Efficacy, Safety and Tolerability of Atorvastatin 40 mg in Patients With Relapsing-remitting Multiple Sclerosis Treated With Interferon-beta-1b
NCT01111656 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2011-09-07
Summary
The "SWiss Atorvastatin and Interferon-Beta 1b Trial In Multiple Sclerosis - Follow up Study" is the follow up study of the "SWiss Atorvastatin and Interferon Beta-1b Trial In Multiple Sclerosis (SWABIMS)" (see http://www.clinicaltrials.gov. Identifier: NCT00942591) SWABIMS evaluated the efficacy, safety and tolerability of atorvastatin 40 mg in addition to interferon-beta 1b compared to interferon-beta 1b monotherapy in patients with relapsing-remitting multiple sclerosis for 15 month. The SWABIMS Follow up study observes patients that finish the SWABIMS study for another 12 month with ongoing unchanged medication.
Conditions
- Relapsing-remitting Multiple Sclerosis
Interventions
- DRUG
-
Interferon beta-1b group
Patients receive interferon beta-1b 250ug subcutaneously every other day
- DRUG
-
Interferon beta-1b/Atorvastatin group
Patients receive interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)
Sponsors & Collaborators
-
Viollier AG, Basel, Switzerland
collaborator UNKNOWN -
PharmaPart
collaborator INDUSTRY -
Insel Gruppe AG, University Hospital Bern
lead OTHER
Principal Investigators
-
Heinrich Mattle, Prof. · Dep. of Neurology, Bern University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 67 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2010-04-30
- Completion
- 2010-04-30
Countries
- Switzerland
Study Locations
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