Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine

Official title

A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Atogepant in Pediatric Subjects 6 to 17 Years of Age With Migraine

Overview

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 participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. 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 migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 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 assessments, blood tests, checking for side effects, and completing questionnaires.

Interventions

• Drug Atogepant
  Oral Tablet

Primary outcome measures

• Percentage of Participants with Adverse Events (AEs) [Time frame: Up to 56 Weeks]
• Percentage of Participants with Potentially Clinically Significant Lab Values [Time frame: Up to 52 Weeks]
• Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG) [Time frame: Up to 52 Weeks]
• Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters [Time frame: Up to 52 Weeks]
• Percentage of with Participants with Treatment-Emergent Suicidal Ideations with Intent, with or without a Plan (i.e., Type 4 or 5 on Columbia-Suicide Severity Rating Scale [C-SSRS]), or any Suicidal Behaviors [Time frame: Up to 52 Weeks]
• Percentage of Participants with Change in Menstrual Cycle (Female Participants Only) [Time frame: Up to 52 Weeks]
• Change from Baseline in Tanner Staging Score [Time frame: Baseline (Week 0) through Week 52]
• Change from Baseline in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF 2) questionnaire [Time frame: Baseline (Week 0) through Week 52]

Eligibility criteria

Inclusion criteria

• Participants must be between 6 and 17 years of age (inclusive), with a history of episodic (ages 6 to 17) or chronic (ages 12 to 17) migraine.
• The participant must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201, or the lead-in Study M23-712.
• Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
• A history of 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.

Exclusion criteria

• 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).
• Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 35 centers

• Rehabilitation & Neurological Services /ID# 250910 — Huntsville
• Preferred Research Partners /ID# 250937 — Little Rock
• Advanced Research Center /ID# 251616 — Anaheim
• Sunwise Clinical Research /ID# 250913 — Lafayette
• Alliance for Research Alliance for Wellness /ID# 250911 — Long Beach
• Excell Research, Inc /ID# 251611 — Oceanside
• Lumos Clinical Research Center /ID# 251608 — San Jose
• Advanced Neurosciences Research, LLC /ID# 250925 — Fort Collins
• … and 27 more centers

Japan · 7 centers

• Konan Medical Center /ID# 254458 — Kobe
• Yamaguchi Clinic /ID# 254763 — Nishinomiya-shi
• Umenotsuji Clinic /ID# 254454 — Kochi
• Sendai Headache and Neurology Clinic Medical Corporation /ID# 254212 — Sendai
• Tominaga Clinic /ID# 254451 — Osaka
• Tokyo Medical University Hospital /ID# 254460 — Shinjuku-ku
• Tatsuoka Neurology Clinic /ID# 254456 — Kyoto

Poland · 6 centers

• Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 250623 — Poznan
• Athleticomed Sp. z o.o /ID# 250620 — Bydgoszcz
• Specjalistyczne Gabinety Sp. z o.o. /ID# 250625 — Krakow
• Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 250622 — Lublin
• OHA-MED sp. z o.o /ID# 250621 — Warsaw
• MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 250624 — Wroclaw

Israel · 5 centers

• Shamir Medical Center /ID# 256858 — Beer Ya'akov
• Hillel Yaffe Medical Center /ID# 248923 — Hadera
• Bnai Zion Medical Center /ID# 251132 — Haifa
• The Chaim Sheba Medical Center /ID# 248990 — Ramat Gan
• Tel Aviv Sourasky Medical Center /ID# 251133 — Tel Aviv

Puerto Rico · 5 centers

• Clinical Research Investigator Group, LLC /ID# 261251 — Bayamón
• Dr. Samuel Sanchez PSC /ID# 261670 — Caguas
• Puerto Rico Health Institute /ID# 250949 — Dorado
• Caribbean Medical Research Center /ID# 253156 — San Juan
• PRCCI Clinical Research Center /ID# 264232 — San Juan

Spain · 4 centers

• Hospital Universitario Vall d'Hebron /ID# 248457 — Barcelona
• Hospital Clinico San Carlos /ID# 249268 — Madrid
• … and 2 more centers

Denmark · 3 centers

• Herlev Hospital /ID# 247725 — Herlev
• Regionshospitalet Godstrup /ID# 247903 — Herning
• Aalborg Universitetshospital /Id# 247429 — Aalborg

France · 3 centers

• CHU Amiens-Picardie Site Sud /ID# 251377 — Amiens
• Centre Hosp Intercommunal de Creteil /ID# 251199 — Créteil
• CHU Toulouse - Hôpital des enfants /ID# 251201 — Toulouse

Netherlands · 3 centers

• Canisius-Wilhelmina Ziekenhuis /ID# 253067 — Nijmegen
• ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 250603 — Terneuzen
• HagaZiekenhuis /ID# 251655 — The Hague

Romania · 3 centers

• Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 250997 — Bucharest
• Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 251112 — Cluj-Napoca
• Delta Health Care S.R.L /ID# 250996 — Bucharest

Belgium · 2 centers

• Uza /Id# 247885 — Edegem
• AZ Sint-Jan Brugge /ID# 247527 — Bruges

Canada · 2 centers

• Stollery Children's Hospital /ID# 251426 — Edmonton
• Montreal Children's Hospital /ID# 250649 — Montreal

Hungary · 2 centers

• Semmelweis Egyetem /ID# 251593 — Budapest
• Mind Klinika Kft. /ID# 251597 — Budapest

Italy · 2 centers

• Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 249182 — Milan
• Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 249184 — Palermo

Sweden · 2 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05707949 · M21-199 · 2022-501099-24-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