Phase 3
N=388
Dysport® Adult Lower Limb Spasticity Study
Leg Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT01249404 ↗Enrolled (actual)
388
Serious AEs
4.4%
Results posted
Oct 2017
Primary outcome: Primary: Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended) — -0.6; -0.8; -0.5 units on a scale — p==0.2859
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
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended) |
-0.6; -0.8; -0.5 | =0.2859 |
| SECONDARY Physician's Global Assesment (PGA) of Treatment Response at Week 4 |
0.9; 0.9; 0.7 | =0.0640 |
| SECONDARY Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed |
0.05; 0.04; 0.05 | =0.7247 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01249404). 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.