drugset / Trial / NCT01603628
BOTOX® Treatment in Pediatric Lower Limb Spasticity
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with lower limb spasticity.
Timeline
- Start
- 2012-09-11
- Primary completion
- 2017-06-28
- Completion
- 2017-06-28
Outcome
Mixed primary results
registry analysis (superiority test); BOTOX® 8 U/kg vs Placebo; p = 0.010; Least Squares (LS) Mean Difference -0.26 (95% CI -0.453 to -0.063); NCT01603628 ↗
registry analysis (superiority test); BOTOX® 8 U/kg vs Placebo; p = 0.023; LS Mean Difference 0.29 (95% CI 0.040 to 0.532); NCT01603628 ↗
registry analysis (superiority test); BOTOX® 4 U/kg vs Placebo; p = 0.299; LS Mean Difference 0.13 (95% CI -0.115 to 0.374); NCT01603628 ↗
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 | 8 iu/kg | Intramuscular |