Multiple Sclerosis Clinical Trial
Official title:
Long Term Clinical Efficacy and Safety of Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in Patients With Multiple Sclerosis - Open Label Extension Study
Open label, one year extension study to evaluate the clinical efficacy and safety of 12 mg sublingual tizanidine administered once nightly in MS patients who successfully completed Phase I/II protocol C2/5/TZ:MS-05 at the Tel Aviv Sourasky Medical Center, Department of Neurology, Dr. Arnon Karni, PI.
The previous study, Protocol C2/5/TZ-MS-05, using 12 mg sublingual tizanidine, confirmed
that administration of once nightly sublingual tizanidine before sleep results in a
statistically and clinically significant reduction in next-day spasticity, as compared to
placebo. The clinical effect following 12 mg sublingual tizanidine was larger (4-5 units on
the Ashworth scale) and more sustained (up to 18-20 hours post-dose) than was seen for 8 mg
tizanidine (earlier study, Protocol C2/5/TZ:MS-03z). This study also reconfirmed that the
increased improvement in next-day reduction of spasticity following overnight sublingual
tizanidine dosing is not accompanied by a concomitant increase in next-day somnolence.
This study, a 12 month open label extension, will allow those patients who successfully
completed Protocol C2/5/TZ-MS-05 and who found tizanidine to be beneficial, to continue
treatment under close medical supervision. The study will provide long-term (12 months)
clinical efficacy and safety data re: the use of once daily sublingual tizanidine,
administered at night, just before bedtime.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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