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.
NCT ID: NCT00047580
Last Updated: 2015-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2002-06-30
2002-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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tizanidine hydrochloride capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Elan Pharmaceuticals
INDUSTRY
Locations
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Radiant Research
Tucson, Arizona, United States
The Neurology Center
Encinitas, California, United States
Northridge Neurological Center
Northridge, California, United States
The Neurology Center
Oceanside, California, United States
Neurology Medical Group of Diablo Valley
Walnut Creek, California, United States
Colorado Neurology Movement Disorders Center
Englewood, Colorado, United States
Yale Center for MS Treatment and Research
New Haven, Connecticut, United States
Neurology Clinic Research Institution
Plantation, Florida, United States
Axiom Clinical Research
Tampa, Florida, United States
Comprehensive Neurology Specialists, PC
Atlanta, Georgia, United States
Neurotrials Research, Inc.
Atlanta, Georgia, United States
Springfield Clinic Neuroscience Institute
Springfield, Illinois, United States
The Minneapolis Clinic of Neurology, Ltd.
Minneapolis, Minnesota, United States
Neurological Associates of Tulsa, Inc.
Tulsa, Oklahoma, United States
Medford Neurological and Spine Clinic
Medford, Oregon, United States
Sargent Rehabilitation Center
Warwick, Rhode Island, United States
Countries
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Other Identifiers
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ELN021-502
Identifier Type: -
Identifier Source: org_study_id