Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
752
Countries
5
Sites
47
Alzheimer's Disease Psychosis
To evaluate the safety and tolerability of long-term ACP-204 treatment in subjects with ADP.
Key facts
- Sponsor
- Acadia Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 3 Dec 2024 → ongoing
- Decision date (initial)
- 2024-06-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Acadia Pharmaceuticals Inc.
External identifiers
- EU CT number
- 2023-507351-29-00
- ClinicalTrials.gov
- NCT06194799
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the safety and tolerability of long-term ACP-204 treatment in subjects with ADP.
Conditions and MedDRA coding
Alzheimer's Disease Psychosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10012271 | Dementia Alzheimer's type | 100000004852 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 3 Approximately 752 subjects will be enrolled in this 52-Week Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis (ADP) to evaluate the long-term safety and tolerability of ACP-204 in subjects with ADP.
|
Not Applicable | None | ACP-204 30mg or 60mg: ACP-204 30 mg given once daily, as capsule OR ACP-204 60 mg given once daily, as capsule |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Subject has successfully completed ACP-204-006 study
- Male or female (age 55 to 85 years old): female must be of non-childbearing potential, male must take appropriate contraceptive method if partner has childbearing potential
- Subject has a designated study partner/caregiver
- Subjects are able to complete all study visits with a study partner/caregiver
- Signed inform consent form with a caregiver or legal representative
Exclusion criteria 4
- Requires treatment with a medication prohibited by the protocol
- Is in hospice and receiving end-of-life palliative care, or has become bedridden
- Unstable clinically significant medical condition other than AD
- Any medical condition that in the opinion of the investigator may affect safety or ability to complete the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Treatment-emergent adverse events [Time Frame: 52 Weeks] Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs) over 52 weeks of treatment. The Safety population consists of all subjects who received at least one dose of study drug in this study.
Secondary endpoints 1
- Clinical Global Impression-Improvement in the ADP context (CGI-I-ADP) score [Time Frame: 52 Weeks]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11086730 · Product
- Active substance
- ACP-204 Tartrate
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 21840 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ACADIA PHARMACEUTICALS
- Paediatric formulation
- No
- Orphan designation
- No
PRD11086728 · Product
- Active substance
- ACP-204 Tartrate
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 21840 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ACADIA PHARMACEUTICALS
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Acadia Pharmaceuticals Inc.
- Sponsor organisation
- Acadia Pharmaceuticals Inc.
- Address
- 3611 Valley Centre Drive Suite 300
- City
- San Diego
- Postcode
- 92130-3331
- Country
- United States
Scientific contact point
- Organisation
- Acadia Pharmaceuticals Inc.
- Contact name
- Bryan Dirks, Vice President, Clinical Development
Public contact point
- Organisation
- Acadia Pharmaceuticals Inc.
- Contact name
- Christine Murphy, Senior Clinical Study Manager
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture, Code 8 |
| Gray Consulting Inc. ORG-100044159
|
Philadelphia, United States | Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other, Code 8 |
| Icon Laboratory Services Inc. ORG-100037135
|
Farmingdale, United States | Laboratory analysis |
Locations
5 EU/EEA countries · 47 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 57 | 13 |
| Czechia | Ongoing, recruiting | 46 | 8 |
| France | Ongoing, recruiting | 36 | 12 |
| Italy | Ongoing, recruiting | 43 | 10 |
| Spain | Ongoing, recruiting | 14 | 4 |
| Rest of world
Brazil, Mexico, Chile, Taiwan, United States, Serbia, Korea, Republic of
|
— | 556 | — |
Investigational sites
Alexandrovska University Hospital
Clinic of neurological disorders, Georgy Sofiiski Str 1, 1431, Sofia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Psychiatry, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
Alexandrovska University Hospital
Clinic of Psychiatry, Georgy Sofiiski Str 1, 1431, Sofia
Higya–DCC OOD
N/A, Ulitsa Sveti Ivan Rilski 3, 4400, Pazardzhik
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET
N/A, Ulitsa Yane Sandanski 61, 5980, Cherven Bryag
Center For Mental Health Prof. N. Shipkovenski EOOD
N/A, Ulitsa Ekzarh Yosif 59, 1000, Sofia
Medical Center Medconsult Pleven OOD
N/A, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Medical Center Lifemed EOOD
N/A, 1st Floor, Ulitsa Ekzarh Yosif 14, Kirdzhali
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
N/A, Ulitsa Dimitir Manov 17, 1408, Sofiya
Medical Center Intermedica Ltd.
