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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
NCT05711394 · View on ClinicalTrials.gov ↗
Study Summary
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 a
Conditions Studied
Interventions
- DRUG Atogepant
- DRUG Placebo-Matching Atogepant
Study Locations (20)
California
- Advanced Research Center /ID# 251381 — Anaheim
- Alliance for Research Alliance for Wellness /ID# 248521 — Long Beach
- Excell Research, Inc /ID# 247532 — Oceanside
- Lumos Clinical Research Center /ID# 249731 — San Jose
- Sunwise Clinical Research /ID# 248529 — Walnut Creek
Florida
- Northwest Florida Clinical Research Group, LLC /ID# 251382 — Gulf Breeze
- Advanced Research Institute of Miami /ID# 248539 — Homestead
- My Preferred Research LLC /ID# 249720 — Miami
- Asclepes Research Centers - Spring Hill /ID# 248525 — Spring Hill
Alabama
- Rehabilitation & Neurological Services /ID# 248517 — Huntsville
- The Center for Clinical Trials - Saraland /ID# 271604 — Saraland
Arkansas
- Preferred Research Partners /ID# 249729 — Little Rock
- Preferred Research Partners /ID# 270406 — Little Rock
Colorado
- Advanced Neurosciences Research, LLC /ID# 247592 — Fort Collins
Georgia
- Coastal Georgia Child Neurology /ID# 249733 — Brunswick
Indiana
- Deaconess Clinic - Gateway Health Center /ID# 247589 — Newburgh
Kansas
- College Park Family Care Center Overland Park /ID# 249734 — Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2028-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05711394
The ClinicalTrials.gov registry entry for NCT05711394 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Episodic Migraine appearing as the primary indexed condition, and to 2 interventions — of which Atogepant is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05711394 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05711394 about?
NCT05711394 is a clinical study titled "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". 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...
What is the current status of trial NCT05711394?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2023-05-01. Estimated completion is 2028-05.
What conditions does trial NCT05711394 study?
This clinical trial studies the following conditions: Episodic Migraine. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05711394?
The interventions under investigation include: Atogepant (DRUG), Placebo-Matching Atogepant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05711394?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05711394 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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