Atorvastatin 40 mg in Patients With Relapsing-Remitting Multiple Sclerosis Treated With Interferon-Beta-1b

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 In Multiple Sclerosis

Short title: "SWABIMS"

Study phase: Phase IIb study

Study design: Multi-center, randomized, rater-blinded, parallel-group-study in Switzerland

Investigational product: Atorvastatin 40mg every day (oral) plus Interferon-beta

Reference product: Interferon-beta-1b 250mg given

Indication: Relapsing-remitting multiple sclerosis (RR-MS)

Study objectives: Comparison of efficacy, safety and tolerability of combination of Atorvastatin 40mg (per os) daily and Interferon-beta-1b e.o.d in patients with relapsing-remitting multiple sclerosis compared to monotherapy with Interferon-beta-1b e.o.d.

Primary Endpoint: Proportion of patients with new T2 lesions after 15 months of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Laboratory: Viollier AG Spalenring 145 / 147 Postfach 4002 Basel; PharmaPart
• Treatments: Atorvastatin; Atorvastatin Calcium; Interferon beta-1b; Interferon-beta; Interferons

Criteria

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