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Nightly sublingual tizanidine HCl in multiple sclerosis: clinical efficacy and safety.
Clin Neuropharmacol. 2010 May; 33(3):151-4.CN

Abstract

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.

METHODS

A double-blind, double-dummy, randomized, 3-treatment, 2-way crossover, comparative, placebo-controlled study was conducted in a neuroimmunology clinic of a university-affiliated medical center (December 2005 to March 2006). Enrolled patients received placebo once nightly and were then randomized to receive oral tizanidine HCl following sublingual tizanidine HCl or sublingual tizanidine HCl following oral tizanidine HCl, each arm for 7 days. The patients were evaluated for spasticity (Ashworth scale), mobility, Global Assessments of Disease Severity and Change, and safety parameters, including next-day somnolence (Epworth Sleepiness Scale), fatigue, hypotension, and hepatotoxicity.

RESULTS

Sixteen MS patients aged 20 to 65 years with spasticity requiring treatment and Expanded Disability Status Scale score of 6.5 or less were enrolled. There were significant reductions in next-day (12-14 hours after dosing) spasticity following sublingual tizanidine compared with placebo and oral tizanidine, oral versus placebo treatment, and sublingual tizanidine versus placebo treatment. Fatigue, hypotension, or hepatotoxicity levels did not increase.

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.

Authors+Show Affiliations

Neuroimmunology Clinic, Department of Neurology, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel-Aviv, Israel.No affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20502134

Citation

Vakhapova, Veronika, et al. "Nightly Sublingual Tizanidine HCl in Multiple Sclerosis: Clinical Efficacy and Safety." Clinical Neuropharmacology, vol. 33, no. 3, 2010, pp. 151-4.
Vakhapova V, Auriel E, Karni A. Nightly sublingual tizanidine HCl in multiple sclerosis: clinical efficacy and safety. Clin Neuropharmacol. 2010;33(3):151-4.
Vakhapova, V., Auriel, E., & Karni, A. (2010). Nightly sublingual tizanidine HCl in multiple sclerosis: clinical efficacy and safety. Clinical Neuropharmacology, 33(3), 151-4. https://doi.org/10.1097/WNF.0b013e3181daad7d
Vakhapova V, Auriel E, Karni A. Nightly Sublingual Tizanidine HCl in Multiple Sclerosis: Clinical Efficacy and Safety. Clin Neuropharmacol. 2010;33(3):151-4. PubMed PMID: 20502134.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Nightly sublingual tizanidine HCl in multiple sclerosis: clinical efficacy and safety. AU - Vakhapova,Veronika, AU - Auriel,Eitan, AU - Karni,Arnon, PY - 2010/5/27/entrez PY - 2010/5/27/pubmed PY - 2010/9/2/medline SP - 151 EP - 4 JF - Clinical neuropharmacology JO - Clin Neuropharmacol VL - 33 IS - 3 N2 - 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. METHODS: A double-blind, double-dummy, randomized, 3-treatment, 2-way crossover, comparative, placebo-controlled study was conducted in a neuroimmunology clinic of a university-affiliated medical center (December 2005 to March 2006). Enrolled patients received placebo once nightly and were then randomized to receive oral tizanidine HCl following sublingual tizanidine HCl or sublingual tizanidine HCl following oral tizanidine HCl, each arm for 7 days. The patients were evaluated for spasticity (Ashworth scale), mobility, Global Assessments of Disease Severity and Change, and safety parameters, including next-day somnolence (Epworth Sleepiness Scale), fatigue, hypotension, and hepatotoxicity. RESULTS: Sixteen MS patients aged 20 to 65 years with spasticity requiring treatment and Expanded Disability Status Scale score of 6.5 or less were enrolled. There were significant reductions in next-day (12-14 hours after dosing) spasticity following sublingual tizanidine compared with placebo and oral tizanidine, oral versus placebo treatment, and sublingual tizanidine versus placebo treatment. Fatigue, hypotension, or hepatotoxicity levels did not increase. 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. SN - 1537-162X UR - https://www.unboundmedicine.com/medline/citation/20502134/Nightly_sublingual_tizanidine_HCl_in_multiple_sclerosis:_clinical_efficacy_and_safety_ L2 - https://doi.org/10.1097/WNF.0b013e3181daad7d DB - PRIME DP - Unbound Medicine ER -