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FOCUS Fatigue Outcome in Copaxone USers

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00267319
First received: December 19, 2005
Last updated: December 4, 2009
Last verified: December 2009
History of Changes
  Purpose
  • 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.

Condition Intervention Phase
Multiple Sclerosis
 Drug: Glatiramer acetate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • fatigue impact scale [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relapse rate [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]
  • depression [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]
  • disability [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: at baseline, month 6 and month 12 ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: June 2003
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single group Drug: Glatiramer acetate

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267319

Locations
Czech Republic
Sanofi-Aventis
Praha, Czech Republic
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Zuzana Priborska Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00267319     History of Changes
Other Study ID Numbers: HMR4002A_4002
Study First Received: December 19, 2005
Last Updated: December 4, 2009
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 21, 2013