Clinical trial • Phase II/III • Neurology

BHV-7000 for Refractory focal onset epilepsy

Phase II/III trial of BHV-7000 for Refractory focal onset epilepsy.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Refractory focal onset epilepsy
Trial Stage
Phase II/III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
17-05-2024
First CTIS Authorization Date
02-09-2024

Trial design

Randomised, bhv-7000 50 mg (oral prolonged-release tablet) vs bhv-7000 75 mg (oral prolonged-release tablet) vs matching placebo; randomized 1:1:1 at baseline visit. detailed dosing schedule not specified in the public summary.-controlled Phase II/III trial in Denmark, Finland, Germany and others.

Randomised
Yes
Comparator
BHV-7000 50 mg (oral prolonged-release tablet) vs BHV-7000 75 mg (oral prolonged-release tablet) vs matching placebo; randomized 1:1:1 at baseline visit. Detailed dosing schedule not specified in the public summary.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
390
Trial Duration For Participant
126

Eligibility

Recruits 390 Vulnerable population selected (isVulnerablePopulationSelected = true). Caregiver informed consent forms are provided (e.g., 'L1_BHV7000-303_Caregiver_ICF_GRC_English_Public' listed among documents). Consent is obtained via main informed consent forms; caregiver consent forms are available where applicable. No paediatric assent provisions are described in the public protocol (participants are adults 18–75)..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Caregiver informed consent forms are provided (e.g., 'L1_BHV7000-303_Caregiver_ICF_GRC_English_Public' listed among documents). Consent is obtained via main informed consent forms; caregiver consent forms are available where applicable. No paediatric assent provisions are described in the public protocol (participants are adults 18–75).

Inclusion criteria

  • {"criterion_text":"- Male and Female participants 18 to 75 years of age at time of consent.\n- Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria. a. Focal seizures i. Focal aware seizures with clinically observable signs and/or symptoms ii. Focal impaired awareness seizures with clinically observable signs and/or symptoms iii. Focal to bilateral tonic-clonic seizures\n- Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.\n- Ability to keep accurate seizure diaries\n- Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total (e.g., 3 ASMs + 1 diet regimen; 2 ASMs + 1 diet regimen + 1 device, etc.)"}

Exclusion criteria

  • {"criterion_text":"- History of status epilepticus (convulsive status epilepticus for > 5 minutes or focal status epilepticus with impaired conscious for > 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.\n- History of repetitive/cluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.\n- Resection neurosurgery for seizures <4 months prior to the screening visit.\n- Radiosurgery performed <2 years prior to the screening visit.\n- Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.\n- Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Proportion of subjects with at least a 50% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP.","definition_or_measurement_approach":"Measured as the proportion of subjects achieving ≥50% reduction in 28-day average seizure frequency during the double-blind phase (DBP) compared to the observation phase (OP). Seizure frequency calculated as 28-day average from electronic seizure diaries."}

Secondary endpoints

  • {"endpoint_text":"- Change in log-transformed 28-day adjusted seizure frequency from OP over the 8-week DBP.","definition_or_measurement_approach":"Change from observation phase (OP) in log-transformed 28-day adjusted seizure frequency measured over the 8-week double-blind period."}
  • {"endpoint_text":"- Change in log-transformed 28-day adjusted seizure frequency from OP over the first month of the DBP.","definition_or_measurement_approach":"Change from OP in log-transformed 28-day adjusted seizure frequency measured during the first month of the DBP."}
  • {"endpoint_text":"- Proportion of subjects with at least a 75% reduction in 28-day average seizure frequency over the course of the DBP compared to the OP.","definition_or_measurement_approach":"Proportion achieving ≥75% reduction in 28-day average seizure frequency during the DBP vs OP."}
  • {"endpoint_text":"- Proportion of subjects that are seizure free during the DBP.","definition_or_measurement_approach":"Proportion of subjects with 100% seizure reduction (seizure freedom) during the DBP."}
  • {"endpoint_text":"- Change in log-transformed 7-day adjusted seizure frequency from OP over the first week of the DBP.","definition_or_measurement_approach":"Change from OP in log-transformed 7-day adjusted seizure frequency during the first week of the DBP."}
  • {"endpoint_text":"- Proportion of subjects at Week 8 with PGI-C response of “minimally improved”, “much improved” or “very much improved”.","definition_or_measurement_approach":"Proportion of subjects at Week 8 reporting Patient Global Impression of Change (PGI-C) categories 'minimally improved', 'much improved' or 'very much improved'."}
  • {"endpoint_text":"- Safety is assessed by the number of unique subjects with deaths, SAEs, AEs leading to discontinuation, moderate and severe AEs and grade 3 and 4 laboratory abnormalities.","definition_or_measurement_approach":"Safety summarized by counts of unique subjects with deaths, serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, moderate/severe AEs, and grade 3–4 laboratory abnormalities."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
390
Recruitment Window Months
20
Consent Approach
Consent obtained from adult participants (participants are aged 18–75). Country-specific informed consent forms (Main ICFs) and pregnancy/caregiver ICFs are provided; many language-specific ICFs are listed (e.g., English, Finnish, German, Spanish, Italian, Portuguese, Romanian, Slovak, Greek, Hungarian, Polish). Pre-ICF telephone data-consent procedures (Scout telephone forms) are included for some countries. Caregiver ICFs are available where applicable (e.g., Greek caregiver ICF).

Methods

  • Country-specific recruitment materials and procedures are used (multiple 'K1' and 'K2' recruitment arrangement documents listed per country e.g., 'K1_BHV-7000-303_Recruitment-Arrangements_DNK_Danish_Public', 'K1_BHV7000-303_Recruitment arrangements_FIN_Finnish_Public', 'K1_BHV7000-303_Recruitment-Arrangements_IT_Public', etc.).
  • Printed patient-facing brochures/trifold materials and site stickers (e.g., 'Rise-and-Shine-Trifold', 'Just-Rise-sitesticker', country trifolds).
  • Local site recruitment via participating hospitals/neurology clinics and epilepsy centres (investigator sites listed per country).
  • GP/physician outreach letters in some countries (e.g., 'K2_BHV7000-303_GP-Letter_IT_Italian_Public').
  • Digital channels and social media adverts and website pages for some countries (e.g., 'K2_BHV7000-303_Social-media-woman-sunset-ad_ES_Spanish_Public', 'K2_BHV7000-303_Website_ES_Spanish_Public').
  • Pre-screening/telephone contact and telephone data-consent procedures via 'Scout' vendor materials (e.g., 'L2_BHV7000-303_Scout-Clinical-Pre-ICF-Telephone-Data-Consent' documents).
  • Use of eDiary/eCOA platforms (WCG eDiary and eCOA vendor documents) for seizure reporting and patient-reported measures which may support remote follow-up.

Geography

Total Number Of Sites
77
Total Number Of Participants
235

Denmark

Earliest CTIS Part Ii Submission Date
19-08-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
448
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Odense University Hospital
Department Name
Neurologisk Afdeling N
Principal Investigator Name
Christoph Patrick Beier
Principal Investigator Email
Christoph.Beier@rsyd.dk
Contact Person Name
Christoph Patrick Beier
Contact Person Email
Christoph.Beier@rsyd.dk
Site Name
Filadelfia
Department Name
Danish Epilepsy Center, Filadelfia Adult Department
Principal Investigator Name
Guido Rubboli
Principal Investigator Email
guru@filadelfia.dk
Contact Person Name
Guido Rubboli
Contact Person Email
guru@filadelfia.dk
Site Name
Region Midtjylland
Department Name
Department of Neurology, Neurological Research Unit
Principal Investigator Name
Jakob Christensen
Principal Investigator Email
jakob@clin.au.dk
Contact Person Name
Jakob Christensen
Contact Person Email
jakob@clin.au.dk

Finland

Earliest CTIS Part Ii Submission Date
06-08-2024
Latest Decision Or Authorization Date
05-12-2025
Processing Time Days
486
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Tampere University Hospital
Principal Investigator Name
Jukka Peltola
Principal Investigator Email
jukka.peltola@tuni.fi
Contact Person Name
Jukka Peltola
Contact Person Email
jukka.peltola@tuni.fi
Site Name
HUS-Yhtymae
Department Name
Dept of Neurology
Principal Investigator Name
Reina Roivainen
Principal Investigator Email
Reina.Roivainen@hus.fi
Contact Person Name
Reina Roivainen
Contact Person Email
Reina.Roivainen@hus.fi
Site Name
Pohjois-Savon hyvinvointialue
Department Name
Kuopio Epilepsy Center, Neurocenter
Principal Investigator Name
Reetta Kälviäinen
Principal Investigator Email
Reetta.Kalviainen@pshyvinvointialue.fi
Contact Person Name
Reetta Kälviäinen

Germany

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
29-12-2025
Processing Time Days
511
Number Of Sites
14
Number Of Participants
48

Sites

Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Neurologische Klinik Epilepsiezentrum
Principal Investigator Name
Hajo Hamer
Principal Investigator Email
hajo.hamer@uk-erlangen.de
Contact Person Name
Hajo Hamer
Contact Person Email
hajo.hamer@uk-erlangen.de
Site Name
Philipps-Universitaet Marburg
Department Name
Fachbereich Medizin Klinik für Neurologie Epilepsiezentrum Hessen
Principal Investigator Name
Susanne Knake
Principal Investigator Email
knake@med.uni-marburg.de
Contact Person Name
Susanne Knake
Contact Person Email
knake@med.uni-marburg.de
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Neurologische Klinik und Poliklinik
Principal Investigator Name
Jan Rémi
Principal Investigator Email
jan.remi@med.uni-muenchen.de
Contact Person Name
Jan Rémi
Contact Person Email
jan.remi@med.uni-muenchen.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik und Poliklinik für Epileptologie
Principal Investigator Name
Rainer Surges
Principal Investigator Email
rainer.surges@ukbonn.de
Contact Person Name
Rainer Surges
Contact Person Email
rainer.surges@ukbonn.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Felicitas Becker
Principal Investigator Email
felicitas.becker@rku.de
Contact Person Name
Felicitas Becker
Contact Person Email
felicitas.becker@rku.de
Site Name
Epilepsiezentrum Kleinwachau gGmbH
Department Name
Fachklinik für Neurologie
Principal Investigator Name
Thomas Mayer
Principal Investigator Email
t.mayer@kleinwachau.de
Contact Person Name
Thomas Mayer
Contact Person Email
t.mayer@kleinwachau.de
Site Name
Gesellschaft Fuer Epilepsieforschung
Principal Investigator Name
Christian Brandt
Principal Investigator Email
Christian.Brandt@mara.de
Contact Person Name
Christian Brandt
Contact Person Email
Christian.Brandt@mara.de
Site Name
Diakonie Kork
Department Name
Epilepsiezentrum
Principal Investigator Name
Bernhard Steinhoff
Principal Investigator Email
BSteinhoff@epilepsiezentrum.de
Contact Person Name
Bernhard Steinhoff
Contact Person Email
BSteinhoff@epilepsiezentrum.de
Site Name
Medical Center - University Of Freiburg
Department Name
Epilepsiezentrum im Neurozentrum
Principal Investigator Name
Andreas Schulze-Bonhage
Contact Person Name
Andreas Schulze-Bonhage
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinikum Klinik für Neurologie - Stroke Unit - Zentrum für Epilepsie
Principal Investigator Name
Bettina Schmitz
Principal Investigator Email
bettina.schmitz@vivantes.de
Contact Person Name
Bettina Schmitz
Contact Person Email
bettina.schmitz@vivantes.de
Site Name
ZfP Südwürttemberg
Department Name
Klinik für Neurologie und Epileptologie
Principal Investigator Name
Christian Tilz
Principal Investigator Email
Christian.Tilz@ZfP-Zentrum.de
Contact Person Name
Christian Tilz
Contact Person Email
Christian.Tilz@ZfP-Zentrum.de
Site Name
Klinikum Osnabrueck GmbH
Department Name
Klinik für Neurologie und neurologische Frührehabilitation
Principal Investigator Name
Christoph Kellinghaus
Principal Investigator Email
christoph.kellinghaus@klinikumos.de
Contact Person Name
Christoph Kellinghaus
Site Name
Universitaetsklinikum Leipzig AöR
Department Name
Klinik und Poliklinik für Neurologie
Principal Investigator Name
Petra Baum
Principal Investigator Email
Petra.Baum@medizin.unileipzig.de
Contact Person Name
Petra Baum
Site Name
Goethe University Frankfurt
Department Name
Klinik für Neurologie, Epilepsiezentrum Frankfurt Rhein-Main
Principal Investigator Name
Felix Rosenow
Principal Investigator Email
rosenow@med.uni-frankfurt.de
Contact Person Name
Felix Rosenow
Contact Person Email
rosenow@med.uni-frankfurt.de

