FOCUS Fatigue Outcome in Copaxone USers
- Registration Number
- NCT00267319
- Lead Sponsor
- Sanofi
- 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:disability, relapse rate, quality of life and depression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single group Glatiramer acetate -
- Primary Outcome Measures
Name Time Method fatigue impact scale at baseline, month 6 and month 12
- Secondary Outcome Measures
Name Time Method relapse rate at baseline, month 6 and month 12 quality of life at baseline, month 6 and month 12 depression at baseline, month 6 and month 12 disability at baseline, month 6 and month 12 Adverse events at baseline, month 6 and month 12
Trial Locations
- Locations (1)
Sanofi-Aventis
🇨🇿Praha, Czech Republic