Phase
Condition
Stroke
Spinal Cord Disorders
Limb Spasticity
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 multiplesclerosis, 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
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 receptorswhether 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 toscreening
Use of illegal drugs or legal drugs for recreational purposes or excessive use ofalcohol
Patients suffering from disabling, symptomatic hypotension (i.e., syncope)
Patients having any systemic disease such as renal insufficiency, clinically relevantelevations 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 pregnancytest, lactating, or do not or will not take adequate contraceptive precautions for theduration of trial
Study Design
Connect with a study center
Radiant Research
Tucson, Arizona 85710
United StatesSite Not Available
The Neurology Center
Encinitas, California 92024
United StatesSite Not Available
Northridge Neurological Center
Northridge, California 91325
United StatesSite Not Available
The Neurology Center
Oceanside, California 92056
United StatesSite Not Available
Neurology Medical Group of Diablo Valley
Walnut Creek, California 94598
United StatesSite Not Available
Colorado Neurology Movement Disorders Center
Englewood, Colorado 80110
United StatesSite Not Available
Yale Center for MS Treatment and Research
New Haven, Connecticut 06510
United StatesSite Not Available
Neurology Clinic Research Institution
Plantation, Florida 33324
United StatesSite Not Available
Axiom Clinical Research
Tampa, Florida 33609
United StatesSite Not Available
Comprehensive Neurology Specialists, PC
Atlanta, Georgia 30338
United StatesSite Not Available
Neurotrials Research, Inc.
Atlanta, Georgia 30342
United StatesSite Not Available
Springfield Clinic Neuroscience Institute
Springfield, Illinois 62702
United StatesSite Not Available
The Minneapolis Clinic of Neurology, Ltd.
Minneapolis, Minnesota 55422
United StatesSite Not Available
Neurological Associates of Tulsa, Inc.
Tulsa, Oklahoma 74136-8327
United StatesSite Not Available
Medford Neurological and Spine Clinic
Medford, Oregon 97504-8456
United StatesSite Not Available
Sargent Rehabilitation Center
Warwick, Rhode Island 02818
United StatesSite Not Available
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