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.

Condition	Treatment or Intervention	Phase
Multiple Sclerosis Muscle Spasticity Spinal Cord Injury Stroke	Drug: tizanidine hydrochloride capsule	Phase III

Further Study Details: 

Expected Total Enrollment:  120

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Arizona
      Radiant Research, Tucson,  Arizona,  85710,  United States
California
      The Neurology Center, Oceanside,  California,  92056,  United States
      The Neurology Center, Encinitas,  California,  92024,  United States
      Neurology Medical Group of Diablo Valley, Walnut Creek,  California,  94598,  United States
      Northridge Neurological Center, Northridge,  California,  91325,  United States
Colorado
      Colorado Neurology Movement Disorders Center, Englewood,  Colorado,  80110,  United States
Connecticut
      Yale Center for MS Treatment and Research, New Haven,  Connecticut,  06510,  United States
Florida
      Neurology Clinic Research Institution, Plantation,  Florida,  33324,  United States
      Axiom Clinical Research, Tampa,  Florida,  33609,  United States
Georgia
      Neurotrials Research, Inc., Atlanta,  Georgia,  30342,  United States
      Comprehensive Neurology Specialists, PC, Atlanta,  Georgia,  30338,  United States
Illinois
      Springfield Clinic Neuroscience Institute, Springfield,  Illinois,  62702,  United States
Minnesota
      The Minneapolis Clinic of Neurology, Ltd., Minneapolis,  Minnesota,  55422,  United States
Oklahoma
      Neurological Associates of Tulsa, Inc., Tulsa,  Oklahoma,  74136-8327,  United States
Oregon
      Medford Neurological and Spine Clinic, Medford,  Oregon,  97504-8456,  United States
Rhode Island
      Sargent Rehabilitation Center, Warwick,  Rhode Island,  02818,  United States

Study ID Numbers:  ELN021-502
Record last reviewed:  October 2002
Last Updated:  October 13, 2004
Record first received:  October 8, 2002
ClinicalTrials.gov Identifier:  NCT00047580
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08