A Multicenter, Open-Label, Randomized, 4-Way Crossover Trial of the Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex (Tizanidine Hydrochloride) Tablets Taken Under Fed and Fasted Conditions in Patients With Moderate to Severe Spasticity

Elan Pharmaceuticals15 sites in 1 country120 target enrollmentJune 2002

ConditionsMultiple Sclerosis Muscle Spasticity Spinal Cord Injury Stroke

Drugstizanidine hydrochloride capsule

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Elan Pharmaceuticals
Enrollment: 120
Locations: 15
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is being conducted to compare the impact of somnolence (sleepiness) on cognition (awareness) as well as the safety and effectiveness of tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride tablets) taken while in the fed state (just after a meal) and in the fasted state (before a meal) in patients with moderate to severe spasticity.

Registry

clinicaltrials.gov

Start Date

June 2002

End Date

September 2002

Last Updated

10 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Elan Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•IRB approved ICF must be signed and dated by patient or patient's legal representative
•Male or Female 18 years of age or older
•Clinical diagnosis of established spasticity (at least 3 months) secondary to multiple sclerosis, stroke, or spinal cord injury
•Currently on stable dose of up to 36mg of Zanaflex
•Must be able to swallow tablets or capsules whole

Exclusion Criteria

•Patients with dementia, aphasia, or other deficits in cognition
•Unwilling or unable to complete cognition test or daily diary
•Known sensitivity to Zanaflex
•Taking Zanaflex on an as needed ("prn") basis
•Currently being treated with drugs having significant effects at the alpha2 receptors whether agonist (i.e., clonidine, methyldopa) or antagonist (i.e., phenothiazines, imipramine)
•Currently on any other muscle relaxant or any drugs having muscle relaxant properties (including baclofen, dantrolene, diazepam and other benzodiazepines, tranquilizers, narcotic analgesics, high dose neuroleptics, chlormezanone, meprobamate, methocarbamol, orphenadrine, carisoprodol, gabapentin and clonidine
•Taking any over-the-counter or prescription sleep aids within 30 days prior to screening
•Use of illegal drugs or legal drugs for recreational purposes or excessive use of alcohol
•Patients suffering from disabling, symptomatic hypotension (i.e., syncope)
•Patients having any systemic disease such as renal insufficiency, clinically relevant elevations in hepatic transaminase, severe, uncontrolled systemic hypertension