drugset / Trial / NCT00636519
Botulism Antitoxin Effects on Paralysis Induced by Botulinum Neurotoxins in the EDB Muscle
Phase 1
Completed
36 enrolled
Emergent BioSolutions
Department of Health and Human Services · collab
RandomizedSingle-groupQuadruple-blindTreatment
Summary
The primary purpose of this study is: 1. To evaluate the model determined by the ability of botulism antitoxin (bivalent, Aventis) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model of muscle paralysis in Stage A. 2. To assess the ability of botulism antitoxin (heptavalent, Cangene) to neutralize Botulinum toxin in the Extensor Digitorum Brevis model of muscle paralysis in Stage B.
Timeline
- Start
- 2008-02
- Primary completion
- 2009-10
- Completion
- 2009-10
Publications
- Background Benedetto AV. The cosmetic uses of Botulinum toxin type A. Int J Dermatol. 1999 Sep;38(9):641-55. doi: 10.1046/j.1365-4362.1999.00722.x. No abstract available.
- Background Carruthers A, Carruthers J. Cosmetic uses of botulinum A exotoxin. Adv Dermatol. 1997;12:325-47; discussion 348. No abstract available.
- Background Tacket CO, Shandera WX, Mann JM, Hargrett NT, Blake PA. Equine antitoxin use and other factors that predict outcome in type A foodborne botulism. Am J Med. 1984 May;76(5):794-8. doi: 10.1016/0002-9343(84)90988-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulism Antitoxin Bivalent (Equine) Types A and B | Protein / enzyme biologic | — | — |
| Subject | Botulism Antitoxin Heptavalent (Equine) Types A-G | Protein / enzyme biologic | — | — |
Indications
No indication recorded.