Clinical trial • Phase III • Neurology

ATOGEPANT for Menstrual migraine

Phase III trial of ATOGEPANT for Menstrual migraine.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Menstrual migraine
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
22-10-2024
First CTIS Authorization Date
19-02-2025

Trial design

Randomised, open-label, placebo for atogepant (placebo comparator); atogepant (active investigational product) — dosing described as 'taken consecutively for 7 days' in main objective; specific mg dose not stated in the provided ctis data.-controlled Phase III trial in Portugal, Germany, Italy and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo for Atogepant (placebo comparator); Atogepant (active investigational product) — dosing described as 'taken consecutively for 7 days' in main objective; specific mg dose not stated in the provided CTIS data.
Target Sample Size
183
Trial Duration For Participant
232

Eligibility

Recruits 183 No vulnerable population selected. Participants are adult females (≥18). Informed consent is required (subject information and informed consent form documents are listed for participating countries, and a pregnancy-specific ICF is available)..

Vulnerable Population
No vulnerable population selected. Participants are adult females (≥18). Informed consent is required (subject information and informed consent form documents are listed for participating countries, and a pregnancy-specific ICF is available).

Inclusion criteria

  • {"criterion_text":"- Adult individuals, at least 18 years old, who by history and eDiary confirmation have regular menstrual cycles within the range of 21 to 35 days in length (Note: menstrual cycle length is calculated as onset of menses until the day before the next onset of menses)."}
  • {"criterion_text":"- History of migraine (with or without aura) according to the ICHD-3 for ≥ 12 months prior to Visit 1/Screening."}
  • {"criterion_text":"- Migraine onset before age 50 years."}
  • {"criterion_text":"- By history at Visit 1/Screening, subject meets ICHD-3 criteria for pure menstrual migraine with or without aura, or menstrually-related migraine with or without aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacks starting during the PMP (Day –2 to Day +3 relative to menses onset) in the opinion of the investigator."}
  • {"criterion_text":"- Subject records 3 PMPs in the eDiary during the screening period, and in at least 2 of 3 PMPs the subject experiences and records a migraine attack in the eDiary with at least 1 migraine day."}

Exclusion criteria

  • {"criterion_text":"- History of an average of 15 or more headache days per month during the 3 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-3."}
  • {"criterion_text":"- An average of 15 or more headache days per month recorded in the eDiary during the screening period."}
  • {"criterion_text":"- History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3."}
  • {"criterion_text":"- Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3."}
  • {"criterion_text":"- Subject required hospital/emergency room treatment for migraine attacks 3 or more times within 6 months prior to Visit 1/Screening."}
  • {"criterion_text":"- Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine per investigator judgment."}
  • {"criterion_text":"- Subject has a condition or situation, which the investigator feels will compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is the change from baseline (CFB) in number of migraine days occurring during the perimenstrual period (PMP) averaged across 3 menstrual cycles during the double-blind (DB) period.","definition_or_measurement_approach":"Change from baseline (CFB) in number of migraine days occurring during the perimenstrual period (PMP), averaged across 3 menstrual cycles during the double-blind period; measured using participant eDiary-recorded migraine days during PMP (Day -2 to Day +3 relative to menses onset)."}

Secondary endpoints

  • {"endpoint_text":"- CFB in number of migraine days (with moderate or severe headache) during the PMP averaged across 3 menstrual cycles during the DB period","definition_or_measurement_approach":"Change from baseline in number of migraine days with moderate or severe headache during PMP averaged across 3 cycles during the double-blind period (eDiary-recorded)."}
  • {"endpoint_text":"- 50% or above reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period","definition_or_measurement_approach":"Proportion of subjects achieving ≥50% reduction from baseline in migraine days averaged across 3 PMPs during the double-blind period."}
  • {"endpoint_text":"- CFB in number of acute medication use days during the PMP averaged across 3 menstrual cycles during the DB period","definition_or_measurement_approach":"Change from baseline in days of acute medication use during PMP averaged across 3 cycles during double-blind period (as recorded by subject eDiary/medication logs)."}
  • {"endpoint_text":"- CFB in number of moderate or severe headache days during the PMP averaged across 3 menstrual cycles during the DB period","definition_or_measurement_approach":"Change from baseline in number of moderate or severe headache days during PMP averaged across 3 cycles during double-blind period (eDiary-recorded severity)."}
  • {"endpoint_text":"- 100% reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period","definition_or_measurement_approach":"Proportion of subjects with complete (100%) reduction from baseline in migraine days averaged across 3 PMPs during the double-blind period."}
  • {"endpoint_text":"- No disability/mild impairment for 100% of PMP days (assessed by FDS) across 3 menstrual cycles during the DB period","definition_or_measurement_approach":"Proportion of subjects with no disability or only mild impairment on Functional Disability Scale (FDS) for 100% of PMP days across 3 cycles during the double-blind period."}
  • {"endpoint_text":"- CFB in number of headache days during the PMP averaged across 3 menstrual cycles during the DB period","definition_or_measurement_approach":"Change from baseline in number of headache days during PMP averaged across 3 cycles during double-blind period (eDiary-recorded)."}

