drugset / Trial / NCT01893411
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
Timeline
- Start
- 2013-06
- Primary completion
- 2015-08
- Completion
- 2016-05
Outcome
Missed primary endpoint
registry p = 0.65; Least Square Mean difference -0.04 (95% CI -0.23 to 0.14) NCT01893411 ↗
registry p = 0.075; LS-Mean difference 0.16 (95% CI -0.02 to 0.34) NCT01893411 ↗
Publications
- Results Heinen F, Kanovsky P, Schroeder AS, Chambers HG, Dabrowski E, Geister TL, Hanschmann A, Martinez-Torres FJ, Pulte I, Banach M, Gaebler-Spira D. IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study. J Pediatr Rehabil Med. 2021;14(2):183-197. doi: 10.3233/PRM-210040.
- 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 | 4 iu/kg | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 12 iu/kg | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 16 iu/kg | Intramuscular |