Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy
Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of one or both arms alone or in combination with injections into one or both legs are effective and safe in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
Timeline
- Start
- 2014-03-28
- Primary completion
- 2017-07-04
- Completion
- 2018-08-28
Outcome
Mixed primary results
registry analysis (superiority test); MP Low Dose Group vs MP High Dose Group; p = 0.017; LS Mean difference -0.22 (95% CI -0.4 to -0.04); MMRM NCT02002884 ↗
registry analysis (superiority test); MP Low Dose Group vs MP Mid Dose Group; p = 0.546; LS-Mean difference -0.07 (95% CI -0.29 to 0.15); MMRM NCT02002884 ↗
registry analysis (superiority test); MP Low Dose Group vs MP High Dose Group; p = 0.34; LS-Mean difference 0.09 (95% CI -0.1 to 0.28); ANCOVA NCT02002884 ↗
Publications
- Results Dabrowski E, Chambers HG, Gaebler-Spira D, Banach M, Kanovsky P, Dersch H, Althaus M, Geister TL, Heinen F. IncobotulinumtoxinA Efficacy/Safety in Upper-Limb Spasticity in Pediatric Cerebral Palsy: Randomized Controlled Trial. Pediatr Neurol. 2021 Oct;123:10-20. doi: 10.1016/j.pediatrneurol.2021.05.014. Epub 2021 May 21.
- Berweck S, Banach M, Gaebler-Spira D, Chambers HG, Schroeder AS, Geister TL, Althaus M, Hanschmann A, Vacchelli M, Bonfert MV, Heinen F, Dabrowski E. Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis. Toxins (Basel). 2022 Aug 25;14(9):585. doi: 10.3390/toxins14090585.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 2 iu/kg | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 6 iu/kg | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 8 iu/kg | Intramuscular |