Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,509
Countries
21
Sites
88
Schizophrenia
The objective of this trial is to collect additional safety data in patients with cognitive impairment due to schizophrenia, who participated in and completed the 26-week treatment period with Iclepertin or matching placebo of one of the phase III clinical trial program for Iclepertin (trial # 1346-0011, 1346-0012, 134…
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 29 Mar 2022 → 18 Mar 2025
- Decision date (initial)
- 2024-06-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511560-93-00
- EudraCT number
- 2020-003745-11
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety
The objective of this trial is to collect additional safety data in patients with cognitive impairment due to schizophrenia, who participated in and completed the 26-week treatment period with Iclepertin or matching placebo of one of the phase III clinical trial program for Iclepertin (trial # 1346-0011, 1346-0012, 1346-0013).
Conditions and MedDRA coding
Schizophrenia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5))
- "Patients, who completed 26 weeks of treatment in the parent trial, must enter the extension trial: - Within 2 weeks the end of treatment visit in 1346-0011, 1346-0013 (i.e. Follow Up 1 timepoint including the applicable time windows). - At the end of safety follow up in 1346-0012 (within 7 days of visit Follow Up 6)."
- Have a study partner, defined as any person capable of understanding trial related procedures, with a minimum of 8th grade level of education, who knows the patient well, has been capable of interacting with the patient on a regular basis. Preferably be the same person throughout the study.
- Further inclusion criteria apply.
Exclusion criteria 6
- Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial
- Any suicidal behavior and/ or suicidal ideation of type 5 based on the C-SSRS in parent trial and up to and including Visit 1 of this study.
- Patients diagnosed with moderate or severe substance use disorder
- Haemoglobin- Hb drop below 100g/L (10g/dL) OR Hb decrease of 25% or more from baseline and is below lower limit of normal in parent trial (alert 3 from last measure Hb in parental trial)
- Patients who have been diagnosed with hemoglobinopathies during the parent trial.
- Further exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence of treatment emergent adverse events (TEAEs) throughout the extension study
Secondary endpoints 2
- Change from baseline in Clinical Global Impressions – Severity (CGI-S) to end of treatment (EOT)
- Change from baseline in Hb to EOT
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9851013 · Product
- Active substance
- Iclepertin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3650 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
Locations
21 EU/EEA countries · 88 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 6 | 1 |
| Belgium | Ended | 6 | 4 |
| Bulgaria | Ended | 6 | 3 |
| Croatia | Ended | 17 | 6 |
| Czechia | Ended | 38 | 6 |
| Denmark | Ended | 16 | 3 |
| Finland | Ended | 6 | 3 |
| France | Ended | 19 | 7 |
| Germany | Ended | 34 | 9 |
| Greece | Ended | 30 | 5 |
| Hungary | Ended | 11 | 1 |
| Italy | Ended | 9 | 2 |
| Lithuania | Ended | 24 | 3 |
| Netherlands | Ended | 1 | 1 |
| Norway | Ended | 4 | 2 |
| Poland | Ended | 58 | 10 |
| Portugal | Ended | 6 | 3 |
| Romania | Ended | 28 | 2 |
| Slovakia | Ended | 40 | 3 |
| Spain | Ended | 32 | 12 |
| Sweden | Ended | 5 | 2 |
| Rest of world
Argentina, Serbia, Canada, Australia, Malaysia, Korea, Republic of, Japan, United States, Taiwan, Mexico, Ukraine, Turkey, Colombia, Philippines, Singapore, United Kingdom, Brazil, China, New Zealand
|
— | 1,113 | — |
Investigational sites
Medical University Of Vienna
Dept. of Psychiatry and Psychotherapy, Division of General Psychiatry, Waehringer Guertel 18-20, Alsergrund, Vienna
UPC Duffel
Psychiatry unit, Rooienberg 19, 2570, Duffel
Organisatie Broeders van Liefde
Clinical Psychiatry, Krijkelberg 1, 3360, Bierbeek
CUP Vivalia - Hôpital Psychiatrique de Bertrix "La Clairière"
Psychiatry clinic, Route des Ardoisières 100, 6800, Bertrix
Meclinas
Private Practice, Stationsstraat 102-108, 2800, Mechelen
Ambulatory For Group Practice For Specialized Psychiatric Help Philipopolis Ltd.
Private practice, Bulevard Vasil Aprilov 9, 4002, Plovdiv
Medical Center Hera EOOD
Private practice, Ulitsa Klisura 20, 1510, Sofiya
Medical Center Spectar Plovdiv EOOD
Private Practice, Ulitsa Makedoniya 107, 4004, Plovdiv
Clinical Hospital Centre Rijeka
Department of Psychiatry, Kresimirova 42, 51000, Rijeka
Klinika za psihijatriju Vrapce
University Psychiatric Hospital, Bolnicka Cesta 32, Zagreb, Grad Zagreb
Clinic for psychiatry Sveti Ivan
Psychiatric Hospital, Jankomir 11, Zagreb, Grad Zagreb
Poliklinika Solmed d.o.o.
Institute for Respiratory, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
University Hospital Centre Zagreb
Psychological Medicine, Ulica Mije Kispatica 12, 10000, Zagreb
Klinika za psihijatriju Vrapce
University Psychiatric Hospital, Bolnicka Cesta 32, Zagreb, Grad Zagreb
INEP medical s.r.o.
Private practice, Krizikova 264/22, Karlin, Prague
Narodni Ustav Dusevniho Zdravi
Clinic Contract Research Department, Topolova 748, 250 67, Klecany
A-Shine s.r.o.
Private practice, Sumavska 2, Vychodni Predmesti, Plzen 3
Psychiatrie Ricany s.r.o.
Private practice, Bezrucova 296/22, 251 01, Ricany
Pragtis s.r.o.
Private practice, Sokolska 66, Nove Mesto, Prague
MPMeditrine s.r.o.
Clinic Contract Research Department, Opavska 962/39, 708 00, Poruba
Region Hovedstadens Psykiatriske
Psykiatrisk Forskningsenhed, Nordre Ringvej 69, 2600, Glostrup
Region Midtjylland
Forskningsenheden for Psykoser, Palle Juul-Jensens Boulevard 175, 8200, Aarhus N
Aalborg University Hospital
Psychiatry, Moelleparkvej 10, 9000, Aalborg
The City of Helsinki Social Services Health Care and Rescue Services Division
Building 19, Nordenskioldinkatu 20, 00250, Helsinki
Jorvi Hospital
Psychiatry, Turuntie 150, 02740, Espoo
Clinical Research Services Turku CRST Oy
Psychiatry, Joukahaisenkatu 2 B, 20520, Turku
Hospital Hotel Dieu
Service d'Addictologie et Psychiatrie de liaison, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Nimes
Pôle Psychiatrie, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Assistance Publique Hopitaux De Paris
Centre Expert, 40 Rue De Mesly, 94000, Creteil
Centre Hospitalier Charles Perrens
Centre Expert de Schizophrénie - Service de Psychiatrie, 121 Rue De La Bechade, 33000, Bordeaux
Centre Hospitalier Universitaire De Nice
Psychiatrie, 30 Voie Romaine, 06000, Nice
Cent Hospitalier Specialise De Rouffach
Pôle de Psychiatrie 8-9, 27 Rue Du 4e Spahis Marocains, 68250, Rouffach
Centre Hospitalier Universitaire De Montpellier
Service de Psychiatrie, 39 Avenue Charles Flahault, Pavillon 32, Montpellier Cedex 5
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
Facharztpraxis für Neurologie & Psychiatrie, Lindenallee 3, Dornholzhausen, Bad Homburg
Dr. med. Joachim Springub Facharzt fuer Neurologie u. Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt fuer Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
Studienzentrum Nord-West, Lange Strasse 25, 26655, Westerstede
Studienzentrum Dr. Bischof GmbH
Studienzentrum Dr. Bischof GmbH, Konrad-Zuse-Strasse 14, West, Boeblingen
Klinikum der Universitaet Muenchen AöR
Klinik für Psychiatrie und Psychotherapie, Nussbaumstrasse 7, Ludwigsvorstadt-Isarvorstadt, Munich
Zentralinstitut Fuer Seelische Gesundheit
Abteilung für Molekulares Neuroimaging, Luisenring J 5, 68159, Mannheim
Practice Dr. Kirsten Hahn
Fachärztin für Psychatrie und Neurologie, Florastrasse 44, 13187, Berlin
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Klinik für Psychiatrie und Psychotherapie, Untere Zahlbacher Strasse 8, Oberstadt, Mainz
Universitaetsklinikum Tuebingen AöR
Klinik für Psychiatrie und Psychotherapie, Calwerstrasse 14, Innenstadt, Tuebingen
Lwl-Klinik Dortmund
Allgemeine Psychiatrie 1, Marsbruchstrasse 179, Aplerbeck, Dortmund
Eginitio Hospital
A’ Psychiatric Clinic, Vassilissas Sofias Avenue 74, 115 28, Athens
University General Hospital Of Thessaloniki Ahepa
3rd Psychiatric Clinic, 1st St Kiriakidis Str, 546 36, Thessaloniki
University General Hospital Attikon
2nd Department of Psychiatry, Rimini Street 1, 124 62, Athens
Geniko Nosokomeio Thessalonikis George Papanikolaou
Adult Psychiatry Department, Exochi, 570 10, Thessaloniki
Medipsych S.A.
“Agios Charalambos” Psychiatric Clinic, Megalou Alexandrou 82, 713 05, Irakleio
Semmelweis University
Department of Psychiatry and Psychotherapy, Balassa J Utca 6, 1083, Budapest
Azienda Ospedaliera Universitaria Senese
Dipartimento di Psichiatria, Strada Delle Scotte 14, 53100, Siena
ASST Fatebenefratelli Sacco
Reparto di Psichiatria 1, Piazzale Principessa Clotilde 3, 20121, Milan
Romuvos klinika UAB
Private practice, Rotuses A. 23, Kauno M. Sav., Kaunas
Lietuvos sveikatos mokslu universiteto Kauno ligonine
Psichiatric clinic Mariu division, A. Krisciuno G. 2, Kauno R. Sav., Ziegzdriu K.
Vilnius City Mental Health Center
Adult psychiatry day hospital, Vasaros G. 5, Vilniaus M. Sav., Vilnius
Universitair Medisch Centrum Groningen
Department of Biomedical Sciences of Cells and Systems, Hanzeplein 1, 9713 GZ, Groningen
Akershus University Hospital
DPS Groruddalen, Sykehusveien 25, 1474, Loerenskog
Ostfold Hospital Trust
DPS Nordre, P. O. Box 16, 1603, Fredrikstad
Revit Sp. z o.o.
Private Practice, Ul. Swobodna 38, 15-756, Bialystok
Wojewodzki Szpital Dla Nerwowo I Psychicznie Chorych Im. Dr J. Bednarza
Hospital, Ul. Sadowa 18, 86-100, Swiecie
Instytut Psychiatrii I Neurologii
Universyty Medical center, Ul. Jana III Sobieskiego 9, 02-957, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Universyty Medical center, Ul. Czechoslowacka 8/10, 92-216, Lodz
Euromedis Sp. z o.o.
Private practice, Ul. Powstancow Wielkopolskich 33 A, 70-111, Szczecin
Clinhouse Sp. z o.o.
Private practice, Ul. Tarnopolska 77, 41-807, Zabrze
MentalMEDIC Grzegorz Giemza Gliwickie Centrum Psychiatrii i Pshychoterapii
Private Practice, ul. Jagiellońska 27a/1, 44-100, Gliwice
Centrum Zdrowia Alcea
Private Practice, ul Matemblewska 1A/17, 80-283, Gdańsk
Indywidualna Specjalistyczna Praktyka Lekarska
Private Practice, ul. Boleslawa Limanowskiego 15A, 60-744, Poznań
Gabinet Lekarski Psychiatryczny Ireneusz Kaczorowski
Private Practice, ul.Kotarbińskiego 14, 97-400, Belchatów
Hospital Beatriz Angelo
Serviço de Psiquiatria, Avenida Carlos Teixeira No 3, 2674-514, Loures
Unidade Local De Saude Da Regiao De Leiria E.P.E.
Serviço de Psiquiatria e Saúde Mental, Rua Das Olhalvas, 2410-197, Leiria
Hospital De Santa Maria E.P.E.
Centro Investigação Clínica, Avenida Professor Egas Moniz Piso 3, 1649-028, Lisbon
Carpe Diem S.R.L.
Psychiatry Department, Strada Negruzzi Costache No.12, 550281, Sibiu
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psychiatry Department, Strada Argeselu Nr 8, 040874, Bucharest
PsychoLine s.r.o.
Private practice, P. Dobsinskeho 4861, 979 01, Rimavska Sobota
Epamed s.r.o.
Private practice, Topasova 9, Zapad, Kosice - Zapad
Nemocnica s poliklinikou Prievdza so sídlom v Bojniciach, psychiatricke oddelenie
Department of Psychiatry, Nemocničná 581/2, 972 01, Bojnice
Complejo Asistencial De Zamora Hospital Provincial De Zamora
Psychiatry Department, Calle De Hernan Cortes 40, 49020, Zamora
Hospital Clinico Universitario De Valencia
Psychiatry Department, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario De Getafe
Servicio de Psiquiatría, Carretera De Madrid Toledo Km 12,500, 28905, Getafe
Hospital Universitario Puerta De Hierro De Majadahonda
Psychiatry Department, Calle De Manuel De Falla 1, 28222, Majadahonda
Hestia Palau S.L.
Servicio de Psiquiatría, Calle De San Antonio Maria Claret 135, 08025, Barcelona
Hospital Universitario De Salamanca
Psychiatry Department, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Son Llatzer
Servicio de Psiquiatría, Carretera De Manacor Km 4, 07198, Palma
Hospital Universitario General De Villalba
Servicio de Psiquiatría, Carretera De Alpedrete A Moralzarzal M 608 Km 41, 28400, Madrid
Complexo Hospitalario Universitario De Vigo
Servicio de Psiquiatría, Estrada Clara Campoamor N 341, 36312, Vigo
University Hospital Virgen Del Rocio S.L.
Unidad de Hospitalización de Salud Mental, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinic De Barcelona
Servicio de Psiquiatría, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Reina Sofia
Psychiatry Department, Avenida Menendez Pidal S/n, 14004, Cordoba
Region Skane Helsingborg Hospital
Clinical Sciences, Clinical Psychosis Research unit, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg
Uppsala University Hospital
Psykosmottagning B, Sjukhusvagen 85, 751 85, Uppsala
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-08-22 | 2024-09-03 | |||
| Belgium | 2022-08-22 | 2022-09-08 | |||
| Bulgaria | 2024-07-18 | 2024-08-26 | |||
| Croatia | 2023-05-24 | 2023-06-28 | |||
| Czechia | 2022-09-22 | 2022-10-25 | |||
| Denmark | 2022-10-26 | 2022-11-09 | |||
| Finland | 2023-03-14 | 2023-04-28 | |||
| France | 2022-06-01 | 2022-07-19 | |||
| Germany | 2022-03-29 | 2022-04-04 | |||
| Greece | 2022-09-07 | 2022-09-20 | |||
| Hungary | 2024-05-22 | 2024-07-15 | |||
| Italy | 2022-05-04 | 2022-10-28 | |||
| Lithuania | 2022-11-23 | 2022-11-30 | |||
| Netherlands | 2024-10-15 | 2024-11-07 | |||
| Norway | 2022-10-24 | 2022-11-02 | |||
| Poland | 2022-09-07 | 2022-09-12 | |||
| Portugal | 2024-10-15 | ||||
| Romania | 2024-02-28 | 2024-03-27 | |||
| Slovakia | 2023-05-15 | 2023-06-19 | |||
| Spain | 2022-11-07 | 2022-11-17 | |||
| Sweden | 2022-08-29 | 2022-11-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 1346-0014_EU structured results SUM-123531
|
2026-03-17T10:11:12 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| lay-summary-1346-0014 | 2026-03-17T10:11:20 | Submitted | Laypersons Summary of Results |
Documents 80 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | lay-summary-1346-0014-belgium-dutch | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-belgium-french | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-belgium-german | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-bulgaria-bulgarian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-croatia-croatian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-czechia-czech | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-denmark-danish | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-english | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-finland-finnish | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-france-french | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-germany-german | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-greece-greek | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-hungary-hungarian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-italy-italian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-lithuania-lithuanian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-netherlands-dutch | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-norway-norwegian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-poland-polish | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-portugal-portuguese | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-romania-romanian | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-slovakia-slovak | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-spain-spanish | 1 |
| Laypersons summary of results (for publication) | lay-summary-1346-0014-sweden-swedish | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-BE | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-CZ | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-DE | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-ES | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-FI | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-BE-dut | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-BE-eng | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-BE-fre | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-CZ | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-CZ-highlighted | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-ES-public | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-data-collection-newborn-DE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-exit-interview-partner-CZ-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-exit-interview-subject-CZ-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-gdpr-CZ | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-gdpr-CZ-highlighted | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-guardian-addendum-CZ | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-guardian-biobanking-CZ | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-guardian-gdpr-CZ | 3 |
| Subject information and informed consent form (for publication) | L1_ ICF-guardian-main-CZ | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-guardian-optional-exit-interview-CZ-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-addendum-covid-19-CZ | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-addendum-covid-19-CZ-highlighted | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-appendix-FI-fin | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-BE-dut-public | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-BE-eng-public | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-BE-fre-public | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-CZ | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-CZ-highlighted | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-DE-public | 4 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-ES-public | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-main-FI | 6 |
| Subject information and informed consent form (for publication) | L1_ ICF-pregnant-partner-DE | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-reconsent-BE-dut-public | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-reconsent-BE-eng-public | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-reconsent-BE-fre-public | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-reconsent-FI | 2 |
| Subject information and informed consent form (for publication) | L1_ ICF-study-partner-BE-dut-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-study-partner-BE-eng-public | 4 |
| Subject information and informed consent form (for publication) | L1_ ICF-study-partner-BE-fre-public | 4 |
| Subject information and informed consent form (for publication) | L1_ ICF-study-partner-CZ | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-study-partner-CZ-hightlighted | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-study-partner-DE | 4 |
| Subject information and informed consent form (for publication) | L1_ ICF-study-partner-ES | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-study-partner-FI | 5 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-DE-public | 1 |
| Subject information and informed consent form (for publication) | L1_ ICF-substudy-partner-DE-public | 1 |
| Subject information and informed consent form (for publication) | L2_ List of submitted documents-CZ | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-eu-ctr-research-register-subject-FI-fin-public | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-study partner-info-brochure-BE-dut | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-study partner-info-brochure-BE-eng | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-study partner-info-brochure-BE-fre | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-study partner-info-brochure-CZ-cze | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-study partner-info-brochure-DE-ger | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-study partner-info-brochure-ES-spa-public | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information-study partner-info-brochure-FI-fin | 1 |
| Summary of results (for publication) | 1346-0014_EU structured results | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-17 | Germany | Acceptable 2024-06-20
|
2024-06-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-09 | Acceptable | 2024-10-14 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-09 | Acceptable | 2024-09-26 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-09 | Acceptable | 2024-10-28 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-09 | Germany | Acceptable | 2024-10-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-09 | 2024-10-28 |