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Sponsored by: |
Elan Pharmaceuticals |
---|---|
Information provided by: | Elan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00047580 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Radiant Research | |
Tucson, Arizona, United States, 85710 | |
United States, California | |
The Neurology Center | |
Oceanside, California, United States, 92056 | |
The Neurology Center | |
Encinitas, California, United States, 92024 | |
Neurology Medical Group of Diablo Valley | |
Walnut Creek, California, United States, 94598 | |
Northridge Neurological Center | |
Northridge, California, United States, 91325 | |
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 |
Study ID Numbers: | ELN021-502 |
Study First Received: | October 8, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00047580 |
Health Authority: | United States: Food and Drug Administration |
Spasticity spasticity secondary to Multiple Sclerosis Spinal Cord Injury Stroke |
Cerebral Infarction Spinal Cord Diseases Disorders of Environmental Origin Demyelinating diseases Brain Diseases Cerebrovascular Disorders Naphazoline Spinal Cord Injuries Signs and Symptoms Malnutrition Multiple Sclerosis Musculoskeletal Diseases Phenylephrine Muscle Hypertonia Neoplasm Metastasis |
Tizanidine Phenylpropanolamine Autoimmune Diseases of the Nervous System Autoimmune Diseases Demyelinating Diseases Clonidine Stroke Wounds and Injuries Vascular Diseases Central Nervous System Diseases Sclerosis Trauma, Nervous System Oxymetazoline Muscle Spasticity Muscular Diseases |
Parasympatholytics Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Neuromuscular Agents Adrenergic Agonists Pathologic Processes Sensory System Agents Therapeutic Uses Muscle Relaxants, Central Cardiovascular Diseases Analgesics |
Neuromuscular Manifestations Sympatholytics Adrenergic alpha-Agonists Immune System Diseases Nervous System Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |