FOCUS Fatigue Outcome in Copaxone USers - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00267319

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 IV

MedlinePlus related topics: Depression Multiple Sclerosis

Drug Information available for: Copolymer 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Fatigue Outcomes of Copaxone Users in Relapsing-Remitting Multiple Sclerosis

Further study details as provided by Sanofi-Aventis:

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
single group: Experimental	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-Aventis

Investigators

Study Director:

Zuzana Priborska

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	HMR4002A_4002
Study First Received:	December 19, 2005
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00267319
Health Authority:	Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:

Copolymer 1
Autoimmune Diseases
Fatigue
Multiple Sclerosis
Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs

Nervous System Diseases
Adjuvants, Immunologic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009