A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
Public ClinicalTrials.gov record NCT06810505. 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 Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Migraine is a disease that most often causes 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. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.
Study identification
- NCT ID
- NCT06810505
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 420 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
- Feb 12, 2025
- Primary completion
- Feb 28, 2031
- Completion
- Feb 28, 2031
- Last update posted
- Sep 2, 2026
2025 – 2031
United States locations
- U.S. sites
- 31
- U.S. states
- 16
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rehabilitation and Neurological Services /ID# 270782 | Huntsville | Alabama | 35805 | Recruiting |
| Preferred Research Partners - Fayetteville /ID# 270419 | Fayetteville | Arkansas | 72703 | Completed |
| Preferred Research Partners /ID# 270389 | Little Rock | Arkansas | 72211 | Recruiting |
| Advanced Research Center /ID# 270257 | Anaheim | California | 92805 | Recruiting |
| Neuro Pain Research Center /ID# 271048 | Fresno | California | 93710 | Recruiting |
| Accellacare - Long Beach /ID# 270398 | Long Beach | California | 90807 | Recruiting |
| Excell Research /ID# 270258 | Oceanside | California | 92056 | Recruiting |
| Lumos Clinical Research Center /ID# 270582 | San Jose | California | 95124 | Recruiting |
| Sunwise Clinical Research /ID# 270431 | Walnut Creek | California | 94596 | Recruiting |
| Northwest Florida Clinical Research Group, LLC /ID# 270833 | Gulf Breeze | Florida | 32561 | Recruiting |
| Auzmer Research /ID# 271158 | Lakeland | Florida | 33813 | Completed |
| My Preferred Research /ID# 270312 | Miami | Florida | 33155 | Recruiting |
| Encore Medical Research - Weston /ID# 271139 | Weston | Florida | 33331 | Recruiting |
| Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263 | Winter Park | Florida | 32789 | Recruiting |
| Deaconess Midtown Hospital /ID# 270572 | Evansville | Indiana | 47710 | Recruiting |
| Michigan Headache & Neurological Institute /ID# 270942 | Ann Arbor | Michigan | 48104 | Recruiting |
| Proven Endpoints LLC /ID# 270269 | Ridgeland | Mississippi | 39157 | Recruiting |
| Cct Research - Papillion Research Center /ID# 270393 | Papillion | Nebraska | 68046 | Recruiting |
| Healthy Perspectives - Innovate Mental Health Services /ID# 270847 | Nashua | New Hampshire | 03060 | Recruiting |
| Dent Neurologic Institute - Amherst /ID# 270260 | Amherst | New York | 14226 | Recruiting |
| Headache Wellness Center /ID# 270568 | Greensboro | North Carolina | 27405 | Completed |
| Frontier Clinical Research - Scottdale /ID# 270854 | Scottdale | Pennsylvania | 15683 | Recruiting |
| Frontier Clinical Research - Smithfield /ID# 270849 | Smithfield | Pennsylvania | 15478 | Recruiting |
| Access Clinical Trials Inc /ID# 270280 | Nashville | Tennessee | 37203 | Recruiting |
| UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577 | Austin | Texas | 78723-3079 | Recruiting |
| Earle Research /ID# 270424 | Houston | Texas | 77058 | Recruiting |
| Clinpoint Trials /ID# 270261 | Waxahachie | Texas | 75165 | Recruiting |
| Pantheon Clinical Research /ID# 270259 | Bountiful | Utah | 84010 | Recruiting |
| Alpine Research Organization - Clinton /ID# 276527 | Clinton | Utah | 84015 | Recruiting |
| Highland Clinical Research /ID# 270281 | Salt Lake City | Utah | 84124 | Recruiting |
| Frontier Clinical Research - Kingwood /ID# 271053 | Kingwood | West Virginia | 26537 | Recruiting |
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 33 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06810505, 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 2, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06810505 live on ClinicalTrials.gov.