Intranasal Civamide for 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).

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Key information

Conditions

Episodic Cluster Headache Brain Diseases Central Nervous System Diseases Cluster Headache Headache Headache Disorders Headache Disorders, Primary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Trigeminal Autonomic Cephalalgias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

San Francisco Clinical Research Center, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Civamide (Zucapsaicin)

Drug

Nasal Solution 0.01%

Sodium Chloride

Drug

Nasal Solution 10%

Sponsors and collaborators

Lead sponsor

Winston Laboratories

Industry

Registry information

Official study title

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Evaluation of Civamide (Zucapsaicin) Nasal Solution in the Treatment of Episodic Cluster Headache

Important dates

Study start: 2003
Primary completion: 2004
Study completion: 2004
First posted: Sep 16, 2003
Registry last updated: Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed