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FOCUS Fatigue Outcome in Copaxone USers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00267319
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : December 7, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
  • 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 or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Glatiramer acetate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis
Study Start Date : June 2003
Actual Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: single group Drug: Glatiramer acetate


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

Secondary Outcome Measures :
  1. relapse rate [ Time Frame: at baseline, month 6 and month 12 ]
  2. quality of life [ Time Frame: at baseline, month 6 and month 12 ]
  3. depression [ Time Frame: at baseline, month 6 and month 12 ]
  4. disability [ Time Frame: at baseline, month 6 and month 12 ]
  5. Adverse events [ Time Frame: at baseline, month 6 and month 12 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267319


Locations
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Czech Republic
Sanofi-Aventis
Praha, Czech Republic
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Zuzana Priborska Sanofi
More Information
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Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00267319    
Other Study ID Numbers: HMR4002A_4002
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Glatiramer Acetate
(T,G)-A-L
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents