Published Studies Related to Tizanidine
Nightly sublingual tizanidine HCl in multiple sclerosis: clinical efficacy and safety. [2010.05]
BACKGROUND: Approximately 90% of patients with multiple sclerosis (MS) experience spasticity during their lifetime. Tizanidine HCl is an alpha2 adrenergic agonist indicated for treating spasticity due to MS or spinal cord injury. OBJECTIVES: To compare the clinical efficacy and safety of once-nightly sublingual versus oral tizanidine HCl (8 mg) or placebo in MS patients with spasticity requiring treatment... CONCLUSIONS: Overnight sublingual tizanidine provides improvement in next-day spasticity compared with placebo, without increasing next-day somnolence. The Epworth somnolence score improved significantly with sublingual tizanidine treatment. This is contrary to the reported day-dose tizanidine use, in which increased somnolence is the most cited cause for patient dissatisfaction and noncompliance.
Nightly sublingual tizanidine HCl in multiple sclerosis: clinical efficacy and
spasticity requiring treatment... CONCLUSIONS: Overnight sublingual tizanidine provides improvement in next-day
Aceclofenac-tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone. [2009.12]
Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain... In this study, aceclofenac-tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain.
Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo-controlled study. [2009.04]
BACKGROUND: While spasticity is commonly treated with oral agents or botulinum neurotoxin (BoNT) injection, these treatments have not been systematically compared... CONCLUSIONS: BoNT is safer and more effective than TZD in reducing tone and disfigurement in upper-extremity spasticity, and may be considered as first-line therapy for this disorder.
Botulinum Neurotoxin vs Tizanidine in Upper Limb Spasticity: A Placebo-Controlled Study. [2008.10.31]
BACKGROUND: While spasticity is commonly treated with oral agents or botulinum neurotoxin (BoNT) injection, these treatments have not been systematically compared... CONCLUSIONS: BoNT is safer and more effective than TZD in reducing tone and disfigurement in upper extremity spasticity, and may be considered as first line therapy for this disorder.
Clinical Trials Related to Tizanidine
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 Spasticity. [Completed]
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
Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy [Recruiting]
This is a study to determine the pharmacokinetics, safety and tolerability, and
pharmacodynamics of Tizanidine in pediatric patients with mild to moderate spasticity due to
Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity [Completed]
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.
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI) [Completed]
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).
BOTOX« Versus Zanaflex« for the Treatment of Post-Stroke or Traumatic Brain Injury Upper Limb Spasticity [Completed]
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