FOCUS Fatigue Outcome in Copaxone USers
Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Intervention: Glatiramer acetate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Zuzana Priborska, Study Director, Affiliation: Sanofi
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.
Clinical Details
Official title: Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: fatigue impact scale
Secondary outcome: relapse ratequality of life depression disability Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Sanofi-Aventis, Praha, Czech Republic
Additional Information
Starting date: June 2003
Last updated: December 4, 2009
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