Trial Condition(s):

Multiple Sclerosis, Relapsing-Remitting

Rehabilitation study in MS patients

Bayer Identifier:

13089

ClinicalTrials.gov Identifier:

NCT00780455

EudraCT Number:

2006-006673-24

Terminated/Withdrawn

Trial Purpose

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.

Inclusion Criteria
- 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 Criteria
- 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.

Trial Summary

Enrollment Goal
4
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

C. H. U. Hopital Purpan

Toulouse, France, 31059

Status
Terminated
 
Locations

Hopital Gui de Chauliac

Montpellier, France, 34295

Status
Terminated
 
Locations

Centre Hospitalier Universitaire

Nimes, France, 30029

Status
Terminated
 
Locations

Centre Hospitalier de Cornouaille - Quimper

QUIMPER, France, 29000

Status
Terminated
 
Locations

Centre Hospitalier - Saint Philibert - Lomme

LOMME, France, 59160

Status
Terminated
 
Locations

Hopital Henri Duffaut - Avignon

AVIGNON, France, 84025

Status
Terminated
 
Locations

Hopital Pontchaillou

Rennes, France, 35038

Status
Completed
 
Locations

Hôpital Emile Muller - Mulhouse

MULHOUSE, France, 68051

Status
Completed
 
Locations

Hopital Maison Blanche

Reims Cedex, France, 51091

Status
Terminated
 
Locations

Hopital Roger Salengro

Lille, France, 59037

Status
Terminated
 

Trial Design