Study Results
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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COMPLETED
PHASE3
2 participants
INTERVENTIONAL
2003-08-31
2004-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Civamide
Nasal Solution 0.01%
Civamide (Zucapsaicin)
Nasal Solution 0.01%
Placebo
Placebo nasal solution with sodium chloride 10%
Sodium Chloride
Nasal Solution 10%
Interventions
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Civamide (Zucapsaicin)
Nasal Solution 0.01%
Sodium Chloride
Nasal Solution 10%
Eligibility Criteria
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Inclusion 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
18 Years
ALL
No
Sponsors
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Winston Laboratories
INDUSTRY
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
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
New York Headache Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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Other Identifiers
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WL-1001-02-05
Identifier Type: -
Identifier Source: org_study_id
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