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

NCT01405950 | Terminated Phase 1 Results DMC

• 1 other identifier: AT10-ZC-08
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity Due to Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (4)

Dose Level 1

EXPERIMENTAL

Drug: Zanaflex Capsules

Dose Level 2

EXPERIMENTAL

Drug: Zanaflex Capsules

Dose Level 3

EXPERIMENTAL

Drug: Zanaflex Capsules

Dose Level 4

EXPERIMENTAL

Drug: Zanaflex Capsules

Interventions

Zanaflex Capsules DRUG

0.025 mg/kg

Also known as: tizanidine HCI (hydrochloride)

Dose Level 1

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acorda Therapeutics: lead
• Syneos Health: collaborator

Study Sites (1)

University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC)

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

tizanidine

Results Point of Contact

• Title: Herbert Henney, PharmD
• Organization: Acorda Therapeutics, Inc.

hhenney@acorda.com

914-347-4300

Study Officials

• Herbert Henney, PharmD

  Acorda Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 29, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 17, 2013
• Results First Posted: May 13, 2013

Record last verified: 2013-06

Locations

US (1)