Clinical trial NCT05707949: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Migraine Prophylaxis
Keywords: Migraine Prophylaxis
Atogepant
QULIPTA
AGN-241689
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-02-01
Enrollment: 650
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs)
timeFrame: Up to 56 Weeks
measure: Percentage of Participants with Potentially Clinically Significant Lab Values
timeFrame: Up to 52 Weeks
measure: Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
timeFrame: Up to 52 Weeks
measure: Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
timeFrame: Up to 52 Weeks
measure: 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
timeFrame: Up to 52 Weeks
measure: Percentage of Participants with Change in Menstrual Cycle (Female Participants Only)
timeFrame: Up to 52 Weeks
measure: Change from Baseline in Tanner Staging Score
timeFrame: Baseline (Week 0) through Week 52
measure: Change from Baseline in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF 2) questionnaire
timeFrame: Baseline (Week 0) through Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rehabilitation & Neurological Services /ID# 250910
state: Alabama
city: Little Rock
country: United States
facility: Preferred Research Partners /ID# 250937
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center /ID# 251616
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research /ID# 250913
state: California
city: Long Beach
country: United States
facility: Alliance for Research Alliance for Wellness /ID# 250911
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc /ID# 251611
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center /ID# 251608
state: California
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC /ID# 250925
state: Colorado
city: Gulf Breeze
country: United States
facility: Northwest Florida Clinical Research Group, LLC /ID# 251614
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami /ID# 250916
state: Florida
city: Miami
country: United States
facility: My Preferred Research LLC /ID# 250931
state: Florida
city: Spring Hill
country: United States
facility: Asclepes Research Centers - Spring Hill /ID# 250912
state: Florida
city: Brunswick
country: United States
facility: Coastal Georgia Child Neurology /ID# 250938
state: Georgia
city: Newburgh
country: United States
facility: Deaconess Clinic - Gateway Health Center /ID# 250923
state: Indiana
city: Overland Park
country: United States
facility: College Park Family Care Center Overland Park /ID# 251609
state: Kansas
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute (MHNI) /ID# 250920
state: Michigan
city: Ridgeland
country: United States
facility: Proven Endpoints LLC /ID# 258083
state: Mississippi
city: Papillion
country: United States
facility: Cognitive Clinical Trials (CCT) - Papillion /ID# 251610
state: Nebraska
city: Morristown
country: United States
facility: Goryeb Children's Hospital /ID# 250934
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center, Inc. /ID# 250915
state: New York
city: New York
country: United States
facility: Modern Migraine MD /ID# 258082
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center /ID# 251612
state: North Carolina
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC /ID# 250922
state: Ohio
city: West Chester
country: United States
facility: CincyScience /ID# 250935
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Institute of Oklahoma City /ID# 250926
state: Oklahoma
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. /ID# 250914
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology /ID# 251613
state: Texas
city: El Paso
country: United States
facility: 3A Research - East El Paso /ID# 250909
state: Texas
city: Friendswood
country: United States
facility: Earle Research /ID# 250908
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands /ID# 250936
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials /ID# 250942
state: Texas
city: Bountiful
country: United States
facility: Pantheon Clinical Research /ID# 251615
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research /ID# 250924
state: Utah
city: Franklin
country: United States
facility: Office of Maria Ona /ID# 250939
state: Virginia
city: Everett
country: United States
facility: Core Clinical Research /ID# 250932
state: Washington
city: Edegem
country: Belgium
facility: Uza /Id# 247885
state: Antwerpen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 247527
city: Edmonton
country: Canada
facility: Stollery Children's Hospital /ID# 251426
state: Alberta
city: Montreal
country: Canada
facility: Montreal Children's Hospital /ID# 250649
state: Quebec
city: Herlev
country: Denmark
facility: Herlev Hospital /ID# 247725
state: Hovedstaden
city: Herning
country: Denmark
facility: Regionshospitalet Godstrup /ID# 247903
state: Midtjylland
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital /Id# 247429
state: Nordjylland
city: Amiens CEDEX 1
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 251377
state: Somme
city: Creteil
country: France
facility: Centre Hosp Intercommunal de Creteil /ID# 251199
state: Val-de-Marne
city: Toulouse CEDEX 9
country: France
facility: CHU Toulouse - Hôpital des enfants /ID# 251201
city: Budapest
country: Hungary
facility: Mind Klinika Kft. /ID# 251597
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 251593
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center /ID# 248923
state: H_efa
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 251132
state: H_efa
city: Beer Ya'akov
country: Israel
facility: Shamir Medical Center /ID# 256858
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 248990
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 251133
state: Tel-Aviv
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 249182
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 249184
city: Kobe-shi
country: Japan
facility: Konan Medical Center /ID# 254458
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Yamaguchi Clinic /ID# 254763
state: Hyogo
city: Kochi-shi
country: Japan
facility: Umenotsuji Clinic /ID# 254454
state: Kochi
city: Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic Medical Corporation /ID# 254212
state: Miyagi
city: Osaka-shi
country: Japan
facility: Tominaga Clinic /ID# 254451
state: Osaka
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 254460
state: Tokyo
city: Kyoto
country: Japan
facility: Tatsuoka Neurology Clinic /ID# 254456
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis /ID# 251655
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis /ID# 253067
city: Terneuzen
country: Netherlands
facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 250603
city: Bydgoszcz
country: Poland
facility: Athleticomed Sp. z o.o /ID# 250620
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 250622
state: Lubelskie
city: Krakow
country: Poland
facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 250625
state: Malopolskie
city: Warszawa
country: Poland
facility: OHA-MED sp. z o.o /ID# 250621
state: Mazowieckie
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 250623
state: Wielkopolskie
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 250624
city: Bayamon
country: Puerto Rico
facility: Clinical Research Investigator Group, LLC /ID# 261251
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 261670
city: Dorado
country: Puerto Rico
facility: Puerto Rico Health Institute /ID# 250949
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center /ID# 253156
city: San Juan
country: Puerto Rico
facility: PRCCI Clinical Research Center /ID# 264232
city: Bucharest
country: Romania
facility: Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 250997
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 251112
state: Cluj
city: Bucharest
country: Romania
facility: Delta Health Care S.R.L /ID# 250996
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 248457
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos /ID# 249268
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 248633
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 248459
city: Molnlycke
country: Sweden
facility: Vastra Gotealandsregionen Regionhalsan /ID# 248981
city: Stockholm
country: Sweden
facility: Sodersjukhuset /ID# 250671
city: Aberdeen
country: United Kingdom
facility: NHS Grampian /ID# 251474
city: Stockport
country: United Kingdom
facility: Stockport NHS foundation trust /ID# 261562
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: