Clinical trial • Phase III • Psychiatry

9-(4-cyclohexyloxyphenyl)-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazine 2,2-dioxide for Major Depressive Disorder

Phase III trial of 9-(4-cyclohexyloxyphenyl)-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazine 2,2-dioxide for Major Depressive Disorder.

Overview

Trial Therapeutic Area
Psychiatry
Trial Disease
Major Depressive Disorder
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
12-03-2025
First CTIS Authorization Date
01-07-2025

Trial design

open-label, none/not specified-controlled Phase III trial in Romania, Sweden, Slovakia and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
286
Trial Duration For Participant
364

Eligibility

Recruits 286 Vulnerable population selected (isVulnerablePopulationSelected = true). Specific details on consent or assent handling are not available in the provided structured data; multiple subject information and informed consent form documents (country-specific versions) are listed but their contents are not extractable from the provided files..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Specific details on consent or assent handling are not available in the provided structured data; multiple subject information and informed consent form documents (country-specific versions) are listed but their contents are not extractable from the provided files.

Inclusion criteria

  • {"criterion_text":"- Subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.\n- Subject has had an inadequate response to oral antidepressant treatments in the current episode of depression.\n- Subject must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.\n- Total MADRS score ≥18 at screening.\n- Willing and able to comply with all study procedures and restrictions in the opinion of the investigator."}

Exclusion criteria

  • {"criterion_text":"- A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.\n- Are considered by the investigator to be at imminent risk of suicide or injury to self or others."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The occurrence of adverse events (AEs) up to Week 52.","definition_or_measurement_approach":"Occurrence of adverse events (AEs) collected/reported up to Week 52 (no further detailed measurement approach available in the structured data)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
286
Recruitment Window Months
58
Consent Approach
Informed consent is used; multiple subject information sheets and informed consent form (ICF) documents are listed (country- and language-specific ICFs, pregnancy follow-up ICFs, pregnant partner ICFs, and other participant-facing materials). Documents indicate ICFs available in multiple languages and country versions, but specific age-related assent procedures are not detailed in the structured data (study population described as adults).

Methods

  • K1/K2 Recruitment arrangements and patient brochures (country-specific recruitment brochures) - documents present for multiple Member States indicating use of brochures and recruitment materials.
  • Social media recruitment tools (Link2Trial) - referenced in recruitment materials (e.g., 'Link2Trial social media recruitment tools MDD' for Netherlands).
  • Site presentations and website materials (e.g., BRC presentation/website for site outreach mentioned for Netherlands).
  • Digital participant engagement via Mural Link Participant App (participant training, notifications, participant reference guides) referenced in multiple country recruitment documents.

Geography

Total Number Of Sites
91
Total Number Of Participants
271

Romania

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
33
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Spitalul Clinic De Psihiatrie Si Neurologie Brasov
Department Name
Psihiatrie Clinica III
Contact Person Name
Petru Ifteni
Contact Person Email
petru_ifteni@yahoo.com
Site Name
Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
Department Name
Psihiatrie
Contact Person Name
Traian Barbu
Contact Person Email
trabar98@yahoo.com
Site Name
Spitalul Clinic Judetean De Urgenta Bihor
Department Name
Psihiatrie II
Contact Person Name
Alin Petris
Contact Person Email
spitalul.judetean@rdsor.ro
Site Name
Institutul Privat de Cercetari Melchisedec, pentru Boli Autoimune, Ereditare si Rare - IPCM
Department Name
Psihiatrie
Contact Person Name
Victor Gheorman
Contact Person Email
gheormanv@gmail.com
Site Name
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Department Name
Psihiatrie Clinica III
Contact Person Name
Mihnea Manea
Contact Person Email
mihnea.manea@live.com

Sweden

Earliest CTIS Part Ii Submission Date
28-05-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
34
Number Of Sites
4
Number Of Participants
29

Sites

Site Name
ProbarE i Stockholm AB
Department Name
ProbarE i Stockholm AB
Contact Person Name
Peter Bosson
Contact Person Email
ewa.karlsson@probare.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
SU/Affektiva FoU-avdelningen
Contact Person Name
Michael Ionnou
Contact Person Email
michael.ioannou@vgregion.se
Site Name
ProbarE i Lund AB
Department Name
ProbarE i Lund AB
Contact Person Name
Anders Luts
Contact Person Email
ewa.karlsson@probare.se
Site Name
Region Skane Helsingborg Hospital
Department Name
Institutionen för kliniska vetenskaper
Contact Person Name
Jonas Eberhard
Contact Person Email
jonas.eberhard@med.lu.se

Slovakia

Earliest CTIS Part Ii Submission Date
21-05-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
41
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Crystal Comfort s.r.o.
Department Name
Psychiatricka ambulancia
Contact Person Name
Dagmar Breznoscakova
Contact Person Email
dbreznoscakova@gmail.com
Site Name
PsychoLine s.r.o.
Department Name
Psychiatricka ambulancia
Contact Person Name
Abdul Mohammad Shinwari
Contact Person Email
psycholinesro@gmail.com
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
II. Psychiatricka klinika
Contact Person Name
Slavka Dubinska
Contact Person Email
slavka.dubinska@unlp.sk
Site Name
Epamed s.r.o.
Department Name
Psychiatricka ambulancia
Contact Person Name
Eva Palova
Contact Person Email
epamed.ke@gmail.com
Site Name
Mentum s.r.o.
Department Name
Psychiatricka ambulancia, Site address: Ruzinovska 10, 820 07 Bratislava, Slovak Republic
Contact Person Name
Peter Molcan
Contact Person Email
molcan@mentum.sk
Site Name
Dana Ignjatovičová, spol. s.r.o.,
Department Name
Psychiatricka ambulancia, Site address:Cesta k nemocnici 1231/23, 974 01 Banska Bystrica, Slovakia
Contact Person Name
Dana Ignjatovicova
Contact Person Email
dana.ignjatovicova@gmail.com
Site Name
Centrum Zdravia R.B.K. s.r.o.
Department Name
Psychiatricka ambulancia, Site address: MUDr. Pribulu 463/15, 089 01 Svidnik, Slovak Republic
Contact Person Name
Rastislav Korba
Contact Person Email
rastislav.korba@gmail.com
Site Name
Nemocnica S Poliklinikou Prievidza So Sidlom V Bojniciach
Department Name
Psychiatricke oddelenie
Contact Person Name
Martin Garaj

Finland

Earliest CTIS Part Ii Submission Date
03-06-2025
Latest Decision Or Authorization Date
02-07-2025
Processing Time Days
29
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Savon Psykiatripalvelu Oy
Department Name
Savon Psykiatripalvelu Oy
Contact Person Name
Antti Lepola
Site Name
Oulu Mentalcare Oy
Department Name
Oulu Mentalcare Oy
Contact Person Name
Markku Timonen
Contact Person Email
markku.timonen@mentalcare.fi
Site Name
Mehilaeinen Oy
Department Name
Satakunnan Psykiatripalvelu
Contact Person Name
Marko Sorvaniemi
Contact Person Email
marko.sorvaniemi@fimnet.fi

Croatia

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
11
Number Of Sites
8
Number Of Participants
18

Sites

Site Name
Poliklinika Neuron
Department Name
Polyclinic Neuron
Contact Person Name
Neven Henisberg
Contact Person Email
neven.henigsberg@zg.ht.hr
Site Name
Clinic for psychiatry Sveti Ivan
Department Name
Clinic for Psychiatry
Contact Person Name
Igor Filipcic
Contact Person Email
igor.filipcic@pbsvi.hr
Site Name
Klinika za psihijatriju Vrapce
Department Name
Psychiatry
Contact Person Name
Miroslav Herceg
Site Name
KBC Zagreb
Department Name
Psychiatry and Psychological medicine
Contact Person Name
Alma Mihaljevic-Peles
Contact Person Email
almamihaljevic12@gmail.com
Site Name
Klinika za psihijatriju Vrapce
Department Name
Biological Psychiatry and Psychogeriatrics
Contact Person Name
Ninoslav Mimica
Site Name
Poliklinika Solmed d.o.o.
Department Name
Poliklinika Solmed
Contact Person Name
Vjekoslav Peitl
Contact Person Email
vjekoslav.peitl@gmail.com
Site Name
KBC Zagreb
Department Name
Psychiatry
Contact Person Name
Marina Sagud
Contact Person Email
msagud@kbc-zagreb.hr
Site Name
Klinika za psihijatriju Vrapce
Department Name
Affective Disorders
Contact Person Name
Porin Makaric

Poland

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
11
Number Of Sites
16
Number Of Participants
32

Sites

Site Name
Prywatne Gabinety Lekarskie „Promedicus” Anna Agnieszka Tomczak
Contact Person Name
Anna Agnieszka Tomczak
Contact Person Email
promedicus@onet.eu
Site Name
MłynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Łazarczyk
Contact Person Name
Joanna Łazarczyk
Contact Person Email
joannalaz@wp.pl
Site Name
Centrum Medyczne Luxmed Sp. z o.o.
Contact Person Name
Dariusz Malicki
Contact Person Email
dariuszmalicki@interia.eu
Site Name
Wojewódzki Szpital Zdrowia Psychicznego im. Dr Józefa Bednarza w Świeciu
Department Name
Oddział Leczenia Zespołów Abstynencyjnych po Substancjach Psychoaktywnych XIV (Detoksykacji)
Contact Person Name
Ewa Gromniak-Haniecka
Contact Person Email
ewa.gromniak-haniecka@wp.pl
Site Name
Gyncentrum Sp. z o.o.
Department Name
NZOZ GynCentrum - Oddział Warszawa
Contact Person Name
Marek Jarema
Contact Person Email
m.jarema@holsaclinical.com
Site Name
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak, Malgorzata Trzaska
Department Name
Ośrodek Badań Klinicznych Clinsante
Contact Person Name
Gerard Kowalkowski
Contact Person Email
gkowalkowski@wp.pl
Site Name
Podlaskie Centrum Psychogeriatrii
Contact Person Name
Jacek Dobryniewski
Contact Person Email
jacekdobryniewski@gmail.com
Site Name
Niepubliczny Zaklad Opieki Zdrowotnej Euromedica Sp. z o.o.
Department Name
Niepubliczny Zakład Opieki Zdrowotnej Euromedica
Contact Person Name
Barbara Janczewska
Contact Person Email
b.janczewskaa@gmail.com
Site Name
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
Contact Person Name
Ireneusz Kaczorowski
Contact Person Email
irek.k@tlen.pl
Site Name
Osrodek Badan Klinicznych Clinsante s.c. Ewa Galczak-Nowak Malgorzata Trzaska
Department Name
Ośrodek Badań Klinicznych Clinsante
Contact Person Name
Agnieszka Bijakowska
Contact Person Email
bijak2@wp.pl
Site Name
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Contact Person Name
Mariusz Perucki
Contact Person Email
mariperu@wp.pl
Site Name
Care Clinic Sp. z o.o.
Department Name
Care Clinic Centrum Medyczne
Contact Person Name
Maciej Żerdziński
Contact Person Email
avalone@wp.pl
Site Name
Centrum Zdrowia Alcea
Contact Person Name
Jakub Grabowski
Contact Person Email
jakub.grabowski@gumed.edu.pl
Site Name
Clinic BBP Bożena Pawełczyk
Contact Person Name
Bożena Pawełczyk
Contact Person Email
bozena.pawelczyk@clinicbbp.com
Site Name
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Contact Person Name
Katarzyna Binkowska-Michalik
Contact Person Email
k.binkmich@pihouse.pl
Site Name
INDYWIDUALNA PRAKTYKA LEKARSKA KINGA BOBINSKA
Contact Person Name
Kinga Bobińska
Contact Person Email
bobinska.gabinet@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
25-03-2025
Latest Decision Or Authorization Date
04-07-2025
Processing Time Days
101
Number Of Sites
10
Number Of Participants
42

Sites

Site Name
Medical Center Saint Naum EOOD
Contact Person Name
Assen Karadaliev
Contact Person Email
karadaliev@hotmail.com
Site Name
Medical Center Intermedica Ltd.
Contact Person Name
Toni Donchev
Contact Person Email
tonyd@abv.bg
Site Name
Medical Center Hera EOOD
Contact Person Name
Sibila Dimitrova-Mitova
Site Name
Medical Center Lifemed EOOD
Contact Person Name
Rozaliya Rangelova
Contact Person Email
rrangelova80@gmail.com
Site Name
Medical Center Mentalcare Ltd.
Contact Person Name
Vasil Kotetarov
Contact Person Email
vasilkotetarov@abv.bg
Site Name
Medical Center Hera EOOD
Contact Person Name
Spiridon Spiridonov
Contact Person Email
spiridon.aleksiev@gmail.com
Site Name
Diagnostics-Consultancy Center Mladost M Varna OOD
Contact Person Name
Petar Petrov
Contact Person Email
pmdown@abv.bg
Site Name
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
Contact Person Name
Petya Dimitrova
Contact Person Email
drdimitrova@abv.bg
Site Name
Center For Mental Health Ruse EOOD
Department Name
Men Dep for treatm of persons with acute psychotic disorders, Women Dep for treatm of persons with
Contact Person Name
Desislava Peycheva
Contact Person Email
dpeycheva1@gmail.com
Site Name
Diagnostics-Consultancy Center Mladost M Varna OOD
Contact Person Name
Hristo Kozhuharov
Contact Person Email
christokojuharov@abv.bg

