Trial Condition(s):
Rehabilitation study in MS patients
13089
Not Available
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 patients with and without FRP.
- 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.
- 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.
Locations | |
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Locations C. H. U. Hopital Purpan Toulouse, France, 31059 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Gui de Chauliac Montpellier, France, 34295 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Universitaire Nimes, France, 30029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier de Cornouaille - Quimper QUIMPER, France, 29000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier - Saint Philibert - Lomme LOMME, France, 59160 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Henri Duffaut - Avignon AVIGNON, France, 84025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Pontchaillou Rennes, France, 35038 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Emile Muller - Mulhouse MULHOUSE, France, 68051 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Maison Blanche Reims Cedex, France, 51091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopital Roger Salengro Lille, France, 59037 | Contact Us: E-mail: [email protected] Phone: Not Available |
Multicenter, open label, randomized and parallel group phase IV pilot study evaluating the effectiveness of functional rehabilitation protocol in RRMS patients treated with Betaferon®
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2