N/A, Belite Brezim, Ulitsa Nishava 62, Sofiya
Medical Center Spectar Plovdiv EOOD
N/A, Ulitsa Makedoniya 107, 4004, Plovdiv
Medical Center Hera EOOD
N/A, Ulitsa Klisura 20, 1510, Sofiya
Umbal - Prof. D-R Stoyan Kirkovich AD
Department of Psychiatry, Ulitsa General Stoletov 2, 6003, Stara Zagora
INEP medical s.r.o.
NA, Krizikova 264/22, Karlin, Prague
Ad71 s.r.o.
NA, Sudkova 2a/686, 109 00, Prague
Forbeli s.r.o.
NA, Kolejni 429/5 Dejvice, 160 00, Prague
Clintrial s.r.o.
NA, Pocernicka 1427/16, Strasnice, Prague 10
Fakultni Nemocnice U Sv Anny V Brne
I.Neurologická klinika, Pekarska 53, Stare Brno, Brno-Stred
Neurohk s.r.o.
NA, Smetanova 830, 565 01, Chocen
Vestra Clinics s.r.o.
NA, Jiraskova 1389, 516 01, Rychnov Nad Kneznou
Brain-Soultherapy s.r.o.
NA, K Nemocnici 1904, 272 01, Kladno
Centre Hospitalier Universitaire De Dijon
Centre Mémoire Ressources et Recherche, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Hospital Pierre Wertheimer
Service Neurologie, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Regional Universitaire De Tours
Centre Mémoire Ressources et Recherche (CMRR), 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Toulouse
Gérontopôle Centre de Recherche Clinique, Place Lange, 31059, Toulouse Cedex 9
CHRU De Nancy
Départment Gériatrie Aigue, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Assistance Publique Hopitaux De Paris
Centre de Neurologie Cognitive, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Assistance Publique Hopitaux De Paris
Pôle de gériatrie, 54 56 Rue Pascal 54a, 75013, Paris
Centre Hospitalier Universitaire Rouen
Service de Neurologie, 1 Rue De Germont, 76000, Rouen
Centre Hospitalier Pasteur
Centre pour Personnes Âgées, 39 Avenue De La Liberte, Bp 60535, Colmar Cedex
Hospices Civils De Lyon
Centre de Recherche Clinique, 27 Rue Gabriel Peri, 69100, Villeurbanne
Centre Hospitalier Et Universitaire De Limoges
Service de Médecine Gériatrique, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire De Toulouse
Service de Neurologie, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Neurology, Via Atinense N. 18, 86077, Pozzilli
Universita' Campus Bio-medico Di Roma
Neurology, Via Alvaro Del Portillo 200, 00128, Rome
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Neurology, Largo Citta' D'ippocrate 1, 84131, Salerno
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Neurology, Via Cherasco 15, 10126, Turin
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neurology, Piazzale Spedali Civili 1, 25123, Brescia
Pia Fondazione Di Culto E Religione Card G Panico
Neurology, Via Pio X 4, 73039, Tricase
Ospedale San Raffaele S.r.l.
