Phase 3
Completed N=289
Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke
Post-stroke Spasticity of the Lower Limb
Source: ClinicalTrials.gov NCT01464307 ↗
Enrolled (actual)
289
Serious AEs
5.9%
Results posted
Nov 2016
Primary outcomePrimary: Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4 — 2.8; 2.8; -0.4; -0.4 Units on a scale — p=0.777
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4 |
2.8; 2.8; -0.4; -0.4 | 0.777 |
| PRIMARY Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12 |
3.5; 4.8; 28.5; 22.8; 22.2; 26.9 | 0.804 |
| SECONDARY Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS) |
37.3; 35.4; 39.3; 33.8; 20; 17 | 0.845 |
| SECONDARY Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits |
2.8; 2.8; 2.4; 2.4; 2.4; 2.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age from 18-80 yrs
- Lower limb spasticity
- Time since stroke greater than 3 months
- Need for 400 U Botulinum toxin type A
Exclusion Criteria
- Body weight below 50kg
- Fixed contractures of the lower limb
- Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
- Infection at the injection site
Data sourced from ClinicalTrials.gov (NCT01464307). 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.