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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

NCT ID: NCT05711394
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: AbbVie
Conditions: Episodic 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 Episodic Migraine in Pediatric Subjects 6-17 Years of Age.

Enrollment: 450 participants (Estimated).

What is being studied

Intervention: atogepant
Drug: Atogepant
Drug: Placebo-Matching Atogepant

Who may be eligible

Ages: 6 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs). * History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months. * Participant has to have 4 to 14 migraine days and \< 15 headache days in the 28-day baseline period per eDiary. * To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 \[2018\]) and per investigator judgment is appropriate to receive preventive treatment for migraine. Exclusion Criteria: * History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018). * Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018). * Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).

Study locations

98 study locations are listed.

Recruiting site status is explicitly provided for 98 locations; 69 are listed as Recruiting.

Countries: Belgium, Canada, Denmark, France, Hungary, Israel, Italy, Japan, Netherlands, Poland, Puerto Rico, Romania, Spain, Sweden, United Kingdom, United States

Antwerpen, Belgium: 1
West-Vlaanderen, Belgium: 1
Alberta, Canada: 1
Ontario, Canada: 1
Quebec, Canada: 1
Capital Region, Denmark: 1
Central Jutland, Denmark: 1
North Denmark, Denmark: 1
Somme, France: 1
Val-de-Marne, France: 1
Central District, Israel: 1
Haifa District, Israel: 1
Tel Aviv, Israel: 2
Milano, Italy: 1
Roma, Italy: 1
Hyōgo, Japan: 2
Kochi, Japan: 1
Miyagi, Japan: 1
Osaka, Japan: 1
Tokyo, Japan: 1
Gelderland, Netherlands: 1
South Holland, Netherlands: 1
Zeeland, Netherlands: 1
Greater Poland Voivodeship, Poland: 1
Kuyavian-Pomeranian Voivodeship, Poland: 1
Lesser Poland Voivodeship, Poland: 1
Lublin Voivodeship, Poland: 1
Masovian Voivodeship, Poland: 1
Bucharest, Romania: 1
Cluj, Romania: 1

Sample of listed locations

Uza /Id# 247339 — Edegem, Antwerpen, 2650, Belgium — Recruiting
Algemeen Ziekenhuis Sint-Jan Brugge /ID# 247201 — Bruges, West-Vlaanderen, 8000, Belgium — Recruiting
Stollery Children's Hospital /ID# 249672 — Edmonton, Alberta, T6G 2B7, Canada — Recruiting
London Health Sciences Center- University Hospital /ID# 252979 — London, Ontario, N6A 5W9, Canada — Recruiting
Herlev Hospital /ID# 247724 — Herlev, Capital Region, 2730, Denmark — Recruiting
Regionshospitalet Godstrup /ID# 247902 — Herning, Central Jutland, 7400, Denmark — Recruiting
Aalborg Sygehus Nord /ID# 247428 — Aalborg, North Denmark, 9000, Denmark — Recruiting
Semmelweis Egyetem /ID# 248360 — Budapest, 1085, Hungary — Recruiting
Shamir Medical Center /ID# 256857 — Beer Ya'akov, Central District, 70300, Israel — Recruiting
The Chaim Sheba Medical Center /ID# 246746 — Ramat Gan, Tel Aviv, 5265601, Israel — Recruiting
Tel Aviv Sourasky Medical Center /ID# 247466 — Tel Aviv, Tel Aviv, 6423906, Israel — Recruiting
Bnai Zion Medical Center /ID# 247469 — Haifa, 3339419, Israel — Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581 — Milan, Milano, 20133, Italy — Recruiting
Ospedale Pediatrico Bambino Gesu /ID# 247647 — Rome, Roma, 00165, Italy — Recruiting
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638 — Palermo, 90127, Italy — Recruiting
Konan Medical Center /ID# 254457 — Kobe, Hyōgo, 658-0064, Japan — Recruiting
Yamaguchi Clinic /ID# 254753 — Nishinomiya, Hyōgo, 663-8204, Japan — Recruiting
Umenotsuji Clinic /ID# 254453 — Kochi, Kochi, 780-8011, Japan — Recruiting
Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211 — Sendai, Miyagi, 982-0014, Japan — Recruiting
Tominaga Clinic - Osaka /ID# 254450 — Osaka, Osaka, 556-0015, Japan — Recruiting
Tokyo Medical University Hospital /ID# 254459 — Shinjuku-ku, Tokyo, 160-0023, Japan — Recruiting
Tatsuoka Neurology Clinic /ID# 254455 — Kyoto, 600-8811, Japan — Recruiting
Canisius-Wilhelmina Ziekenhuis /ID# 253065 — Nijmegen, Gelderland, 6532 SZ, Netherlands — Recruiting
HagaZiekenhuis /ID# 247318 — The Hague, South Holland, 2545 AA, Netherlands — Recruiting
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301 — Terneuzen, Zeeland, 4535 PA, Netherlands — Recruiting

Study details

Start date: May 1, 2023
Primary completion date: March 1, 2028
Completion date: May 1, 2028
First posted: February 3, 2023

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05711394
Registry last updated: September 16, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT05711394 on ClinicalTrials.gov

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

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