Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
126
Countries
4
Sites
28
Lewy body Dementia psychosis (LBDP)
To evaluate the safety and tolerability of long-term ACP-204 treatment in subjects with LBDP
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
- 17 May 2026 → ongoing
- Decision date (initial)
- 2025-11-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Acadia Pharmaceuticals Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Dose response
To evaluate the safety and tolerability of long-term ACP-204 treatment in subjects with LBDP
Secondary objectives 1
- safety objective: to evaluate the safety and tolerability of long-term ACP-204 treatment in subjects with LBDP based on additional safety measures
Conditions and MedDRA coding
Lewy body Dementia psychosis (LBDP)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | PT | 10067889 | Dementia with Lewy bodies | 100000004852 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- The subject may benefit from long-term therapy with open-label ACP-204 treatment in the judgment of the Investigator
- Subject has completed Visit 6 (EOT) of the antecedent ACP-204-012 study and did not have an early discontinuation from the antecedent study
- Can complete all study visits with a study partner/caregiver
- Can understand the nature of the study and protocol requirements and provide written informed consent. If the subject is deemed not competent to provide informed consent, the following requirements for consent must be met: a. The subject’s LAR (or study partner/caregiver, if local regulations allow) must provide written informed consent. b. The subject must provide written (if capable) informed assent per local regulations.
- If the subject is a female, she must be of nonchildbearing potential
- If the subject is male, he must agree to the following during the study intervention period and for at least 90 days after the last dose of study drug: a. Refrain from donating sperm, AND b. Either be abstinent from sexual intercourse where pregnancy can occur (abstinent on a long-term and persistent basis) and agree to remain abstinent OR Use a condom and subject's female partner (if of childbearing potential and not pregnant) must use an additional contraceptive method
Exclusion criteria 8
- Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason
- Is in hospice, is receiving end-of-life palliative care, or is bedridden
- Has a heart rate <50 beats per minute, as measured by vital signs at Baseline (EOT visit of the antecedent study). If bradycardia is secondary to iatrogenic or treatable causes and these causes are addressed, a heart rate assessment can be repeated.
- Has a BMI <18.5 kg/m or known unintentional weight loss ≥7% of body weight over past 6 months
- Has a clinically significant laboratory abnormality in the antecedent ACP-204-012 study, excepting at ACP-204-012 EOT, that in the judgment of the Investigator or Medical Monitor, will either: a. jeopardize the safe participation of the subject in this study; OR b. interfere with the conduct or interpretation of safety or efficacy evaluations in the study
- Is actively suicidal at Visit 1 (Baseline, EOT visit of the antecedent study)
- Has a neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or mental disorder, including cancer or malignancies that, in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
- Requires treatment with a medication or other substance that is prohibited by the protocol or will be used in a way that violates a use restriction
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Treatment-emergent adverse events (TEAEs)
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
- 30 mg milligram(s)
- Max total dose
- 10920 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
- 12830 El Camino Real Suite 400
- City
- San Diego
- Postcode
- 92130-2976
- Country
- United States
Scientific contact point
- Organisation
- Acadia Pharmaceuticals Inc.
- Contact name
- Bryan Dirks, Vice President, Clinical Development Lead
Public contact point
- Organisation
- Acadia Pharmaceuticals Inc.
- Contact name
- Imran Ghiasuddin , Senior Clinical Study Manager
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Primevigilance Limited ORG-100027742
|
Guildford, United Kingdom | Code 8 |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| MEDPACE LABORATORIES ORG-100042942
|
Leuven, Belgium | Laboratory analysis |
| Catalent Germany Schorndorf GmbH ORG-100011845
|
Schorndorf, Germany | Code 14 |
Locations
4 EU/EEA countries · 28 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 15 | 7 |
| Czechia | Authorised, recruitment pending | 10 | 5 |
| France | Authorised, recruitment pending | 13 | 10 |
| Italy | Authorised, recruitment pending | 11 | 6 |
| Rest of world
United States, Serbia
|
— | 77 | — |
Investigational sites
Dr. Ivo Natsov Outpatient Clinic For Individual Practice For Specialized Medical Care In Psychiatry ET
N/A, Ulitsa Yane Sandanski 61, 5980, Cherven Bryag
Alexandrovska University Hospital
Department for Neurodegenerative and Immune inflammatory Diseases of CNS and neuroinfections, Georgy Sofiiski Str 1, 1431, Sofia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Psychiatry, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
Diagnostics-Consultancy Center Mladost M Varna OOD
N/A, Bulevard Republika 15, 9020, Varna
Children's Health Medical Center EOOD
N/A, Ulitsa Maestro Kinev 2 A, 1618, Sofia
Medical Center Saint Naum EOOD
N/A, Ulitsa D-R Lyuben Rusev 1, 1113, Sofiya
Diagnostic And Consultation Centre St.Vrach And St.St. Kuzma And Damian OOD
N/A, Ulitsa Dimitir Manov 17, 1408, Sofiya
Fakultni Nemocnice U Sv Anny V Brne
I.Neurologická klinika, Pekarska 53, Stare Brno, Brno-Stred
Vestra Clinics s.r.o.
