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NCT00033839 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Episodic Cluster Headache, sponsored by Winston Laboratories.

Completed
Registry status
Phase 3
Development phase
60
Enrollment target
20
Study locations

NCT00033839: Completed Phase 3 study of Episodic Cluster Headache, sponsored by Winston Laboratories.

NCT00033839 is a Phase 3 study of Episodic Cluster Headache that has completed, run by Winston Laboratories. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00033839, a Phase 3 study of Episodic Cluster Headache, has completed, sponsored by Winston Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
60 participants
Enrollment target
20
Study locations

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
Winston Laboratories

8 total trials

What the finished NCT00033839 record still lists

NCT00033839 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

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.

NCT00033839 names 20 study sites across 14 states, led by California, Arizona, Michigan.

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.

What interventions are being tested in trial NCT00033839?

The interventions under investigation include: Civamide (Zucapsaicin) (DRUG).

Who is sponsoring clinical trial NCT00033839?

This trial is sponsored by Winston Laboratories, which has 8 total clinical trials registered on ClinicalTrials.gov.

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.

How this trial's enrollment target compares

Where NCT00033839's enrollment target sits among peer trials

60 1804th of 2000 higher than 177 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00033839, the US trial registry maintained by the National Library of Medicine. NCT00033839 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.