Conditions: Spasticity Due to Cerebral Palsy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief 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.

Detailed description:
Evaluation of the study's progress after the amendment remained challenging with continued pre-screen failures noted in areas of Botox injection inclusion; family participation refusal / disinterest and gastric or jejunostomy tube placement. A third protocol amendment to improve enrollment was discussed with the Investigators who did not believe further amendment would overcome the barriers expressed by parents that would subject their children to an intense study time commitment without direct benefit. The investigative sites were notified that the study was closed to enrollment March 27, 2012.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Zanaflex Capsules intervention 2: Zanaflex Capsules intervention 3: Zanaflex Capsules intervention 4: Zanaflex Capsules
Intervention descriptions: intervention 1: 0.025 mg/kg intervention 2: 0.05 mg/kg intervention 3: 0.075 mg/kg intervention 4: 0.1 mg/kg

Protocol document: