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

NCT ID
NCT06810505
Registry status
Recruiting
Study type
Interventional
Phase
Phase 3
Sponsor
AbbVie
Conditions
Chronic Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 420 participants (Estimated).

What is being studied

  • Intervention: atogepant
  • Drug: Atogepant
  • Drug: Placebo for Atogepant

Who may be eligible

Ages
12 Years to 17 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1. * During the last 28 days of the screening/baseline period, and as per eDiary: * Participant must have completed the eDiary for a minimum of 20 out of 28 days. * Participant has \>= 15 headache days. * Participant has \>= 8 migraine days. Exclusion Criteria: * Clinically significant hypertension per investigator's judgment. * History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.

Study locations

65 study locations are listed.

Recruiting site status is explicitly provided for 65 locations; 60 are listed as Recruiting.

Countries: Canada, Denmark, Hungary, Italy, Japan, Netherlands, Poland, Portugal, Puerto Rico, United Kingdom, United States

  • Ontario, Canada: 1
  • Quebec, Canada: 1
  • Capital Region, Denmark: 1
  • Central Jutland, Denmark: 1
  • Milano, Italy: 1
  • Roma, Italy: 1
  • Hyōgo, Japan: 1
  • Kochi, Japan: 1
  • Osaka, Japan: 1
  • Tokyo, Japan: 2
  • Yamagata, Japan: 1
  • Yamanashi, Japan: 1
  • Gelderland, Netherlands: 1
  • South Holland, Netherlands: 1
  • Greater Poland Voivodeship, Poland: 1
  • Kuyavian-Pomeranian Voivodeship, Poland: 1
  • Lesser Poland Voivodeship, Poland: 1
  • Lower Silesian Voivodeship, Poland: 1
  • Masovian Voivodeship, Poland: 1
  • Lisbon District, Portugal: 1
  • Setúbal District, Portugal: 1
  • Greater London, United Kingdom: 1
  • Kent, United Kingdom: 1
  • Scotland, United Kingdom: 1
  • Alabama, United States: 1
  • Arkansas, United States: 2
  • California, United States: 6
  • Florida, United States: 5
  • Indiana, United States: 1
  • Michigan, United States: 1

Sample of listed locations

  • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659 — London, Ontario, N6A 5W9, Canada — Recruiting
  • Herlev Hospital /ID# 270482 — Herlev, Capital Region, 2730, Denmark — Recruiting
  • Regionshospitalet Godstrup /ID# 270481 — Herning, Central Jutland, 7400, Denmark — Recruiting
  • Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500 — Budapest, 1141, Hungary — Recruiting
  • Semmelweis Egyetem /ID# 271219 — Budapest, 1085, Hungary — Recruiting
  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756 — Milan, Milano, 20133, Italy — Recruiting
  • Ospedale Pediatrico Bambino Gesu /ID# 270759 — Rome, Roma, 00165, Italy — Recruiting
  • Konan Medical Center /ID# 270486 — Kobe, Hyōgo, 658-0064, Japan — Recruiting
  • Umenotsuji Clinic /ID# 270484 — Kochi, Kochi, 780-8011, Japan — Recruiting
  • Tominaga Clinic - Osaka /ID# 270483 — Osaka, Osaka, 556-0015, Japan — Recruiting
  • Tokyo Headache Clinic /ID# 271610 — Shibuya-ku, Tokyo, 151-0051, Japan — Recruiting
  • Tokyo Medical University Hospital /ID# 270487 — Shinjuku-ku, Tokyo, 160-0023, Japan — Recruiting
  • Tendo Brain Clinic /ID# 271410 — Tendo-shi, Yamagata, 994-0083, Japan — Recruiting
  • Nagaseki Headache Clinic /ID# 271699 — Kai, Yamanashi, 400-0124, Japan — Recruiting
  • Tanaka Neurosurgery & Headache Clinic /ID# 271346 — Kagoshima, 890-0052, Japan — Recruiting
  • Canisius-Wilhelmina Ziekenhuis /ID# 270374 — Nijmegen, Gelderland, 6532 SZ, Netherlands — Recruiting
  • HagaZiekenhuis /ID# 270379 — The Hague, South Holland, 2545 AA, Netherlands — Recruiting
  • Clinical Research Center Medic-R /ID# 270235 — Poznan, Greater Poland Voivodeship, 60-848, Poland — Recruiting
  • Athleticomed Sp. z o.o /ID# 270243 — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-752, Poland — Recruiting
  • Specjalistyczne Gabinety Sp. z o.o /ID# 270238 — Krakow, Lesser Poland Voivodeship, 30-539, Poland — Recruiting
  • MIGRE Polskie Centrum Leczenia Migreny /ID# 270239 — Wroclaw, Lower Silesian Voivodeship, 52-210, Poland — Recruiting
  • Oha-Med Sp. Z O.O /ID# 270242 — Warsaw, Masovian Voivodeship, 01-018, Poland — Recruiting
  • Hospital da Luz /ID# 277991 — Lisbon, Lisbon District, 1500-650, Portugal — Recruiting
  • Unidade Local de Saude de Almada-Seixal, EPE /ID# 278092 — Almada, Setúbal District, 2805-267, Portugal — Recruiting
  • Unidade Local de Saude de Coimbra /ID# 277993 — Coimbra, 3000-075, Portugal — Recruiting

Study details

Start date
February 13, 2025
Primary completion date
March 1, 2031
Completion date
March 1, 2031
First posted
February 5, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT06810505
Registry last updated
September 22, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT06810505 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Migraines studies | Clinical trial FAQ