FOCUS Fatigue Outcome in Copaxone USers

Multiple Sclerosis Clinical Trial

Official title:

Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267319
• Other study ID #: HMR4002A_4002
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2005
• Last updated: December 4, 2009
• Start date: June 2003

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Glatiramer acetate

Locations

Country	Name	City	State
Czech Republic	Sanofi-Aventis	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue impact scale		at baseline, month 6 and month 12	No
Secondary	relapse rate		at baseline, month 6 and month 12	No
Secondary	quality of life		at baseline, month 6 and month 12	No
Secondary	depression		at baseline, month 6 and month 12	No
Secondary	disability		at baseline, month 6 and month 12	No
Secondary	Adverse events		at baseline, month 6 and month 12	No