Clinical trial • Phase III • Neurology

ATOGEPANT for Migraine | Episodic migraine

Phase III trial of ATOGEPANT for Migraine | Episodic migraine.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Migraine | Episodic migraine
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-11-2023
First CTIS Authorization Date
20-03-2024

Trial design

Randomised, open-label, placebo for atogepant tablets 60mg (matching placebo); atogepant (active investigational product; dose not specified in the part i product metadata though placebo label references 60 mg tablets)-controlled Phase III trial in Belgium, Hungary, Poland and others.

Randomised
Yes
Open Label
Yes
Comparator
Placebo for atogepant tablets 60mg (matching placebo); Atogepant (active investigational product; dose not specified in the Part I product metadata though placebo label references 60 mg tablets)
Target Sample Size
772
Trial Duration For Participant
203

Eligibility

Recruits 772 Informed consent must be obtained: "Subjects must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures." Participants must be adults (Aged 18 to 75 years, inclusive) and meet the legal age of majority per local law. Specific informed consent documents are provided for pregnant partners and for the Triptan-Unsuitable substudy; ICFs are available in multiple local languages (see consent_approach). The CTIS record flags "isVulnerablePopulationSelected": true but no additional assent procedures for minors are applicable because minimum age is 18..

Pregnancy Exclusion
Female subjects who are not pregnant or breastfeeding, and are not planning to become pregnant or donate eggs during the study and for approximately 30 days after the last dose of study drug.
Vulnerable Population
Informed consent must be obtained: "Subjects must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures." Participants must be adults (Aged 18 to 75 years, inclusive) and meet the legal age of majority per local law. Specific informed consent documents are provided for pregnant partners and for the Triptan-Unsuitable substudy; ICFs are available in multiple local languages (see consent_approach). The CTIS record flags "isVulnerablePopulationSelected": true but no additional assent procedures for minors are applicable because minimum age is 18.

Inclusion criteria

  • {"criterion_text":"- Subjects must voluntarily sign and date an informed consent, approved by an IEC/IRB, prior to the initiation of any screening or study-specific procedures."}
  • {"criterion_text":"- History of migraines lasting between 4 to 72 hours when untreated or treated unsuccessfully and migraine episodes separated by at least 48 hours of headache pain freedom."}
  • {"criterion_text":"- History of 2 to 8 migraine attacks per month with moderate to severe headache pain in each of the 3 months prior to Visit 1/Screening per investigator judgment."}
  • {"criterion_text":"- Female subjects who are not pregnant or breastfeeding, and are not planning to become pregnant or donate eggs during the study and for approximately 30 days after the last dose of study drug."}
  • {"criterion_text":"- Female subjects (or individuals) of childbearing potential must have a negative serum pregnancy test at Visit 1/Screening and a negative urine pregnancy test at Visit 2/Randomization. Subjects with a borderline serum pregnancy test at Visit 1/Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥3 days later to document continued lack of a positive result (unless prohibited by local requirements). Subjects with a urine pregnancy test at Visit 2/Randomization that is borderline or ambiguous must have a serum pregnancy test. In such cases, the subjects must be excluded from participation if the serum pregnancy result is positive."}
  • {"criterion_text":"- Female subjects (or individuals) of childbearing potential must practice at least 1 protocol-specified method of birth control, from 30 days prior to Visit 2/Randomization until 30 days after the last dose of study drug. Female subjects of nonchildbearing potential do not need to use birth control."}
  • {"criterion_text":"- Has used prescription or nonprescription medication for the acute treatment of migraine in the past."}
  • {"criterion_text":"- Oral migraine medications used for prophylaxis on-label or off-label (e.g., topiramate, amitriptyline, beta blockers, flunarizine, venlafaxine, etc.), and injectable onabotulinum toxin A and other therapies used for migraine prevention are permitted provided that the treatment is stable for at least 3 months prior to Visit 2/Randomization and continues without change in dose throughout the study."}
  • {"criterion_text":"- Subjects enrolling in the Triptan-Unsuitable substudy (applicable only after completion of enrollment in the main study) must meet all the inclusion criteria listed for the main study and must not meet any of the exclusion criteria listed for the main study. In addition, subjects must meet the following inclusion criterion: Subject must be \"\"triptan-unsuitable\"\" defined as meeting 1 of the 2 following criteria: -has a contraindication to triptans based upon local label and investigator judgment, irrespective of prior triptan use OR meets the following triptan failure definition for ≥2 different triptans: Currently uses a triptan or has used a triptan in the past and has not achieved pain relief (defined as the reduction of a moderate/severe migraine headache to a mild headache or no headache) at 2 hours postdose in ≥2 out of 4 attacks based upon subject interview and investigator judgment OR -Used a triptan in the past but no longer uses a triptan due to AEs based upon subject interview and investigator judgment."}
  • {"criterion_text":"- Ability and willingness to read, understand, and complete study questionnaires and eDiary."}
  • {"criterion_text":"- Aged 18 to 75 years, inclusive, at Visit 1/Screening (subjects must also meet the legal age of majority per local law)."}
  • {"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 the age of 50."}

