Phase 3
Completed N=243
Dysport® Adult Upper Limb Spasticity
Nervous System Disorders
Source: ClinicalTrials.gov NCT01313299 ↗
Enrolled (actual)
243
Serious AEs
3.7%
Results posted
Oct 2015
Primary outcomePrimary: Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG) — -0.3; -1.2; -1.4 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG) |
-0.3; -1.2; -1.4 | — |
| SECONDARY Physician's Global Assessment (PGA) of Treatment Response |
0.6; 1.4; 1.8 | — |
| SECONDARY Change From Baseline in DAS Score for the Principal Target of Treatment (PTT) |
-0.5; -0.7; -0.7 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01313299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.