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.
Public ClinicalTrials.gov record NCT00047580. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00047580
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 120 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2002
- Primary completion
- Not listed
- Completion
- Aug 31, 2002
- Last update posted
- Dec 13, 2015
2002
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Radiant Research | Tucson | Arizona | 85710 | — |
| The Neurology Center | Encinitas | California | 92024 | — |
| Northridge Neurological Center | Northridge | California | 91325 | — |
| The Neurology Center | Oceanside | California | 92056 | — |
| Neurology Medical Group of Diablo Valley | Walnut Creek | California | 94598 | — |
| Colorado Neurology Movement Disorders Center | Englewood | Colorado | 80110 | — |
| Yale Center for MS Treatment and Research | New Haven | Connecticut | 06510 | — |
| Neurology Clinic Research Institution | Plantation | Florida | 33324 | — |
| Axiom Clinical Research | Tampa | Florida | 33609 | — |
| Comprehensive Neurology Specialists, PC | Atlanta | Georgia | 30338 | — |
| Neurotrials Research, Inc. | Atlanta | Georgia | 30342 | — |
| Springfield Clinic Neuroscience Institute | Springfield | Illinois | 62702 | — |
| The Minneapolis Clinic of Neurology, Ltd. | Minneapolis | Minnesota | 55422 | — |
| Neurological Associates of Tulsa, Inc. | Tulsa | Oklahoma | 74136-8327 | — |
| Medford Neurological and Spine Clinic | Medford | Oregon | 97504-8456 | — |
| Sargent Rehabilitation Center | Warwick | Rhode Island | 02818 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00047580, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 13, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00047580 live on ClinicalTrials.gov.