Intranasal Civamide for Episodic Cluster Headache

NCT ID: NCT00069082

Last Updated: 2011-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Episodic Cluster Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Civamide

Nasal Solution 0.01%

Group Type ACTIVE_COMPARATOR

Civamide (Zucapsaicin)

Intervention Type DRUG

Nasal Solution 0.01%

Placebo

Placebo nasal solution with sodium chloride 10%

Group Type PLACEBO_COMPARATOR

Sodium Chloride

Intervention Type DRUG

Nasal Solution 10%

Interventions

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Civamide (Zucapsaicin)

Nasal Solution 0.01%

Intervention Type DRUG

Sodium Chloride

Nasal Solution 10%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Winston Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Winston Laboratories, Inc.

Principal Investigators

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Scott B Phillips, MD

Role: STUDY_DIRECTOR

Winston Laboratories

Locations

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San Francisco Clinical Research Center

San Francisco, California, United States

Site Status

California Medical Clinic for Headache

Santa Monica, California, United States

Site Status

Colorado Neurology and Headache Clinic

Denver, Colorado, United States

Site Status

Diamond Headache Clinic

Chicago, Illinois, United States

Site Status

New York Headache Center

New York, New York, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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WL-1001-02-05

Identifier Type: -

Identifier Source: org_study_id

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