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:
Participant gender:
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).