Recruitment

Registry Or Advocacy Recruitment
True (Autocruitment LLC is listed as a third party with role 'Recruitment Materials').
Digital Remote Recruitment
True (AutoCruitment websites and digital materials, phone screens and online pre-screening described in recruitment documents).
Planned Sample Size
183
Recruitment Window Months
29
Consent Approach
Informed consent is obtained from adult participants (participants are adults ≥18). Subject information and informed consent forms (ICFs) and pregnancy-specific ICFs are provided; country/language-specific ICF documents are listed (examples: German, Portuguese, Italian, Hungarian, Polish, Czech, Spanish).

Methods

  • Posters (site posters) — country-specific posters referenced (e.g., K2 ... Poster_Public files for DE, IT, PL, HU, ES, PT, CZ).
  • Brochures / recruitment brochures (country-specific) — multiple 'Brochure' documents for participating countries.
  • Website / AutoCruitment digital materials (online recruitment) — documents titled AutoCruitment Website, AutoCruitment Digital Materials for multiple countries.
  • Phone screening / phone screen materials — country-specific 'Phone Screen' documents listed.
  • Study visit guides and recruitment procedures documents provided for each country (K1/K2 Study Visit Guide).

Geography

Total Number Of Sites
62
Total Number Of Participants
265

Portugal

Earliest CTIS Part Ii Submission Date
10-12-2024
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
407
Number Of Sites
10
Number Of Participants
22

Sites

Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Neurology
Contact Person Name
Isabel Pavao Martins
Contact Person Email
ipavaomartins@gmail.com
Site Name
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Neurology
Contact Person Name
Ines Carvalho
Site Name
Unidade Local De Saude Da Arrabida E.P.E.
Department Name
Neurology
Contact Person Name
Gonçalo Bonifacio
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Neurology
Contact Person Name
Sara Duarte
Site Name
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Department Name
Neurology
Contact Person Name
Beatriz Santiago
Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Neurology
Contact Person Name
Andreia Costa
Contact Person Email
andreiafgcosta@gmail.com
Site Name
Unidade Local De Saude De Almada-Seixal E.P.E.
Department Name
Neurology
Contact Person Name
Liliana Pereira
Site Name
Hospital Da Luz S.A.
Department Name
Neurology
Contact Person Name
Raquel Gil-Gouveia
Contact Person Email
rgouveia@hospitaldaluz.pt
Site Name
Unidade Local De Saude De Loures-Odivelas EPE
Department Name
Neurology
Contact Person Name
Ana Ribeiro
Contact Person Email
anaribeiro@sapo.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Neurology
Contact Person Name
Sara Varanda
Contact Person Email
svaranda@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
28-01-2025
Latest Decision Or Authorization Date
22-01-2026
Processing Time Days
359
Number Of Sites
9
Number Of Participants
67

Sites

Site Name
Neurozentrum Bielefeld
Contact Person Name
Matthias Boehringer
Contact Person Email
judithkatzmann@gmail.com
Site Name
Ambenet GmbH Das Ambulante Behandlungsnetz
Contact Person Name
Hans-Detlev Stahl
Contact Person Email
studien@ambenet.de
Site Name
ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen
Department Name
Weidenauer Strasse 120
Contact Person Name
Eugen Schlegel
Contact Person Email
blinow@zns-siegen.de
Site Name
Klinikum Ibbenbueren gGmbH
Contact Person Name
Florian Bethke
Contact Person Email
S.kammann@mathias-stiftung.de
Site Name
Neuro Centrum Science GmbH
Contact Person Name
Stefan Ries
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik und Poliklinik für Neurologie, Ferdinand-Sauerbruch Straße
Contact Person Name
Robert Fleischmann
Site Name
Pharmakologisches Studienzentrum Chemnitz GmbH
Contact Person Name
Ralf Bodenschatz
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Neurologie mit Experimenteller Neurologie, Kopfschmerzambulanz
Contact Person Name
Bianca Raffaelli
Contact Person Email
bianca.raffaelli@charite.de
Site Name
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
Department Name
Privatpraxis Dr. med. J. Springub, Studienzentrum Nord-West
Contact Person Name
Joachim Springub
Contact Person Email
joachim.springub@ewetel.net

