Phase 3
N=468
BOTOX® Treatment in Adult Patients With Post-Stroke Lower Limb Spasticity
Muscle Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT01575054 ↗Enrolled (actual)
468
Serious AEs
4.1%
Results posted
Feb 2016
Primary outcome: Primary: Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale — 4.1; 4.1; -0.81; -0.61 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- botulinum toxin Type A (Biological); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Ankle Plantar Flexors Using a 6-Point Scale |
4.1; 4.1; -0.81; -0.61 | — |
| SECONDARY Clinical Global Impression (CGI) of Overall Change by Physician Using a 9-Point Scale |
0.86; 0.65 | — |
| SECONDARY Goal Attainment Scores on the 6-Point Physician-Assessed Goal Attainment Scale (GAS) |
-0.8; -1.0; -0.5; -0.8 | — |
| SECONDARY Change From Baseline in Average Pain Score While Walking on the 11-Point Pain Scale |
4.5; 4.5; -0.8; -1.1 | — |
| SECONDARY Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of Optional Muscles Using a 6-Point Scale |
3.3; 3.2; -0.9; -1.0; 3.3; 3.4 | — |
Summary
This study will evaluate the safety and efficacy of BOTOX® in the treatment of adult post-stroke lower limb spasticity.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of post-stroke lower limb spasticity for at least 3 months
- Minimum body weight of 50 kg
- Never treated with botulinum toxin of any serotype for any reason, or if previously treated with botulinum toxin of any serotype, if previously treated for spasticity in the affected lower limb, must have been administered
- 20 weeks before Day 1, or if previously treated for any other indication must have been administered ≥12 weeks prior to Day 1
Exclusion Criteria
- Spasticity in the opposite leg that requires treatment
- Casting of the study limb within 6 months or planned casting during the first 12 weeks of the study
- Treatment modalities in the study limb including ultrasound, electrical nerve stimulation, electrical stimulation, acupuncture within 1 month of Day 1 or treatments planned during the study
- Not able to perform 10 meter walking test independently with or without assistive device
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Data sourced from ClinicalTrials.gov (NCT01575054). 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.