Intranasal Civamide for Episodic Cluster Headache

June 8, 2011 updated by: Winston Laboratories

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States
        • San Francisco Clinical Research Center
      • Santa Monica, California, United States
        • California Medical Clinic for Headache
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Neurology and Headache Clinic
    • Illinois
      • Chicago, Illinois, United States
        • Diamond Headache Clinic
    • New York
      • New York, New York, United States
        • New York Headache Center
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • At least 2 year history of episodic cluster headache (meeting IHS criteria)
  • At least 2 previous episodes
  • Expected duration of cluster period is at least 6 weeks but not longer than 24 weeks
  • At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Civamide
Nasal Solution 0.01%
Drug: Civamide (Zucapsaicin)
Nasal Solution 0.01%
Placebo Comparator: Placebo
Placebo nasal solution with sodium chloride 10%
Drug: Sodium Chloride
Nasal Solution 10%

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Winston Laboratories

Investigators

  • Study Director: Scott B Phillips, MD, Winston Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

January 1, 2004

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

September 15, 2003

First Submitted That Met QC Criteria

September 15, 2003

First Posted (Estimate)

September 16, 2003

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WL-1001-02-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Episodic Cluster Headache

Clinical Trials on Civamide (Zucapsaicin)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe