Rehabilitation Study in MS Patients
This study has been terminated.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00780455
First received: May 28, 2008
Last updated: March 21, 2013
Last verified: March 2013
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis, Relapsing-Remitting |
Drug: Interferon beta-1b, FRP within 15 days after randomization Drug: Interferon beta-1b, FRP about 6 weeks after randomization |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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® |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Time of Discomfort Appearance [ Time Frame: Up to 6 minutes ] [ Designated as safety issue: No ]
- Distance of Discomfort Appearance [ Time Frame: Up to 6 minutes ] [ Designated as safety issue: No ]
- Rhythm Change During 6 Minutes Walking Test [ Time Frame: Up to 6 minutes ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Covered Distance Gain Between 15 Days and 6 Weeks After Inclusion Visit. [ Time Frame: 15 days and 6 weeks after inclusion visit ] [ Designated as 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 ] [ Designated as safety issue: No ]The isokinetic evaluation analyses the flexor/extensor ratio at different rates. The evaluation will be done at the beginning on the best clinical side otherwise on the strongest.
- 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 ] [ Designated as safety issue: No ]Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance).
- 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 ] [ Designated as safety issue: No ]Posturography protocol: Static equilibrium performances are evaluated in the standing patient on a fixed platform, in the standardized position (arms dangling, feet open at 30° and malleolus at a 5 cm distance).
- 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 ] [ Designated as safety issue: No ]FSS is an auto-questionnaire estimating the fatigue. It includes 9 questions on 7 points as well as an analogical visual scale estimating the state of fatigue over the last two weeks
- Quality of Life Assessed by Use of Self-questionnaire (SEP-59) [ Time Frame: After 1 week, 6 and 12 weeks after inclusion visit ] [ Designated as safety issue: No ]SEP (Sclérose en plaques) - 59: auto-questionnaire, multidimensional investigating the felt health. It contains a generic part SF (Short Form) 36 constituted by 36 items including the main concepts of quality of life and a specific part to the MS which investigates the dimensions susceptible to be degraded. 59 items are grouped in 16 dimensions: physical activity, limitations bound connected to the physical health, to the mental health, the social well-being, the pain, the energy, the emotional well-being, general Health, distress, cognitive function sexual function/satisfaction, well-being general, sleep and social support
| Enrollment: | 4 |
| Study Start Date: | October 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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
|
Drug: 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
|
|
Experimental: 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
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780455
Locations
| France | |
| Rennes, Bretagne, France, 35038 | |
| Avignon, France, 84025 | |
| Lille, France, 59037 | |
| Lomme, France, 59160 | |
| Montpellier, France, 34295 | |
| Mulhouse, France, 68051 | |
| Nimes, France, 30029 | |
| Quimper, France, 29000 | |
| Reims Cedex, France, 51091 | |
| Toulouse, France, 31059 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Affairs Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00780455 History of Changes |
| Other Study ID Numbers: | 13089, 2006-006673-24, 308083 |
| Study First Received: | May 28, 2008 |
| Results First Received: | January 22, 2013 |
| Last Updated: | March 21, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Bayer:
|
KineSEP Rehabilitation Betaferon |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Interferon-beta |
Interferons Interferon beta-1b Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 21, 2013