Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva GTC
• Treatments: Clonidine; Tizanidine

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