Dysport® Adult Lower Limb Spasticity Study

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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 brain injury.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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