Comparison of Safety and Efficacy 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.

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047580
• Other study ID #: ELN021-502
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2002
• Last updated: December 10, 2015
• Start date: June 2002
• Est. completion date: September 2002

Study information

• Verified date: December 2015
• Source: Elan Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Any clinically significant illnesses, within four weeks of screening

• Patients with known sleep disorders

• Patients who participated in a clinical trial within thiry days prior to screening

• Women of childbearing potential who are pregnant, have a positive serum pregnancy test, lactating, or do not or will not take adequate contraceptive precautions for the duration of trial

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Muscle Spasticity
• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke

Intervention

Drug:
• tizanidine hydrochloride capsule

Locations

Country	Name	City	State
United States	Comprehensive Neurology Specialists, PC	Atlanta	Georgia
United States	Neurotrials Research, Inc.	Atlanta	Georgia
United States	The Neurology Center	Encinitas	California
United States	Colorado Neurology Movement Disorders Center	Englewood	Colorado
United States	Medford Neurological and Spine Clinic	Medford	Oregon
United States	The Minneapolis Clinic of Neurology, Ltd.	Minneapolis	Minnesota
United States	Yale Center for MS Treatment and Research	New Haven	Connecticut
United States	Northridge Neurological Center	Northridge	California
United States	The Neurology Center	Oceanside	California
United States	Neurology Clinic Research Institution	Plantation	Florida
United States	Springfield Clinic Neuroscience Institute	Springfield	Illinois
United States	Axiom Clinical Research	Tampa	Florida
United States	Radiant Research	Tucson	Arizona
United States	Neurological Associates of Tulsa, Inc.	Tulsa	Oklahoma
United States	Neurology Medical Group of Diablo Valley	Walnut Creek	California
United States	Sargent Rehabilitation Center	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Elan Pharmaceuticals

Country where clinical trial is conducted

United States,