Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity
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|ClinicalTrials.gov Identifier: NCT00358293|
Recruitment Status : Completed
First Posted : July 31, 2006
Last Update Posted : January 21, 2009
|Condition or disease||Intervention/treatment||Phase|
|Muscle Spasticity||Drug: Tizanidine (sublingual or oral)||Phase 1 Phase 2|
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 20 MS patients, at a dose of 8 mg, it was shown to improve next-day spasticity (statistically significant improvement in Ashworth scores) about 12 hours post-dosing), improvement in nighttime (first quartile) sleep efficiency (as demonstrated by actigraphic measurement), and no increase in daytime somnolence.
Current study is being undertaken to evaluate if increased dosing (12 mg once nightly) of sublingual tizanidine (vs. oral) will show a concomitant increase in clinical effect, i.e., longer improvement, with next-day spasticity score improvement both in AM (as previously) as well as at PM (late afternoon) evaluation, with no increase in daytime somnolence.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Double-Blind, Randomized, Crossover Study to Evaluate the Clinical Efficacy and Safety of Oral Tizanidine HCl (12 mg) Versus Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in MS Patients|
|Study Start Date :||December 2006|
|Study Completion Date :||February 2007|
- Clinical efficacy - improvement in next-day spasticity (Ashworth scores)
- Safety - no increase in next-day somnolence (measured objectively using PVT psychomotor vigilance task monitoring) and subjectively, using Epworth Sleepiness Scale (ESS) and Fatigue Severity Scale (FSS) questionnaires
- Secondary clinical efficacy - objective measure of sleep (actigraphy measures)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358293
|Tel Aviv Sourasky Medical Center- Neurology Department|
|Tel Aviv, Israel|
|Principal Investigator:||Arnon Karni, MD||Department of Neurology, Tel Aviv Sourasky Medical Center|