Greece

Earliest CTIS Part Ii Submission Date
11-03-2025
Latest Decision Or Authorization Date
24-12-2025
Processing Time Days
288
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
University General Hospital Of Ioannina
Department Name
Neurology Clinic
Principal Investigator Name
Sofia Markoula
Principal Investigator Email
neuromarkoula@gmail.com
Contact Person Name
Sofia Markoula
Contact Person Email
neuromarkoula@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
3rd Department of Neurology Aristotle University of Thessaloniki
Principal Investigator Name
Dimitrios Kazis
Principal Investigator Email
dimitrios.kazis@gmail.com
Contact Person Name
Dimitrios Kazis
Contact Person Email
dimitrios.kazis@gmail.com
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
2nd Department of Neurology
Principal Investigator Name
Theodora Afrantou
Principal Investigator Email
afrantou@gmail.com
Contact Person Name
Theodora Afrantou
Contact Person Email
afrantou@gmail.com
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
1st Department of Neurology
Principal Investigator Name
Vasilios Kimiskidis
Principal Investigator Email
kimiskid@auth.gr
Contact Person Name
Vasilios Kimiskidis
Contact Person Email
kimiskid@auth.gr
Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd Neurology Clinic, NKUA
Principal Investigator Name
Anastasios Bonakis
Principal Investigator Email
bonakistasos@gmail.com
Contact Person Name
Anastasios Bonakis
Contact Person Email
bonakistasos@gmail.com
Site Name
University General Hospital Of Alexandroupoli
Department Name
Department of Neurology
Principal Investigator Name
Aikaterini Terzoudi
Principal Investigator Email
katerzoudi@hotmail.com
Contact Person Name
Aikaterini Terzoudi
Contact Person Email
katerzoudi@hotmail.com

Portugal

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
02-12-2025
Processing Time Days
463
Number Of Sites
6
Number Of Participants
21

Sites

Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Neurology
Principal Investigator Name
Francisco Sales
Principal Investigator Email
franciscosales@chuc.min-saude.pt
Contact Person Name
Francisco Sales
Site Name
Unidade Local De Saude Lisboa Ocidental E.P.E.
Department Name
Neurology
Principal Investigator Name
Francisca Sá
Principal Investigator Email
fsa@chlo.min-saude.pt
Contact Person Name
Francisca Sá
Contact Person Email
fsa@chlo.min-saude.pt
Site Name
Hospital Da Luz Torres De Lisboa
Department Name
Neurology Unit
Principal Investigator Name
Nuno Canas
Principal Investigator Email
nunocanas@netcabo.pt
Contact Person Name
Nuno Canas
Contact Person Email
nunocanas@netcabo.pt
Site Name
Hospital Pedro Hispano
Department Name
Neurology Unit
Principal Investigator Name
Sara Ribeiro
Principal Investigator Email
sara.duarteribeiro@ulsm.min-saude.pt
Contact Person Name
Sara Ribeiro
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Neurology Unit
Principal Investigator Name
Esmeralda Lourenço
Principal Investigator Email
esmeraldalourenco@gmail.com
Contact Person Name
Esmeralda Lourenço
Contact Person Email
esmeraldalourenco@gmail.com
Site Name
Unidade Local De Saude De Entre O Douro E Vouga E.P.E.
Department Name
Serviço de Neurologia
Principal Investigator Name
Peter Grebe
Principal Investigator Email
hans.grebe@chedv.min-saude.pt
Contact Person Name
Peter Grebe
Contact Person Email
hans.grebe@chedv.min-saude.pt

Spain

Earliest CTIS Part Ii Submission Date
19-08-2024
Latest Decision Or Authorization Date
03-12-2025
Processing Time Days
471
Number Of Sites
17
Number Of Participants
58

