FOCUS Fatigue Outcome in Copaxone USers
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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
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- 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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: single group |
Drug: Glatiramer acetate |
- fatigue impact scale [ Time Frame: at baseline, month 6 and month 12 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.

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
Czech Republic | |
Sanofi-Aventis | |
Praha, Czech Republic |
Study Director: | Zuzana Priborska | Sanofi |
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 |
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 |