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. - Tabular View

Tracking Information
First Received Date ^ICMJE	October 8, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	June 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00047580 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label
Condition ^ICMJE	Multiple Sclerosis Muscle Spasticity Spinal Cord Injury Stroke
Intervention ^ICMJE	Drug: tizanidine hydrochloride capsule
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	September 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00047580
Responsible Party
Study ID Numbers ^ICMJE	ELN021-502
Study Sponsor ^ICMJE	Elan Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Elan Pharmaceuticals
Verification Date	October 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP