Status:
COMPLETED
Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
PharmaPart
Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Title: Efficacy, safety and tolerability of Atorvastatin 40 mg in patients with relapsing-remitting multiple sclerosis treated with interferon-beta-1b SWiss Atorvastatin and Interferon-Beta 1b Trial I...
Detailed Description
Background Multiple sclerosis is considered to be a chronic inflammatory demyelinating autoimmune disease of the central nervous system. Statins are lipid-lowering drugs which inhibit the 3-hydroxy-3...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with relapsing-remitting forms of multiple sclerosis (according to McDonald's criteria)
- At least 1 relapse in the past two year
- \> 3 Lesions on spinal or brain-MRI
- EDSS score between 0 and 3.5, inclusive
- Age between 18 and 55 years
- Written informed consent
- Negative pregnancy test results (all women)
- Exclusion Criteria
- Any disease other than multiple sclerosis that would better explain the patient's signs and symptoms
- Primary progressive MS
- Secondary progressive MS
- Uncontrolled severe medical disorder
- A history of drug abuse in the 6 months prior to screening
- Previous therapy with Monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (except steroids)
- Participation in any other studies
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00942591
Start Date
May 1 2005
End Date
May 1 2009
Last Update
July 21 2009
Active Locations (1)
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1
Prof. H. Mattle, Dep. of Neurology, Bern University Hospital
Bern, Switzerland, 3010