Neurology, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Neurology, Viale Del Policlinico 155, 00161, Rome
Fondazione Istituto G. Giglio Di Cafalu
U.O Neurologia, Contrada Pietra Pollastra Snc, 90015, Cefalu'
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Neurology, Largo Francesco Vito 1, 00168, Rome
Hospital Universitario Virgen De La Macarena
Neurology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Complejo Asistencial De Zamora Hospital Provincial De Zamora
Neurology, Calle De Hernan Cortes 40, 49020, Zamora
Hospital Germans Trias I Pujol
Neurology, Carretera Canyet 1a Planta, 08916, Badalona
Hospital Universitario Regional De Malaga
Neurology, Avenida De Carlos De Haya Sn, 29010, Malaga
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-12-03 | 2024-12-23 | |||
| Czechia | 2025-02-03 | 2025-02-03 | |||
| France | 2024-12-04 | 2025-01-02 | |||
| Italy | 2025-04-14 | 2025-05-08 | |||
| Spain | 2025-06-12 | 2025-07-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 135 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ACP-204-ACA227961-MTF_Scale Footers_FINAL_Signed_red-san | 1 |
| Protocol (for publication) | D1_ACP-204-008_Bulgaria Memo_red-san | N/A |
| Protocol (for publication) | D1_Protocol_2023-507351-29-00_red-san | PA3-EU 1.0 |
| Protocol (for publication) | D4_Caregiver facing-document_EQ-5D-5L-Proxy_Digital_EN_san | 1.0 |
| Protocol (for publication) | D4_Caregiver facing-document_EQ-5D-5L-Proxy_Digital_ESP es_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document_EQ-5D-5L-Proxy_Digital_ITA it_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document_EQ-5D-5L-Proxy_Screenshots_BGR_bg_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document_EQ-5D-5L-Proxy_Screenshots_CZE_cs_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document_EQ-5D-5L-Proxy_Screenshots_EN_san | 2.0 |
| Protocol (for publication) | D4_Caregiver facing-document_EQ-5D-5L-Proxy_Screenshots_FRA fr_san | NA |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_Bulgarian Bulgaria_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_CZE cs_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_EN_san | N/A |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_FRA fr_san | 1 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_Patient_EN_san | AU1.1 |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_Patient_ESP es_san | N/A |
| Protocol (for publication) | D4_Caregiver facing-document- QoL-AD_Patient_ITA it_san | 1 |
| Protocol (for publication) | D4_Patient facing document_Patient ID Card_BGR bg_san | 01BGR(bg) |
| Protocol (for publication) | D4_Patient facing document_Patient ID Card_CZE cs_san | 01CZE(cs) |
| Protocol (for publication) | D4_Patient facing document_Patient ID Card_ESP es_san | 01ESP(es) |
| Protocol (for publication) | D4_Patient facing document_Patient ID Card_FRA fr_san | V01FRA(fr) |
| Protocol (for publication) | D4_Patient facing document_Patient ID Card_ITA it_san | 01ITA(it) |
| Protocol (for publication) | D4_Patient facing-document-MMSE Screenshots_EN_san | N/A |
| Protocol (for publication) | D4_Patient facing-document-MMSE Screenshots_FRA fr_san | N/A |
| Protocol (for publication) | D4_Patient facing-document-MMSE Stimuli_EN_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE Stimuli_FRA fr_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_Bulgarian Bulgaria_san | 1.0 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_CZE cs_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_EN_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-MMSE_ESP es_san | N/A |
| Protocol (for publication) | D4_Patient facing-document-MMSE_ITA it_san | N/A |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_Bulgarian Bulgaria_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_CZE cs_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_EN_san | N/A |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_ESP es_san | 1 |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_FRA fr_san | N/A |
| Protocol (for publication) | D4_Patient facing-document-WAIS-IV_Response Booklet 1_ITA it_san | 1 |
| Protocol (for publication) | D4_Patient-facing_document_Patient_ID_Card_EN_2023-507351-29-00_san | 01 Global |
| Protocol (for publication) | D4_Patient-facing_NPI-C_BG_2023-507351-29-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_CZ_2023-507351-29-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_EN_2023-507351-29-00_clean | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_ES_2023-507351-29-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_FR_2023-507351-29-00 | 1.0 |
| Protocol (for publication) | D4_Patient-facing_NPI-C_IT_2023-507351-29-00 | 1.0 |
| Recruitment arrangements (for publication) | K_2023-507351-29_Recruit and Consent Form_FRAfr_v1_19Jan2024_san | 1 |
| Recruitment arrangements (for publication) | K0_Cover letter_Bulgaria_RA_Part II_final_san | 1.0 |
| Recruitment arrangements (for publication) | K0_Cover letter_Bulgaria_SM-1_Part II_final_san | 1.0 |
