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

Spasticity Due to Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01405950
• Other study ID #: AT10-ZC-08
• Status: Terminated
• Phase: Phase 1
• First received: July 25, 2011
• Last updated: June 10, 2013
• Start date: May 2011
• Est. completion date: March 2012

Study information

• Verified date: June 2013
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spasticity Due to Cerebral Palsy

Intervention

Drug:
• Zanaflex Capsules
0.025 mg/kg
• Zanaflex Capsules
0.05 mg/kg
• Zanaflex Capsules
0.075 mg/kg
• Zanaflex Capsules
0.1 mg/kg

Locations

Country	Name	City	State
United States	University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC)	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Acorda Therapeutics	INC Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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).	Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours	No
Secondary	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: 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).	Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours	No