drugset / Trial / NCT01249417
Dysport® Pediatric Lower Limb Spasticity Study
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.
Timeline
- Start
- 2011-07
- Primary completion
- 2014-02
- Completion
- 2014-06
Outcome
Met primary endpoint
registry analysis (unspecified test); Dysport 10 U/Kg vs Placebo; p = 0.0029; Difference in LS means -0.38 (95% CI -0.64 to -0.13); ANCOVA NCT01249417 ↗
registry analysis (unspecified test); Dysport 15 U/Kg vs Placebo; p = 0.0002; Difference in LS means -0.49 (95% CI -0.75 to -0.23); ANCOVA NCT01249417 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 10 iu/kg | Intramuscular |
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 15 iu/kg | Intramuscular |