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

NCT00358293 Phase 1/Phase 2 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.

Details

Lead sponsor	Teva GTC
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	20
Start date	2006-12
Completion	2007-02

Conditions

• Muscle Spasticity

Interventions

• Tizanidine (sublingual or oral)

Primary outcomes

• 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

Countries

Israel