NCT00267319CompletedPhase 4
Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- fatigue impact scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
single group
Experimental
Intervention: Glatiramer acetate (Drug)
Outcomes
Primary Outcomes
fatigue impact scale
Time Frame: at baseline, month 6 and month 12
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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