Status:
COMPLETED
Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMS
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Fatigue
Eligibility:
All Genders
18-65 years
Brief Summary
The primary objective of this trial is to observe the Multiple Sclerosis (MS) related fatigue during treatment with Tysabri as measured by changes in the fatigue scale for motor and cognitive function...
Eligibility Criteria
Inclusion
- Key
- Tysabri prescribed according to national guidelines but not yet started treatment
- Signed informed consent form
- FSMC sum score above \> 43 at baseline (mild fatigue)
- Key
Exclusion
- FSMC sum score below 43 at baseline
- History of treatment with Tysabri
- EDSS \> 6 at baseline
- Amphetamine as medication
- Major depression
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Key Trial Info
Start Date :
March 23 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2011
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT00884481
Start Date
March 23 2009
End Date
June 30 2011
Last Update
November 8 2018
Active Locations (27)
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1
Research Site
Graz, Austria
2
Research Site
Innsbruck, Austria
3
Research Site
Salzburg, Austria
4
Research Site
Vienna, Austria