FOCUS Fatigue Outcome in Copaxone USers

December 4, 2009 updated by: Sanofi

Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis

  • 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single group
Drug: Glatiramer acetate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fatigue impact scale
Time Frame: at baseline, month 6 and month 12
at baseline, month 6 and month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
relapse rate
Time Frame: at baseline, month 6 and month 12
at baseline, month 6 and month 12
quality of life
Time Frame: at baseline, month 6 and month 12
at baseline, month 6 and month 12
depression
Time Frame: at baseline, month 6 and month 12
at baseline, month 6 and month 12
disability
Time Frame: at baseline, month 6 and month 12
at baseline, month 6 and month 12
Adverse events
Time Frame: at baseline, month 6 and month 12
at baseline, month 6 and month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Zuzana Priborska, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria

December 19, 2005

First Posted (Estimate)

December 20, 2005

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMR4002A_4002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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