Exclusion criteria

  • {"criterion_text":"- Subject has difficulty in distinguishing migraine headache from tension-type or other headaches per the investigator's judgment."}
  • {"criterion_text":"- Positive result on the urine drug screen at Visit 1/Screening unless explained by allowed concomitant medication use (e.g., opioids prescribed for migraine pain, use of benzodiazepines for insomnia)."}
  • {"criterion_text":"- Positive result on the hepatitis B surface antigen or the anti-hepatitis C antibody testing at Visit 1/Screening."}
  • {"criterion_text":"- Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy and other significant neurological disorders other than migraine per investigator judgment."}
  • {"criterion_text":"- Presence of chronic, nonheadache pain condition requiring daily pain medication."}
  • {"criterion_text":"- Clinically significant cardiovascular, cerebrovascular, hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, psychiatric, or neurologic disease. -If there is a history of such disease but the condition has been stable for more than 6 months prior to Visit 1/Screening and is judged by the investigator as not likely to interfere with the subject's participation in the study, the subject may be included. -Subjects on dialysis for renal failure are not allowed to participate in the study."}
  • {"criterion_text":"- Significant risk of self-harm, based on clinical interview or responses on the C-SSRS, or harm to others per the opinion of the investigator; subjects must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 6 months or report suicidal behavior in the last 6 months prior to Visit 1/Screening or Visit 2/Randomization."}
  • {"criterion_text":"- History of malignancy in the 5 years prior to Visit 1/Screening, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer."}
  • {"criterion_text":"- History of any prior gastrointestinal conditions (e.g., diarrhea syndromes, inflammatory bowel disease) that may affect the absorption or metabolism of study drug. -Subjects with prior gastric bariatric interventions (e.g., Lap Band) which have been reversed may participate."}
  • {"criterion_text":"- History of acute hepatitis within 6 months of Visit 1/Screening or any history of chronic liver disease (including nonalcoholic fatty liver disease, viral chronic hepatitis, and cirrhosis)."}
  • {"criterion_text":"- History of hypersensitivity or clinically significant adverse reaction to a CGRP receptor antagonist."}
  • {"criterion_text":"- History of an average of 15 or more headache days per month in the 6 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-3. (Note: subjects with a diagnosis of chronic migraine who, in the opinion of the investigator, have fewer than 15 headache days per month due to concomitant prophylactic treatment are allowed to participate in the study)."}
  • {"criterion_text":"- Subject is an employee or immediate family member (parents, spouses, siblings, or children) of one of the investigators, study staff, or AbbVie."}
  • {"criterion_text":"- Subject has 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."}
  • {"criterion_text":"- Subject has taken medication for acute treatment of headache (including acetaminophen, NSAIDs, triptans, ditans, ergotamine, opioids, gepants, or combination analgesics) 10 or more days per month in any of the 3 months prior to Visit 2/Randomization."}
  • {"criterion_text":"- Subject has taken strong CYP3A4 inhibitors, including but not limited to systemic (oral/IV) itraconazole, ketoconazole, clarithromycin, telithromycin, nefazodone, and HIV protease inhibitors within 30 days or 5 half-lives of the drug (whichever is longer) prior to Visit 2/Randomization."}
