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

Primary Purpose

Spasticity Due to Cerebral Palsy

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Zanaflex Capsules
Zanaflex Capsules
Zanaflex Capsules
Zanaflex Capsules
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasticity Due to Cerebral Palsy

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Level 1

Dose Level 2

Dose Level 3

Dose Level 4

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
July 25, 2011
Last Updated
June 10, 2013
Sponsor
Acorda Therapeutics
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT01405950
Brief Title
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Please see 'Further study details as provided by Acorda Therapeutics' for explanation of why study stopped.
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
Collaborators
Syneos Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity Due to Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Level 1
Arm Type
Experimental
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Title
Dose Level 3
Arm Type
Experimental
Arm Title
Dose Level 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zanaflex Capsules
Other Intervention Name(s)
tizanidine HCI (hydrochloride)
Intervention Description
0.025 mg/kg
Intervention Type
Drug
Intervention Name(s)
Zanaflex Capsules
Other Intervention Name(s)
tizanidine HCI (hydrochloride)
Intervention Description
0.05 mg/kg
Intervention Type
Drug
Intervention Name(s)
Zanaflex Capsules
Other Intervention Name(s)
tizanidine HCI (hydrochloride)
Intervention Description
0.075 mg/kg
Intervention Type
Drug
Intervention Name(s)
Zanaflex Capsules
Other Intervention Name(s)
tizanidine HCI (hydrochloride)
Intervention Description
0.1 mg/kg
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours
Secondary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
Baseline and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, and 8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert Henney, PharmD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Louisville Department of Neurology dba Kentucky Neuroscience Research Health Care Outpatient Center (HCOC)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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