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.
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
1 other identifier
interventional
120
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-sclerosis
Started Jun 2002
Shorter than P25 for phase_3 multiple-sclerosis
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 8, 2002
CompletedFirst Posted
Study publicly available on registry
October 10, 2002
CompletedDecember 14, 2015
December 1, 2015
October 8, 2002
December 10, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Radiant Research
Tucson, Arizona, 85710, United States
The Neurology Center
Encinitas, California, 92024, United States
Northridge Neurological Center
Northridge, California, 91325, United States
The Neurology Center
Oceanside, California, 92056, United States
Neurology Medical Group of Diablo Valley
Walnut Creek, California, 94598, 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
Comprehensive Neurology Specialists, PC
Atlanta, Georgia, 30338, United States
Neurotrials Research, Inc.
Atlanta, Georgia, 30342, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 8, 2002
First Posted
October 10, 2002
Study Start
June 1, 2002
Study Completion
September 1, 2002
Last Updated
December 14, 2015
Record last verified: 2015-12