Intranasal Civamide for Episodic Cluster Headache

Winston Laboratories2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Episodic Cluster Headache

Interventions

Civamide (Zucapsaicin)DRUG

Nasal Solution 0.01%

Sodium ChlorideDRUG

Nasal Solution 10%

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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

Locations (6)

San Francisco Clinical Research Center

San Francisco, California, United States

California Medical Clinic for Headache

Santa Monica, California, United States

Colorado Neurology and Headache Clinic

Denver, Colorado, United States

Diamond Headache Clinic

Chicago, Illinois, United States

Data from ClinicalTrials.gov

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