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.

Last updated: December 10, 2015
Sponsor: Elan Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Stroke

Spinal Cord Disorders

Limb Spasticity

Treatment

N/A

Clinical Study ID

NCT00047580
ELN021-502
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 multiplesclerosis, 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

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 receptorswhether 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 toscreening

  • Use of illegal drugs or legal drugs for recreational purposes or excessive use ofalcohol

  • Patients suffering from disabling, symptomatic hypotension (i.e., syncope)

  • Patients having any systemic disease such as renal insufficiency, clinically relevantelevations 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 pregnancytest, lactating, or do not or will not take adequate contraceptive precautions for theduration of trial

Study Design

Total Participants: 120
Study Start date:
June 01, 2002
Estimated Completion Date:
September 30, 2002

Connect with a study center

  • Radiant Research

    Tucson, Arizona 85710
    United States

    Site Not Available

  • The Neurology Center

    Encinitas, California 92024
    United States

    Site Not Available

  • Northridge Neurological Center

    Northridge, California 91325
    United States

    Site Not Available

  • The Neurology Center

    Oceanside, California 92056
    United States

    Site Not Available

  • Neurology Medical Group of Diablo Valley

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Colorado Neurology Movement Disorders Center

    Englewood, Colorado 80110
    United States

    Site Not Available

  • Yale Center for MS Treatment and Research

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Neurology Clinic Research Institution

    Plantation, Florida 33324
    United States

    Site Not Available

  • Axiom Clinical Research

    Tampa, Florida 33609
    United States

    Site Not Available

  • Comprehensive Neurology Specialists, PC

    Atlanta, Georgia 30338
    United States

    Site Not Available

  • Neurotrials Research, Inc.

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Springfield Clinic Neuroscience Institute

    Springfield, Illinois 62702
    United States

    Site Not Available

  • The Minneapolis Clinic of Neurology, Ltd.

    Minneapolis, Minnesota 55422
    United States

    Site Not Available

  • Neurological Associates of Tulsa, Inc.

    Tulsa, Oklahoma 74136-8327
    United States

    Site Not Available

  • Medford Neurological and Spine Clinic

    Medford, Oregon 97504-8456
    United States

    Site Not Available

  • Sargent Rehabilitation Center

    Warwick, Rhode Island 02818
    United States

    Site Not Available

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