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

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ClinicalTrials.gov Identifier: NCT01405950
Recruitment Status : Terminated (Please see 'Further study details as provided by Acorda Therapeutics' for explanation of why study stopped.)
First Posted : July 29, 2011
Results First Posted : May 13, 2013
Last Update Posted : June 17, 2013
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Acorda Therapeutics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Spasticity Due to Cerebral Palsy
Intervention Drug: Zanaflex Capsules
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4
Hide Arm/Group Description Zanaflex Capsules : 0.025 mg/kg Zanaflex Capsules : 0.05 mg/kg Zanaflex Capsules : 0.075 mg/kg Zanaflex Capsules : 0.1 mg/kg
Period Title: Overall Study
Started 8 2 0 0
Completed 7 2 0 0
Not Completed 1 0 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0
Arm/Group Title Dose Level 1 Dose Level 2 Total
Hide Arm/Group Description Zanaflex Capsules : 0.025 mg/kg Zanaflex Capsules : 0.05 mg/kg Total of all reporting groups
Overall Number of Baseline Participants 8 2 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 10 participants
2-3 years 3 0 3
4-5 years 1 0 1
6-12 years 3 2 5
13-16 years 1 0 1
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 10 participants
Female
5
  62.5%
1
  50.0%
6
  60.0%
Male
3
  37.5%
1
  50.0%
4
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 2 participants 10 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
8
 100.0%
2
 100.0%
10
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics Population
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4
Hide Arm/Group Description:
Zanaflex Capsules : 0.025 mg/kg
Zanaflex Capsules : 0.05 mg/kg
Zanaflex Capsules: 0.075 mg/kg
Zanaflex Capsules: 0.1 mg/kg
Overall Number of Participants Analyzed 7 2 0 0
Mean (Standard Error)
Unit of Measure: hour*nanogram/mililiter
5.60  (1.79) 6.11  (1.29)
2.Secondary Outcome
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics Population
Arm/Group Title Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4
Hide Arm/Group Description:
Zanaflex Capsules : 0.025 mg/kg
Zanaflex Capsules : 0.05 mg/kg
Zanaflex Capsules: 0.075 mg/kg
Zanaflex Capsules: 0.1 mg/kg
Overall Number of Participants Analyzed 7 2 0 0
Mean (Standard Error)
Unit of Measure: nanogram/mililiter
1.87  (0.60) 5.29  (0.05)
Time Frame Up to 30 days.
Adverse Event Reporting Description Treatment-emergent adverse events (TEAE) were defined as AEs with date/time of onset (or worsening) on or after the start–date/time of administration of study drug and no more than 1 day after the last dose of study drug.
 
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description Zanaflex Capsules : 0.025 mg/kg Zanaflex Capsules : 0.05 mg/kg
All-Cause Mortality
Dose Level 1 Dose Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1 Dose Level 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose Level 1 Dose Level 2
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      2/2 (100.00%)    
Musculoskeletal and connective tissue disorders     
Musculoskeletal Stiffness  0/8 (0.00%)  0 1/2 (50.00%)  1
Nervous system disorders     
Somnolence  1/8 (12.50%)  1 2/2 (100.00%)  2
1
Term from vocabulary, MedDRA (13.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
Results Point of Contact
Name/Title: Herbert Henney, PharmD
Organization: Acorda Therapeutics, Inc.
Phone: 914-347-4300 ext 5138
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01405950     History of Changes
Other Study ID Numbers: AT10-ZC-08
First Submitted: July 25, 2011
First Posted: July 29, 2011
Results First Submitted: March 27, 2013
Results First Posted: May 13, 2013
Last Update Posted: June 17, 2013