Status:
COMPLETED
Dysport® Adult Lower Limb Spasticity Study
Lead Sponsor:
Ipsen
Conditions:
Leg Spasticity
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 brai...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT01249404
Start Date
March 1 2011
End Date
May 1 2014
Last Update
September 28 2022
Active Locations (62)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
Rancho Los Amigos
Downey, California, United States, 90242
3
Pacific Neuroscience Medical Group
Oxnard, California, United States, 93030
4
Associated Neurologists of Southern CT, PC
Fairfield, Connecticut, United States, 06824