NCT00033839

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2002

Geographic Reach
1 country

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2002

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

1.5 years

First QC Date

April 11, 2002

Last Update Submit

June 8, 2011

Conditions

Episodic Cluster Headache

Keywords

HeadacheClusterECEpisodic Cluster

Interventions

Civamide (Zucapsaicin)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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 16 weeks * At least 1 but not more than 8 headaches on each of the 3 days immediately prior to treatment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (26)

Valley Neurological Headache & Research Center

Phoenix, Arizona, 85020, United States

Location

Neurological Associates of Tucson

Tucson, Arizona, 85712, United States

Location

Northern California Headache Clinic

Mountain View, California, 94040, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

New England Center for Headache, PC

Stamford, Connecticut, 06902, United States

Location

Neurology Clinical Research, Inc.

Plantation, Florida, 33324, United States

Location

Neurology and Headache Specialists of Atlanta

Decatur, Georgia, 30033, United States

Location

Diamond Headache Clinic

Chicago, Illinois, 60614, United States

Location

Boston Clinical Research Center

Wellesley Hills, Massachusetts, 02481, United States

Location

Michigan Headache Pain & Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Henry Ford Hospital Department of Neurology

Detroit, Michigan, 48202, United States

Location

Department of Neurology Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mercy Health Research

Chesterfield, Missouri, 63017, United States

Location

Headache Care Center/Clinvest

Springfield, Missouri, 65804, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

New York Headache Center

New York, New York, 10021, United States

Location

The Headache Wellness Center

Greensboro, North Carolina, 27401, United States

Location

Cincinnati Headache Clinic

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

Neurological Associates of Tulsa, Inc.

Tulsa, Oklahoma, 74136, United States

Location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

Nashville Neuroscience Center

Nashville, Tennessee, 37203, United States

Location

Houston Headache Clinic

Houston, Texas, 77004, United States

Location

The Neurology and Headache Treatment Center (Innovative Clinical Research)

Alexandria, Virginia, 22304, United States

Location

MeSH Terms

Conditions

Cluster HeadacheHeadache

Interventions

zucapsaicin

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Scott B. Phillips, M.D.

    Winston Laboratories

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 11, 2002

First Posted

April 12, 2002

Study Start

January 1, 2002

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

US(26)