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Rehabilitation Study in MS Patients

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Interferon beta-1b, FRP within 15 days after randomization (Drug); Interferon beta-1b, FRP about 6 weeks after randomization (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Time of Discomfort Appearance

Distance of Discomfort Appearance

Rhythm Change During 6 Minutes Walking Test

Secondary outcome:

Covered Distance Gain Between MR2 Visit and MR3 Visit

Knee Isokinetic Gain Between Baseline and 12 Weeks After MR1 Visit

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

Posturography Gain in Static Equilibrium Performances Between MR2 and MR3 Visits

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

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 - 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.

Locations and Contacts

Avignon 84025, France

Lille 59037, France

Lomme 59160, France

Montpellier 34295, France

Mulhouse 68051, France

Nimes 30029, France

Quimper 29000, France

Reims Cedex 51091, France

Toulouse 31059, France

Rennes, Bretagne 35038, France

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: October 2008
Last updated: May 8, 2015

Page last updated: August 23, 2015

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