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.

This study has been completed.
Sponsor:
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00047580
First received: October 8, 2002
Last updated: June 23, 2005
Last verified: October 2002
  Purpose

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 Intervention Phase
Multiple Sclerosis
Muscle Spasticity
Spinal Cord Injury
Stroke
Drug: tizanidine hydrochloride capsule
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment: 120
Study Start Date: June 2002
Estimated Study Completion Date: September 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047580

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

No publications provided

ClinicalTrials.gov Identifier: NCT00047580     History of Changes
Other Study ID Numbers: ELN021-502
Study First Received: October 8, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:
Spasticity
spasticity secondary to Multiple Sclerosis
Spinal Cord Injury
Stroke

Additional relevant MeSH terms:
Multiple Sclerosis
Muscle Spasticity
Sclerosis
Spinal Cord Injuries
Stroke
Wounds and Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Tizanidine
Clonidine
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on August 28, 2014