A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
Public ClinicalTrials.gov record NCT05711394. 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, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide. Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
Study identification
- NCT ID
- NCT05711394
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 450 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 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
- Apr 30, 2023
- Primary completion
- Feb 29, 2028
- Completion
- Apr 30, 2028
- Last update posted
- Sep 8, 2026
2023 – 2028
United States locations
- U.S. sites
- 42
- U.S. states
- 22
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rehabilitation & Neurological Services /ID# 248517 | Huntsville | Alabama | 35805-4046 | Recruiting |
| The Center for Clinical Trials - Saraland /ID# 271604 | Saraland | Alabama | 36571 | Recruiting |
| Preferred Research Partners /ID# 249729 | Little Rock | Arkansas | 72211 | Recruiting |
| Preferred Research Partners /ID# 270406 | Little Rock | Arkansas | 72211 | Completed |
| Advanced Research Center /ID# 251381 | Anaheim | California | 92805 | Recruiting |
| Alliance for Research Alliance for Wellness /ID# 248521 | Long Beach | California | 90807 | Recruiting |
| Excell Research, Inc /ID# 247532 | Oceanside | California | 92056 | Completed |
| Lumos Clinical Research Center /ID# 249731 | San Jose | California | 95124-4108 | Recruiting |
| Sunwise Clinical Research /ID# 248529 | Walnut Creek | California | 94596 | Recruiting |
| Advanced Neurosciences Research, LLC /ID# 247592 | Fort Collins | Colorado | 80528 | Completed |
| Northwest Florida Clinical Research Group, LLC /ID# 251382 | Gulf Breeze | Florida | 32561-4495 | Recruiting |
| Advanced Research Institute of Miami /ID# 248539 | Homestead | Florida | 33030-4613 | Completed |
| My Preferred Research LLC /ID# 249720 | Miami | Florida | 33155 | Recruiting |
| FWD Clinical Research - Spring Hill /ID# 248525 | Spring Hill | Florida | 34609-5692 | Completed |
| Coastal Georgia Child Neurology /ID# 249733 | Brunswick | Georgia | 31520-1601 | Recruiting |
| Deaconess Clinic - Gateway Health Center /ID# 247589 | Newburgh | Indiana | 47630 | Recruiting |
| College Park Family Care Center Overland Park /ID# 249734 | Overland Park | Kansas | 66210-2761 | Completed |
| Michigan Headache & Neurological Institute (MHNI) /ID# 247468 | Ann Arbor | Michigan | 48104-5131 | Recruiting |
| Proven Endpoints LLC /ID# 258066 | Ridgeland | Mississippi | 39157 | Recruiting |
| Cognitive Clinical Trials (CCT) - Papillion /ID# 248536 | Papillion | Nebraska | 68046-4131 | Completed |
| Goryeb Childrens Hospital /ID# 249724 | Morristown | New Jersey | 07960 | Recruiting |
| Dent Neurologic Institute - Amherst /ID# 248534 | Amherst | New York | 14226 | Recruiting |
| Modern Migraine MD /ID# 258074 | New York | New York | 10001 | Completed |
| Headache Wellness Center /ID# 251018 | Greensboro | North Carolina | 27405 | Recruiting |
| Patient Priority Clinical Sites, LLC /ID# 247535 | Cincinnati | Ohio | 45215-2123 | Recruiting |
| Cincinnati Childrens Hospital Medical Center /ID# 258070 | Cincinnati | Ohio | 45229 | Recruiting |
| CincyScience /ID# 249726 | West Chester | Ohio | 45069 | Completed |
| Lynn Institute of Oklahoma City /ID# 247600 | Oklahoma City | Oklahoma | 73112 | Recruiting |
| Children's Hospital of Philadelphia - Main /ID# 258071 | Philadelphia | Pennsylvania | 19104-4319 | Recruiting |
| Le Bonheur Children's Hospital /ID# 261084 | Memphis | Tennessee | 38103 | Completed |
| Access Clinical Trials, Inc. /ID# 248532 | Nashville | Tennessee | 37203 | Recruiting |
| UT Health Austin at Dell Children's Neurology Clinic /ID# 264082 | Austin | Texas | 78723-3079 | Recruiting |
| FutureSearch Trials of Neurology /ID# 247470 | Austin | Texas | 78731 | Completed |
| 3A Research - East El Paso /ID# 248516 | El Paso | Texas | 79925-7945 | Completed |
| Earle Research /ID# 248501 | Friendswood | Texas | 77546 | Recruiting |
| Family Psychiatry of The Woodlands /ID# 249727 | The Woodlands | Texas | 77381 | Completed |
| ClinPoint Trials /ID# 248540 | Waxahachie | Texas | 75165-1430 | Recruiting |
| Pantheon Clinical Research /ID# 251601 | Bountiful | Utah | 84010-4968 | Recruiting |
| Alpine Research Organization - Clinton /ID# 276497 | Clinton | Utah | 84015 | Recruiting |
| Highland Clinical Research /ID# 247590 | Salt Lake City | Utah | 84124 | Recruiting |
| Office of Maria Ona /ID# 249738 | Franklin | Virginia | 23851 | Recruiting |
| Core Clinical Research /ID# 249721 | Everett | Washington | 98201 | Completed |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05711394, 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 Sep 8, 2026 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05711394 live on ClinicalTrials.gov.