Italy

Earliest CTIS Part Ii Submission Date
31-01-2025
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
357
Number Of Sites
10
Number Of Participants
24

Sites

Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Contact Person Name
Mariarosaria Valente
Site Name
Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco Pasquali
Contact Person Name
Gianluca Coppola
Contact Person Email
gianluca.coppola@uniroma1.it
Site Name
Istituto Auxologico Italiano
Contact Person Name
Alberto Doretti
Contact Person Email
a.doretti@auxologico.it
Site Name
Azienda Ospedaliero Universitaria Careggi
Contact Person Name
Alberto Chiarugi
Contact Person Email
alberto.chiarugi@unifi.it
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Contact Person Name
Cristina Tassorelli
Contact Person Email
cristina.tassorelli@mondino.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Person Name
Catello Vollono
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Contact Person Name
Roberto De Simone
Contact Person Email
rodesimo@unina.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Contact Person Name
Antonio Russo
Contact Person Email
antonio.russo@unicampania.it
Site Name
Hospital Santa Maria Della Misericordia
Contact Person Name
Paola Sarchielli
Contact Person Email
paola.sarchielli@unipg.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Contact Person Name
Licia Grazzi
Contact Person Email
licia.grazzi@istituto-besta.it

Hungary

Earliest CTIS Part Ii Submission Date
18-12-2024
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
401
Number Of Sites
6
Number Of Participants
22

Sites

Site Name
S-Medicon Kft.
Department Name
Neurologia
Contact Person Name
Maria Satori
Contact Person Email
satori.maria@gmail.com
Site Name
Cortex Study Center
Contact Person Name
Zsuzsanna Horvath
Contact Person Email
zs.horvath35@gmail.com
Site Name
MIND Klinika Kft.
Contact Person Name
Szabolcs Szatmari
Contact Person Email
szatmari.szabolcs.88@gmail.com
Site Name
Semmelweis University
Department Name
Gyermekgyogyaszati Klinika Neurologia
Contact Person Name
Mark Kristof Farkas
Contact Person Email
kristofm.farkas@gmail.com
Site Name
Budapesti Uzsoki Utcai Korhaz
Department Name
Neurologia
Contact Person Name
Gabor Jakab
Contact Person Email
jakabg@uzsoki.hu
Site Name
Semmelweis University
Department Name
Idegsebeszeti es Neurointervencios Klinika Fejfajas Ambulancia
Contact Person Name
Judit Afra
Contact Person Email
ajudit1@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
31-01-2025
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
360
Number Of Sites
8
Number Of Participants
47

Sites

Site Name
Athleticomed Sp. z o.o.
Contact Person Name
Magdalena Nowaczewska
Contact Person Email
m.nowaczewska@athleticomed.pl
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Contact Person Name
Magdalena Boczarska-Jedynak
Site Name
Neuro-Care Sp. z o.o. sp.k.
Contact Person Name
Gabriela Kłodowska
Contact Person Email
g.klodowska@neuro-care.pl
Site Name
Solumed Centrum Medyczne Sp. z o.o.
Department Name
M/A
Contact Person Name
Olgierd Stefanski
Contact Person Email
olgierd_stefanski@interia.pl
Site Name
MIGRE Polskie Centrum Leczenia Migreny ANNA GRYGLAS-DWORAK
Contact Person Name
Anna Gryglas-Dworak
Contact Person Email
anna.gryglas@gmail.com
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Contact Person Name
Magdalena Nowowiejska-Jastrzebowska
Contact Person Email
m.nowojast@pihouse.pl
Site Name
Novo-Med Zielinski I Wspolnicy Sp. j.
Contact Person Name
Agnieszka Krzak-Kubica
Contact Person Email
agukrzak@gmail.com
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Neurologii
Contact Person Name
Agnieszka Słowik
Contact Person Email
neurologiabk@su.krakow.pl

Czechia

Earliest CTIS Part Ii Submission Date
04-11-2024
Latest Decision Or Authorization Date
23-01-2026
Processing Time Days
445
Number Of Sites
11
Number Of Participants
65

