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FOCUS Fatigue Outcome in Copaxone USers

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: December 19, 2005
Last updated: December 4, 2009
Last verified: December 2009
  • 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
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:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • fatigue impact scale [ Time Frame: at baseline, month 6 and month 12 ]

Secondary Outcome Measures:
  • relapse rate [ Time Frame: at baseline, month 6 and month 12 ]
  • quality of life [ Time Frame: at baseline, month 6 and month 12 ]
  • depression [ Time Frame: at baseline, month 6 and month 12 ]
  • disability [ Time Frame: at baseline, month 6 and month 12 ]
  • Adverse events [ Time Frame: at baseline, month 6 and month 12 ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00267319

Czech Republic
Praha, Czech Republic
Sponsors and Collaborators
Study Director: Zuzana Priborska Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00267319     History of Changes
Other Study ID Numbers: HMR4002A_4002
Study First Received: December 19, 2005
Last Updated: December 4, 2009

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Glatiramer Acetate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents processed this record on June 22, 2017