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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
 Demyelinating Diseases
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 27, 2015