Rehabilitation Study in MS Patients

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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 patients with and without FRP.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Interferon beta-1b; Interferon-beta; Interferons

Criteria

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
• 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.