stop_circleTerminated/Withdrawn
Multiple Sclerosis, Relapsing-Remitting
Bayer Identifier:
13089
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Rehabilitation study in MS patients
Trial 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.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
4Trial Dates
October 2008 - September 2009Phase
Phase 4Could I Receive a placebo
NoProducts
Betaseron (Interferon beta-1b, BAY86-5046)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | C. H. U. Hopital Purpan | Toulouse, 31059, France |
Terminated | Hopital Gui de Chauliac | Montpellier, 34295, France |
Terminated | Centre Hospitalier Universitaire | Nimes, 30029, France |
Terminated | Centre Hospitalier de Cornouaille - Quimper | QUIMPER, 29000, France |
Terminated | Centre Hospitalier - Saint Philibert - Lomme | LOMME, 59160, France |
Terminated | Hopital Henri Duffaut - Avignon | AVIGNON, 84025, France |
Completed | Hopital Pontchaillou | Rennes, 35038, France |
Completed | Hôpital Emile Muller - Mulhouse | MULHOUSE, 68051, France |
Terminated | Hopital Maison Blanche | Reims Cedex, 51091, France |
Terminated | Hopital Roger Salengro | Lille, 59037, France |
Primary Outcome
- Total walking area (in covered meters) either after 6 minute or at the time of the premature stop of the test.date_rangeTime Frame:Up to 6 minutesenhanced_encryptionNoSafety Issue:
- Time of discomfort appearancedate_rangeTime Frame:Up to 6 minutesenhanced_encryptionNoSafety Issue:
- Distance of discomfort appearancedate_rangeTime Frame:Up to 6 minutesenhanced_encryptionNoSafety Issue:
- Rhythm change during 6 minutes walking testdate_rangeTime Frame:Up to 6 minutesenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Covered distance gain between 15 days and 6 weeks after inclusion visit.date_rangeTime Frame:15 days and 6 weeks after inclusion visitenhanced_encryptionNoSafety Issue:
- Knee isokinetic gain between 15 days and 6 weeks after inclusion visitdate_rangeTime Frame:15 days and 6 weeks after inclusion visitenhanced_encryptionNoSafety Issue:
- Posturography gain in static equilibrium performances between 15 days and 6 weeks after inclusion visitdate_rangeTime Frame:15 days and 6 weeks after inclusion visitenhanced_encryptionNoSafety Issue:
- Posturography gain in static equilibrium performances between 6 weeks and 12 weeks after inclusion visitdate_rangeTime Frame:6 weeks and 12 weeks after inclusion visitenhanced_encryptionNoSafety Issue:
- Number of participants with fatigue based on participants selfassessment using the Fatigue Severity Scale (FSS)date_rangeTime Frame:baseline, after 1 week, 6 and 12 weeks after inclusion visitenhanced_encryptionNoSafety Issue:
- Quality of life asessed by use of self-questionnaire (SEP-59)date_rangeTime Frame:after 1 week, 6 and 12 weeks after inclusion visitenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2