Status:
TERMINATED
Rehabilitation Study in MS Patients
Lead Sponsor:
Bayer
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of pat...
Eligibility Criteria
Inclusion
- Female and Male patients aged 18 and more;
- Confirmed diagnosis of RRMS according to the MacDonald or Poser criteria;
- First indication for Betaferon treatment (as described in Summary of Product Characteristics (SmPC));
- No relapse of multiple sclerosis (MS) in the last two months before the inclusion;
- Walking patients having an Expanded Disability Status Scale (EDSS) score between \> 1 and \</= 4 at the inclusion visit;
- Female of child-bearing potential must agree to practice adequate contraception methods over all the duration of the study;
- Patient can follow all the study and comply with all procedures of the trial protocol
- Laboratory evaluations (i.e. evaluation of hepatic enzymes gammaGT, full blood count and differential white blood cell \[WBC\]) must be available and the results must be normal;
- Written informed consent.
Exclusion
- Any contraindication to Betaferon as described in the SmPC of the product;
- Patient with a previously orthopaedic surgical intervention within the past year of the inclusion;
- Patient previously included in this study;
- Patient previously treated within the past 3 months with Rebif, Avonex or Copaxone;
- Patient previously treated within the past 12 months with Betaferon;
- Participation in any clinical trial within the past 30 days involving the investigational drug intake.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00780455
Start Date
October 1 2008
End Date
September 1 2009
Last Update
May 29 2015
Active Locations (10)
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1
Rennes, Brittany Region, France, 35038
2
Avignon, France, 84025
3
Lille, France, 59037
4
Lomme, France, 59160