Terminated/Withdrawn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

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.

Trial summary

Enrollment Goal

Trial Dates

October 2008 - September 2009

Phase

Phase 4

Could I Receive a placebo

Products

Betaseron (Interferon beta-1b, BAY86-5046)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Terminated	C. H. U. Hopital Purpan	Toulouse, 31059, France
Terminated	Hopital Gui de Chauliac	Montpellier, 34295, France
Terminated	Centre Hospitalier Universitaire	Nimes, 30029, France
Terminated	Centre Hospitalier de Cornouaille - Quimper	QUIMPER, 29000, France
Terminated	Centre Hospitalier - Saint Philibert - Lomme	LOMME, 59160, France
Terminated	Hopital Henri Duffaut - Avignon	AVIGNON, 84025, France
Completed	Hopital Pontchaillou	Rennes, 35038, France
Completed	Hôpital Emile Muller - Mulhouse	MULHOUSE, 68051, France
Terminated	Hopital Maison Blanche	Reims Cedex, 51091, France
Terminated	Hopital Roger Salengro	Lille, 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.
Time Frame:
Up to 6 minutes
Safety Issue:
No
Time of discomfort appearance
Time Frame:
Up to 6 minutes
Safety Issue:
No
Distance of discomfort appearance
Time Frame:
Up to 6 minutes
Safety Issue:
No
Rhythm change during 6 minutes walking test
Time Frame:
Up to 6 minutes
Safety Issue:
No

Secondary Outcome

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

Additional Information

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