| Recruitment arrangements (for publication) | K1_ACP-204-008 Recruitment Arrangements and Consent Procedures | 2-0 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF Procedure_san | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | V2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_san | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_san | 2.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Caregiver_clean-san | V3.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_1_1_SIS and ICF Main ICF Master_san | 3.0 |
| Subject information and informed consent form (for publication) | L1_1_2_SIS and ICF_Main ICF_EN_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_1_3_SIS and ICF_Main ICF_BG_san | V3.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_2_1_SIS and ICF Caregiver ICF Master_san | 3.0 |
| Subject information and informed consent form (for publication) | L1_2_2_SIS and ICF Caregiver ICF EN_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2_3_SIS and ICF Caregiver ICF BG_san | V3.0BGR1.0 |
| Subject information and informed consent form (for publication) | L1_2023-507351-29_ICF_Main_CLEAN_san | V3.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_3_1_SIS and ICF PP ICF Master_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_3_2_SIS and ICF PP ICF EN_san | 1.1 |
| Subject information and informed consent form (for publication) | L1_3_3_SIS and ICF PP ICF BG_san | V1.0BGR1.1 |
| Subject information and informed consent form (for publication) | L1_ACP-204-008_Italy_Pregnant Partner_ITA-san | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_ACP-204-008_Main ICF | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_san | V3.0CZE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_clean-san | V3.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy sheet_ITA-san | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L2_ eConsaent_Glossary_san | V01 |
| Subject information and informed consent form (for publication) | L2_ eConsaent_Video Storyboard_san | V02 EU |
| Subject information and informed consent form (for publication) | L2_1_Other subject Information material_eConsent Glossary_BGR_san | V01.1BGR |
| Subject information and informed consent form (for publication) | L2_10_SDI_BGR_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_11_NPI-12_BGR_san | AU1.1 |
| Subject information and informed consent form (for publication) | L2_12_GCAS Last-Visit_BGR_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_12_GCAS Screening_BGR_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_13_QOL-AD-Patient_BGR_san | AU1.1 |
| Subject information and informed consent form (for publication) | L2_14_CGI-S_I_ADP_BGR_san | N/A |
| Subject information and informed consent form (for publication) | L2_15_C-SSRS-Baseline-Screening_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_15_C-SSRS-SinceLastVisit_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_16_WAIS-IV_Administration and Scoring Manual_Coding_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_17_MMSE_Screenshots_BGR_san | 1 |
| Subject information and informed consent form (for publication) | L2_18_IFU-HCG Cassette Urine 25mIU-CE-OTC HG_BGR_san | B21515-02 |
| Subject information and informed consent form (for publication) | L2_2_Other subject Information material_eConsent Video Storyboard_BGR_san | V02 BGR |
| Subject information and informed consent form (for publication) | L2_2023-507351-29_ICF_Caregiver_CLEAN_san | V3.0FRA2.0 |
| Subject information and informed consent form (for publication) | L2_3_eConsent Submission Letter_BG_san | 4.0 |
| Subject information and informed consent form (for publication) | L2_3_eConsent Submission Letter_EN_san | 4.0 |
| Subject information and informed consent form (for publication) | L2_4_Getting Started Patient-facing landing page_BGR_san | 1.1 |
| Subject information and informed consent form (for publication) | L2_5_IQVIA Complete Consent Security and Privacy Quick Reference Guide_BGR_san | 1.3 |
| Subject information and informed consent form (for publication) | L2_6_IQVIA Complete Consent Participant-Facing Screenshots_BGR_san | 1.3 |
| Subject information and informed consent form (for publication) | L2_7_SAPS-H D_BGR_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_8_The UKU Side Effect Rating Scale_BGR_san | N/A |
| Subject information and informed consent form (for publication) | L2_9_ESRS-A_Instructions_BGR_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_9_ESRS-A_Long Form_BGR_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_ACP-204-008_Caregiver ICF | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L2_Caregiver ICF_san | V3.0CZE1. |
| Subject information and informed consent form (for publication) | L2_Clincierge_Oznameni o ochrane osobnich udaju_san | CZE-ces 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge_Prirucka Pay Portal_san | CZE-ces 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge_Uvitaci dopis pro ucastnika_san | CZE-ces 1 |
| Subject information and informed consent form (for publication) | L2_Clincierge_Zasady cestovani_san | CZE-ces 1 |
| Subject information and informed consent form (for publication) | L2_eConsent Security and Privacy Quick Reference Guide _san | V1.3 CZ |
| Subject information and informed consent form (for publication) | L2_eConsent_Getting Started Patient-facing landing page _san | V1.1 Czech |
| Subject information and informed consent form (for publication) | L2_eConsent_Particpant screenshot_san | V1.3 Czech |
| Subject information and informed consent form (for publication) | L2_Main GDPR_san | CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ACP-204-008_Video Storyboard | V2 |
| Subject information and informed consent form (for publication) | L2_Other subject material_eConsent Submission Letter_Italy-san | V4.0 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Glossary_ITA-san | V01.1 |
| Subject information and informed consent form (for publication) | L2_Other subject material_Video Storyboard_ITA-clean-san | 02 |
| Subject information and informed consent form (for publication) | L2_Pregnant Partner GDPR_san | CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Pregnant Partner ICF CZE_san | V1.0CZE1.1 |
| Subject information and informed consent form (for publication) | L3_2023-507351-29_ICF_Pregnancy FU_FRAfr_V1-0FRA1-1_24Jan2024_san | V1.0FRA1.1 |
| Subject information and informed consent form (for publication) | L3_ACP-204-008_Pregnant Partner ICF | 1-0ESP1-0 |
| Subject information and informed consent form (for publication) | L4_2023-507351-29_eConsent_Getting Started Landing Page_FRAfr_v1-1_03May2022_san | 1.1 |
| Subject information and informed consent form (for publication) | L4_2023-507351-29_eConsent_Glossary_FRAfr_V01-1_06Oct2023_san | 01.1 |
| Subject information and informed consent form (for publication) | L4_2023-507351-29_eConsent_Pt-facing Screenshots_emails_FRAfr_v1-3_08Feb2023_san | 1.3 |
| Subject information and informed consent form (for publication) | L4_2023-507351-29_eConsent_Security and Privacy QRG_FRAfr_v1-3_16Jan2023_san | 1.3 |
| Subject information and informed consent form (for publication) | L4_2023-507351-29_eConsent_Submission Letter_FRAen_V4-0_03Jan2024_san | 4.0 |
| Subject information and informed consent form (for publication) | L4_2023-507351-29_eConsent_Video Storyboard_CLEAN_san | 02 EU |
| Subject information and informed consent form (for publication) | L4_Other subject information material_ACP-204-008_Clincierge_Data Protection Notice | 1-0 |
| Subject information and informed consent form (for publication) | L5_2023-507351-29_Clincierge Travel Policy_FRAfr_v1-0_01Jun2023_san | 1.0 |
| Subject information and informed consent form (for publication) | L5_2023-507351-29_Clincierge Welcome Letter_FRAfr_v1-0_01Jun2023_san | 1.0 |
| Subject information and informed consent form (for publication) | L5_2023-507351-29_Clincierge_Data Protection Consent_FRAfr_CLEAN_san | 2.0 |
| Subject information and informed consent form (for publication) | L5_Other subject information material_ACP-204-008_Clincierge_Pay Portal Guide | 1-0 |
| Subject information and informed consent form (for publication) | L7_Other subject information material_ACP-204-208_Glossary | 01 |
| Subject information and informed consent form (for publication) | L8_Other subject information material_ACP-204-208_Consent Privacy Quick Reference Guide | 1-3 |
| Subject information and informed consent form (for publication) | L9_Other subject information material_ACP-204-008_eConsent Sub Letter | 4-0 |
| Subject information and informed consent form (for publication) | List of submitted documents | NA |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_BG_2023-507351-29-00_san | PA3-EU 1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_CZ_2023-507351-29-00_san | PA3-EU 1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_EN_2023-507351-29-00_san | PA3 EU 1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_ES_2023-507351-29-00_san | PA3-EU 1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_FR_2023-507351-29-00_san | PA3-EU 1.0 |
| Synopsis of the protocol (for publication) | D1_Layman Language Protocol synopsis_IT_2023-507351-29-00_san | PA3-EU 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2023-507351-29-00_san | PA2 EU 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2023-507351-29-00_san | PA3-EU 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2023-507351-29-00_san | PA3-EU 1.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-09 | Czechia | Acceptable with conditions 2024-05-30
|
2024-05-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-08 | Acceptable with conditions 2024-05-30
|
2024-10-08 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-13 | Czechia | Acceptable 2025-03-28
|
2025-03-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-16 | Acceptable | 2025-04-25 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-10 | Czechia | Acceptable | 2025-06-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-23 | Acceptable | 2025-09-11 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-25 | Acceptable | 2025-12-19 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-20 | Czechia | Acceptable 2026-03-23
|
2026-03-23 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-05-14 | Czechia | Acceptable 2026-03-23
|
2026-05-14 |