Sites

Site Name
Clintrial s.r.o.
Department Name
Neurologie
Contact Person Name
Miroslava Chylová
Contact Person Email
m.chylova@clintrial.cz
Site Name
Neurologie Brno s.r.o.
Department Name
Neurologie
Contact Person Name
Ingrid Niedermayerová
Site Name
Pratia Prague s.r.o.
Department Name
Neurologie
Contact Person Name
Eva Medová
Contact Person Email
eva.medova@ccrprague.com
Site Name
A-Shine s.r.o.
Department Name
Neurologie
Contact Person Name
Luboš Janů
Contact Person Email
lubos.janu@seznam.cz
Site Name
Neuro plus s.r.o.
Department Name
Neurologie
Contact Person Name
Andrea Bartková
Contact Person Email
andrea.bartkova@fnol.cz
Site Name
MINKSneuro s.r.o.
Department Name
Neurologie
Contact Person Name
Eduard Minks
Contact Person Email
eduardminks@seznam.cz
Site Name
Neurohk s.r.o.
Department Name
Neurologie
Contact Person Name
Martin Vališ
Contact Person Email
valismar@seznam.cz
Site Name
Dado Medical s.r.o.
Department Name
Neurologie
Contact Person Name
David Doležil
Contact Person Email
research@dadomedical.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
Neurologie
Contact Person Name
Petr Mečíř
Contact Person Email
mecir.petr@vfn.cz
Site Name
Fakultni Thomayerova nemocnice
Department Name
Neurologie
Contact Person Name
Jolana Marková
Contact Person Email
jolana.markova@ftn.cz
Site Name
Neuro plus s.r.o. (additional listed site)
Department Name
Neurologie
Contact Person Name
Andrea Bartková
Contact Person Email
andrea.bartkova@fnol.cz

Spain

Earliest CTIS Part Ii Submission Date
16-07-2025
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
194
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Neurología
Contact Person Name
Mª Neus Fabregat
Contact Person Email
FABREGAT@CLINIC.CAT
Site Name
Hospital Clinico San Carlos
Department Name
Neurología
Contact Person Name
Nuria Gonzalez
Contact Person Email
nurigongar@gmail.com
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Neurología
Contact Person Name
Angel Luis Guerrero
Contact Person Email
gueneurol@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Neurología
Contact Person Name
Francisco Javier Díaz de Terán
Contact Person Email
javierddt@gmail.com
Site Name
Hospital Germans Trias I Pujol
Department Name
Neurología
Contact Person Name
Laura Dorado
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurología
Contact Person Name
Patricia Pozo
Contact Person Email
patricia.pozo@vhir.org
Site Name
Hospital Universitario De Canarias
Department Name
Neurología
Contact Person Name
Cristian Morales
Site Name
Hospital Clinico San Carlos (additional listed site)
Department Name
Neurología
Contact Person Name
Nuria Gonzalez
Contact Person Email
nurigongar@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
IQVIA Limited
Responsibilities
Clinical trial services; contact: eu_clinical_trials_information@iqvia.com (sponsorDuties code: 3)
Name
Syneos Health Inc.
Responsibilities
Hepatic Events Adjudication Committee (HEAC)
Name
Altasciences Compagnie Inc.
Responsibilities
sponsorDuties code: 4 (listed role)
Name
Signant Health Global Solutions Limited
Responsibilities
electronic clinical outcome assessment (eCOA), C-SSRS rater training facilitation
Name
Labcorp Central Laboratory Services LP
Responsibilities
Central laboratory services
Name
Labcorp Central Laboratory Services SARL
Responsibilities
Central laboratory services

Third parties

  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 3 (document lists code '3') ; contact email: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Reimbursement of study-related subject expenses and study-related travel booking service","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Hepatic Events Adjudication Committee (HEAC)","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"electronic clinical outcome assessment (eCOA), C-SSRS rater training facilitation","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4 (central laboratory services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 7 (listed in document)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties code: 4 (central laboratory services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Autocruitment LLC","duties_or_roles":"Recruitment Materials","organisation_type":"Patient organisation/association"}

Investigational products

Investigational Product Name
Atogepant
Active Substance
ATOGEPANT
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 1; euMpNumber: PRD9649619 (recorded in CTIS product dictionary)
Frequency
Taken consecutively for 7 days (as stated in main objective); specific mg dose not provided in CTIS data
Investigational Product Name
Placebo for Atogepant
Modality
Other

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