  • {"criterion_text":"- Subject has taken strong or moderate CYP3A4 inducers, including but not limited to barbiturates (e.g., phenobarbital and primidone), efavirenz, carbamazepine, phenytoin, rifampin, and St John's wort within 30 days or 5 half-lives of the drug (whichever is longer) prior to Visit 2/Randomization."}
  • {"criterion_text":"- Subject has taken strong OATP1B1/OATP1B3 inhibitors (e.g., cyclosporine, telmisartan) within 30 days or 5 half-lives (whichever is longer) of the drug prior to Visit 2/Randomization."}
  • {"criterion_text":"- Subject has taken drugs with narrow therapeutic margins with theoretical potential for CYP drug interactions (e.g., warfarin) within 30 days or 5 half-lives (whichever is longer) of the drug prior to Visit 2/Randomization."}
  • {"criterion_text":"- Subject has been exposed to any gepant within 30 days prior to Visit 2/Randomization."}
  • {"criterion_text":"- Subject has been exposed to injectable monoclonal antibodies blocking the CGRP pathway within 6 months prior to Visit 2/Randomization."}
  • {"criterion_text":"- History of clinically significant drug or alcohol abuse or dependency in the 12 months prior to Visit 1/Screening, or subject had concomitant cannabis or ingested CBD oil use, either recreational or for medical reasons, within 30 days prior to Visit 2/Randomization."}
  • {"criterion_text":"- Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), and painful cranial neuropathy as defined by ICHD-3."}
  • {"criterion_text":"- Subject has been treated with any investigational drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to Visit 2/Randomization or is currently enrolled in another clinical study or was previously enrolled in this study."}
  • {"criterion_text":"- Subject has been treated with oral herbal medicine including, but not limited to, traditional Chinese medicine within 30 days or 5 half-lives (whichever is longer) prior to Visit 2/Randomization."}
  • {"criterion_text":"- Subject required hospital/emergency room treatment for migraine attacks on 3 or more occasions within 6 months prior to Visit 1/Screening."}
  • {"criterion_text":"- ECG with clinically significant abnormalities at Visit 1/Screening, as determined by the investigator."}
  • {"criterion_text":"- QTcF > 450 msec for males or QTcF > 470 msec for females at Visit 1/Screening based on the report of the central reviewer."}
  • {"criterion_text":"- Hypertension defined as sitting systolic blood pressure > 160 mm Hg or sitting diastolic blood pressure > 100 mm Hg at Visit 1/Screening or Visit 2/Randomization. Blood pressure measurements that exceed these limits may be repeated only once."}
  • {"criterion_text":"- Clinically significant abnormalities in the physical examination as determined by the investigator."}
  • {"criterion_text":"- Clinically significant laboratory abnormalities as determined by the investigator, or laboratory values meeting any of the following criteria at Visit 1/Screening: ALT or AST > 1 × ULN; Total bilirubin > 1 × ULN (except for subjects with a diagnosis of Gilbert's disease); Serum albumin < 2.8 g/dL [4.06 µmol/L]"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Pain freedom (defined as a reduction in headache severity from moderate/severe at baseline [predose] to no pain) at 2 hours after the DB dose for the first attack","definition_or_measurement_approach":"Defined in-text: reduction in headache severity from moderate/severe at baseline (predose) to no pain; measured at 2 hours after the double-blind dose for the first attack."}

