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COMPLETED 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.

NCT00047580 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 120 participants
Start Date 2002-06
Est. Completion 2002-09
Phase Phase 3

Sponsor

Elan Pharmaceuticals

1 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Elan Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00047580 reports 16 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00047580?

The interventions under investigation include: tizanidine hydrochloride capsule (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00047580?

This trial is sponsored by Elan Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial