Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
NCT ID: NCT03338920
Last Updated: 2023-07-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
159 participants
INTERVENTIONAL
2017-11-02
2022-04-11
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
TRIPLE
Study Groups
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Sumatriptan nasal powder
Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).
sumatriptan nasal powder
nasal powder administered via nosepiece
Placebo
Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.
Placebo
lactose monohydrate powder administered via nosepiece
Interventions
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sumatriptan nasal powder
nasal powder administered via nosepiece
Placebo
lactose monohydrate powder administered via nosepiece
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of episodic migraine with or without aura according to International Classification of Headache Disorders-Third edition, beta version (ICHD-IIIB, 1.2.1 or 1.1) criteria, for at least 1 year prior to the screening/enrollment visit
* Experienced migraine attacks of moderate-to-severe intensity and typically lasting ≥ 3 hours untreated, occurring at a frequency of ≥ 2 to ≤ 14 attacks per month for the past 6 months prior to the screening/enrollment visit
* Participant's parent or legal guardian must be willing to sign a copy of the informed consent form as well as documentation for Written Authorization for Use and Release of Health and Research Study Information, after the nature and risks of study participation have been fully explained. Participants must be willing to provide informed assent.
Exclusion Criteria
* Participants with the following headache types: retinal (ICHD-IIIB, 1.2.4), with brainstem aura (ICHD-IIIB, 1.2.2), hemiplegic (ICHD-IIIB, 1.2.3), status migrainosus (ICHD-IIIB, 1.4.1), other forms of complicated migraine, or secondary headaches
* Participants who have not responded to an adequate dose and appropriate duration of treatment with 2 or more triptans
* Participants with known nasal obstruction, current uncontrolled nasopharyngeal illness, or known velum insufficiency (i.e., a cleft palate and/or structural abnormalities in the soft palate and nasopharynx) that may interfere with the proper use of study medication
* Participants whose conditions in the investigator's opinion may put the participant at significant safety risk or confound the study results. This includes participants who in the investigator's opinion should not be enrolled in the study due to the risks described in the Warnings and Precautions or Contraindications sections of the ONZETRA Xsail Prescribing Information.
12 Years
17 Years
ALL
No
Sponsors
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Currax Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Kyle, MD
Role: STUDY_CHAIR
Currax Pharmaceuticals
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Advanced Research Center
Anaheim, California, United States
Axis Clinical Trial Network
Los Angeles, California, United States
Axis Clinical Trial Network
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Alpine Clinical Research Center, Inc.
Boulder, Colorado, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, United States
New England Institute for Neurology and Headache
Stamford, Connecticut, United States
International Research Partners, LLC
Doral, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Eastern Research, Inc.
Hialeah, Florida, United States
South Florida Clinical Trials
Hialeah, Florida, United States
Allied Biomedical Research Institute
Miami, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, United States
St. Luke's Health System
Meridian, Idaho, United States
AMITA Health Medical Group Pediatric Neurology
Hoffman Estates, Illinois, United States
UK Headache Center Kentucky Neuroscience Institute
Lexington, Kentucky, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Center for Pharmaceutical Research, LLC
Kansas City, Missouri, United States
Clinvest Research, LLC.
Springfield, Missouri, United States
Meridian Clinical Research, LLC
Hastings, Nebraska, United States
Meridian Clinical Research, LLC
Lincoln, Nebraska, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Dent Neurosciences Research Center
Amherst, New York, United States
New York Clinical Trials
Brooklyn, New York, United States
NYCT, A Member of the Alliance, Inc.
New York, New York, United States
Headache Wellness Center
Greensboro, North Carolina, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
OK Clinical Research, LLC
Edmond, Oklahoma, United States
Lynn Health Science Institute
Norman, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Preferred Primary Care Physicians, Inc.
Pittsburgh, Pennsylvania, United States
Road Runner Research
San Antonio, Texas, United States
Olympus Family Medicine
Salt Lake City, Utah, United States
South Ogden Family Medicine/CCT Research
South Ogden, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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17-AVP-825-301
Identifier Type: -
Identifier Source: org_study_id
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