Dysport® Adult Upper Limb Spasticity

• Status: Completed
• Trial end date: 2013-09-01
• 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 upper 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:

• Adult patients - post stroke or brain injury

• Modified Ashworth Scale ≥ 2

• Ambulatory patients

Exclusion Criteria:

• Previous treatment with botulinum toxin of any type within 4 months prior to study entry for any condition

• Physiotherapy initiated less than 4 weeks before inclusion

• Previous surgery, alcohol, phenol in upper limb

• Neurological/neuromuscular disorders which may interfere with protocol evaluations