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CLINICAL TRIALS PROFILE FOR TIZANIDINE HYDROCHLORIDE

All Clinical Trials for Tizanidine Hydrochloride

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Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00047580	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 Sp	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.
NCT00178646	Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity	Completed	Allergan	Phase 4	2002-01-01	The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke.
NCT00178646	Comparative Efficacy of Three Preparations of Botox-A in Treating Spasticity	Completed	The University of Texas Health Science Center, Houston	Phase 4	2002-01-01	The study seeks to compare the effectiveness of three preparations of BOTOX-A® in treating muscle tightness and spasms in the feet and ankles of people with stroke.
NCT00228267	Propofol Injection for Daily Headache	Completed	University of Alberta	Phase 2	2004-09-01	Hypothesis A single subanesthetic dose of propofol will result in improved pain and quality of life for the next 30 days in persons with chronic daily headache (CDH) Specific objectives To measure the effect of a single infusion of propofol at 40 mcg / kg / minute over 60 mins on headache-related quality of life (measured by the Headache Disability Index) and on headache severity (measured by the Headache Index) in subjects with chronic daily headache over 30 days45-47
NCT00287157	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).
NCT00358293	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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