Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe
Completed
Elan Pharmaceuticals
Phase 3
2002-06-01
This study is being conducted to compare the impact of somnolence (sleepiness) on cognition
(awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules
versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after
a meal) and in the fasted state (before a meal) in patients with moderate to severe
spasticity.
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)
Completed
Teva GTC
Phase 1
2006-12-01
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).
Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity
Completed
Teva GTC
Phase 1/Phase 2
2006-12-01
Nightly administration of 8 mg of a unique sublingual (under the tongue) formulation of
tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve
next-day spasticity, about 12 hours following dosing in 20 multiple sclerosis (MS) patients.
This improvement was statistically significant when compared to oral tizanidine dosing. The
current study is being undertaken to see if increasing the dose to 12 mg once nightly will
result in an even greater improvement, with a longer effect, i.e., next day improvement in
spasticity both in the morning as well as in the late afternoon.
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