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RECRUITING Phase 3

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

NCT06810505 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Atogepant
  • DRUG Placebo for Atogepant

Study Locations (20)

California

  • Advanced Research Center /ID# 270257 — Anaheim
  • Neuro Pain Research Center /ID# 271048 — Fresno
  • Accellacare - Long Beach /ID# 270398 — Long Beach
  • Excell Research /ID# 270258 — Oceanside
  • Lumos Clinical Research Center /ID# 270582 — San Jose
  • Sunwise Clinical Research /ID# 270431 — Walnut Creek

Florida

  • Northwest Florida Clinical Research Group, LLC /ID# 270833 — Gulf Breeze
  • Auzmer Research /ID# 271158 — Lakeland
  • My Preferred Research /ID# 270312 — Miami
  • Encore Medical Research - Weston /ID# 271139 — Weston
  • Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263 — Winter Park

Arkansas

  • Preferred Research Partner, Inc /ID# 270389 — Little Rock
  • Preferred Research Partners /ID# 270419 — Little Rock

Alabama

  • Rehabilitation & Neurological Services /ID# 270782 — Huntsville

Indiana

  • Deaconess Midtown Hospital /ID# 270572 — Evansville

Michigan

  • Michigan Headache & Neurological Institute /ID# 270942 — Ann Arbor

Mississippi

  • Proven Endpoints LLC /ID# 270269 — Ridgeland

Nebraska

  • Cct Research - Papillion Research Center /ID# 270393 — Papillion

Trial Details

FieldValue
Enrollment Target 420 participants
Start Date 2025-02-13
Est. Completion 2031-03
Phase Phase 3

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06810505

The ClinicalTrials.gov registry entry for NCT06810505 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 420 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 Chronic 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: NCT06810505 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Arkansas. 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 NCT06810505 about?

NCT06810505 is a clinical study titled "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". 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 w...

What is the current status of trial NCT06810505?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 420 participants. The study started on 2025-02-13. Estimated completion is 2031-03.

What conditions does trial NCT06810505 study?

This clinical trial studies the following conditions: Chronic 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 NCT06810505?

The interventions under investigation include: Atogepant (DRUG), Placebo for Atogepant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06810505?

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 NCT06810505 being conducted?

This trial has 20 study locations across Alabama, Arkansas, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial