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.
Information source: Elan Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis; Muscle Spasticity; Spinal Cord Injury; Stroke
Intervention: tizanidine hydrochloride capsule (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Elan Pharmaceuticals
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Radiant Research, Tucson, Arizona 85710, United States
The Neurology Center, Oceanside, California 92056, United States
The Neurology Center, Encinitas, California 92024, United States
Neurology Medical Group of Diablo Valley, Walnut Creek, California 94598, United States
Northridge Neurological Center, Northridge, California 91325, United States
Colorado Neurology Movement Disorders Center, Englewood, Colorado 80110, United States
Yale Center for MS Treatment and Research, New Haven, Connecticut 06510, United States
Neurology Clinic Research Institution, Plantation, Florida 33324, United States
Axiom Clinical Research, Tampa, Florida 33609, United States
Neurotrials Research, Inc., Atlanta, Georgia 30342, United States
Comprehensive Neurology Specialists, PC, Atlanta, Georgia 30338, United States
Springfield Clinic Neuroscience Institute, Springfield, Illinois 62702, United States
The Minneapolis Clinic of Neurology, Ltd., Minneapolis, Minnesota 55422, United States
Neurological Associates of Tulsa, Inc., Tulsa, Oklahoma 74136-8327, United States
Medford Neurological and Spine Clinic, Medford, Oregon 97504-8456, United States
Sargent Rehabilitation Center, Warwick, Rhode Island 02818, United States
Additional Information
Starting date: June 2002
Ending date: September 2002
Last updated: June 23, 2005
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