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:
Elan Pharmaceuticals
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00047580
First received: October 8, 2002
Last updated: June 23, 2005
Last verified: October 2002
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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
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 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 Wounds and Injuries Cerebrovascular Disorders Brain Diseases Vascular Diseases Cardiovascular Diseases Tizanidine Clonidine Analgesics Sensory System Agents |
ClinicalTrials.gov processed this record on June 17, 2013