MSFrontier

Rehabilitation Study in MS Patients

Multicenter, Open Label, Randomized and Parallel Group Phase IV Pilot Study Evaluating the Effectiveness of Functional Rehabilitation Protocol in RRMS Patients Treated With Betaferon®
Stopped earlyPhase 4Relapsing MSNCT00780455

What it found

Stopped early

The trial ended early for another reason (see below).

What was tested

Treatment tested

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Interferon Beta-1b, FRP Within 15 Days After Randomization20 (0.0%)
Interferon Beta-1b, FRP About 6 Weeks After Randomization20 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Total Walking Area (in Covered Meters) Either After 6 Minute or at the Time of the Premature Stop of the Test.

    Up to 6 minutes

    Walking and mobility

  • Time of Discomfort Appearance

    Up to 6 minutes

  • Distance of Discomfort Appearance

    Up to 6 minutes

  • Rhythm Change During 6 Minutes Walking Test

    Up to 6 minutes

    Walking and mobility

Other measures (6)

  • Covered Distance Gain Between MR2 Visit and MR3 Visit

    At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)

    Immune response

  • Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit

    At baseline and 12 weeks after MR1 visit

    Physical function

  • Posturography Gain in Static Equilibrium Performances Between Baseline and 12 Weeks After MR1 Visit

    At baseline and 12 weeks after MR1 visit

  • Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits

    At MR2 visit (6 weeks after MR1 visit) and MR3 visit (12 weeks after MR1 visit)

    Immune response

  • Number of Participants With Fatigue Based on Participants Self Assessment Using the Fatigue Severity Scale (FSS)

    From baseline to 12 weeks after MR1 visit

    Fatigue

  • Quality of Life Assessed by Use of Self-questionnaire (SEP-59)

    From baseline to 12 weeks after MR1 visit

    Thinking and memoryPhysical functionBladder, bowel and sexual functionPainMood and sleepQuality of life (reported by participants)

Who could take part

Relapsing MS · 18 and over

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Oct 2008

    2. Main results due

      Sept 2009

    3. Finished

      Sept 2009

    4. Results posted

      Feb 2013

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