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Sponsored by: |
Teva R&D Initiative |
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Information provided by: | Teva R&D Initiative |
ClinicalTrials.gov Identifier: | NCT00358293 |
Nightly administration of 8 mg of a unique sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve next-day spasticity, about 12 hours following dosing in 20 multiple sclerosis (MS) patients. This improvement was statistically significant when compared to oral tizanidine dosing. The current study is being undertaken to see if increasing the dose to 12 mg once nightly will result in an even greater improvement, with a longer effect, i.e., next day improvement in spasticity both in the morning as well as in the late afternoon.
Condition | Intervention | Phase |
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Muscle Spasticity |
Drug: Tizanidine (sublingual or oral) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Crossover Study to Evaluate the Clinical Efficacy and Safety of Oral Tizanidine HCl (12 mg) Versus Novel Sublingual Tizanidine HCl (12 mg) for the Treatment of Spasticity in MS Patients |
Estimated Enrollment: | 20 |
Study Start Date: | December 2006 |
Study Completion Date: | February 2007 |
Sublingual tizanidine, a novel test formulation of the known effective antispasticity agent, has been shown to have a unique pharmacokinetic profile [(i.e., nearly twice the bioavailability/AUC), but with little or no increase in peak plasma levels (Cmax) as compared to oral tizanidine (Zanaflex)]. When administered nightly to 20 MS patients, at a dose of 8 mg, it was shown to improve next-day spasticity (statistically significant improvement in Ashworth scores) about 12 hours post-dosing), improvement in nighttime (first quartile) sleep efficiency (as demonstrated by actigraphic measurement), and no increase in daytime somnolence.
Current study is being undertaken to evaluate if increased dosing (12 mg once nightly) of sublingual tizanidine (vs. oral) will show a concomitant increase in clinical effect, i.e., longer improvement, with next-day spasticity score improvement both in AM (as previously) as well as at PM (late afternoon) evaluation, with no increase in daytime somnolence.
Ages Eligible for Study: | 20 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
May be allowed to take other anti-spasticity medication during study (including oral baclofen) as per individual dosing regimen, with the following qualifications:
Exclusion Criteria:
Israel | |
Tel Aviv Sourasky Medical Center- Neurology Department | |
Tel Aviv, Israel |
Principal Investigator: | Arnon Karni, MD | Department of Neurology, Tel Aviv Sourasky Medical Center |
Study ID Numbers: | Protocol C2/5/TZ-MS-05 |
Study First Received: | July 27, 2006 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00358293 |
Health Authority: | Israel: Ministry of Health |
Multiple Sclerosis Spasticity Sublingual Tizanidine Ashworth Scores Spasticity in Multiple Sclerosis Patients |
Autoimmune Diseases Demyelinating Diseases Sclerosis Demyelinating diseases Signs and Symptoms Muscle Spasticity Multiple Sclerosis |
Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Demyelinating Autoimmune Diseases, CNS Neurologic Manifestations Tizanidine Autoimmune Diseases of the Nervous System |
Parasympatholytics Neuromuscular Manifestations Neurotransmitter Agents Adrenergic alpha-Agonists Immune System Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Neuromuscular Agents |
Adrenergic Agonists Pharmacologic Actions Autonomic Agents Sensory System Agents Muscle Relaxants, Central Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |