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NCT06810505 · ClinicalTrials.gov registry record · 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

A Phase 3 study of Chronic Migraine, sponsored by AbbVie.

Recruiting
Registry status
Phase 3
Development phase
420
Enrollment target
20
Study locations

NCT06810505 is a Phase 3 study of Chronic Migraine that is actively recruiting participants, run by AbbVie. The registered enrollment target is 420 participants, above the 319-participant average among 17 other Chronic Migraine trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT06810505, a Phase 3 study of Chronic Migraine, is actively recruiting participants, sponsored by AbbVie.

RECRUITING
Registry status
Phase 3
Development phase
420 participants
Enrollment target
20
Study locations

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

Chronic Migraine

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

526 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, categorized as Phase 3. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 319-participant average among 17 other Chronic Migraine trials with a reported enrollment target (32% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

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.

NCT06810505 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Arkansas.

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.

What interventions are being tested in trial NCT06810505?

The interventions under investigation include: Atogepant (DRUG), Placebo for Atogepant (DRUG).

Who is sponsoring clinical trial NCT06810505?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.