drugset / Trial / NCT01405950
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.
Timeline
- Start
- 2011-05
- Primary completion
- 2012-03
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tizanidine | Small molecule | 0.025 mg/kg | Oral |
| Subject | Tizanidine | Small molecule | 0.05 mg/kg | Oral |
| Subject | Tizanidine | Small molecule | 0.075 mg/kg | Oral |
| Subject | Tizanidine | Small molecule | 0.1 mg/kg | Oral |