Clinical trial NCT05711394: 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
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Episodic Migraine
Keywords: Episodic Migraine
Atogepant
QULIPTA
AGN-241689
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-02-03
Enrollment: 450
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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 pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17.

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 episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide.

Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 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:

* 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).

Primary outcomes:
measure: Change from Baseline in Mean Monthly Migraine Days
timeFrame: Baseline (Week 0) through Week 12
Secondary outcomes:
measure: Change from Baseline in Mean Monthly Headache Days
timeFrame: Baseline (Week 0) through Week 12
measure: Change from Baseline in Mean Monthly Acute Medication Use Days
timeFrame: Baseline (Week 0) through Week 12
measure: Percentage of Participants who Achieve at least a 50% Reduction in Average of Monthly Migraine Days
timeFrame: Baseline (Week 0) to 3 Months
measure: Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) total score
timeFrame: Baseline (Week 0) through Week 12
measure: Change from baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) total score
timeFrame: Baseline (Week 0) through Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rehabilitation & Neurological Services /ID# 248517
state: Alabama
city: Little Rock
country: United States
facility: Preferred Research Partners /ID# 249729
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners /ID# 270406
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center /ID# 251381
state: California
city: Long Beach
country: United States
facility: Alliance for Research Alliance for Wellness /ID# 248521
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc /ID# 247532
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research Center /ID# 249731
state: California
city: Walnut Creek
country: United States
facility: Sunwise Clinical Research /ID# 248529
state: California
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research, LLC /ID# 247592
state: Colorado
city: Gulf Breeze
country: United States
facility: Northwest Florida Clinical Research Group, LLC /ID# 251382
state: Florida
city: Homestead
country: United States
facility: Advanced Research Institute of Miami /ID# 248539
state: Florida
city: Miami
country: United States
facility: My Preferred Research LLC /ID# 249720
state: Florida
city: Spring Hill
country: United States
facility: Asclepes Research Centers - Spring Hill /ID# 248525
state: Florida
city: Brunswick
country: United States
facility: Coastal Georgia Child Neurology /ID# 249733
state: Georgia
city: Newburgh
country: United States
facility: Deaconess Clinic - Gateway Health Center /ID# 247589
state: Indiana
city: Overland Park
country: United States
facility: College Park Family Care Center Overland Park /ID# 249734
state: Kansas
city: Ann Arbor
country: United States
facility: Michigan Headache & Neurological Institute (MHNI) /ID# 247468
state: Michigan
city: Ridgeland
country: United States
facility: Proven Endpoints LLC /ID# 258066
state: Mississippi
city: Papillion
country: United States
facility: Cognitive Clinical Trials (CCT) - Papillion /ID# 248536
state: Nebraska
city: Morristown
country: United States
facility: Goryeb Children's Hospital /ID# 249724
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst /ID# 248534
state: New York
city: New York
country: United States
facility: Modern Migraine MD /ID# 258074
state: New York
city: Greensboro
country: United States
facility: Headache Wellness Center /ID# 251018
state: North Carolina
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, LLC /ID# 247535
state: Ohio
city: West Chester
country: United States
facility: CincyScience /ID# 249726
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Institute of Oklahoma City /ID# 247600
state: Oklahoma
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital /ID# 261084
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. /ID# 248532
state: Tennessee
city: Austin
country: United States
facility: UT Health Austin at Dell Children's Neurology Clinic /ID# 264082
state: Texas
city: Austin
country: United States
facility: FutureSearch Trials of Neurology /ID# 247470
state: Texas
city: El Paso
country: United States
facility: 3A Research - East El Paso /ID# 248516
state: Texas
city: Friendswood
country: United States
facility: Earle Research /ID# 248501
state: Texas
city: The Woodlands
country: United States
facility: Family Psychiatry of The Woodlands /ID# 249727
state: Texas
city: Waxahachie
country: United States
facility: ClinPoint Trials /ID# 248540
state: Texas
city: Bountiful
country: United States
facility: Pantheon Clinical Research /ID# 251601
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research /ID# 247590
state: Utah
city: Franklin
country: United States
facility: Office of Maria Ona /ID# 249738
state: Virginia
city: Everett
country: United States
facility: Core Clinical Research /ID# 249721
state: Washington
city: Edegem
country: Belgium
facility: Uza /Id# 247339
state: Antwerpen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 247201
city: Edmonton
country: Canada
facility: Stollery Children's Hospital /ID# 249672
state: Alberta
city: London
country: Canada
facility: London Health Sciences Center- University Hospital /ID# 252979
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site /ID# 247271
state: Quebec
city: Herlev
country: Denmark
facility: Herlev Hospital /ID# 247724
state: Hovedstaden
city: Herning
country: Denmark
facility: Regionshospitalet Godstrup /ID# 247902
state: Midtjylland
city: Aalborg
country: Denmark
facility: Aalborg Sygehus Nord /ID# 247428
state: Nordjylland
city: Amiens CEDEX 1
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 248833
state: Somme
city: Creteil
country: France
facility: Centre Hosp Intercommunal de Creteil /ID# 248832
state: Val-de-Marne
city: Toulouse CEDEX 9
country: France
facility: CHU Toulouse - Hôpital des enfants /ID# 247553
city: Budapest
country: Hungary
facility: MIND Clinic /ID# 248687
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 248360
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center /ID# 246747
state: H_efa
city: Haifa
country: Israel
facility: Bnai Zion Medical Center /ID# 247469
state: H_efa
city: Beer Ya'akov
country: Israel
facility: Shamir Medical Center /ID# 256857
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 246746
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 247466
state: Tel-Aviv
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581
state: Milano
city: Rome
country: Italy
facility: Ospedale Pediatrico Bambino Gesù /ID# 247647
state: Roma
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638
city: Kobe-shi
country: Japan
facility: Konan Medical Center /ID# 254457
state: Hyogo
city: Nishinomiya
country: Japan
facility: Yamaguchi Clinic /ID# 254753
state: Hyogo
city: Kochi-shi
country: Japan
facility: Umenotsuji Clinic /ID# 254453
state: Kochi
city: Sendai-shi
country: Japan
facility: Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211
state: Miyagi
city: Osaka-shi
country: Japan
facility: Tominaga Clinic /ID# 254450
state: Osaka
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 254459
state: Tokyo
city: Kyoto
country: Japan
facility: Tatsuoka Neurology Clinic /ID# 254455
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis /ID# 253065
state: Gelderland
city: Terneuzen
country: Netherlands
facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301
state: Zeeland
city: Den Haag
country: Netherlands
facility: HagaZiekenhuis /ID# 247318
state: Zuid-Holland
city: Bydgoszcz
country: Poland
facility: Athleticomed Sp. z o.o /ID# 248789
state: Kujawsko-pomorskie
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382
state: Lubelskie
city: Krakow
country: Poland
facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 247384
state: Malopolskie
city: Warszawa
country: Poland
facility: OHA-MED sp. z o.o /ID# 248614
state: Mazowieckie
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z.o.o. Medic-R sp. k /ID# 247383
state: Wielkopolskie
city: Wroclaw
country: Poland
facility: MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381
city: Bayamon
country: Puerto Rico
facility: Clinical Research Investigator Group, LLC /ID# 261254
city: Caguas
country: Puerto Rico
facility: Dr. Samuel Sanchez PSC /ID# 248495
city: Dorado
country: Puerto Rico
facility: Puerto Rico Health Institute /ID# 249741
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center /ID# 251634
city: San Juan
country: Puerto Rico
facility: PRCCI Clinical Research Center /ID# 262726
city: Bucharest
country: Romania
facility: Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595
state: Cluj
city: Bucharest
country: Romania
facility: Delta Health Care S.R.L /ID# 248130
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron /ID# 247967
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos /ID# 249267
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 248632
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 247969
city: Stockholm
country: Sweden
facility: Sodersjukhuset /ID# 248279
state: Stockholms Lan
city: Molnlycke
country: Sweden
facility: Vastra Gotealandsregionen Regionhalsan /ID# 248277
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust /ID# 249065
state: Kent
city: Aberdeen
country: United Kingdom
facility: NHS Grampian /ID# 249067
city: Stockport
country: United Kingdom
facility: Stockport NHS foundation trust /ID# 261121
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: