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

June 10, 2013 updated by: Acorda Therapeutics

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level 1
Drug: Zanaflex Capsules
0.025 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.05 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.075 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.1 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Experimental: Dose Level 2
Drug: Zanaflex Capsules
0.025 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.05 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.075 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.1 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Experimental: Dose Level 3
Drug: Zanaflex Capsules
0.025 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.05 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.075 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.1 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Experimental: Dose Level 4
Drug: Zanaflex Capsules
0.025 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.05 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.075 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)
Drug: Zanaflex Capsules
0.1 mg/kg
Other Names:
  • tizanidine HCI (hydrochloride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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).
Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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).
Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Collaborators

Syneos Health

Investigators

  • Study Director: Herbert Henney, PharmD, Acorda Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 28, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Estimate)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT10-ZC-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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