Secondary endpoints

  • {"endpoint_text":"- Absence of the MBS at 2 hours after the DB dose for the first attack (coprimary endpoint for China)","definition_or_measurement_approach":"Absence of the most bothersome symptom (MBS) measured at 2 hours after double-blind dose for the first attack."}
  • {"endpoint_text":"- Pain relief (defined as the reduction of a moderate/severe migraine headache at baseline [predose] to a mild headache or to no headache) at 2 hours after the DB dose for the first attack","definition_or_measurement_approach":"Reduction from moderate/severe at baseline to mild or no headache at 2 hours post-dose for first attack."}
  • {"endpoint_text":"- Sustained pain relief from 2 to 24 hours (defined as pain relief at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a moderate/severe headache from 2 to 24 hours) after the DB dose for the first attack","definition_or_measurement_approach":"Pain relief at 2 hours with no rescue medication and no recurrence of moderate/severe headache between 2 and 24 hours."}
  • {"endpoint_text":"- Sustained pain relief from 2 to 48 hours after the DB dose for the first attack","definition_or_measurement_approach":"Sustained pain relief measured from 2 to 48 hours post-dose (details analogous to 2–24 hour definition)."}
  • {"endpoint_text":"- Use of rescue medication within 24 hours after the DB dose for the first attack","definition_or_measurement_approach":"Recorded use of any rescue medication within 24 hours after the double-blind dose for the first attack."}
  • {"endpoint_text":"- Ability to function normally at 2 hours after the DB dose for the first attack","definition_or_measurement_approach":"Participant-reported ability to function normally assessed at 2 hours after DB dose for first attack."}
  • {"endpoint_text":"- Sustained pain freedom from 2 to 24 hours (defined as pain freedom at 2 hours after the DB dose with no administration of rescue medication and no occurrence of a mild/moderate/severe headache from 2 to 24 hours) after the DB dose for the first attack","definition_or_measurement_approach":"Pain freedom at 2 hours with no rescue medication and no recurrence of headache (any severity) between 2 and 24 hours."}
  • {"endpoint_text":"- Sustained pain freedom from 2 to 48 hours after the DB dose for the first attack","definition_or_measurement_approach":"Sustained pain freedom measured from 2 to 48 hours post-dose for first attack."}
  • {"endpoint_text":"- Absence of photophobia at 2 hours after the DB dose for the first attack","definition_or_measurement_approach":"Absence of light sensitivity (photophobia) assessed at 2 hours after DB dose for first attack."}
  • {"endpoint_text":"- Absence of phonophobia at 2 hours after the DB dose for the first attack","definition_or_measurement_approach":"Absence of sound sensitivity (phonophobia) assessed at 2 hours after DB dose for first attack."}
  • {"endpoint_text":"- Pain freedom at 8 hours after the DB dose for the first attack","definition_or_measurement_approach":"Pain freedom assessed at 8 hours after DB dose for first attack."}
  • {"endpoint_text":"- Ability to function normally 8 hours after the DB dose for the first attack","definition_or_measurement_approach":"Participant-reported normal functioning at 8 hours post-dose for first attack."}
  • {"endpoint_text":"- Pain relief at 1 hour after the DB dose for the first attack","definition_or_measurement_approach":"Pain relief (moderate/severe to mild or none) measured at 1 hour after DB dose."}
  • {"endpoint_text":"- Absence of nausea at 2 hours after the DB dose for the first attack","definition_or_measurement_approach":"Absence of nausea assessed at 2 hours after DB dose for first attack."}
  • {"endpoint_text":"- Pain relief at 30 minutes after the DB dose for the first attack","definition_or_measurement_approach":"Pain relief measured at 30 minutes post-dose for first attack."}
  • {"endpoint_text":"- Ability to function normally at 1 hour after the DB dose for the first attack","definition_or_measurement_approach":"Participant-reported normal functioning at 1 hour after DB dose for first attack."}

Recruitment

Registry Or Advocacy Recruitment
True, Autocruitment LLC
Digital Remote Recruitment
True, the CTIS document list includes 'Digital Outreach and Website Materials' and country-specific website/digital outreach documents; AutoCruitment and online website pages are used for candidate identification and pre-screening.
Planned Sample Size
772
Recruitment Window Months
29
Consent Approach
Subjects must voluntarily sign and date an informed consent approved by an IEC/IRB prior to any screening or study-specific procedures. Subjects must be adults and meet the legal age of majority per local law (inclusion age 18–75). Specific informed consent documents are provided per country and per substudy (e.g., Triptan-Unsuitable substudy ICFs) and dedicated ICFs exist for pregnant partners. ICF documents are available in multiple local languages (examples in the CTIS record include English, Dutch, French, Hungarian, Polish, Spanish, Portuguese, Czech, Italian, Swedish, German, Slovak).

Methods

  • Website materials (country-specific website pages and website materials are listed for multiple countries: e.g., 'Website', 'Website material' documents per country).
  • Digital outreach (documents titled 'Digital Outreach and Website Materials' exist for multiple countries indicating online/digital recruitment channels).
  • Printed brochures and posters (country-specific 'Brochure' and 'Poster' recruitment materials present).
  • Telephone pre-screening / phone screen scripts (documents titled 'phone screen' for multiple countries).
  • Third-party patient recruitment provider (Autocruitment LLC) involvement listed in sponsor third parties and recruitment materials in some countries.
  • Country-specific tailored recruitment packs: recruitment documents exist per Member State (Belgium, Hungary, Poland, Italy, Portugal, Sweden, Czechia, Germany, Slovakia, Spain) indicating local-language and local-site directed recruitment approaches.

Geography

Total Number Of Sites
79
Total Number Of Participants
1013

Belgium

Earliest CTIS Part Ii Submission Date
04-03-2024
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
21
Number Of Sites
9
Number Of Participants
84

Sites

Site Name
Cabinet Prive Dr. Sava
Department Name
Neurology
Contact Person Name
Simona Sava
Contact Person Email
simonaliliana.sava@gmail.com
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Neurology
Contact Person Name
Frederik Vanhee
Contact Person Email
frederik.vanhee@azgroeninge.be
Site Name
UZ Brussel
Department Name
Neurology
Contact Person Name
Jan Versijpt
Contact Person Email
jan.versijpt@uzbrussel.be
Site Name
Antwerp University Hospital
Department Name
Neurology
Contact Person Name
Patrick Cras
Contact Person Email
patrick.cras@uza.be
Site Name
Centre Hospitalier Regional De La Citadelle
Department Name
Neurology
Contact Person Name
Grégory Timmermans
Site Name
Jessa Ziekenhuis
Department Name
Neurology
Contact Person Name
Nina De Klippel
Contact Person Email
nina.deklippel@jessazh.be
Site Name
Heilig-Hartziekenhuis Lier
Department Name
Neurology
Contact Person Name
Peter Dedeken
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Neurology
Contact Person Name
Annelies Van Dycke
Contact Person Email
annelies.vandycke@azsintjan.be
Site Name
President Kennedylaan 4 (Kortrijk site)
Department Name
Neurology

Hungary

Earliest CTIS Part Ii Submission Date
10-05-2024
Latest Decision Or Authorization Date
17-06-2024
Processing Time Days
38
Number Of Sites
7
Number Of Participants
89

Sites

Site Name
Cortex Study Center
Contact Person Name
Zsuzsanna Horvath
Contact Person Email
studycenter@cortexps.hu
Site Name
Orszagos Mentalis Ideggyogyaszati Es Idegsebeszeti Intezet
Department Name
Fejfajas Ambulancia
Contact Person Name
Judit Afra
Contact Person Email
Ajudit1@gmail.com
Site Name
Uno Medical Trials Kft.
Contact Person Name
Katalin Guba
Contact Person Email
gubakatalin@gmail.com
Site Name
Semmelweis University (Tuzolto Utca 7-9)
Department Name
Gyermekgyogyaszati Klinika (Tuzolto utcai reszleg)
Contact Person Name
Mark Kristof Farkas
Contact Person Email
farkas.kristof@semmelweis.hu
Site Name
Semmelweis University (Amerikai Ut 57)
Department Name
Idegsebeszeti es Neurointervencios Klinika
Contact Person Name
Judit Afra
Contact Person Email
Ajudit1@gmail.com
Site Name
S-Medicon Kft.
Department Name
Neurologia
Contact Person Name
Maria Satori
Contact Person Email
satori.maria@gmail.com
Site Name
Semmelweis University (Bokay Janos Utca 53)
Department Name
Gyermekgyogyaszati Klinika (Bokay utcai reszleg)
Contact Person Name
Mark Kristof Farkas
Contact Person Email
farkas.kristof@semmelweis.hu

Poland

Earliest CTIS Part Ii Submission Date
08-03-2024
Latest Decision Or Authorization Date
02-04-2024
Processing Time Days
25
Number Of Sites
10
Number Of Participants
177

Sites

Site Name
Silmedic Sp. z o.o.
Contact Person Name
Ilona Palka-Kisielowska
Contact Person Email
ikisielowska@silmedic.pl
Site Name
Athleticomed Sp. z o.o.
Contact Person Name
Magdalena Nowaczewska
Contact Person Email
m.nowaczewska@athleticomed.pl
Site Name
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej
Contact Person Name
Anna Szczepańska-Szerej
Contact Person Email
aszerej@poczta.onet.pl
Site Name
Linden Sp. z o.o. sp.k.
Contact Person Name
Małgorzata Krawczyk
Site Name
Solumed Centrum Medyczne Sp. z o.o.
Contact Person Name
Olgierd Stefański
Contact Person Email
olgierd_stefanski@interia.pl
Site Name
MIGRE Polskie Centrum Leczenia Migreny
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-Jastrzębowska
Contact Person Email
m.nowojast@pihouse.pl
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Contact Person Name
Anna Piątek
Contact Person Email
anna.piatek@cr-center.pl
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Contact Person Name
Magdalena Boczarska-Jedynak
Site Name
Vitamed Galaj I Cichomski Sp. j.
Contact Person Name
Józef Kościelniak
Contact Person Email
joseph_kos@wp.pl

Italy

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
27-03-2024
Processing Time Days
14
Number Of Sites
12
Number Of Participants
118

Sites

Site Name
Azienda Sociosanitaria Ligure 2
Department Name
Testa collo
Contact Person Name
Cinzia Finocchi
Contact Person Email
c.finocchi@als2.liguria.it
Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
Neuroscience
Contact Person Name
Innocenzo Rainero
Contact Person Email
Innocenzo.rainero@unito.it
Site Name
Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco Pasquali
Department Name
medico-surgical Sciences and Biotechnologies
Contact Person Name
Gianluca Coppola
Contact Person Email
giancluca.coppola@uniroma1.it
Site Name
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Department Name
Centro per lo Studio e la Cura delle Cefalee
Contact Person Name
Armando Perrotta
Contact Person Email
arm.perrotta@gmail.com
Site Name
Fondazione Policlinico Universitario Campus Bio-Medico
Department Name
Headache and Neurosonology Unit. Neurology
Contact Person Name
Fabrizio Vernieri
Site Name
Azienda Sanitaria Locale Avezzano Sulmona L'Aquila
Department Name
Applied Clinical and Biotechnological Sciences- Department of Neurology and Stroke Unit
Contact Person Name
Raffele Ornello
Contact Person Email
Raffaele.ornello@univaq.it
Site Name
Istituto Auxologico Italiano IRCCS
Department Name
Neurology
Contact Person Name
Alberto Doretti
Contact Person Email
a.doretti@auxologico.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O.C. Neurologia
Contact Person Name
Renata Rao
Contact Person Email
renaraodoc@gmail.com
Site Name
Instituto Di Ricovero E Cura A Carattere Scientifico (Ospedale Bellaria)
Department Name
Ospedale Bellaria
Contact Person Name
Davide Mascarella
Contact Person Email
davide.mascarella2@unibo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Neurology
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it
Site Name
Neurological Institute Foundation Casimiro Mondino
Department Name
U.O. Neuroriabilitazione
Contact Person Name
Cristina Tassorelli
Contact Person Email
cristina.tassorelli@unipv.it
Site Name
Azienda Sociosanitaria Ligure 2 (additional site)

Portugal

Earliest CTIS Part Ii Submission Date
20-02-2024
Latest Decision Or Authorization Date
22-03-2024
Processing Time Days
31
Number Of Sites
7
Number Of Participants
70

