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Sponsors and Collaborators: |
Alpharma ApS Sanofi-Aventis Jette Frederiksen |
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Information provided by: | Alpharma |
ClinicalTrials.gov Identifier: | NCT00429442 |
A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in patients treated with Copaxone for at least 3 months
Condition | Intervention | Phase |
---|---|---|
Relapsing Remitting Multiple Sclerosis |
Drug: Simvastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Double Blind, Randomised, Placebo Controlled Study Investigating Simvastatin as an Add-on Treatment to Copaxone for the Treatment of Relapsing Multiple Sclerosis in Patients Treated With Copaxone for at Least 3 Months |
Estimated Enrollment: | 20 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | April 2010 |
This is a double blind, placebo controlled, randomised, phase 3 study. Patients that have been treated with Copaxone for at least 6 months at the screening visit will be randomised for treatment with simvastatin or placebo as an add-on to their Copaxone treatment. Patients will start treatment with 40 mg peroral simvastatin daily (or an apparently identical placebo) for one month. Hereafter, patients will escalate dosage to 80 mg daily. The patients will be examined clinically at screening, baseline and at 3, 6 and 12 months. Blood samples for immunology will be performed at baseline and at 1, 3, 6 and 12 months. Blood samples for safety assessments will be performed at all study visits. MRI will be performed (T1-weighted and T2-weighted) at baseline and at 6 and 12 months.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A patient may be included if s/he fulfils all criteria mentioned below:
Exclusion Criteria:
The patient must not be included if any of the criteria mentioned below are fulfilled:
Contact: Jette L Frederiksen, DMSC | +45 43233041 | jefr@glo.regionh.dk |
Contact: Anna Tsakiri, MD | +45 43233524 | ants@dadlnet.dk |
Denmark | |
Department of Neurology, Glostrup University Hospital | |
Glostrup, Denmark, 2600 |
Principal Investigator: | Jette L Frederiksen, DMSC | Department of Neurology, Glostrup Hospital, Denmark |
Study ID Numbers: | CoSim-01 |
Study First Received: | January 30, 2007 |
Last Updated: | January 30, 2007 |
ClinicalTrials.gov Identifier: | NCT00429442 |
Health Authority: | Denmark: Danish Medicines Agency |
Simvastatin CNS Inflammation Copaxone |
Copolymer 1 Autoimmune Diseases Multiple Sclerosis Demyelinating Diseases Simvastatin Demyelinating Autoimmune Diseases, CNS |
Demyelinating diseases Sclerosis Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases of the Nervous System Inflammation |
Antimetabolites Immune System Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Antilipemic Agents Physiological Effects of Drugs Nervous System Diseases Adjuvants, Immunologic |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Immunosuppressive Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses |