Clinical trial • Phase III • Neurology

ATOGEPANT for Chronic migraine

Phase III trial of ATOGEPANT for Chronic migraine.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Chronic migraine
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
11-02-2025
First CTIS Authorization Date
22-05-2025

Trial design

Randomised, placebo for atogepant (matching placebo arm). dose and schedule for placebo not specified in the available record.-controlled Phase III trial across 18 sites in Hungary, Netherlands, Denmark and others.

Randomised
Yes
Comparator
Placebo for Atogepant (matching placebo arm). Dose and schedule for placebo not specified in the available record.
Target Sample Size
306
Trial Duration For Participant
84

Eligibility

Recruits 306 paediatric patients.

Vulnerable Population
The trial enrolls pediatric participants aged 12 to 17 years (minors). Consent/assent handling includes parent/guardian informed consent and adolescent assent documents (country-specific ICFs and assent forms are provided, e.g. Adolescent 12-17yrs PIS ICF, Parent-Guardian PIS ICF, and age-specific assent forms such as 12-15 and 15-17). Materials and recruitment information are prepared for parents/guardians and for adolescents; a dedicated Parent/Guardian ICF and adolescent assent/I CF are provided per country.

Inclusion criteria

  • {"criterion_text":"- Weight is ≥ 20 kg (44 pounds) and < 135 kg (298 pounds).\n- Subject has 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 as of Visit 1.\n- Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the treatment of migraine."}

Exclusion criteria

  • {"criterion_text":"- Migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).\n- Current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from Baseline in Mean Monthly Migraine Days Across the 12-Week Treatment Period","definition_or_measurement_approach":"Change from baseline in mean monthly migraine days measured across the 12-week treatment period (i.e. difference between baseline monthly migraine days and mean monthly migraine days during the 12-week treatment period)."}

Secondary endpoints

  • {"endpoint_text":"- Change from Baseline in Mean Monthly Headache Days Across the 12-Week Treatment Period","definition_or_measurement_approach":"Change from baseline in mean monthly headache days measured across the 12-week treatment period."}
  • {"endpoint_text":"- Change from Baseline in Mean Monthly Acute Medication Use Days Across the 12-Week Treatment Period.","definition_or_measurement_approach":"Change from baseline in mean monthly days of acute medication use measured across the 12-week treatment period."}
  • {"endpoint_text":"- Percentage of Participants who Achieve at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days.","definition_or_measurement_approach":"Proportion of participants achieving ≥50% reduction in the 3-month average monthly migraine days compared with baseline."}
  • {"endpoint_text":"- Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score at Week 12.","definition_or_measurement_approach":"Change from baseline in PedsQL total score assessed at Week 12."}
  • {"endpoint_text":"- Change from Baseline on the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score at Week 12.","definition_or_measurement_approach":"Change from baseline in PedMIDAS total score assessed at Week 12."}
  • {"endpoint_text":"- Change from baseline in mean monthly headache days of at least moderate severity across the 12-week treatment period.","definition_or_measurement_approach":"Change from baseline in mean monthly headache days rated at least moderate severity, measured across the 12-week treatment period."}

Recruitment

Registry Or Advocacy Recruitment
True, Autocruitment LLC
Digital Remote Recruitment
True — online screeners, phone screeners, study websites, digital recruitment materials and eCOA are used (country-specific materials listed for NL, IT, PL, PT).
Planned Sample Size
306
Recruitment Window Months
68
Consent Approach
Informed consent is handled with parent/guardian informed consent forms and age-appropriate assent/information sheets for adolescent participants (documents include Parent-Guardian PIS/ICF and Adolescent 12-17yrs PIS/ICF and country-specific assent forms for 12-15 and 15-17 years). Separate pregnancy-related ICFs (e.g., Pregnant Partner PIS/ICF) and optional consent modules are provided where relevant. Contact and public/scientific contact provided by the sponsor (Global Clinical Trials Helpdesk: global-clinical-trials@abbvie.com). Materials are provided per country in appropriate local languages (country-specific PIS/ICF and recruitment packs referenced).

Methods

  • Site-based recruitment via participating hospitals/clinics and pediatric neurology departments (physician/clinic referral) — country sites listed (e.g. Semmelweis University HU, Haga Hospital NL, Region Midtjylland DK, IRCCS Istituto Neurologico Carlo Besta IT, multiple Pediatric Departments PT, multiple sites PL).
  • Recruitment brochures and doctor-to-parent/physician letters (country-specific K2 and K1 recruitment materials).
  • Digital recruitment channels: study websites, online screener and phone screener (explicitly referenced in Italy and Poland recruitment materials).
  • Use of patient recruitment/retention vendor (Autocruitment LLC) and other third-party recruitment companies.
  • Electronic clinical outcome assessment (eCOA) and digital materials for participants (Signant Health involvement).

Geography

Total Number Of Sites
18
Total Number Of Participants
120

Hungary

Earliest CTIS Part Ii Submission Date
17-04-2025
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
245
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Semmelweis University
Department Name
Gyermekgyogyaszati Klinika, Tuzolto utcai reszleg, Neurologiai Osztaly
Principal Investigator Name
Mark Kristof Farkas
Principal Investigator Email
kristofm.farkas@gmail.com
Contact Person Name
Mark Kristof Farkas
Contact Person Email
kristofm.farkas@gmail.com
Site Name
CEBA Egeszseguegyi Bt.
Department Name
Rozsavolgyi Rendelo
Principal Investigator Name
Csaba Bartha
Principal Investigator Email
csabartha@gmail.com
Contact Person Name
Csaba Bartha
Contact Person Email
csabartha@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
02-05-2025
Latest Decision Or Authorization Date
16-12-2025
Processing Time Days
228
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Haga Hospital
Principal Investigator Name
Elke Jacobs
Principal Investigator Email
e.jacobs@hagaziekenhuis.nl
Contact Person Name
Elke Jacobs
Contact Person Email
e.jacobs@hagaziekenhuis.nl
Site Name
Canisius Wilhelmina Ziekenhuis
Principal Investigator Name
Willemijn Leen
Principal Investigator Email
w.leen@cwz.nl
Contact Person Name
Willemijn Leen
Contact Person Email
w.leen@cwz.nl

Denmark

Earliest CTIS Part Ii Submission Date
06-05-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
189
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
Region Midtjylland
Principal Investigator Name
Luise Borch
Principal Investigator Email
luise.borch@rm.dk
Contact Person Name
Luise Borch
Contact Person Email
luise.borch@rm.dk
Site Name
Region Hovedstaden
Principal Investigator Name
Nanette Marinette Monique Mol Debes
Principal Investigator Email
nanette.marinette.monique.debes@regionh.dk
Contact Person Name
Nanette Marinette Monique Mol Debes

Italy

Earliest CTIS Part Ii Submission Date
20-02-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
264
Number Of Sites
2
Number Of Participants
15

Sites

Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
SC Neurologia 3
Principal Investigator Name
Licia Grazzi
Principal Investigator Email
licia.grazzi@istituto-besta.it
Contact Person Name
Licia Grazzi
Contact Person Email
licia.grazzi@istituto-besta.it
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
UOC Trials Padiglione Salviati
Principal Investigator Name
Massimiliano Valeriani
Principal Investigator Email
valeriani@opbg.net
Contact Person Name
Massimiliano Valeriani
Contact Person Email
valeriani@opbg.net

Portugal

Earliest CTIS Part Ii Submission Date
27-11-2025
Latest Decision Or Authorization Date
20-02-2026
Processing Time Days
85
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Pediatric Department
Principal Investigator Name
Sofia Quintas
Principal Investigator Email
sofiamendesquintas@gmail.com
Contact Person Name
Sofia Quintas
Contact Person Email
sofiamendesquintas@gmail.com
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Pediatric Department
Principal Investigator Name
Teresa Silverio
Principal Investigator Email
maria.silverio@ulsas.min-saude.pt
Contact Person Name
Teresa Silverio
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Pediatric Department
Principal Investigator Name
Ines Carrilho
Principal Investigator Email
icarrilho.dia@chporto.min-saude.pt
Contact Person Name
Ines Carrilho
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Pediatric Department
Principal Investigator Name
Filipe Palavra
Principal Investigator Email
filipepalavra@gmail.com
Contact Person Name
Filipe Palavra
Contact Person Email
filipepalavra@gmail.com
Site Name
Hospital Da Luz S.A.
Department Name
Neurology Service
Principal Investigator Name
Raquel Gil-Gouveia
Principal Investigator Email
rgouveia@hospitaldaluz.pt
Contact Person Name
Raquel Gil-Gouveia
Contact Person Email
rgouveia@hospitaldaluz.pt

Poland

Earliest CTIS Part Ii Submission Date
28-04-2025
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
308
Number Of Sites
5
Number Of Participants
35

Sites

Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Principal Investigator Name
Ilona Pieczonka-Ruszkowska
Principal Investigator Email
ilona.pieczonka-ruszkowska@cr-center.pl
Contact Person Name
Ilona Pieczonka-Ruszkowska
Site Name
OHA-Med Sp. z o.o.
Principal Investigator Name
Agnieszka Pojmanska
Principal Investigator Email
KLINIKA@DRSEKOWSKA.PL
Contact Person Name
Agnieszka Pojmanska
Contact Person Email
KLINIKA@DRSEKOWSKA.PL
Site Name
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Principal Investigator Name
Anna Gryglas-Dworak
Principal Investigator Email
anna.gryglas@gmail.com
Contact Person Name
Anna Gryglas-Dworak
Contact Person Email
anna.gryglas@gmail.com
Site Name
Specjalistyczne Gabinety Sp. z o.o.
Principal Investigator Name
Lucyna Horodecka-Wardega
Principal Investigator Email
lhwardega@specjalistycznegabinety.pl
Contact Person Name
Lucyna Horodecka-Wardega
Site Name
Athleticomed Sp. z o.o.
Principal Investigator Name
Magdalena Nowaczewska
Principal Investigator Email
m.nowaczewska@athleticomed.pl
Contact Person Name
Magdalena Nowaczewska
Contact Person Email
m.nowaczewska@athleticomed.pl

Sponsor

Primary sponsor

Full Name
AbbVie Deutschland GmbH & Co. KG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Altasciences Compagnie Inc.
Responsibilities
code 4
Name
Endpoint Clinical Inc.
Responsibilities
code 3
Name
Labcorp
Responsibilities
code 4
Name
Labcorp Central Laboratory Services SARL
Responsibilities
code 4
Name
Syneos Health Inc.
Responsibilities
Hepatic Events Adjudication Committee (HEAC)
Name
Signant Health Global LLC
Responsibilities
electronic clinical outcome assessment (eCOA)
Name
Eresearchtechnology Inc.
Responsibilities
ECG
Name
Veeva Systems Inc.
Responsibilities
code 7

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Autocruitment LLC","duties_or_roles":"Patient Recruitment and Retention","organisation_type":"Patient organisation/association"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"electronic clinical outcome assessment (eCOA)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Hepatic Events Adjudication Committee (HEAC)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Atogepant
Active Substance
ATOGEPANT
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus=1
Frequency
daily
Investigational Product Name
Placebo for Atogepant
Modality
Other

Related trials

Other published trials that may interest you.