----, Jiraskova 1389, 516 01, Rychnov Nad Kneznou
Vseobecna Fakultni Nemocnice V Praze
Neurologická klinika, Katerinska 468/30, Nove Mesto, Prague
Neurohk s.r.o.
---, Smetanova 830, 565 01, Chocen
Neuropsychiatrie s.r.o.
---, Terronska 580/19, Bubenec, Prague 6
Hospices Civils De Lyon
Geriatrics, 27 Rue Gabriel Peri, 69100, Villeurbanne
Assistance Publique Hopitaux De Paris
Geriatrics, 54 56 Rue Pascal 54a, 75013, Paris
Centre Hospitalier Universitaire De Lille
CMRR, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Centre Hospitalier Regional Universitaire De Tours
Memory Clinic, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Assistance Publique Hopitaux De Paris
CMRR, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Centre Hospitalier Universitaire De Toulouse
Neurology, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
CHRU De Nancy
Geriatry, 11 Rue Du Morvan, Bp 80001, Vandoeuvre Les Nancy Cedex
Hospices Civils De Lyon
Neurology, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Toulouse
Gerontopole, Place Lange, 31059, Toulouse Cedex 9
Les Hopitaux Universitaires De Strasbourg
CMRR, 21 Rue David Richard, 67000, Strasbourg
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Neurologia, Piazza Luigi Miraglia 2, 80138, Naples
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Neurologia, Largo Citta' D'ippocrate 1, 84131, Salerno
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neurologia, Piazzale Spedali Civili 1, 25123, Brescia
Universita' Campus Bio-medico Di Roma
Neurologia, Via Alvaro Del Portillo 200, 00128, Rome
Pia Fondazione Di Culto E Religione Card G Panico
Neurologia, Via Pio X 4, 73039, Tricase
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Neurologia, Viale Del Policlinico 155, 00161, Rome
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 | 2026-05-17 | 2026-05-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 138 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Memorandum to Protocol_2025_521711-39-00_Bulgaria_red-san | NA |
| Protocol (for publication) | D1_Protocol_2025-521711-39-00_red_san | 1.0 |
| Protocol (for publication) | D4_Caregiver Facing document_QoL_AD_Caregiver_Screenshots_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_Caregiver facing material_QoL_AD_Care_ePRO_V4H_screenshot_san | NA |
| Protocol (for publication) | D4_CGI-S_LBDP_French_France_san | 1 |
| Protocol (for publication) | D4_ESRS-A_Long Form_ French_France_san | 1 |
| Protocol (for publication) | D4_Facing document_QoL_AD_Care_Screenshots_Traditional Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Facing document_QoL_AD_Subject_Screenshots_Traditional Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Pacient Facing document_WAIS-IV Response Booklet 1_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_Patieng Facing document_WAIS-IV Response Booklet 1_Italian IT_san | 1 |
| Protocol (for publication) | D4_Patient Facing document_QoL_AD_caregiver_ePRO-V4H_screenshot_Italian_IT_san | NA |
| Protocol (for publication) | D4_Patient Facing document_QoL_AD_Subject_ePRO-V4H_screenshot_Italian_IT_san | NA |
| Protocol (for publication) | D4_Patient Facing document_QoL_AD_Subject_Screenshots_Bulgarian Bulgaria_san | 1 |
| Protocol (for publication) | D4_Patient facing document_WAIS-IV Response Booklet 1_ English_san | 1 |
| Protocol (for publication) | D4_Patient Facing document_WAIS-IV Response Booklet 1_Czech CZ_san | 1 |
| Protocol (for publication) | D4_Patient facing material_QoL_AD_sub_eClinRO_V4H_MAIN_screenshot_san | NA |
| Protocol (for publication) | D4_Patient facing material_QoL_AD_Subject_Screenshots_French France_san | 1 |
| Protocol (for publication) | D4_QoL_AD_Care_Screenshots_Traditional French France_san | 1 |
| Protocol (for publication) | D4_Sale_SAPS-H_D_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_SAPS-H_D_French France _san | 1 |
| Protocol (for publication) | D4_Scale_ CAF Clinical Assessment of Fluctuation_Bulgarian_Bulgara_san | 1 |
| Protocol (for publication) | D4_Scale_ CAF Clinical Assessment of Fluctuation_English _san | 1 |
| Protocol (for publication) | D4_Scale_ ESRS-A_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_Scale_ ESRS-A_English_san | 1 |
| Protocol (for publication) | D4_Scale_ NPI-C_ita-IT_san | 1 |
| Protocol (for publication) | D4_Scale__SDI _1_Bulgarian Bulgaria_san | 1 |
| Protocol (for publication) | D4_Scale_C-SSRS SinceLastVisit_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_Scale_C-SSRS SinceLastVisit_English_san | 1 |
