Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
Public ClinicalTrials.gov record NCT03338920. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of ONZETRA® Xsail® (Sumatriptan Nasal Powder) for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03338920
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 159 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2, 2017 (Actual)
- Primary completion
- Apr 11, 2022 (Actual)
- Completion
- Apr 11, 2022 (Actual)
- Last update posted
- Jul 24, 2023
2017 – 2022
United States locations
- U.S. sites
- 40
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Advanced Research Center | Anaheim | California | 92805 | — |
| Axis Clinical Trial Network | Los Angeles | California | 90017 | — |
| Axis Clinical Trial Network | Los Angeles | California | 90036 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Alpine Clinical Research Center, Inc. | Boulder | Colorado | 80301 | — |
| Colorado Springs Neurological Associates | Colorado Springs | Colorado | 80907 | — |
| Mountain View Clinical Research, Inc. | Denver | Colorado | 80209 | — |
| New England Institute for Neurology and Headache | Stamford | Connecticut | 06905 | — |
| International Research Partners, LLC | Doral | Florida | 33166 | — |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | — |
| Eastern Research, Inc. | Hialeah | Florida | 33013 | — |
| South Florida Clinical Trials | Hialeah | Florida | 33016 | — |
| Allied Biomedical Research Institute | Miami | Florida | 33155 | — |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | — |
| Clinical Integrative Research Center of Atlanta | Atlanta | Georgia | 30328 | — |
| St. Luke's Health System | Meridian | Idaho | 83642 | — |
| AMITA Health Medical Group Pediatric Neurology | Hoffman Estates | Illinois | 60169 | — |
| UK Headache Center Kentucky Neuroscience Institute | Lexington | Kentucky | 40536 | — |
| Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan | 48104 | — |
| Center for Pharmaceutical Research, LLC | Kansas City | Missouri | 64114 | — |
| Clinvest Research, LLC. | Springfield | Missouri | 65810 | — |
| Meridian Clinical Research, LLC | Hastings | Nebraska | 68901 | — |
| Meridian Clinical Research, LLC | Lincoln | Nebraska | 68510 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Dent Neurosciences Research Center | Amherst | New York | 14226 | — |
| New York Clinical Trials | Brooklyn | New York | 11201 | — |
| NYCT, A Member of the Alliance, Inc. | New York | New York | 10022 | — |
| Headache Wellness Center | Greensboro | North Carolina | 27405 | — |
| Hometown Urgent Care and Research | Cincinnati | Ohio | 45215 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Hometown Urgent Care and Research | Dayton | Ohio | 45424 | — |
| OK Clinical Research, LLC | Edmond | Oklahoma | 73034 | — |
| Lynn Health Science Institute | Norman | Oklahoma | 73072 | — |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | — |
| Preferred Primary Care Physicians, Inc. | Pittsburgh | Pennsylvania | 15236 | — |
| Road Runner Research | San Antonio | Texas | 78249 | — |
| Olympus Family Medicine | Salt Lake City | Utah | 84117 | — |
| South Ogden Family Medicine/CCT Research | South Ogden | Utah | 84405 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03338920, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 24, 2023 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03338920 live on ClinicalTrials.gov.