Rehabilitation Study in MS Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interferon beta-1b, FRP within 15 days after randomization

Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization

Group Type EXPERIMENTAL

Interferon beta-1b, FRP within 15 days after randomization

Intervention Type DRUG

Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization

Interferon beta-1b, FRP about 6 weeks after randomization

Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization

Group Type EXPERIMENTAL

Interferon beta-1b, FRP about 6 weeks after randomization

Intervention Type DRUG

Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.

Interventions

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Interferon beta-1b, FRP within 15 days after randomization

Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization

Intervention Type DRUG

Interferon beta-1b, FRP about 6 weeks after randomization

Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No