Back to resultsPilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Sublingual Tizanidine HCl
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Actigraphy, Spasticity, Cognition and Functioning
Eligibility Criteria
Inclusion Criteria: Males/Females 8-18 years of age with documented history of TBI Documented Loss of Consciousness(LOC) for more than 24 H, or initial GCS (Glasgow Coma Score) lower than 8 Current Spasticity that interferes with task performance Patient is able to cooperate and understand general explanations Exclusion Criteria: History of allergy to tizanidine or any inactive component (including lactose intolerance) Use of other hypnotic medication within 3 days of baseline visit and during the study Botox therapy within 6 weeks of baseline, or use of Baclofen pump during the trial Use of CYP1A2 inhibitors (ex. ciprofloxacin or fluvoxamine) for the duration of the study Female patients on oral contraceptives Significant abnormalities in clinical screening laboratory parameters (ALT, AST, Bilirubin>2 x uln; Creatinine>2 mg/dl;WBC <2300/mm3, platelets<80,000/mm3) Taking of other medications that may adversely interfere with the actions of the study medication or outcome variables within 2 weeks of 5 half-lives of the baseline visit
Sites / Locations
- Alyn Hospital Pediatric and Adolescent Rehabilitation Center
Outcomes
Primary Outcome Measures
Improvement in Spasticity, Cognition and Daily Function
Secondary Outcome Measures
Improvement in nighttime actigraphy sleep parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00287157
Brief Title
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
Official Title
A Double-Blind, Randomized, Two-Way Crossover, Comparative Study to Evaluate the Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl Versus Placebo in Children With Chronic Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Teva GTC
4. Oversight
5. Study Description
Brief Summary
Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in CP (cerebral palsy) patients. It is hypothesized that this improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with resulting improvement in quality-of-life (i.e.,improvements in next-day functioning, cognition and movement) may also be seen in a similar patient population, i.e., children with traumatic brain injury (TBI).
Detailed Description
Sublingual tizanidine, a novel test formulation of the known effective antispasticity agent, has been shown to have a unique pharmacokinetic profile [(i.e., nearly twice the bioavailability/AUC), but with little or no increase in peak plasma levels (Cmax), as compared to oral tizanidine (Zanaflex)]. When administered nightly to CP (Cerebral Palsy) patients to more effectively reduce the muscle spasms that disrupt sleep, it was shown to improve sleep efficiency, decrease sleep fragmentation and improve the sleep cycle. This improvement in night-time sleep was translated into a potential improvement in next-day functioning (improvement in next-day measures of spasticity and movement).
It is hypothesized that a similar type of improvement in sleep with consequent positive impact on next day improvement in spasticity, cognition and function, may also be manifest in a similar patient population, children with traumatic brain injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, Actigraphy, Spasticity, Cognition and Functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sublingual Tizanidine HCl
Primary Outcome Measure Information:
Title
Improvement in Spasticity, Cognition and Daily Function
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Improvement in nighttime actigraphy sleep parameters
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males/Females 8-18 years of age with documented history of TBI
Documented Loss of Consciousness(LOC) for more than 24 H, or initial GCS (Glasgow Coma Score) lower than 8
Current Spasticity that interferes with task performance
Patient is able to cooperate and understand general explanations
Exclusion Criteria:
History of allergy to tizanidine or any inactive component (including lactose intolerance)
Use of other hypnotic medication within 3 days of baseline visit and during the study
Botox therapy within 6 weeks of baseline, or use of Baclofen pump during the trial
Use of CYP1A2 inhibitors (ex. ciprofloxacin or fluvoxamine) for the duration of the study
Female patients on oral contraceptives
Significant abnormalities in clinical screening laboratory parameters (ALT, AST, Bilirubin>2 x uln; Creatinine>2 mg/dl;WBC <2300/mm3, platelets<80,000/mm3)
Taking of other medications that may adversely interfere with the actions of the study medication or outcome variables within 2 weeks of 5 half-lives of the baseline visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ido Yatsiv, MD
Organizational Affiliation
Hadassah Medical Center, Ein Kerem, Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alyn Hospital Pediatric and Adolescent Rehabilitation Center
City
Jerusalem
ZIP/Postal Code
01090
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
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