drugset / Trial / NCT01603602
BOTOX® Treatment in Pediatric Upper Limb Spasticity
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.
Timeline
- Start
- 2012-07-12
- Primary completion
- 2017-06-29
- Completion
- 2017-07-06
Outcome
Mixed primary results
registry A negative change from Baseline indicates improvement. NCT01603602 ↗
registry analysis (superiority test); BOTOX® 6 U/kg vs Placebo; p <0.001; Least Squares (LS) Mean Difference -0.66 (95% CI -0.938 to -0.379) NCT01603602 ↗
registry analysis (superiority test); BOTOX® 6 U/kg vs Placebo; p = 0.155; LS Mean Difference 0.21 (95% CI -0.082 to 0.511) NCT01603602 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 3 iu/kg | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 6 iu/kg | Intramuscular |