Clinical trial NCT00047580: 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.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Muscle Spasticity
Spinal Cord Injury
Stroke
Keywords: Spasticity
spasticity secondary to Multiple Sclerosis
Spinal Cord Injury
Stroke
Lead sponsor: Elan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2002-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Radiant Research
state: Arizona
city: Encinitas
country: United States
facility: The Neurology Center
state: California
city: Northridge
country: United States
facility: Northridge Neurological Center
state: California
city: Oceanside
country: United States
facility: The Neurology Center
state: California
city: Walnut Creek
country: United States
facility: Neurology Medical Group of Diablo Valley
state: California
city: Englewood
country: United States
facility: Colorado Neurology Movement Disorders Center
state: Colorado
city: New Haven
country: United States
facility: Yale Center for MS Treatment and Research
state: Connecticut
city: Plantation
country: United States
facility: Neurology Clinic Research Institution
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research
state: Florida
city: Atlanta
country: United States
facility: Comprehensive Neurology Specialists, PC
state: Georgia
city: Atlanta
country: United States
facility: Neurotrials Research, Inc.
state: Georgia
city: Springfield
country: United States
facility: Springfield Clinic Neuroscience Institute
state: Illinois
city: Minneapolis
country: United States
facility: The Minneapolis Clinic of Neurology, Ltd.
state: Minnesota
city: Tulsa
country: United States
facility: Neurological Associates of Tulsa, Inc.
state: Oklahoma
city: Medford
country: United States
facility: Medford Neurological and Spine Clinic
state: Oregon
city: Warwick
country: United States
facility: Sargent Rehabilitation Center
state: Rhode Island
Study officials:
References: