Back to resultsFOCUS Fatigue Outcome in Copaxone USers
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 4
Locations
Czech Republic
Study Type
Interventional
Intervention
Glatiramer acetate
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility 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.
Sites / Locations
- Sanofi-Aventis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single group
Arm Description
Outcomes
Primary Outcome Measures
fatigue impact scale
Secondary Outcome Measures
relapse rate
quality of life
depression
disability
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00267319
Brief Title
FOCUS Fatigue Outcome in Copaxone USers
Official Title
Fatigue Outcomes of Copaxone Users in Relapsing-remitting Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Glatiramer acetate
Primary Outcome Measure Information:
Title
fatigue impact scale
Time Frame
at baseline, month 6 and month 12
Secondary Outcome Measure Information:
Title
relapse rate
Time Frame
at baseline, month 6 and month 12
Title
quality of life
Time Frame
at baseline, month 6 and month 12
Title
depression
Time Frame
at baseline, month 6 and month 12
Title
disability
Time Frame
at baseline, month 6 and month 12
Title
Adverse events
Time Frame
at baseline, month 6 and month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zuzana Priborska
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Praha
Country
Czech Republic
12. IPD Sharing Statement
Learn more about this trial
FOCUS Fatigue Outcome in Copaxone USers
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