Who is sponsoring NCT00464958?

NCT00464958 is sponsored by Teva GTC.

What condition does NCT00464958 study?

NCT00464958 studies Spasticity, Multiple Sclerosis.

What drugs are being tested in NCT00464958?

Interventions: sublingual tizanidine 12 mg.

What is the status of NCT00464958?

NCT00464958 is currently TERMINATED.

Last reviewed 2009-02-17 · How we verify

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

NCT00464958 Phase 1/Phase 2 TERMINATED

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.

Details

Lead sponsor	Teva GTC
Phase	Phase 1/Phase 2
Status	TERMINATED
Enrolment	10
Start date	2008-01
Completion	2008-12

Conditions

Spasticity
Multiple Sclerosis

Interventions

sublingual tizanidine 12 mg

Primary outcomes

Clinical Efficacy- reduction in next-day spasticity (Ashworth scores) — 12 months
Safety- No increase in next-day somnolence/fatigue, measured via Epworth Sleepiness Scale (ESS) and Fatigue Severity Scale (FSS) questionnaires — 12 months

Countries

Israel