Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
- Conditions
- Acute Migraine With or Without Aura
- Interventions
- Drug: Placebo
- Registration Number
- NCT03338920
- Lead Sponsor
- Currax Pharmaceuticals
- Brief Summary
This study will be conducted to evaluate the safety and efficacy of sumatriptan nasal powder (AVP-825) compared to placebo in the acute treatment of migraine in adolescent participants, 12 through 17 years of age.
- Detailed Description
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating AVP-825 for the acute treatment of migraine with or without aura in adolescent subjects (12 to 17 years old).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 159
- Male and female participants 12 to 17 years (inclusive) of age at the time of informed consent
- 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.
- Participants with ≥ 15 headache days per month in total (migraine, probable migraine, or tension-type)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sumatriptan nasal powder sumatriptan nasal powder Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece). Placebo Placebo Participants will be dosed with matching placebo via nosepieces containing capsules filled with lactose instead of sumatriptan.
- Primary Outcome Measures
Name Time Method Number of Participants Who Were Headache Pain Free at 120 Minutes After Treatment 120 minutes Participants will self-report the severity of their headache.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (36)
Direct Helpers Research Center
🇺🇸Hialeah, Florida, United States
Center for Pharmaceutical Research, LLC
🇺🇸Kansas City, Missouri, United States
Alpine Clinical Research Center, Inc.
🇺🇸Boulder, Colorado, United States
Advanced Research Center
🇺🇸Anaheim, California, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
Clinvest Research, LLC.
🇺🇸Springfield, Missouri, United States
UK Headache Center Kentucky Neuroscience Institute
🇺🇸Lexington, Kentucky, United States
Mountain View Clinical Research, Inc.
🇺🇸Denver, Colorado, United States
South Florida Clinical Trials
🇺🇸Hialeah, Florida, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
NYCT, A Member of the Alliance, Inc.
🇺🇸New York, New York, United States
Axis Clinical Trial Network
🇺🇸Los Angeles, California, United States
International Research Partners, LLC
🇺🇸Doral, Florida, United States
Clinical Integrative Research Center of Atlanta
🇺🇸Atlanta, Georgia, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Allied Biomedical Research Institute
🇺🇸Miami, Florida, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Road Runner Research
🇺🇸San Antonio, Texas, United States
Eastern Research, Inc.
🇺🇸Hialeah, Florida, United States
New England Institute for Neurology and Headache
🇺🇸Stamford, Connecticut, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
St. Luke's Health System
🇺🇸Meridian, Idaho, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Meridian Clinical Research, LLC
🇺🇸Lincoln, Nebraska, United States
AMITA Health Medical Group Pediatric Neurology
🇺🇸Hoffman Estates, Illinois, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
New York Clinical Trials
🇺🇸Brooklyn, New York, United States
Headache Wellness Center
🇺🇸Greensboro, North Carolina, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
OK Clinical Research, LLC
🇺🇸Edmond, Oklahoma, United States
Preferred Primary Care Physicians, Inc.
🇺🇸Pittsburgh, Pennsylvania, United States
South Ogden Family Medicine/CCT Research
🇺🇸South Ogden, Utah, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Olympus Family Medicine
🇺🇸Salt Lake City, Utah, United States