Sites

Site Name
Centro Hospitalar de Setubal E.P.E.
Department Name
Neurology
Contact Person Name
Rui Matos
Contact Person Email
rui.matos@chs.min-saude.pt
Site Name
Hospital Garcia De Orta E.P.E.
Department Name
Neurology
Contact Person Name
Liliana Pereira
Site Name
Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
Department Name
Neurology
Contact Person Name
Ines Carvalho
Site Name
Hospital Da Luz S.A.
Department Name
Neurology
Contact Person Name
Raquel Gil-Gouveia
Contact Person Email
rgouveia@hospitaldaluz.pt
Site Name
Hospital De Santa Maria E.P.E.
Department Name
Neurology
Contact Person Name
Isabel Pavao Martins
Contact Person Email
ipavaomartins@gmail.com
Site Name
Centro Hospitalar Universitario De Santo Antonio E.P.E.
Department Name
Neurology
Contact Person Name
Carlos Andrade
Site Name
Hospital Garcia De Orta (additional site)

Sweden

Earliest CTIS Part Ii Submission Date
28-02-2024
Latest Decision Or Authorization Date
25-03-2024
Processing Time Days
26
Number Of Sites
2
Number Of Participants
23

Sites

Site Name
CTC Clinical Trial Consultants AB
Contact Person Name
Anne-Marie Landtblom
Contact Person Email
anne-marie.landtblom@ctc-ab.se
Site Name
Skaneuro AB (Skaneuro Privatmott)
Department Name
Skåneuro Privatmottagning
Contact Person Name
Gürdal Sahin
Contact Person Email
gurdal@skaneuro.se

Czechia

Earliest CTIS Part Ii Submission Date
05-03-2024
Latest Decision Or Authorization Date
27-03-2024
Processing Time Days
22
Number Of Sites
11
Number Of Participants
204

Sites

Site Name
Dado Medical s.r.o.
Contact Person Name
David Dolezil
Contact Person Email
research@dadomedical.cz
Site Name
Fakultni Thomayerova nemocnice
Contact Person Name
Jolana Markova
Contact Person Email
jolana.markova@ftn.cz
Site Name
Axon Clinical s.r.o.
Contact Person Name
Zuzana Matousova
Contact Person Email
zuzmat62@gmail.com
Site Name
CCR Ostrava s.r.o.
Contact Person Name
Sylva Brtnikova
Contact Person Email
sylva.brtnikova@ccrostrava.com
Site Name
Praglandia s.r.o.
Contact Person Name
Luisa Bartlova
Contact Person Email
l.bartl@praglandia.cz
Site Name
Vestra Clinics s.r.o.
Contact Person Name
Ladislav Pazdera
Contact Person Email
pazdera@vestraclinics.org
Site Name
Clintrial s.r.o.
Contact Person Name
Miroslava Chylova
Contact Person Email
m.chylova@clintrial.cz
Site Name
Neurohk s.r.o.
Contact Person Name
Martin Valis
Contact Person Email
valismar@seznam.cz
Site Name
INEP medical s.r.o.
Contact Person Name
Tomas Nezadal
Contact Person Email
nezadal@gmail.com
Site Name
Forbeli s.r.o.
Contact Person Name
Michal Bajacek
Contact Person Email
mbajacek@yahoo.co.uk
Site Name
Fakultni Nemocnice Ostrava
Contact Person Name
Michal Bar
Contact Person Email
michal.bar@fno.cz

Germany

Earliest CTIS Part Ii Submission Date
01-03-2024
Latest Decision Or Authorization Date
22-03-2024
Processing Time Days
21
Number Of Sites
6
Number Of Participants
81

Sites

Site Name
Ambenet GmbH Das Ambulante Behandlungsnetz
Contact Person Name
Hans-Detlev Stahl
Contact Person Email
studien@ambenet.de
Site Name
Neuropraxis München Süd
Contact Person Name
Bettina von Borries
Site Name
Kopfschmerzzentrum Frankfurt
Contact Person Name
Charly Gaul
Contact Person Email
info@kopfschmerz-frankfurt.de
Site Name
Velocity Clinical Research Germany GmbH
Contact Person Name
Mauricio Sendeski
Contact Person Email
wiesbaden@velocityclinical.com
Site Name
Universitaetsklinikum Essen AöR
Contact Person Name
Dagny Holle-Lee
Site Name
Charite Universitaetsmedizin Berlin KöR
Contact Person Name
Bianca Raffaelli
Contact Person Email
bianca.raffaelli@charite.de

