Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
Public ClinicalTrials.gov record NCT05707949. 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 Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Migraine
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 participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. 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 migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 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
- NCT05707949
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 650 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
- Jun 5, 2023 (Actual)
- Primary completion
- Apr 2032 (Estimated)
- Completion
- Apr 2032 (Estimated)
- Last update posted
- Aug 11, 2025
2023 – 2032
United States locations
- U.S. sites
- 35
- U.S. states
- 21
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rehabilitation & Neurological Services /ID# 250910 | Huntsville | Alabama | 35805-4046 | — |
| Preferred Research Partners /ID# 250937 | Little Rock | Arkansas | 72211 | — |
| Advanced Research Center /ID# 251616 | Anaheim | California | 92805 | — |
| Sunwise Clinical Research /ID# 250913 | Lafayette | California | 94549-4579 | — |
| Alliance for Research Alliance for Wellness /ID# 250911 | Long Beach | California | 90807 | — |
| Excell Research, Inc /ID# 251611 | Oceanside | California | 92056 | — |
| Lumos Clinical Research Center /ID# 251608 | San Jose | California | 95124-4108 | — |
| Advanced Neurosciences Research, LLC /ID# 250925 | Fort Collins | Colorado | 80528 | — |
| Northwest Florida Clinical Research Group, LLC /ID# 251614 | Gulf Breeze | Florida | 32561-4495 | — |
| Advanced Research Institute of Miami /ID# 250916 | Homestead | Florida | 33030-4613 | — |
| My Preferred Research LLC /ID# 250931 | Miami | Florida | 33155 | — |
| Asclepes Research Centers - Spring Hill /ID# 250912 | Spring Hill | Florida | 34609-5692 | — |
| Coastal Georgia Child Neurology /ID# 250938 | Brunswick | Georgia | 31520-1601 | — |
| Deaconess Clinic - Gateway Health Center /ID# 250923 | Newburgh | Indiana | 47630 | — |
| College Park Family Care Center Overland Park /ID# 251609 | Overland Park | Kansas | 66210-2761 | — |
| Michigan Headache & Neurological Institute (MHNI) /ID# 250920 | Ann Arbor | Michigan | 48104-5131 | — |
| Proven Endpoints LLC /ID# 258083 | Ridgeland | Mississippi | 39157 | — |
| Cognitive Clinical Trials (CCT) - Papillion /ID# 251610 | Papillion | Nebraska | 68046-4131 | — |
| Goryeb Children's Hospital /ID# 250934 | Morristown | New Jersey | 07960 | — |
| Dent Neurosciences Research Center, Inc. /ID# 250915 | Amherst | New York | 14226 | — |
| Modern Migraine MD /ID# 258082 | New York | New York | 10001 | — |
| Headache Wellness Center /ID# 251612 | Greensboro | North Carolina | 27405 | — |
| Patient Priority Clinical Sites, LLC /ID# 250922 | Cincinnati | Ohio | 45215-2123 | — |
| CincyScience /ID# 250935 | West Chester | Ohio | 45069 | — |
| Lynn Institute of Oklahoma City /ID# 250926 | Oklahoma City | Oklahoma | 73112 | — |
| Access Clinical Trials, Inc. /ID# 250914 | Nashville | Tennessee | 37203 | — |
| FutureSearch Trials of Neurology /ID# 251613 | Austin | Texas | 78731 | — |
| 3A Research - East El Paso /ID# 250909 | El Paso | Texas | 79925-7945 | — |
| Earle Research /ID# 250908 | Friendswood | Texas | 77546 | — |
| Family Psychiatry of The Woodlands /ID# 250936 | The Woodlands | Texas | 77381 | — |
| ClinPoint Trials /ID# 250942 | Waxahachie | Texas | 75165-1430 | — |
| Pantheon Clinical Research /ID# 251615 | Bountiful | Utah | 84010-4968 | — |
| Highland Clinical Research /ID# 250924 | Salt Lake City | Utah | 84124 | — |
| Office of Maria Ona /ID# 250939 | Franklin | Virginia | 23851 | — |
| Core Clinical Research /ID# 250932 | Everett | Washington | 98201 | — |
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 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05707949, 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 Aug 11, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05707949 live on ClinicalTrials.gov.