stop_circleTerminated/Withdrawn

Multiple Sclerosis, Relapsing-Remitting

Bayer Identifier:

13089

ClinicalTrials.gov Identifier:

NCT00780455

EudraCT Number:

2006-006673-24

EU CT Number:

Not Available
Rehabilitation study in MS patients

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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.
  • - 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
October 2008 - September 2009
Phase
Phase 4
Could I Receive a placebo
No
Products
Betaseron (Interferon beta-1b, BAY86-5046)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
C. H. U. Hopital PurpanToulouse, 31059, France
Terminated
Hopital Gui de ChauliacMontpellier, 34295, France
Terminated
Centre Hospitalier UniversitaireNimes, 30029, France
Terminated
Centre Hospitalier de Cornouaille - QuimperQUIMPER, 29000, France
Terminated
Centre Hospitalier - Saint Philibert - LommeLOMME, 59160, France
Terminated
Hopital Henri Duffaut - AvignonAVIGNON, 84025, France
Completed
Hopital PontchaillouRennes, 35038, France
Completed
Hôpital Emile Muller - MulhouseMULHOUSE, 68051, France
Terminated
Hopital Maison BlancheReims Cedex, 51091, France
Terminated
Hopital Roger SalengroLille, 59037, France

Primary Outcome

  • Total walking area (in covered meters) either after 6 minute or at the time of the premature stop of the test.
    date_rangeTime Frame:
    Up to 6 minutes
    enhanced_encryption
    Safety Issue:
    No
  • Time of discomfort appearance
    date_rangeTime Frame:
    Up to 6 minutes
    enhanced_encryption
    Safety Issue:
    No
  • Distance of discomfort appearance
    date_rangeTime Frame:
    Up to 6 minutes
    enhanced_encryption
    Safety Issue:
    No
  • Rhythm change during 6 minutes walking test
    date_rangeTime Frame:
    Up to 6 minutes
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Covered distance gain between 15 days and 6 weeks after inclusion visit.
    date_rangeTime Frame:
    15 days and 6 weeks after inclusion visit
    enhanced_encryption
    Safety Issue:
    No
  • Knee isokinetic gain between 15 days and 6 weeks after inclusion visit
    date_rangeTime Frame:
    15 days and 6 weeks after inclusion visit
    enhanced_encryption
    Safety Issue:
    No
  • Posturography gain in static equilibrium performances between 15 days and 6 weeks after inclusion visit
    date_rangeTime Frame:
    15 days and 6 weeks after inclusion visit
    enhanced_encryption
    Safety Issue:
    No
  • Posturography gain in static equilibrium performances between 6 weeks and 12 weeks after inclusion visit
    date_rangeTime Frame:
    6 weeks and 12 weeks after inclusion visit
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with fatigue based on participants selfassessment using the Fatigue Severity Scale (FSS)
    date_rangeTime Frame:
    baseline, after 1 week, 6 and 12 weeks after inclusion visit
    enhanced_encryption
    Safety Issue:
    No
  • Quality of life asessed by use of self-questionnaire (SEP-59)
    date_rangeTime Frame:
    after 1 week, 6 and 12 weeks after inclusion visit
    enhanced_encryption
    Safety Issue:
    No

Trial design

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

Additional Information

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