Clinical trial NCT00780455: Rehabilitation Study in MS Patients
Official title: Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: KineSEP
Rehabilitation
Betaferon
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-10-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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 \</= 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.

Primary outcomes:
measure: Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.
timeFrame: Up to 6 minutes
measure: Time of Discomfort Appearance
timeFrame: Up to 6 minutes
measure: Distance of Discomfort Appearance
timeFrame: Up to 6 minutes
measure: Rhythm Change During 6 Minutes Walking Test
timeFrame: Up to 6 minutes
Secondary outcomes:
measure: Covered Distance Gain Between MR2 Visit and MR3 Visit
timeFrame: At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)
measure: Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit
timeFrame: At baseline and 12 weeks after MR1 visit
measure: Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit
timeFrame: At baseline and 12 weeks after MR1 visit
measure: Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits
timeFrame: At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)
measure: Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)
timeFrame: From baseline to 12 weeks after MR1 visit
measure: Quality of Life Assessed by Use of Self-questionnaire (SEP-59)
timeFrame: From baseline to 12 weeks after MR1 visit
Other outcomes:
Locations:
city: Rennes
country: France
state: Bretagne
city: Avignon
country: France
city: Lille
country: France
city: Lomme
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Nimes
country: France
city: Quimper
country: France
city: Reims Cedex
country: France
city: Toulouse
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: