FOCUS Fatigue Outcome in Copaxone USers

Sanofi111 enrolled

Overview

* 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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

111

Conditions

Multiple Sclerosis

Interventions

Glatiramer acetateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (1)

Sanofi-Aventis

Prague, Czechia