Latvia

Earliest CTIS Part Ii Submission Date
27-06-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
4
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
L. Keruze practice in Psychiatry
Contact Person Name
Linda Keruze
Contact Person Email
lkeruze@inbox.lv
Site Name
Slimnica Gintermuiza VSIA
Contact Person Name
Ineta Rozina
Contact Person Email
ineta29@inbox.lv
Site Name
Siguldas Slimnica
Contact Person Name
Ilona Paegle
Contact Person Email
ilona.paegle@inbox.lv

Lithuania

Earliest CTIS Part Ii Submission Date
05-06-2025
Latest Decision Or Authorization Date
02-07-2025
Processing Time Days
27
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Vilnius City Mental Health Center
Department Name
psichiatrijos
Contact Person Name
Jolita Valantiejienė
Contact Person Email
jolivalant@gmail.com
Site Name
Romuvos klinika UAB
Department Name
psichiatrijos
Contact Person Name
Daiva Deltuvienė
Contact Person Email
daiva.deltuviene@gmail.com
Site Name
Respublikine Klaipedos ligonine VšĮ
Department Name
psichiatrijos
Contact Person Name
Loreta Šiaudvytytė
Contact Person Email
loretasiaud@gmail.com
Site Name
Saules seimos medicinos centras UAB
Department Name
psichiatrijos
Contact Person Name
Simona Kušleikienė
Contact Person Email
s.kusleikiene@ssmc.lt
Site Name
Lietuvos sveikatos mokslu universiteto Kauno ligonine
Department Name
psichiatrijos
Contact Person Name
Dalia Vijūnė
Contact Person Email
gudeikiene@yahoo.com

Belgium

Earliest CTIS Part Ii Submission Date
23-06-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
8
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Az Sint-Lucas
Department Name
Psychiatry
Contact Person Name
Thomas Santy
Contact Person Email
thomas.santy@stlucas.be
Site Name
Anima
Department Name
Psychiatry
Contact Person Name
Erik Buntinx
Contact Person Email
erik.buntinx@anima-alken.be
Site Name
Meclinas
Department Name
Psychiatry
Contact Person Name
Claudia Cornelist
Contact Person Email
claudia.cornelis@meclinas.com

Czechia

Earliest CTIS Part Ii Submission Date
26-06-2025
Latest Decision Or Authorization Date
02-07-2025
Processing Time Days
6
Number Of Sites
8
Number Of Participants
21

Sites

Site Name
Medical Services Prague s.r.o.
Department Name
Psychiatry
Contact Person Name
Erik Herman
Contact Person Email
erik.herman@seznam.cz
Site Name
INEP medical s.r.o.
Department Name
Psychiatry
Contact Person Name
Alexander Nawka
Contact Person Email
nawka@inep.cz
Site Name
Psychiatricka ambulance MUDr Marta Ondrusova
Department Name
Psychiatry
Contact Person Name
Marta Ondrušová
Contact Person Email
MOndrusova@seznam.cz
Site Name
Clintrial s.r.o.
Department Name
Psychiatry
Contact Person Name
Zdeněk Šolle
Contact Person Email
zdenek.solle@clintrial.cz
Site Name
Neuropsychiatrie Petrska s.r.o.
Department Name
Psychiatry
Contact Person Name
Aleš Urban
Contact Person Email
ordinace@psychiatrie-urban.cz
Site Name
Praglandia s.r.o.
Department Name
Psychiatry
Contact Person Name
Radka Šafandová
Contact Person Email
r.safand@praglandia.cz
Site Name
A-Shine s.r.o.
Department Name
Psychiatry
Contact Person Name
Luboš Janů
Contact Person Email
lubos.janu@seznam.cz
Site Name
Narodni Ustav Dusevniho Zdravi
Department Name
Psychiatry
Contact Person Name
Barbora Kohútová
Contact Person Email
barbora.kohutova@nudz.cz

Estonia

Earliest CTIS Part Ii Submission Date
29-01-2026
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
15
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Tartu University Hospital
Department Name
Psychiatry
Contact Person Name
Roman Pihlakas
Contact Person Email
roman.pihlakas@kliinikum.ee
Site Name
Marienthali Kliinik OÜ
Contact Person Name
Anu Arold
Contact Person Email
anu.arold@mppk.ee
Site Name
Arstikeskus Confido AS
Contact Person Name
Mari-Liis Laanetu
Contact Person Email
info@confido.ee

Italy

Earliest CTIS Part Ii Submission Date
12-12-2025
Latest Decision Or Authorization Date
21-01-2026
Processing Time Days
40
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Psychiatry Department
Contact Person Name
Gabriele Sani
Contact Person Email
gabriele.sani@unicatt.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Mood Disorder Unit
Contact Person Name
Raffaella Zanardi
Contact Person Email
zanardi.raffaella@hsr.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Department of Neuroscience and Mental Health
Contact Person Name
Paola Rocca
Contact Person Email
paola.rocca@unito.it

Spain

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
4
Number Of Sites
3
Number Of Participants
5

Sites

Site Name
Hestia Palau S.L.
Department Name
Psychiatry
Contact Person Name
Elena Ros
Contact Person Email
e.ros@bcnneuroscience.com
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Psychiatry
Contact Person Name
Francisco Montañes
Site Name
Hospital Universitari Vall D Hebron
Department Name
Psychiatry
Contact Person Name
Julia Vendrell
Contact Person Email
julia.vendrell@vallhebron.cat

Netherlands

Earliest CTIS Part Ii Submission Date
19-06-2025
Latest Decision Or Authorization Date
01-07-2025
Processing Time Days
12
Number Of Sites
4
Number Of Participants
22

Sites

Site Name
Universitair Medisch Centrum Groningen
Department Name
Psychiatry
Contact Person Name
Robert Schoevers
Contact Person Email
r.a.schoevers@umcg.nl
Site Name
Brain Research Center Den Bosch B.V.
Department Name
Psychiatry
Contact Person Name
Roel Mocking
Contact Person Email
r.j.mocking@amsterdamumc.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Psychiatry
Contact Person Name
Nic van der Wee
Contact Person Email
n.j.a.van_der_wee@lumc.nl
Site Name
Brain Research Center Amsterdam B.V.
Department Name
Psychiatry
Contact Person Name
Roel Mocking
Contact Person Email
r.j.mocking@amsterdamumc.nl

Hungary

Earliest CTIS Part Ii Submission Date
16-05-2025
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
52
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Obudai Egeszseguegyi Centrum Kft.
Department Name
-
Contact Person Name
Gyöngyi Szabó
Contact Person Email
gyongyi.szabo@oec.hu
Site Name
Dr. Mathe Es Tarsa Bt.
Department Name
-
Contact Person Name
Éva Máthé
Contact Person Email
matheevazs@gmail.com
Site Name
Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet
Department Name
"C" Pszichiátriai Osztály
Contact Person Name
Csaba Almási
Contact Person Email
imrecsabaalmasi@gmail.com
Site Name
Semmelweis University
Department Name
Pszichiatriai es Pszichoterapias Klinika
Contact Person Name
Csilla Katalin Bolyos
Contact Person Email
bolyos.csilla@semmelweis.hu
Site Name
Gyoengyosi Bugat Pal Koerhaz
Department Name
Rehabilitációs Elmegyógyászati Osztály
Contact Person Name
Tibor Kelemen

Sponsor

Primary sponsor

Full Name
Neurocrine Biosciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Signant Health Global LLC
Responsibilities
eCOA/eConsent and patient-facing electronic data capture tools (sponsor duty code 3 shown)
Name
Medidata Solutions Inc.
Responsibilities
eClinical platform services (sponsor duty code 7 shown)
Name
IQVIA Limited
Responsibilities
Operational CRO services including cardiac services & supplying ECG machines and other listed duties (codes 1,12,15,2,5)
Name
Cytel Inc.
Responsibilities
Statistical/adjudication support (Adjudication Committee listed)
Name
Q Squared Solutions Limited
Responsibilities
Clinical operations support (sponsor duty code 4 shown)

Third parties

  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Code 3 (listed as sponsor duty) - electronic data capture / patient-facing eCOA vendor (Signant) (responsibility code provided in structured data)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Code 7 (listed as sponsor duty) - eClinical platform responsibilities (Medidata) (responsibility code provided in structured data)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Epilepsy Study Consortium Inc.","duties_or_roles":"Adjudication Committee (listed value for sponsor duty)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Code 7 (listed as sponsor duty)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Massachusetts General Hospital","duties_or_roles":"Treatment history determination","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Adjudication Committee (listed value)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Code 4 (listed as sponsor duty)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Multiple sponsor duties including code 1, 12, 15 (Cardiac Services & supplying ECG machines), code 2, code 5 (various operational and clinical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Marken LLP","duties_or_roles":"Direct to Patient IP delivery","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
NBI-1065845
Active Substance
9-(4-cyclohexyloxyphenyl)-7-methyl-3,4-dihydropyrazino[2,1-c][1,2,4]thiadiazine 2,2-dioxide
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Not authorised in the population involved (investigational for this trial)
Combination Treatment
Yes

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