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FOCUS Fatigue Outcome in Copaxone USers

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis

Intervention: Glatiramer acetate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Zuzana Priborska, Study Director, Affiliation: Sanofi

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.

Clinical Details

Official title: Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: fatigue impact scale

Secondary outcome:

relapse rate

quality of life

depression

disability

Adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis, Praha, Czech Republic
Additional Information

Starting date: June 2003
Last updated: December 4, 2009

Page last updated: August 20, 2015

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