Phase 4
N=32
Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity
Stroke · Brain Injuries · Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT00178646 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Spastic Hypertonia as Measured by the Ashworth Scale — 2.4; 2.33; 2.36 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Botox (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spastic Hypertonia as Measured by the Ashworth Scale |
1.42; 1.13; 1.1 | — |
| PRIMARY Spastic Hypertonia as Measured by the Ashworth Scale |
1.42; 1.13; 1.1 | — |
| PRIMARY Spastic Hypertonia as Measured by the Ashworth Scale |
1.42; 1.13; 1.1 | — |
| PRIMARY Spastic Hypertonia as Measured by the Ashworth Scale |
1.42; 1.13; 1.1 | — |
| PRIMARY Spastic Hypertonia as Measured by the Ashworth Scale |
1.42; 1.13; 1.1 | — |
| SECONDARY Range of Motion as Measured by Goniometry |
-1.82; 2.25; -2.30 | — |
| SECONDARY Range of Motion as Measured by Goniometry |
-1.82; 2.25; -2.30 | — |
Summary
The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke.
Eligibility Criteria
Inclusion Criteria -
- Spasticity resulting from ABI (stroke, including vascular malformations, traumatic brain injury)
- Ashworth Score (resting) of at least 2 of the primary ankle plantarflexor (gastrocnemius)
- Onset of primary illness at least six months prior to study inclusion
- At least 12 years of age
Exclusion Criteria -
- Hypersensitivity or allergy to botulinum toxin
- History of myasthenia gravis or other neuromuscular disease
- Current use of aminoglycosides
- Botulinum toxin or phenol injection to study limb within six months prior to recruitment
- Current use of other spasmolytic drug, such as diazepam, baclofen, dantrolene, tizanidine
- Presence of contracture or significant muscle atrophy
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00178646). 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.