Phase 3
N=243
Dysport® Adult Upper Limb Spasticity
Nervous System Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01313299 ↗Enrolled (actual)
243
Serious AEs
3.7%
Results posted
Oct 2015
Primary outcome: Primary: Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG) — -0.3; -1.2; -1.4 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Botulinum toxin type A (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Sep 2013
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 | — |
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.
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.