Status:
COMPLETED
FOCUS Fatigue Outcome in Copaxone USers
Lead Sponsor:
Sanofi
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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:di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00267319
Start Date
June 1 2003
Last Update
December 7 2009
Active Locations (1)
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1
Sanofi-Aventis
Prague, Czechia