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FOCUS Fatigue Outcome in Copaxone USers

NCT ID: NCT00267319

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Brief Summary

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* 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

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single group

Group Type EXPERIMENTAL

Glatiramer acetate

Intervention Type DRUG

Interventions

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Glatiramer acetate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Zuzana Priborska

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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HMR4002A_4002

Identifier Type: -

Identifier Source: org_study_id