Sites

Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Neurology
Principal Investigator Name
Rosario Vela Yebra
Principal Investigator Email
rvelayebra18@gmail.com
Contact Person Name
Rosario Vela Yebra
Contact Person Email
rvelayebra18@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurology
Principal Investigator Name
Manuel Toledo Argany
Principal Investigator Email
manuel.toledo@vallhebron.cat
Contact Person Name
Manuel Toledo Argany
Contact Person Email
manuel.toledo@vallhebron.cat
Site Name
Centro De Neurologia Avanzada S.L.P.
Department Name
Neurology
Principal Investigator Name
Juan Jesus Rodriguez Uranga
Principal Investigator Email
uranganeuro@gmail.com
Contact Person Name
Juan Jesus Rodriguez Uranga
Contact Person Email
uranganeuro@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurology
Principal Investigator Name
Pedro J. Serrano Castro
Principal Investigator Email
p.serrano.eecc@gmail.com
Contact Person Name
Pedro J. Serrano Castro
Contact Person Email
p.serrano.eecc@gmail.com
Site Name
Hospital Vithas La Salud
Department Name
Neurology
Principal Investigator Name
Juan Carlos Sanchez Alvarez
Principal Investigator Email
jucasan9@gmail.com
Contact Person Name
Juan Carlos Sanchez Alvarez
Contact Person Email
jucasan9@gmail.com
Site Name
Hospital Ruber Internacional
Department Name
Neurology
Principal Investigator Name
Alvaro Beltran Corbellini
Principal Investigator Email
alvaro.beltran.ce@ruberinternacional.es
Contact Person Name
Alvaro Beltran Corbellini
Site Name
Hospital Germans Trias I Pujol
Department Name
Neurologia
Principal Investigator Name
Laia Grau Lopez
Principal Investigator Email
lgrau.germanstrias@gencat.cat
Contact Person Name
Laia Grau Lopez
Contact Person Email
lgrau.germanstrias@gencat.cat
Site Name
Hospital Alvaro Cunqueiro
Department Name
Neurology
Principal Investigator Name
Maria Dolores Castro Vilanova
Principal Investigator Email
maria.dolores.castro.vilanova@sergas.es
Contact Person Name
Maria Dolores Castro Vilanova
Site Name
Hospital Del Mar
Department Name
Neurology
Principal Investigator Name
Rodrigo Alberto Rocamora Zuñiga
Principal Investigator Email
rrocamora@psmar.cat
Contact Person Name
Rodrigo Alberto Rocamora Zuñiga
Contact Person Email
rrocamora@psmar.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Neurology
Principal Investigator Name
Vicente Villanueva
Principal Investigator Email
villanueva_vichab@gva.es
Contact Person Name
Vicente Villanueva
Contact Person Email
villanueva_vichab@gva.es
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Neurology
Principal Investigator Name
Dulce Campos
Principal Investigator Email
dmcampos@saludcastillayleon.es
Contact Person Name
Dulce Campos
Contact Person Email
dmcampos@saludcastillayleon.es
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Neurology
Principal Investigator Name
Jesus Ruiz-Gimenez
Contact Person Name
Jesus Ruiz-Gimenez
Site Name
Bellvitge University Hospital
Department Name
Neurology
Principal Investigator Name
Merce Falip Centellas
Principal Investigator Email
mfalip@bellvitgehospital.cat
Contact Person Name
Merce Falip Centellas
Contact Person Email
mfalip@bellvitgehospital.cat
Site Name
Hospital Universitario De Navarra
Department Name
Neurology
Principal Investigator Name
Idoya Rubio Baines
Principal Investigator Email
idoia.rubio.baines@navarra.es
Contact Person Name
Idoya Rubio Baines
Contact Person Email
idoia.rubio.baines@navarra.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Neurology
Principal Investigator Name
Jose Maria Serratosa
Principal Investigator Email
joseserratosa@icloud.com
Contact Person Name
Jose Maria Serratosa
Contact Person Email
joseserratosa@icloud.com
Site Name
Fundacio Assistencial De Mutua De Terrassa Fpc
Department Name
Neurology
Principal Investigator Name
Belen Diaz Fernandez
Principal Investigator Email
bdiaz@mutuaterrassa.cat
Contact Person Name
Belen Diaz Fernandez
Contact Person Email
bdiaz@mutuaterrassa.cat
Site Name
Hospital Blua Sanitas Valdebebas
Department Name
Neurology
Principal Investigator Name
Angel Aledo-Serrano
Principal Investigator Email
aledo.ensayos@gmail.com
Contact Person Name
Angel Aledo-Serrano
Contact Person Email
aledo.ensayos@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
26-08-2024
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
576
Number Of Sites
18
Number Of Participants
51

Sites

Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Neurology Unit
Principal Investigator Name
Francesca Izzi
Principal Investigator Email
fraizzi@tin.it
Contact Person Name
Francesca Izzi
Contact Person Email
fraizzi@tin.it
Site Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Department Name
SC Neuropsichiatria Infantile
Principal Investigator Name
Valentina De Giorgis
Principal Investigator Email
valentina.degiorgis@mondino.it
Contact Person Name
Valentina De Giorgis
Contact Person Email
valentina.degiorgis@mondino.it
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Neuroscience Excellence Center
Principal Investigator Name
Renzo Guerrini
Principal Investigator Email
renzo.guerrini@meyer.it
Contact Person Name
Renzo Guerrini
Contact Person Email
renzo.guerrini@meyer.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Neuroscienze
Principal Investigator Name
Stefano Meletti
Principal Investigator Email
stefano.meletti@unimore.it
Contact Person Name
Stefano Meletti
Contact Person Email
stefano.meletti@unimore.it
Site Name
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo
Department Name
Epilepsy and Sleep Center
Principal Investigator Name
Valentina Chiesa
Principal Investigator Email
epilessia.hsp@asst-santipaolocarlo.it
Contact Person Name
Valentina Chiesa
Site Name
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Department Name
Scienze Neurologiche
Principal Investigator Name
Pier Paolo Quarato
Principal Investigator Email
spleen333@libero.it
Contact Person Name
Pier Paolo Quarato
Contact Person Email
spleen333@libero.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Child Neuropsychiatry
Principal Investigator Name
Francesca Darra
Principal Investigator Email
francesca.darra@univr.it
Contact Person Name
Francesca Darra
Contact Person Email
francesca.darra@univr.it
Site Name
Azienda Ospedaliero Universitaria Renato Dulbecco
Department Name
Department of Medical and Surgical Sciences, Neurology Unit
Principal Investigator Name
Antonio Gambardella
Principal Investigator Email
a.gambardella@unicz.it
Contact Person Name
Antonio Gambardella
Contact Person Email
a.gambardella@unicz.it
Site Name
Azienda Ospedaliero Di Rilievo Nazionale Antonio Cardarelli
Department Name
Clinical Neurophysiology Department
Principal Investigator Name
Francesco Habetswallner
Principal Investigator Email
francesco.habetswallner@aocardarelli.it
Contact Person Name
Francesco Habetswallner
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Dipartimento di Medicina Sperimentale e Clinica
Principal Investigator Name
Simona Lattanzi
Principal Investigator Email
s.lattanzi@univpm.it
Contact Person Name
Simona Lattanzi
Contact Person Email
s.lattanzi@univpm.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Pediatric Neuropsychiatry
Principal Investigator Name
Domenica Immacolata Battaglia
Contact Person Name
Domenica Immacolata Battaglia
Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Clinical and Experimental Neurology
Principal Investigator Name
Nicola Specchio
Principal Investigator Email
nicola.specchio@opbg.net
Contact Person Name
Nicola Specchio
Contact Person Email
nicola.specchio@opbg.net
Site Name
Azienda Unita Sanitaria Locale Di Bologna
Department Name
Programma Epilessia
Principal Investigator Name
Laura Licchetta
Principal Investigator Email
laura.licchetta@ausl.bologna.it
Contact Person Name
Laura Licchetta
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
SC Neurologia 7 – Epilettologia Clinica e Sperimentale
Principal Investigator Name
Laura Canafoglia
Principal Investigator Email
laura.canafoglia@istituto-besta.it
Contact Person Name
Laura Canafoglia
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Dipartimento di Neurologia
Principal Investigator Name
Massimo Filippi
Principal Investigator Email
Filippi.massimo@hsr.it
Contact Person Name
Massimo Filippi
Contact Person Email
Filippi.massimo@hsr.it
Site Name
Universita' Degli Studi G. D'Annunzio Di Chieti
Department Name
Deparment of Neuroscience, Imaging and Clinical Sciences
Principal Investigator Name
Stefano Sensi
Principal Investigator Email
ssensi@uci.edu
Contact Person Name
Stefano Sensi
Contact Person Email
ssensi@uci.edu
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health
Principal Investigator Name
Pasquale Striano
Principal Investigator Email
pasqualestriano@gaslini.org
Contact Person Name
Pasquale Striano
Contact Person Email
pasqualestriano@gaslini.org

Romania

Earliest CTIS Part Ii Submission Date
11-03-2025
Latest Decision Or Authorization Date
19-01-2026
Processing Time Days
344
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Spitalul Universitar De Urgenta Bucuresti
Department Name
Sectia Clinica Neurologie
Principal Investigator Name
Ioana-Raluca Mindruta
Principal Investigator Email
ioanamindruta@me.com
Contact Person Name
Ioana-Raluca Mindruta
Contact Person Email
ioanamindruta@me.com
Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
Sectia Clinica Neurologie II
Principal Investigator Name
Jozsef-Attila Szasz
Principal Investigator Email
szaszneuro@yahoo.com
Contact Person Name
Jozsef-Attila Szasz
Contact Person Email
szaszneuro@yahoo.com

