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.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Elan Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | 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.
