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Mallinckrodt
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Dow
US Army
Teva
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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR ZANAFLEX

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Clinical Trials for Zanaflex

Trial ID Title Status Sponsor Phase 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 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.
NCT00287157 Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI) Completed Teva GTC Phase 1 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 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.
NCT00430196 BOTOX® Versus Zanaflex® for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity Completed Allergan Phase 4 In this study, we will compare BOTOX® versus Zanaflex ® for the treatment of muscle overactivity in the upper limb following stroke or brain traums. This is a critical step in the development of local intramuscular treatment for patients with muscle overactivity following an acute brain lesions, as opposed to the more classic oral treatments. This study will be a multicenter, randomized, prospective, parallel, double blind study that enrolls subjects at twelve sites (including Mt. Sinai) throughout the United States and Europe. The purpose of this study is to evaluate the safety and efficacy of BOTOX® compared to Zanaflex® in reducing upper limb muscle tone in post-stroke subjects, as well as evaluating changes in muscle tone-related disability and drug-therapy tolerance. This will be an 18 week study. Subjects are eligible if they have been medically stable with upper limb spasticity 6 months after their first stroke. Subjects will be randomized to one of three treatment groups: Treatment Group I - intramuscular BOTOX® plus oral placebo, Treatment Group II - intramuscular placebo plus oral Zanaflex®, Treatment Group III - intramuscular placebo plus oral placebo. The dose of BOTOX® will be at the discretion of the investigator with a maximum of 500 U per subject. The dose of the Zanaflex® will be 4mg/day to a maximum of 36mg/day. The study anticipates that 150 subjects will be enrolled to provide sufficient information to answer the primary objective of safety and efficacy of the study.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Zanaflex

Condition Name

Condition Name for Zanaflex
Intervention Trials
Muscle Spasticity 2
Healthy 2
Spinal Cord Injury 1
Spasticity 1
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Condition MeSH

Condition MeSH for Zanaflex
Intervention Trials
Muscle Spasticity 3
Multiple Sclerosis 2
Sclerosis 1
Wounds and Injuries 1
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Clinical Trial Locations for Zanaflex

Trials by Country

Trials by Country for Zanaflex
Location Trials
United States 12
Israel 2
Canada 2
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Trials by US State

Trials by US State for Zanaflex
Location Trials
Texas 1
Rhode Island 1
Oregon 1
Oklahoma 1
Minnesota 1
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Clinical Trial Progress for Zanaflex

Clinical Trial Phase

Clinical Trial Phase for Zanaflex
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Zanaflex
Clinical Trial Phase Trials
Completed 7
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Clinical Trial Sponsors for Zanaflex

Sponsor Name

Sponsor Name for Zanaflex
Sponsor Trials
Teva GTC 2
Dr. Reddy's Laboratories Limited 2
Allergan 1
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Sponsor Type

Sponsor Type for Zanaflex
Sponsor Trials
Industry 7
Other 1
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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Colorcon
Chinese Patent Office
Federal Trade Commission
Accenture
Covington
Queensland Health
McKinsey
Moodys

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