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

Phase 1

Terminated

• Conditions: Spasticity Due to Cerebral Palsy
• Interventions: Drug: Zanaflex Capsules

• Registration Number: NCT01405950
• Lead Sponsor: Acorda Therapeutics

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-03-27
• Results First Submitted QC: 2013-03-27
• Results First Posted: 2013-05-13
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-10
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Have clinically diagnosed spasticity resulting from cerebral palsy
• Have a motor disability resulting from a static, nonprogressive brain injury or malformation occurring prenatally or before the age of 2 years
• Have mild to moderate spasticity at screening
• Have a parent or legally accepted representative able to understand and comply with study requirements who voluntarily provides informed consent and agrees to be primarily responsible for adhering to the requirements of the study

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Exclusion Criteria

• Have a history of hypersensitivity or allergic reaction to tizanidine or any of the capsule components
• Have dietary restrictions or food allergies that conflict with a standardized meal
• Have clinically significant psychiatric, gastrointestinal, pulmonary, hematologic, endocrine, cardiovascular, renal, or hepatic disease that requires pharmacologic intervention
• Have an ongoing seizure disorder that requires medical therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Level 1	Zanaflex Capsules	-
Dose Level 2	Zanaflex Capsules	-
Dose Level 3	Zanaflex Capsules	-
Dose Level 4	Zanaflex Capsules	-

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Parameter Cmax (Maximum Observed Drug Concentration in Plasma) 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).

Trial Locations

Locations (1)

University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC); 🇺🇸 Louisville, Kentucky, United States