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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
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).
Details
| Lead sponsor | Teva GTC |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 5 |
| Start date | 2006-12 |
| Completion | 2007-05 |
Conditions
- Traumatic Brain Injury
Interventions
- Sublingual Tizanidine HCl
Primary outcomes
- Improvement in Spasticity, Cognition and Daily Function — 4 weeks
Countries
Israel