NCT01405950

Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spasticity Due to Cerebral Palsy

Interventions

Type	Name	Description
DRUG	Zanaflex Capsules	0.025 mg/kg
DRUG	Zanaflex Capsules	0.05 mg/kg
DRUG	Zanaflex Capsules	0.075 mg/kg
DRUG	Zanaflex Capsules	0.1 mg/kg

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-07-29
• Last updated: 2013-06-17
• Results posted: 2013-05-13

Locations

1 site across 1 country: United States