Traumatic Brain Injury Clinical Trial
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
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).
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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