Status:
COMPLETED
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
Lead Sponsor:
Teva GTC
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
8-18 years
Phase:
PHASE1
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 functi...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00287157
Start Date
December 1 2006
End Date
May 1 2007
Last Update
January 21 2009
Active Locations (1)
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1
Alyn Hospital Pediatric and Adolescent Rehabilitation Center
Jerusalem, Israel, 01090