Single-Dose, Phase 1b Study to Assess Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects With Mild to Moderate Spasticity Due to Cerebral Palsy

NCT01405950 Phase 1 TERMINATED Results posted

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.

Details

Lead sponsor	Acorda Therapeutics
Phase	Phase 1
Status	TERMINATED
Enrolment	10
Start date	2011-05
Completion	2012-03

Conditions

• Spasticity Due to Cerebral Palsy

Interventions

• Zanaflex Capsules
• Zanaflex Capsules
• Zanaflex Capsules
• Zanaflex Capsules

Primary outcomes

• Pharmacokinetic (PK) Parameter AUC0-8 (Area Under the Concentration-time Curve From Time 0 to 8 Hours) of a Single Dose of Tizanidine at 4 Different Dose Levels in Children and Adolescents With Cerebral Palsy and Mild to Moderate Spasticity. — Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
  Baseline: immediately before the standardized meal (i.e., before administration of tizanidine) on dosing day 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours after administration of tizanidine PK parameters will be derived by using WinNonlin Pro (version 5.0.1 or later, Pharsight Corp).

Countries

United States