| Protocol (for publication) | D4_Scale_C-SSRS-SinceLastVisit_Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_C-SSRS-SinceLastVisit_French_France_san | 1 |
| Protocol (for publication) | D4_Scale_C-SSRS-SinceLastVisit_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_CAF_CS_CZ_san | 1.0 |
| Protocol (for publication) | D4_Scale_CAF_frFR_san | 1.0 |
| Protocol (for publication) | D4_Scale_CAF_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_CDC Fall Risk Factors Checklist_Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_CDC Fall Risk Factors Checklist_French_France_san | 1 |
| Protocol (for publication) | D4_Scale_CDC Fall Risk Factors Checklist_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_CGI-I_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_Scale_CGI-I_English _san | 1 |
| Protocol (for publication) | D4_Scale_CGI-I_LBDP_Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_CGI-I_LBDP_French_France_san | 1.0 |
| Protocol (for publication) | D4_Scale_CGI-I_LBDP_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_CGI-S_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_Scale_CGI-S_English_san | 1 |
| Protocol (for publication) | D4_Scale_CGI-S_LBDP_Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_CGI-S_LBDP_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_ESRS-A_Long Form_ Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_ESRS-A_Long Form_ Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_GCAS Last-Visit_Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_GCAS Last-Visit_French_France_san | 1 |
| Protocol (for publication) | D4_Scale_GCAS Last-Visit_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_GCAS Since-Last-Visit_Bulgarian_Bulgarian_san | 1 |
| Protocol (for publication) | D4_Scale_GCAS Since-Last-Visit_English_san | 1 |
| Protocol (for publication) | D4_Scale_MMSE Stimuli_Bulgarian_Bulgaria_V1_2025-Jun-13_san | 1 |
| Protocol (for publication) | D4_Scale_MMSE Stimuli_Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_MMSE Stimuli_English_san | 1 |
| Protocol (for publication) | D4_Scale_MMSE Stimuli_French_France_san | 1 |
| Protocol (for publication) | D4_Scale_MMSE Stimuli_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_MMSE_Bulgarian _Bulgaria_san | 1 |
| Protocol (for publication) | D4_Scale_MMSE_Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_MMSE_English_san | 1 |
| Protocol (for publication) | D4_Scale_MMSE_French France_san_ | 1 |
| Protocol (for publication) | D4_Scale_MMSE_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_Modified CDC Fall Risk Factors Checklist_Bulgarian _Bulgaria_san | 1 |
| Protocol (for publication) | D4_Scale_Modified CDC Fall Risk Factors Checklist_English_san | 1 |
| Protocol (for publication) | D4_Scale_NPI-C_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_Scale_NPI-C_cse-CZ_san | 1 |
| Protocol (for publication) | D4_Scale_NPI-C_English_san | 1 |
| Protocol (for publication) | D4_Scale_NPI-C_fra-FR_san | 1.0 |
| Protocol (for publication) | D4_Scale_ONE DAY FLUCTUATION ASSESSMENT SCALE_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_scale_One Day Fluctuation Assessment_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_Scale_ONE DAY FLUCTUATION ASSESSMENT_Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_One Day Fluctuation Assessment_English_san | 1 |
| Protocol (for publication) | D4_Scale_ONE DAY FLUCTUATION ASSESSMENT_French_France_san | 1 |
| Protocol (for publication) | D4_Scale_SAPS-H D_English_san | 1 |
| Protocol (for publication) | D4_Scale_SAPS-H_D_Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_SAPS-H_D_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_SDI 1_English_san | 1 |
| Protocol (for publication) | D4_Scale_SDI_Czech _Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_SDI_French France_san | 1 |
| Protocol (for publication) | D4_Scale_SDI_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_STEADI-Assessment-TUG_French_France_san | 1 |
| Protocol (for publication) | D4_Scale_STEADI-Assessment-TUG_Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_STEADI-Assessment-TUG-508_csCZ_san | 1 |
| Protocol (for publication) | D4_Scale_The UKU Side Effect Rating Scale _Czech_Czech Republic_san | 1 |
| Protocol (for publication) | D4_Scale_The UKU Side Effect Rating Scale _French _France_san | 1 |
