FOCUS Fatigue Outcome in Copaxone USers

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

• The study primarily investigates the effect of copaxone on fatigue during treatment, compared to baseline in patients with relapsing-remitting multiple sclerosis.

• Secondary outcome measures are:disability, relapse rate, quality of life and depression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: (T,G)-A-L; Glatiramer Acetate

Criteria

Inclusion Criteria:

• relapsing-remitting Multiple Sclerosis (MS),

• at least 2 relapses in previous 2 years prior to copaxone or interferon beta treatment,

• ambulant patients i.e disability score EDSS MAX 5,5,

• clinically stable MS

• relapse free and steroid free at least 30 days prior to start copaxone treatment

Exclusion Criteria:

• hypersensitivity to glatiramer acetate or mannitol,

• pregnancy,

• fertile female not willing to use effective contraception,

• previous treatment with copaxone

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.