drugset / Trial / NCT00358293

Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity

NCT00358293

Phase 1/2 Completed 20 enrolled Teva GTC
RandomizedCrossoverDouble-blindTreatment

Summary

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.

Timeline

Start
2006-12
Primary completion
Completion
2007-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Tizanidine Small molecule 12 mg Other

Indications

No indication recorded.