| Protocol (for publication) | D4_Scale_The UKU Side Effect Rating Scale _Italian_Italy_san | 1 |
| Protocol (for publication) | D4_Scale_TUG_STEADI-Assessment_English_san | 1 |
| Protocol (for publication) | D4_Scale_UKU Side Effect Rating Scale_Bulgarian _Bulgaria_scan | 1 |
| Protocol (for publication) | D4_Scale_UKU Side Effect Rating Scale_English_san | 1 |
| Protocol (for publication) | D4_TUG_STEADI-Assessment_Bulgarian_Bulgaria_san | 1 |
| Protocol (for publication) | D4_WAIS-IV Response Booklet 1_French FR_san | 1 |
| Protocol (for publication) | D5_ACP-204-013_Justification for the Collection of ethnic origins data_FRANCE red_san | NA |
| Protocol (for publication) | D5_Vulnerable Population Justification_red_san | NA |
| Recruitment arrangements (for publication) | K0_Cover letter_Bulgaria_Part II_IN_placeholder_san | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent Procedure_San | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent_Italy | V1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BG_san | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_EN_san | 3.0 |
| Recruitment arrangements (for publication) | K2_1_Recruitment material_Informed Consent Flip Chart_san | v1 |
| Recruitment arrangements (for publication) | K2_Consent Flip Chart_san | 1 |
| Recruitment arrangements (for publication) | K2_Consent Flip Chart_San | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ACP-204-013_Consent Flip Chart_Italy | V1 |
| Subject information and informed consent form (for publication) | L1_1_1_SIS and ICF Main_Master_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_1_2_SIS and ICF Main ICF_EN_red-san | 3.0 |
| Subject information and informed consent form (for publication) | L1_1_3_SIS and ICF Main ICF_BG_red-san | V1.0BGR3.0 |
| Subject information and informed consent form (for publication) | L1_2_1_SIS and ICF Caregiver ICF_Master_san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2_2_SIS and ICF Caregiver ICF_EN_red-san | 1.0 |
| Subject information and informed consent form (for publication) | L1_2_3_SIS and ICF Caregiver ICF_BG_red-san | V1.0BGR1.0 |
| 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 | 2.0 |
| Subject information and informed consent form (for publication) | L1_3_3_SIS and ICF_PP ICF_BG_san | V1.0BGR2.0 |
| Subject information and informed consent form (for publication) | L1_ACP-204-013_Italy_Main ICF_ITA-san_red | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L1_Caregiver ICF_San | V1.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_red and san | V1.0CZE2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Red_San | V1.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_track_san | V1.0CZE2.0 |
| Subject information and informed consent form (for publication) | L1_Pregnancy ICF_San | V1.0FRA2.0 |
| Subject information and informed consent form (for publication) | L2_ACP-204-013 Italy Caregiver ICF_ITA-san | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2_ACP-204-013 Italy Pregnant Partner ICF_ITA-san_red | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2_ACP-204-013_Italy_Main Privacy ICF_ITA-san_red | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L2_Caregiver ICF_san | V1.0CZE2.0 |
| Subject information and informed consent form (for publication) | L2_Caregiver ICF_track_san | V1.0CZE2.0 |
| 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_Main GDPR_san | CZE(cs)1.0 |
| Subject information and informed consent form (for publication) | L2_Patient ID Card_San | 1.0 |
| Subject information and informed consent form (for publication) | L2_Pregnant Partner ICF CZE_san | V1.0CZE1.0 |
| Subject information and informed consent form (for publication) | L3_Clincierge Data Treatment Consent_San | 1.0 |
| Subject information and informed consent form (for publication) | List of submitted documents | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BU_2025-521711-39-00_san | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2025-521711-39-00_san | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2025-521711-39-00_san | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2025-521711-39-00_san | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2025-521711-39-00_san | 1.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-14 | Czechia | Acceptable with conditions 2025-11-03
|
2025-11-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-13 | Acceptable with conditions | 2026-04-23 |