Slovakia

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
21-03-2024
Processing Time Days
8
Number Of Sites
6
Number Of Participants
101

Sites

Site Name
Cliniq s.r.o.
Department Name
Poliklinika Bezrucova (Cliniq s.r.o.)
Contact Person Name
Ivana Krehelova
Contact Person Email
krehelova@polibez.sk
Site Name
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas
Department Name
neurologická ambulancia
Contact Person Name
Michal Kovacik
Contact Person Email
michal22kovacik@gmail.com
Site Name
University Hospital Bratislava
Department Name
Neurologická ambulancia III pre extrapyramídové ochorenia
Contact Person Name
Peter Valkovic
Contact Person Email
peter.valkovic@gmail.com
Site Name
MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
Department Name
MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
Contact Person Name
Beata Dupejova
Contact Person Email
dupejova@gmail.com
Site Name
Sanera s.r.o.
Department Name
SANERA s.r.o.
Contact Person Name
Hedviga Jakubikova
Contact Person Email
hjakub@gmail.com
Site Name
Univerzitna nemocnica Nemocnica svaeteho Michala a.s.
Department Name
neurologická ambulancia
Contact Person Name
Frantisek Jurcaga
Contact Person Email
fjurcaga@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
08-03-2024
Latest Decision Or Authorization Date
20-03-2024
Processing Time Days
12
Number Of Sites
9
Number Of Participants
66

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Neurología
Contact Person Name
Carmen González Oria
Contact Person Email
carmengoria@hormail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurología
Contact Person Name
Samuel Díaz Insa
Contact Person Email
sdiazinsa@yahoo.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Neurología
Contact Person Name
Julio Pascual Gomez
Contact Person Email
julio.pascual@scsalud.es
Site Name
Clinica Universidad De Navarra
Department Name
Neurología
Contact Person Name
Pablo Irimia Sieira
Contact Person Email
pirimia@unav.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Neurología
Contact Person Name
Sonia Santos Lasaosa
Contact Person Email
sonia.santos.2903@gmail.com
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Neurología
Contact Person Name
Ángel Luis Guerrero Peral
Contact Person Email
gueneurol@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurología
Contact Person Name
Patricia Pozo Rosich
Contact Person Email
ppozorosich@yahoo.com
Site Name
Hospital Universitario La Paz
Department Name
Neurología
Contact Person Name
F. Javier Díaz de Terán Velasco
Contact Person Email
javierddt@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla (additional site)

Sponsor

Primary sponsor

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

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
Data and Safety Monitoring Board (DSMB) and Hepatic Events Adjudication Committee (HEAC)
Name
Veeva Systems Inc.
Responsibilities
Clinical data management / systems (sponsorDuties code: 7)
Name
Endpoint Clinical Inc.
Responsibilities
eClinical systems (sponsorDuties code: 3)
Name
Velocity Clinical Research Germany GmbH
Responsibilities
listed as a site/CRO partner in country site lists (local study conduct)
Name
Labcorp Central Laboratory Services LP / S.a.r.l.
Responsibilities
Central laboratory services

Third parties

  • {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"Data and Safety Monitoring Board (DSMB) and Hepatic Events Adjudication Committee (HEAC)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"sponsorDuties code: 4","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; sponsorDuties code: 15 and 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG (sponsorDuties code: 15, value: ECG)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Autocruitment LLC","duties_or_roles":"Recruitment Materials","organisation_type":"Patient organisation/association"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"sponsorDuties code: 3","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"}

Investigational products

Investigational Product Name
Atogepant
Active Substance
ATOGEPANT
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus: 1 in product metadata)
Investigational Product Name
Placebo for atogepant tablets 60mg
Modality
Other
Authorisation Status
Not applicable

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