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COMPLETED Phase 3

A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache

NCT00033839 · View on ClinicalTrials.gov ↗

Study Summary

This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).

Conditions Studied

Interventions

  • DRUG Civamide (Zucapsaicin)

Study Locations (20)

California

  • Northern California Headache Clinic — Mountain View
  • San Francisco Clinical Research Center — San Francisco
  • California Medical Clinic for Headache — Santa Monica

Arizona

  • Valley Neurological Headache & Research Center — Phoenix
  • Neurological Associates of Tucson — Tucson

Michigan

  • Michigan Headache Pain & Neurological Institute — Ann Arbor
  • Henry Ford Hospital Department of Neurology — Detroit

Missouri

  • Mercy Health Research — Chesterfield
  • Headache Care Center/Clinvest — Springfield

Ohio

  • Cincinnati Headache Clinic — Cincinnati
  • Cleveland Clinic Foundation — Cleveland

Connecticut

  • New England Center for Headache, PC — Stamford

Florida

  • Neurology Clinical Research, Inc. — Plantation

Georgia

  • Neurology and Headache Specialists of Atlanta — Decatur

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2002-01
Est. Completion 2003-07
Phase Phase 3

Sponsor

Winston Laboratories

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00033839

The ClinicalTrials.gov registry entry for NCT00033839 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 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Winston Laboratories, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Episodic Cluster Headache appearing as the primary indexed condition, and to 1 intervention — of which Civamide (Zucapsaicin) 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: NCT00033839 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Arizona, Michigan. 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 NCT00033839 about?

NCT00033839 is a clinical study titled "A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache". This is a 49-day study to evaluate the effectiveness of Intranasal Civamide (Zucapsaicin) in the treatment of an episodic cluster headache period compared to placebo (medically inactive substance which does not contain any active ingredients).

What is the current status of trial NCT00033839?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2002-01. Estimated completion is 2003-07.

What conditions does trial NCT00033839 study?

This clinical trial studies the following conditions: Episodic Cluster Headache. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00033839?

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

Who is sponsoring clinical trial NCT00033839?

This trial is sponsored by Winston Laboratories, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00033839 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. 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