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NCT00047580 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study of Stroke and Multiple Sclerosis, sponsored by Elan Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 16
- Study locations
NCT00047580 is a Phase 3 study of Stroke and Multiple Sclerosis that has completed, run by Elan Pharmaceuticals. The registered enrollment target is 120 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The trial reports 16 study locations across 11 states.
The verdict
NCT00047580, a Phase 3 study of Stroke and Multiple Sclerosis, has completed, sponsored by Elan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 16
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG tizanidine hydrochloride capsule
Study Locations (16)
California
- The Neurology Center - Encinitas
- Northridge Neurological Center - Northridge
- The Neurology Center - Oceanside
- Neurology Medical Group of Diablo Valley - Walnut Creek
Florida
- Neurology Clinic Research Institution - Plantation
- Axiom Clinical Research - Tampa
Georgia
- Comprehensive Neurology Specialists, PC - Atlanta
- Neurotrials Research, Inc. - Atlanta
Arizona
- Radiant Research - Tucson
Colorado
- Colorado Neurology Movement Disorders Center - Englewood
Connecticut
- Yale Center for MS Treatment and Research - New Haven
Illinois
- Springfield Clinic Neuroscience Institute - Springfield
Minnesota
- The Minneapolis Clinic of Neurology, Ltd. - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2002-06 |
| Est. Completion | 2002-09 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00047580
The ClinicalTrials.gov registry entry for NCT00047580 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower). The listed sponsor is Elan Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Stroke appearing as the primary indexed condition, and to 1 intervention - of which tizanidine hydrochloride capsule is the first listed.
NCT00047580 reports 16 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT00047580 about?
NCT00047580 is a clinical study titled "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 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 ...
What is the current status of trial NCT00047580?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2002-06. Estimated completion is 2002-09.
What conditions does trial NCT00047580 study?
This clinical trial studies the following conditions: Stroke, Multiple Sclerosis, Spinal Cord Injury, Muscle Spasticity.
What interventions are being tested in trial NCT00047580?
The interventions under investigation include: tizanidine hydrochloride capsule (DRUG).
Who is sponsoring clinical trial NCT00047580?
This trial is sponsored by Elan Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00047580 being conducted?
This trial has 16 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.