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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: Completed Phase 3 study of Stroke and Multiple Sclerosis, sponsored by Elan Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00047580 record still lists
NCT00047580 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (99% lower).
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 lists 16 locations in 11 states (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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Where NCT00047580's enrollment target sits among peer trials
120 117th of 454 higher than 329 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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