Clinical trial
A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury
Name
Y-55-52120-140
Description
The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
Trial arms
Trial start
2011-03-01
Estimated PCD
2013-12-01
Trial end
2014-05-01
Status
Completed
Phase
Early phase I
Treatment
Botulinum toxin type A
I.M. injection on day 1 (single treatment cycle)
Arms:
Dysport® 1000 U, IM, Dysport® 1500 U, IM
Other names:
AbobotulinumtoxinA (Dysport®)
Placebo
I.M. injection on day 1 (single treatment cycle)
Arms:
Placebo
Size
388
Primary endpoint
Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
Baseline and Week 4
Eligibility criteria
Inclusion Criteria:
* Subjects aged 18 to 80 years of age
* Post stroke or brain injury
* Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
* Ambulatory patients
Exclusion Criteria:
* Fixed contractures
* Physiotherapy initiated less than 4 weeks before entry
* Previous surgery or previous treatment with phenol and/or alcohol in lower limb
* Neurological/neuromuscular disorders which may interfere with protocol evaluations
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 388, 'type': 'ACTUAL'}}
Updated at
2022-09-28
1 organization
2 products
1 indication
Organization
IpsenProduct
PlaceboIndication
SpasticityProduct
Botulinum toxin type A