epileptics\r<br>\r<br> - Subject is pregnant or attempting to conceive\r<br>\r<br> - Visual or physical impairment that precludes completion of diaries and questionnaires\r<br> by himself/herself\r<br>\r<br> - Contraindication to ibuprofen:known hypersensitivity to the active ingredient\r<br> ibuprofen\r<br>\r<br> - Known hypersensitivity to non-steroidal anti-inflammatory drugs which can lead to\r<br> asthmatic attacks, gastric and/or intestinal ulcers, gastro-intestinal bleeding,\r<br> cerebro-vascular bleeding or other active bleeding, severe hepatic dysfunction, severe\r<br> kidney dysfunction, severe cardiac insufficiency, or systemic lupus erythematosus\r<br>", "exclusion_criteria": null, "condition": "Relapsing Multiple Sclerosis;Relapsing Multiple Sclerosis;Relapsing Multiple Sclerosis;Relapsing Multiple Sclerosis", "intervention": "Drug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRN;Drug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRN;Drug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRN;Drug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRN", "primary_outcome": "Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu-like Symptom Score", "secondary_outcome": "Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Total Score;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Satisfaction Score;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score;Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score", "secondary_id": "27571", "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": 3683, "title": "ATP Expression in Lymphocytes of MS Patients by Means of \"ImmuKnow®\" Assay.", "summary": null, "published_date": "2008-08-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.870336Z", "link": "http://clinicaltrials.gov/show/NCT00618267", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00618267" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "4636888", "last_refreshed_on": "2015-02-19", "scientific_title": "Single Center, Pilot Study to Measure ATP Expression in Lymphocytes of MS Patients Undergoing Various Therapies by Means of Using the \"ImmuKnow®\" Test", "primary_sponsor": "Biogen Idec", "retrospective_flag": "Yes", "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": "2008-03-27", "target_size": "100", "study_type": "Observational", "study_design": "Observational Model: Cohort, Time Perspective: Prospective", "phase": "N/A", "countries": "United States", "contact_firstname": "", "contact_lastname": "Samia J Khoury, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "Harvard Medical School, Brigham and Women's Hospital - Partners MS Center", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> 1. Patients must be taking 1 of the following medications for 3 months or more: Cytoxan,\r<br> Cellcept, Novantrone Betaseron, Rebif, Avonex or Copaxone.\r<br>\r<br> 2. Patients must be able to provide written informed consent.\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> 1. Patients on combination of multiple medications.\r<br>\r<br> 2. Restricted treatment whereby no use in 50 days prior to enrollment visit is\r<br> permitted: systemic steroids.\r<br>\r<br> 3. With educational completion below 8th grade school equivalent or non-fluent in\r<br> English.\r<br>\r<br> 4. Any other reason, in the opinion of both the Investigator and/or Sponsor, the patient\r<br> is determined not suitable for study participation.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis", "intervention": null, "primary_outcome": "The primary objective of this study is to determine the effects of various therapies (immunomodulatory as well as immunosuppressive) on ATP levels in CD4+ cells.", "secondary_outcome": "Secondary objective is to correlate the expression of ATP in CD4+ cells with CD4+ cell count.", "secondary_id": "Biogen Idec 014-07-NAT;014-07-NAT", "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": 3682, "title": "Management of Pain in Persons With Multiple Sclerosis", "summary": null, "published_date": "2008-12-02T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.849368Z", "link": "http://clinicaltrials.gov/show/NCT00621374", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00621374" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "4637124", "last_refreshed_on": "2015-02-19", "scientific_title": "Pilot Study of CBT and Self-hypnosis Training for Pain in Persons With Multiple Sclerosis", "primary_sponsor": "University of Washington", "retrospective_flag": "No", "date_registration": null, "source_register": "ClinicalTrials.gov", "recruitment_status": "Not recruiting", "other_records": "No", "inclusion_agemin": "18 Years", "inclusion_agemax": "N/A", "inclusion_gender": "Both", "date_enrollement": "2008-02-27", "target_size": "22", "study_type": "Interventional", "study_design": "Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment", "phase": "N/A", "countries": "United States", "contact_firstname": "", "contact_lastname": "Mark P Jensen, Ph.D.", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "University of Washington", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Chronic ongoing pain (i.e., pain at all times) with an average pain intensity of at\r<br> least 4/10 on 0-10 numeric rating scale\r<br>\r<br> - Pain is either worse or started since the onset of other MS symptoms.\r<br>\r<br> - Pain of at least six months duration.\r<br>\r<br> - Reads, speaks and understands English.\r<br>\r<br> - Definitive diagnosis of multiple sclerosis (MS)\r<br>\r<br> - At least 18 years of age\r<br>\r<br> - Recruited from a recruitment source approved by the IRB\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Severe cognitive impairment resulting in the inability to verbally comprehend, learn,\r<br> and recall new auditory verbal information, as reflected by a TICS score of 20 or\r<br> less.\r<br>\r<br> - Currently participating in counseling and/or psychotherapy more than once a week.\r<br>\r<br> - Currently taking anti-psychotic medications\r<br>\r<br> - Has been hospitalized for psychiatric reasons in the past six months\r<br>\r<br> - Experiencing current active suicidal ideation.\r<br>\r<br> - Has received treatment or participated in a clinical trial that involved significant\r<br> elements of either CBT or hypnosis within the past year.\r<br>", "exclusion_criteria": null, "condition": "Multiple Sclerosis;Pain", "intervention": "Behavioral: Cognitive Behavioral Therapy (CBT) +Hypnosis (HYP);Behavioral: Cognitive Behavioral Therapy (CBT);Behavioral: Self-Hypnosis Training (HYP);Behavioral: Education Control (CONT)", "primary_outcome": "A composite of average daily pain intensity measured using a 0-10 NRS via four phone interviews performed on different days by research staff.", "secondary_outcome": "Sleep quality- Medical Outcomes Sleep Study Measure (Hays et al., 2005);Depression- (CMDI; Nyenhuis et al., 1998);Catastrophizing cognitions- (PCS; Sullivan et al. 1995);Adaptive cognitions (CPAQ; McCracken et al., 2004);Distinguishing neuropathic vs. non-neuropathic pain (S-LANSS; Bennett et al., 2005);Pain Interference-(Brief Pain Inventory, Cleeland et al., 1994);Impact of Fatigue (FIS; Fisk et al. 1993);Fatigue Severity (FSS; Krupp et al., 1989);Health Status (SF-36; Ware et al., 1992)", "secondary_id": "NMSS Award# PP1465;32022-A", "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": 3681, "title": "Flupirtine as Oral Treatment in Multiple Sclerosis", "summary": null, "published_date": "2008-02-15T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.829224Z", "link": "https://clinicaltrials.gov/show/NCT00623415", "source": "WHO XML import", "relevant": null, "identifiers": { "nct": "NCT00623415" }, "categories": [], "export_date": "2024-04-27T00:00:00Z", "internal_number": "10204516", "last_refreshed_on": "2020-12-12", "scientific_title": "Multicentric, Prospective, Double Blind, Randomized/Stratified, Placebo-controlled Pilot-study for Evaluation of Safety and Efficacy of Flupirtine add-on to Interferon-ß1b on Neurodegeneration in Patients With Relapsing Remitting Multiple Sclerosis", "primary_sponsor": "Charite University, Berlin, Germany", "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": "2007-12-27", "target_size": "30", "study_type": "Interventional", "study_design": "Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).", "phase": "Phase 2", "countries": "Germany", "contact_firstname": "", "contact_lastname": "Friedemann Paul, MD", "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": "NeuroCure Clinical Research Center, Charité Berlin, Germany", "inclusion_criteria": "<br> Inclusion Criteria:\r<br>\r<br> - Relapsing-remitting MS according to the revised McDonald-Criteria (2005)\r<br>\r<br> - EDSS = 4.0\r<br>\r<br> - Stable treatment with Interferon-ß1b for at least 6 months\r<br>\r<br> - Sufficient birth control (Pearl-Index <1)\r<br>\r<br> Exclusion Criteria:\r<br>\r<br> - Any other MS-course than RRMS\r<br>\r<br> - Clinically relevant gastrointestinal disease\r<br>\r<br> - Clinically relevant pulmonary, cardiological, infectious or CNS-disease\r<br>\r<br> - Clinically relevant disease of liver or bile system, pathological value for\r<br> transaminases, gamma-GT or bilirubin.\r<br>\r<br> - Hepatitis (except uncomplicated hepatitis A with complete remission\r<br>\r<br> - Clinically relevant dysfunction of kidneys (creatinine >180 µmol/l) or bone marrow (HB\r<br> < 8.5 g/dl, WBC < 2.5/nl thrombocytes < 125/nl)\r<br>\r<br> - Myasthenia gravis\r<br>\r<br> - Oral anticoagulation (phenprocoumon)\r<br>\r<br> - Treatment with carbamazepine or paracetamol\r<br>\r<br> - Drug or alcohol abuse\r<br>\r<br> - Pregnancy or lactation period\r<br>\r<br> - Treatment at any time before or during study with complete lymphoradiation, monoclonal\r<br> antibodies (e.g. anti-CD4, Campath 1H, natalizumab), mitoxantrone, cyclophosphamide,\r<br> cyclosporin, azathioprine\r<br>\r<br> - Treatment within 6 months before randomization with any other immunomodulatory\r<br> substance than interferon-ß1b or intravenous methylprednisolone\r<br>", "exclusion_criteria": null, "condition": "Relapsing Remitting Multiple Sclerosis", "intervention": "Drug: Flupirtine;Drug: Placebo", "primary_outcome": "Cumulative number of new T2-hypertensive lesions on cranial magnetic resonance imaging (MRI)", "secondary_outcome": "Cerebral atrophy (brain parenchymal fraction);Number of new and total gadolinium(Gd)-enhancing lesions;Disease progression (measured by Expanded Disability Status (EDSS), Multiple Sclerosis Functional Composite (MSFC));Retinal nerve fiber layer thickness, assessed by Optical coherence tomography", "secondary_id": "2006-005262-39", "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": 3680, "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 relapsing-remitting multiple sclerosis", "summary": null, "published_date": "2008-02-26T00:00:00Z", "discovery_date": "2023-12-06T18:18:22.808687Z", "link": "https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006338-32", "source": "WHO XML import", "relevant": null, "identifiers": { "euctr": "EUCTR2007-006338-32-FR" }, "categories": [ { "category_id": 8, "category_description": "", "category_name": "Ocrelizumab", "category_slug": "ocrelizumab", "category_terms": [ "ocrelizumab", "ocrevus" ], "article_count": 228 } ], "export_date": "2024-04-27T00:00:00Z", "internal_number": "13553083", "last_refreshed_on": "2023-11-20", "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 relapsing-remitting multiple sclerosis", "primary_sponsor": "Hoffman La Roche Ltd", "retrospective_flag": "Yes", "date_registration": null, "source_register": "EU Clinical Trials Register", "recruitment_status": "Not Recruiting", "other_records": "Yes", "inclusion_agemin": null, "inclusion_agemax": null, "inclusion_gender": "<br>Female: yes<br>Male: yes<br>", "date_enrollement": "2008-06-05", "target_size": "200", "study_type": "Interventional clinical trial of medicinal product", "study_design": "Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: partially blinded study If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no", "phase": "Human pharmacology (Phase I): no\nTherapeutic exploratory (Phase II): yes\nTherapeutic confirmatory - (Phase III): no\nTherapeutic use (Phase IV): no", "countries": "Czech Republic;Netherlands;Belgium;Finland;Denmark;United Kingdom;Italy;Slovakia;France;Bulgaria;Germany;Spain", "contact_firstname": null, "contact_lastname": null, "contact_address": null, "contact_email": null, "contact_tel": null, "contact_affiliation": null, "inclusion_criteria": "Inclusion criteria: <br>1. Ability to provide written informed consent and to be compliant with the schedule of protocol assessments;<br>2. RRMS, as defined by the McDonald criteria (2005);<br>3. Ages 18-55 years,<br>4. Evidence of recent MS activity as defined below: <br> a. At least six T2 lesions on an MRI scan done in the year prior to screening, based on local reading. Should an MRI scan be unavailable within the last year or showing less than six T2 lesions, a screening MRI scan with at least six T2 lesions is required for the patient to be eligible, or<br> b. Patient had 2 documented relapses within the year prior to screening;<br>5. EDSS at baseline from 1.0 to 6.0 points;<br>6. At least two documented relapses within the last 3 years prior to screening, at least one of which occurred within the last year prior to screening;<br>7. For sexually active female and male patients of reproductive potential, use of reliable means of contraception as described below: <br>- Two methods of contraception throughout the trial, including the active treatment phase AND for 48 weeks after the last dose of ocrelizumab, or until their B-cells have repleted, whichever is the longer.<br>- Acceptable methods of contraception include one primary (e.g. systemic hormonal contraception or tubal ligation of the female partner, vasectomy of the male partner) AND one secondary barrier method (e.g. latex condoms, spermicide) OR a double barrier method (e.g. latex condom, intrauterine device, vaginal ring or pessary plus spermicide (e.g. foam, vaginal suppository, gel, cream)) may be used.<br>8. For patients of non reproductive potential:<br> a. Women may be enrolled if postmenopausal (i.e. spontaneous amenorrhea for the past year confirmed by an FSH level greater than 40 mIU/mL unless the patient is receiving a hormonal therapy for their menopause or surgically sterile (i.e. hysterectomy, complete bilateral oophorectomy);<br> b. Men may be enrolled if they are surgically sterile.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br>", "exclusion_criteria": "Exclusion criteria: <br>1. Secondary or primary progressive MS at screening<br>2. Disease duration > 15 years in patients with an EDSS = 2.0<br>3. Incompatibility with MRI <br>4. Contra-indications to or intolerance of oral or i.v. corticosteroids, including methylprednisolone administered i.v., according to the country label<br>5. Known presence of other neurologic disorders, including but not limited to, the following: <br>- History of ischemic cerebrovascular disorders or ischemia of the spinal cord<br>- History or known presence of CNS or spinal cord tumor, potential metabolic causes of myelopathy, infectious causes of myelopathy, history of genetically inherited progressive CNS degenerative disorder, Neuromyelitis optica, history or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease, history or known presence of sarcoidosis, history of severe, clinically significant brain or spinal cord trauma, history of progressive multifocal leukoencephalopathy<br><br>Exclusions Related to General Health:<br>1. Pregnancy or lactation<br>2. Lack of peripheral venous access<br>3. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies<br>4. Significant, uncontrolled disease, such as cardiovascular, cardiac arrhythmia, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal<br>5. Congestive heart failure NYHA III or IV functional severity<br>6. Known active bacterial, viral, fungal, mycobacterial infection or other infection [including tuberculosis [TB] or atypical mycobacterial disease (but excluding fungal infection of nail beds)] or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks prior to screening or oral antibiotics within 2 weeks prior to screening<br>7. History or known presence of recurrent or chronic infection (e.g., hepatitis B or C, HIV, syphilis, tuberculosis)<br>8. History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved)<br>9. History of alcohol or drug abuse within 24 weeks prior to randomization<br>10. History of or currently active primary or secondary immunodeficiency<br>11. History or laboratory evidence of coagulation disorders<br><br>Exclusions Related to Medications<br>1. Treatment with any investigational agent within 4 weeks of screening or five half-lives of the investigational drug (whichever is longer)<br>2. Receipt of a live vaccine within 6 weeks prior to randomization<br><br>Exclusions Related to Medications Potentially Used for the Treatment of MS<br>1. Incompatibility with Avonex use (see protocol)<br>2. Previous treatment with rituximab<br>3. Previous treatment with lymphocyte-depleting therapies (e.g., Campath, anti-CD4, cladribine, cyclophosphamide, total body irradiation, bone marrow transplantation) except mitoxantrone which should not be used within 48 weeks prior to randomization<br>4. Treatment with lymphocyte trafficking blockers (e.g. natalizumab, FTY720) within 24 weeks prior to randomization<br>5. Treatment with beta interferons, glatiramer acetate, i.v. Immunoglobulin (i.v. Ig), plasmapheresis, or immunosuppressive therapies (e.g., mycophenolate mofetil [MMF], cyclosporine or azathioprine) within 12 weeks prior to randomization<br>6. Systemic corticosteroid therapy within 4 weeks prior to randomization<br><br>Exclusions Related to Laboratory Findi", "condition": "Relapsing remitting multiple sclerosis <br>MedDRA version: 9.1\nLevel: LLT\nClassification code 10063399\nTerm: Relapsing-remitting multiple sclerosis", "intervention": "<br>Product Name: Ocrelizumab<br>Product Code: RO4964913/F03<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: ocrelizumab<br>Current Sponsor code: RO4964913/F03<br>Other descriptive name: RhuMab 2H7<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 30-<br>Pharmaceutical form of the placebo: Concentrate for solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br>Trade Name: Avonex<br>Pharmaceutical Form: Powder and solvent for solution for injection<br>INN or Proposed INN: INTERFERON BETA-1A<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>", "primary_outcome": "Main Objective: The primary objective in this study is to investigate the effect of ocrelizumab given as two dose regimens of 600 or 1000 mg intravenously on the total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at weeks 12, 16, 20 and 24 as compared with placebo.;Secondary Objective: - The annualized protocol defined relapse rate by Week 24;<br>- Proportion of patients who remain relapse-free by Week 24;<br>- The total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at Weeks 4, 8, 12, 16, 20 and 24;<br>- The total number of new and/or enlarging gadolinium-enhancing T1 lesions on MRI scans of the brain at Weeks 4, 8, 12, 16, 20 and 24;<br>- Change in total volume of T2 lesions on MRI scans of the brain from baseline to Week 24;<br>- To evaluate the safety and tolerability of two dose regimens of ocrelizumab in patients with RRMS as compared with placebo and Avonex at Week 24 and the overall safety of ocrelizumab administered for up to 96 weeks;<br>- To investigate the pharmacokinetics and other pharmacodynamic study endpoints of ocrelizumab.<br>;Primary end point(s): To investigate the effect of ocrelizumab given as two dose regimens of 600 or 1000 mg intravenously on the total number of gadolinium-enhancing T1 lesions observed on MRI scans of the brain at weeks 12, 16, 20 and 24 as compared to placebo.", "secondary_outcome": null, "secondary_id": "WA21493", "source_support": null, "ethics_review_status": "Approved", "ethics_review_approval_date": "2008-06-05", "ethics_review_contact_name": null, "ethics_review_contact_address": null, "ethics_review_contact_phone": null, "ethics_review_contact_email": null, "results_date_completed": "2012-09-03", "results_url_link": null } ] }