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Completed Phase 3 Interventional

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.

ClinicalTrials.gov ID: NCT00047580

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.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 10:19 PM EDT

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
Lead sponsor
Elan Pharmaceuticals
Industry
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
Jun 2002 (Type not available)
Primary completion
Not listed
Completion
Sep 2002 (Type not available)
Last update posted
Dec 14, 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.

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 14, 2015 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00047580 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →