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.

This study has been completed.

First Received: October 8, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	Elan Pharmaceuticals
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00047580

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis Muscle Spasticity Spinal Cord Injury Stroke	Drug: tizanidine hydrochloride capsule	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis Spinal Cord Injuries

Drug Information available for: Tizanidine Tizanidine hydrochloride

U.S. FDA Resources

Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment:	120
Study Start Date:	June 2002
Estimated Study Completion Date:	September 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047580

Locations

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

Sponsors and Collaborators

Elan Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	ELN021-502
Study First Received:	October 8, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00047580 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:

Spasticity
spasticity secondary to Multiple Sclerosis
Spinal Cord Injury
Stroke

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neuromuscular Agents
Brain Diseases
Spinal Cord Injuries
Pathologic Processes
Therapeutic Uses
Muscle Relaxants, Central
Cardiovascular Diseases
Tizanidine
Autoimmune Diseases of the Nervous System
Neuromuscular Manifestations
Demyelinating Diseases

Immune System Diseases
Nervous System Diseases
Wounds and Injuries
Sclerosis
Trauma, Nervous System
Antihypertensive Agents
Muscle Spasticity
Demyelinating Autoimmune Diseases, CNS
Parasympatholytics
Spinal Cord Diseases
Disorders of Environmental Origin
Cerebrovascular Disorders
Adrenergic Agonists
Signs and Symptoms
Multiple Sclerosis

ClinicalTrials.gov processed this record on March 18, 2010