FOCUS Fatigue Outcome in Copaxone USers

Sanofi

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Glatiramer acetate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00267319

HMR4002A_4002

Details and patient eligibility

About

• 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.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

single group

Experimental group

Treatment:

Drug: Glatiramer acetate