Slovakia

Earliest CTIS Part Ii Submission Date
15-05-2025
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
298
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
In Medic s.r.o.
Department Name
IN MEDIC s.r.o.
Principal Investigator Name
Jana Chamilova
Principal Investigator Email
jana.chamilova7@gmail.com
Contact Person Name
Jana Chamilova
Contact Person Email
jana.chamilova7@gmail.com
Site Name
Penta Hospitals SK a.s.
Department Name
Vseobecna nemocnica Rimavska Sobota
Principal Investigator Name
Erika Zacharová
Principal Investigator Email
erika.zacharova@pentahospitals.sk
Contact Person Name
Erika Zacharová

Hungary

Earliest CTIS Part Ii Submission Date
16-10-2025
Latest Decision Or Authorization Date
07-01-2026
Processing Time Days
83
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Semmelweis University
Department Name
Neurointervenciós Klinikája
Principal Investigator Name
Anna Kelemen
Principal Investigator Email
akelemen61@gmail.com
Contact Person Name
Anna Kelemen
Contact Person Email
akelemen61@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
16-10-2025
Latest Decision Or Authorization Date
08-02-2026
Processing Time Days
115
Number Of Sites
5
Number Of Participants
11

Sites

Site Name
LANDA Specjalistyczne Gabinety Lekarskie
Principal Investigator Name
Magdalena Bosak
Principal Investigator Email
bosak@smo.com.pl
Contact Person Name
Magdalena Bosak
Contact Person Email
bosak@smo.com.pl
Site Name
Mtz Clinical Research Powered By Pratia
Principal Investigator Name
Zygmunt Jamrozik
Principal Investigator Email
badacz@pratia.com
Contact Person Name
Zygmunt Jamrozik
Contact Person Email
badacz@pratia.com
Site Name
Premium Clinic Wrocław sp. z o.o.
Principal Investigator Name
Aleksandra Szczepańska
Principal Investigator Email
a.szczepanska@premiumclinic.wroclaw.pl
Contact Person Name
Aleksandra Szczepańska
Site Name
Neurosphera Sp. z o.o.
Principal Investigator Name
Beata Zwolińska
Principal Investigator Email
beata.m.zwolinska@gmail.com
Contact Person Name
Beata Zwolińska
Contact Person Email
beata.m.zwolinska@gmail.com
Site Name
Pratia S.A.
Principal Investigator Name
Elżbieta Szczygieł-Pilut
Principal Investigator Email
eszczygiel-pilut@pratia.pl
Contact Person Name
Elżbieta Szczygieł-Pilut
Contact Person Email
eszczygiel-pilut@pratia.pl

Sponsor

Primary sponsor

Full Name
Biohaven Therapeutics Ltd.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Pharmaceutical Product Development LLC (PPD)
Responsibilities
Multiple operational trial functions (multiple sponsorDuties codes listed in application; contact EUCTRInquiry.sm@ppd.com).
Name
PPD Global Central Labs
Responsibilities
Central laboratory services (sponsorDuties code 4).
Name
4g Clinical LLC
Responsibilities
Operational support (sponsorDuties code 3).
Name
Scout Clinical
Responsibilities
Patient travel and reimbursement.
Name
Medidata Solutions Inc.
Responsibilities
Data capture/vendor responsibilities (sponsorDuties code 7).
Name
Eresearchtechnology Inc.
Responsibilities
Central ECG.
Name
WCG Clinical Inc.
Responsibilities
eCOA.
Name
Syneos Health Clinique Inc.
Responsibilities
PK analysis.

Third parties

  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient Travel and Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: 1,11,12,13,14,2,5,6,8,9 (multiple operational roles listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"central ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"eCOA","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"PK analysis","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
BHV-7000
Active Substance
BHV-7000
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Authorisation Status
prodAuthStatus=1
Starting Dose
50 mg
Dose Levels
50 mg | 75 mg
Maximum Dose
75 mg daily
Investigational Product Name
Placebo BHV-7000
Modality
Other
Investigational Product Name
Placebo for BHV-7000
Modality
Other
Combination Treatment
Yes

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