drugset / Trial / NCT00822523
Assessment of the Effect of Botulinum Toxin in Extensor Digitorum Brevis Via Strain Gauge and Nerve Conduction Studies
RandomizedParallel-groupQuadruple-blindDiagnostic
Summary
The purpose of this feasibility study is to determine if temporary weakness of a small foot muscle caused by local injection of botulinum toxin into that muscle can be measured with a strain gauge in addition to the previously known valid measurements via nerve conduction studies and surface electromyogram.
Timeline
- Start
- 2009-01
- Primary completion
- 2009-03
- Completion
- 2015-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Botulinum Toxin Type A, 20 Units vs Botulinum Toxin, Type A, 2 Units vs Placebo; p = 0.61; t-test, 2 sided NCT00822523 ↗
Publications
- Background Sloop RR, Escutin RO, Matus JA, Cole BA, Peterson GW. Dose-response curve of human extensor digitorum brevis muscle function to intramuscularly injected botulinum toxin type A. Neurology. 1996 May;46(5):1382-6. doi: 10.1212/wnl.46.5.1382.
- Background Hamjian JA, Walker FO. Serial neurophysiological studies of intramuscular botulinum-A toxin in humans. Muscle Nerve. 1994 Dec;17(12):1385-92. doi: 10.1002/mus.880171207.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 2 iu | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 20 iu | Intramuscular |