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.

December 10, 2015 updated by: Elan Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Radiant Research
    • California
      • Encinitas, California, United States, 92024
        • The Neurology Center
      • Northridge, California, United States, 91325
        • Northridge Neurological Center
      • Oceanside, California, United States, 92056
        • The Neurology Center
      • Walnut Creek, California, United States, 94598
        • Neurology Medical Group of Diablo Valley
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Colorado Neurology Movement Disorders Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Center for MS Treatment and Research
    • Florida
      • Plantation, Florida, United States, 33324
        • Neurology Clinic Research Institution
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • NeuroTrials Research, Inc.
      • Atlanta, Georgia, United States, 30338
        • Comprehensive Neurology Specialists, PC
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic Neuroscience Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55422
        • The Minneapolis Clinic of Neurology, Ltd.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136-8327
        • Neurological Associates of Tulsa, Inc.
    • Oregon
      • Medford, Oregon, United States, 97504-8456
        • Medford Neurological and Spine Clinic
    • Rhode Island
      • Warwick, Rhode Island, United States, 02818
        • Sargent Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2002

Study Completion

September 1, 2002

Study Registration Dates

First Submitted

October 8, 2002

First Submitted That Met QC Criteria

October 9, 2002

First Posted (Estimate)

October 10, 2002

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELN021-502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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