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Episodic Cluster HeadachePhase 3NCT00033839

A Phase III Study of Civamide Nasal Solution (Zucapsaicin) for the Treatment of Episodic Cluster Headache

A Phase 3 study testing Civamide (Zucapsaicin) in people with Episodic Cluster Headache, run by Winston Laboratories at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Episodic Cluster Headache
What is being tested?
Civamide (Zucapsaicin)
How many people
60 participants
Where
26 sitesUnited States
Study dates
Jan 2002to Jul 2003
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  • 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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • The Neurology and Headache Treatment Center (Innovative Clinical Research)

    Alexandria, Virginia, 22304

  • Michigan Headache Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

  • Mercy Health Research

    Chesterfield, Missouri, 63017

  • Diamond Headache Clinic

    Chicago, Illinois, 60614

  • Cincinnati Headache Clinic

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Neurology and Headache Specialists of Atlanta

    Decatur, Georgia, 30033

  • Henry Ford Hospital Department of Neurology

    Detroit, Michigan, 48202

  • The Headache Wellness Center

    Greensboro, North Carolina, 27401

  • Houston Headache Clinic

    Houston, Texas, 77004

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Northern California Headache Clinic

    Mountain View, California, 94040

  • Nashville Neuroscience Center

    Nashville, Tennessee, 37203

  • New York Headache Center

    New York, New York, 10021

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • Jefferson Headache Center

    Philadelphia, Pennsylvania, 19107

  • Valley Neurological Headache & Research Center

    Phoenix, Arizona, 85020

  • Neurology Clinical Research, Inc.

    Plantation, Florida, 33324

  • Department of Neurology Mayo Clinic

    Rochester, Minnesota, 55905

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • California Medical Clinic for Headache

    Santa Monica, California, 90404

  • Headache Care Center/Clinvest

    Springfield, Missouri, 65804

  • New England Center for Headache, PC

    Stamford, Connecticut, 06902

  • Neurological Associates of Tucson

    Tucson, Arizona, 85712

  • Neurological Associates of Tulsa, Inc.

    Tulsa, Oklahoma, 74136

  • Boston Clinical Research Center

    Wellesley Hills, Massachusetts, 02481

Other trials in United States

About this study

Official 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

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).

Being tested
Civamide (Zucapsaicin)
Keywords
Headache, Cluster, EC, Episodic Cluster
Medical subject headings
Cluster Headache, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Civamide (Zucapsaicin)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2002 (estimated)
  2. Study startJan 2002
  3. Primary completionJul 2003
  4. Study completionJul 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00033839
Sponsor's protocol ID
WL-1001-02-02
Status last verified
Jun 2011
First submitted
11 Apr 2002
Last updated
10 Jun 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Civamide (Zucapsaicin) in people with Episodic Cluster Headache, run by Winston Laboratories at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00033839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.

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