Study of the Effects on Motor Recovery of Early Post-stroke Spasticity Treatment
Status:
Completed
Trial end date:
2020-12-09
Target enrollment:
Participant gender:
Summary
Stroke is the first cause of motor impairment and disability in adults. Then the main
objective of rehabilitation during the first six months following stroke is to facilitate
motor recovery. Many post-stroke hemiplegics develop spasticity which is responsible for an
increase of disability. Then antispastic drugs are frequently prescribed to the patients even
during the post-stroke recovery phase. Until recently most of french patients were treated by
oral tablets of baclofen. Now the number of patients receiving intramuscular injections of
botulinum A toxin is increasing. However in the literature, these drugs have been tested in
post-stroke spasticity during the chronicle phase, after the sixth month and their action on
motor recovery remain largely unknown. Then it is necessary to evaluate more accurately the
effects of its drugs on motor recovery. The main criterion of its study is the time course of
Fugl-Meyer Motor Assessment (FMA). Spastic patients with a single stroke, since less than two
months, will be included in the try. They receive at the same time oral tablets for five
months and intramuscular injections. Patients are randomized in three arms planned with a
distribution balanced by group of 5 patients with a 2 -2- 1 model: botulinum toxin and
placebo baclofen (120 patients), oral baclofen and placebo botulinum toxin (120 patients),
placebo baclofen and placebo botulinum toxin (60 patients). The FMA score will be assessed
before treatment start, one month and three months later. Spasticity, functional abilities,
capacity in the activities of daily life, pain and quality of life will be also assessed
during the study with Tardieu score, Rivermead Motor Assessment scale, Barthel index, Rankin
score, Visual Analogic Scale and Reintegration to Normal Life Index respectively. A positive
difference of 12 points in the time course of FMA in the botulinum toxin group in comparison
with the baclofen group will be considered as the minimum relevant effect. 300 patients have
been planned to be included in 20 centers during the 2 years of trial.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital, Toulouse
Collaborator:
Merz Pharmaceuticals GmbH
Treatments:
abobotulinumtoxinA Baclofen Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA