Protocol Lay Person Short Title: A Trial of the Safety and Efficacy of Flexible Doses of SEP-363856 as Adjunctive Therapy in the Treatment of Adults with Major Depressive Disorder.

2022-500538-27-00 Protocol 382-201-00001 Phase II and Phase III (Integrated) Ended

Start 30 Mar 2023 · End 13 Nov 2025 · Status Ended · 6 EU/EEA countries · 30 sites · Protocol 382-201-00001

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Ended
Participants planned 944
Countries 6
Sites 30

Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.

To compare the efficacy of SEP-363856 (50 to 75 mg/day) to placebo as adjunctive therapy to an assigned open-label ADT in subjects with MDD who demonstrate an inadequate response to a prospective 8-week trial of the same assigned open label ADT.

Key facts

Sponsor
Otsuka Pharmaceutical Development And Commercialization 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
30 Mar 2023 → 13 Nov 2025
Decision date (initial)
2023-02-27
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Otsuka Pharmaceutical Development and Commercialization Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To compare the efficacy of SEP-363856 (50 to 75 mg/day) to placebo as adjunctive therapy to an assigned open-label ADT in subjects with MDD who demonstrate an inadequate response to a prospective 8-week trial of the same assigned open label ADT.

Secondary objectives 1

  1. To evaluate the safety and tolerability of SEP-363856 (50 to 75 mg/day) as adjunctive therapy to ADT in subjects with MDD.

Conditions and MedDRA coding

Adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. The study population includes subjects 18 to 65 years of age inclusive at the time of consent with MDD as the main diagnosis and who are currently experiencing a major depressive episode (MDE) as determined by the DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) and confirmed by the Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT) and appropriate clinical psychiatric assessment. The current MDE must have a duration of ≥ 8 weeks and < 2 years. In addition, subjects must have reported a history for the current MDE of an inadequate response to at least 1 and no more than 3 adequate ADTs. Subjects must also have a total score ≥ 18 at the screening and baseline visit on the 17-item Hamilton Depression Rating Scale (HAM-D17).

Exclusion criteria 1

  1. Any subject who, in the opinion of the clinical trial sponsor, investigator, or medical monitor, should not participate in the trial will be excluded.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change from the end of Phase A (Week 8 visit) to the end of Phase B (Week 14 visit) in the MADRS total score.

Secondary endpoints 2

  1. Standard safety variables to be examined in this trial will include AEs, physical examinations (including body weight and waist circumference), vital signs (blood pressure, heart rate, and body temperature), 12-lead ECGs, and clinical laboratory assessments (hematology, serum chemistry, urinalysis, prolactin, glycosylated hemoglobin, and coagulation parameters).
  2. In addition to the standard safety variables, other safety variables including C-SSRS, SAS, AIMS, BARS, CSFQ, and PSQI will also be evaluated.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Ulotaront

PRD11128379 · Product

Active substance
Ulotaront
Substance synonyms
SEP-363856, (S)-1-(4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine, SEP-856
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
75 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Not Authorised
MA holder
OTSUKA PHARMACEUTICAL CO., LTD.
Paediatric formulation
No
Orphan designation
No

Ulotaront

PRD11128378 · Product

Active substance
Ulotaront
Substance synonyms
SEP-363856, (S)-1-(4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine, SEP-856
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
75 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Not Authorised
MA holder
OTSUKA PHARMACEUTICAL CO., LTD.
Paediatric formulation
No
Orphan designation
No

Ulotaront

PRD11128377 · Product

Active substance
Ulotaront
Substance synonyms
SEP-363856, (S)-1-(4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine, SEP-856
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
75 mg milligram(s)
Max total dose
75 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Not Authorised
MA holder
OTSUKA PHARMACEUTICAL CO., LTD.
Paediatric formulation
No
Orphan designation
No

Placebo 1

SEP-363856 matching placebo

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Auxiliary 6

Fluoxetine

SCP965499 · ATC

Active substance
Fluoxetine
Route of administration
ORAL
Max daily dose
60 mg milligram(s)
Max total dose
5880 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
N06AB03 — FLUOXETINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
AxMP authorised in the EU, but sourced from the US market is used in commercial primary packaging (US product) with additional labelling for use in this trial to fulfil EU regulatory labelling requirements. US product is used due to operational complexity and non-availability of marketed product in certain EU member states.

Duloxetine

SCP12711734 · ATC

Active substance
Duloxetine
Route of administration
ORAL
Max daily dose
60 mg milligram(s)
Max total dose
5880 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
N06AX21 — DULOXETINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
AxMP authorised in the EU, but sourced from the US market is used in commercial primary packaging (US product) with additional labelling for use in this trial to fulfil EU regulatory labelling requirements. US product is used due to operational complexity and non-availability of marketed product in certain EU member states.

Citalopram

SCP150080 · ATC

Active substance
Citalopram
Route of administration
ORAL
Max daily dose
20 mg milligram(s)
Max total dose
1960 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
N06AB10 — ESCITALOPRAM
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
AxMP authorised in the EU, but sourced from the US market is used in commercial primary packaging (US product) with additional labelling for use in this trial to fulfil EU regulatory labelling requirements. US product is used due to operational complexity and non-availability of marketed product in certain EU member states.

Venlafaxine

SCP16258179 · ATC

Active substance
Venlafaxine
Route of administration
ORAL
Max daily dose
225 mg milligram(s)
Max total dose
22050 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
N06AX16 — VENLAFAXINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
AxMP authorised in the EU, but sourced from the US market is used in commercial primary packaging (US product) with additional labelling for use in this trial to fulfil EU regulatory labelling requirements. US product is used due to operational complexity and non-availability of marketed product in certain EU member states.

Paroxetine

SCP166487 · ATC

Active substance
Paroxetine
Route of administration
ORAL
Max daily dose
62.5 mg milligram(s)
Max total dose
6125 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
N06AB05 — PAROXETINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
AxMP authorised in the EU, but sourced from the US market is used in commercial primary packaging (US product) with additional labelling for use in this trial to fulfil EU regulatory labelling requirements. US product is used due to operational complexity and non-availability of marketed product in certain EU member states.

Sertraline

SCP1153665 · ATC

Active substance
Sertraline
Route of administration
ORAL
Max daily dose
200 mg milligram(s)
Max total dose
19600 mg milligram(s)
Max treatment duration
14 Week(s)
Authorisation status
Authorised
ATC code
N06AB06 — SERTRALINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
AxMP authorised in the EU, but sourced from the US market is used in commercial primary packaging (US product) with additional labelling for use in this trial to fulfil EU regulatory labelling requirements. US product is used due to operational complexity and non-availability of marketed product in certain EU member states.

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Otsuka Pharmaceutical Development And Commercialization Inc.

2 Total trials 2 Ended
Commercial
Sponsor organisation
Otsuka Pharmaceutical Development And Commercialization Inc.
Address
2440 Research Boulevard
City
Rockville
Postcode
20850-3238
Country
United States

Scientific contact point

Organisation
Otsuka Pharmaceutical Development And Commercialization Inc.
Contact name
Brian Rothman

Public contact point

Organisation
Otsuka Pharmaceutical Development And Commercialization Inc.
Contact name
Heather Sutton

Third parties 15

OrganisationCity, countryDuties
Syneos Health Netherlands B.V.
ORG-100013861
 Amsterdam, Netherlands On site monitoring, Code 13, Code 5
Welocalize Inc.
ORG-100042032
 New York, United States Other
Clinical Ink Inc.
ORG-100042433
 Winston Salem, United States E-data capture
Almac
ORG-100013160
 Souderton, United States Code 14
EPL Pathology Archives LLC
ORG-100042096
 Leesburg, United States Other
Eresearchtechnology Inc.
ORG-100013039
 Philadelphia, United States Other
Pharmaceutical Product Development LLC
ORG-100016999
 Highland Heights, United States Laboratory analysis
Pro-Ficiency LLC
ORG-100042038
 Durham, United States Other
Cognizant Worldwide Limited
ORG-100042036
 London, United Kingdom Other
WCG Clinical Inc.
ORG-100040730
 Bala Cynwyd, United States Other
Infinity Biologix LLC
ORG-100040369
 Piscataway, United States Laboratory analysis
Inato
ORG-100044345
 Neuilly Sur Seine Cedex, France Other
Labcorp Early Development Laboratories Inc.
ORG-100012865
 Madison, United States Laboratory analysis
Labcorp Endpoint Clinical Inc.
ORG-100040567
 Wakefield, United States Interactive response technologies (IRT)
Signant Health Global LLC
ORG-100040604
 Blue Bell, United States Other

Locations

6 EU/EEA countries · 30 investigational sites

By country

CountryMS statusPlanned subjectsSites
Bulgaria Ended 40 6
Czechia Ended 39 5
Germany Ended 39 5
Hungary Ended 17 3
Poland Ended 77 8
Spain Ended 44 3
Rest of world
United States, Canada
 — 688 —

Investigational sites

Bulgaria

6 sites · Ended
Medical Center Medconsult Pleven OOD
N/A, Floor 4, Ulitsa Sveti Sveti Kiril I Metodiy 18, Pleven
Diagnostics-Consultancy Center Mladost M Varna OOD
N/A, Bulevard Republika 15, 9020, Varna
Ambulatory For Group Practice For Specialized Psychiatric Help Philipopolis Ltd.
N/A, Bulevard Vasil Aprilov 9, 4002, Plovdiv
Center For Mental Health Vratsa EOOD
Department of General Psychiatry, Belasita Str 1, 3000, Vratsa
Medical Center Saint Naum EOOD
N/A, Ulitsa D-R Lyuben Rusev 1, 1113, Sofiya
Higya–DCC OOD
N/A, Ulitsa Sveti Ivan Rilski 3, 4400, Pazardzhik

Czechia

5 sites · Ended
AGE Centrum s.r.o.
N/A, Na Sibeniku 914/1, 779 00, Olomouc
A-Shine s.r.o.
N/A, Sumavska 2, Vychodni Predmesti, Plzen 3
Clintrial s.r.o.
N/A, Pocernicka 1427/16, Strasnice, Prague 10
Brain-Soultherapy s.r.o.
N/A, K Nemocnici 1904, 272 01, Kladno
Narodni Ustav Dusevniho Zdravi
N/A, Topolova 748, 250 67, Klecany

Germany

5 sites · Ended
Velocity Clinical Research Germany GmbH
N/A, Hasengartenstrasse 42, 65189, Wiesbaden
Facharzt für Psychiatrie und Psychotherapie
N/A, Olof-Palme-Platz 4, 18439, Stralsund
Studienzentrum Nord-West
N/A, Kuhlenstraße 2, 26655, Westerstede
Pharmakologisches Studienzentrum Chemnitz GmbH
N/A, Carolastrasse 2, Zentrum, Chemnitz
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH
N/A, Goethestrasse 1, Feldstadt, Schwerin

Hungary

3 sites · Ended
Processus Kft.
N/A, Szent Istvan Krt 4 II 4, 1137, Budapest
Semmelweis University
Psychiatry and Psychotherapy, Balassa J Utca 6, 1083, Budapest
Clinexpert Kft.
N/A, Kaszasdulo Utca 5, 1033, Budapest III

Poland

8 sites · Ended
PCS Sp. z o.o.
N/A, Ul. Dluga 34, Lady, Raszyn
Indywidualna Specjalistyczna Praktyka Lekarska Agnieszka Remlinger-Molenda
N/A, Ul. Szkolkarska 32, 62-002, Suchy Las
Praktyka Lekarska Małgorzata Wojtanowska-Bogacka
N/A, ul. Barwicka 14 h/4, 60-192, Poznań
Centrum Medyczne Luxmed Sp. z o.o.
N/A, Ul. Krolewska 11, 20-109, Lublin
Osrodek Badan Klinicznych Clinsante S.C. Ewa Galczak-Nowak Malgorzata
N/A, Ul. Tytusa Chalubinskiego 6, 85-794, Bydgoszcz
MłynowaMed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Łazarczyk
N/A, Młynowa 38 lok 13U, 15-404, Białystok
E4r&D Sp. z o.o.
N/A, Ul. Aldony 2a/3, 80-438, Gdansk
Centrum Zdrowia Psychicznego BIOMED - Jan Latała
N/A, Szydłówek Górny 1c/3, 25-411, Kielce

Spain

3 sites · Ended
Complejo Asistencial De Zamora Hospital Provincial De Zamora
N/A, Calle De Hernan Cortes 40, 49020, Zamora
Hospital Clinic De Barcelona
N/A, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
N/A, Passeig De La Vall D Hebron 119-129, 08035, Barcelona

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Bulgaria 2023-03-30 2025-10-30 2023-03-30 2025-08-01
Czechia 2023-04-20 2025-11-05 2023-04-20 2025-08-01
Germany 2023-03-30 2025-10-27 2023-03-30 2025-08-01
Hungary 2023-10-12 2025-11-05 2023-10-12 2025-08-01
Poland 2023-04-13 2025-11-04 2023-04-13 2025-08-01
Spain 2023-12-15 2024-08-19 2023-12-15 2024-08-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 170 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) CZ_eScale_CSFQ_F_C_cs 1.192
Protocol (for publication) CZ_eScale_CSFQ_M_C_cs 1.192
Protocol (for publication) CZ_eScale_PGI_S_cs 1.164
Protocol (for publication) CZ_eScale_PSQI_cs 1.177
Protocol (for publication) CZ_eScale_SF_36_cs 1.164
Protocol (for publication) D1_Protocol 382-201-00001 Amendment 5_redacted 5.0
Protocol (for publication) D1_Protocol 382-201-00001 Blinded Addendum 3_redacted 3.0
Protocol (for publication) PL_eScale_CSFQ_F_C_pl 1.192
Protocol (for publication) PL_eScale_CSFQ_M_C_pl 1.192
Protocol (for publication) PL_eScale_PGI_S_pl 1.164
Protocol (for publication) PL_eScale_PSQI_pl 1.177
Protocol (for publication) PL_eScale_SF_36_pl 1.164
Recruitment arrangements (for publication) BG_Advocacy_Facebook_Post_bg_Redacted 1.0
Recruitment arrangements (for publication) BG_Advocacy_FAQ_Sheet_bg 1.0
Recruitment arrangements (for publication) BG_Advocacy_Member_Letter_bg 1.0
Recruitment arrangements (for publication) BG_Advocacy_Study_Fact_Sheet_bg 1.0
Recruitment arrangements (for publication) BG_Advocacy_Study_Letter_bg 1.0
Recruitment arrangements (for publication) BG_Advocacy_Study_Listing_Text_bg 1.0
Recruitment arrangements (for publication) BG_Advocacy_Twitter_Post_bg_Redacted 1.0
Recruitment arrangements (for publication) BG_Dr_to_Patient_Letter_bg 1.0
Recruitment arrangements (for publication) BG_Facebook_Post_bg_Redacted 1.0
Recruitment arrangements (for publication) BG_Flowchart_bg 1.0
Recruitment arrangements (for publication) BG_Participant_Resource_Guide_bg 1.0
Recruitment arrangements (for publication) BG_Patient_Brochure_bg 1.0
Recruitment arrangements (for publication) BG_Poster_bg 1.0
Recruitment arrangements (for publication) BG_Recruitment and Informed consent procedure template_bg N/A
Recruitment arrangements (for publication) BG_Retention_Items_Redacted 1.0
Recruitment arrangements (for publication) BG_Visit_Reminder_Card_bg 1.0
Recruitment arrangements (for publication) CZ_Advocacy_Facebook_Post_cs_Redacted 1.0
Recruitment arrangements (for publication) CZ_Advocacy_FAQ_Sheet_cs 1.0
Recruitment arrangements (for publication) CZ_Advocacy_Member_Letter_cs 1.0
Recruitment arrangements (for publication) CZ_Advocacy_Study_Fact_Sheet_cs 1.0
Recruitment arrangements (for publication) CZ_Advocacy_Study_Letter_cs 1.0
Recruitment arrangements (for publication) CZ_Advocacy_Study_Listing_Text_cs 1.0
Recruitment arrangements (for publication) CZ_Advocacy_Twitter_Post_cs_Redacted 1.0
Recruitment arrangements (for publication) CZ_CSFQ_F_cs N/A
Recruitment arrangements (for publication) CZ_CSFQ_M_cs N/A
Recruitment arrangements (for publication) CZ_Dr_to_Patient_Letter_cs 1.0
Recruitment arrangements (for publication) CZ_Facebook_Post_cs_Redacted 1.0
Recruitment arrangements (for publication) CZ_Flowchart_cs 1.0
Recruitment arrangements (for publication) CZ_Participant_Resource_Guide_cs 1.0
Recruitment arrangements (for publication) CZ_Patient_Brochure_cs 1.0
Recruitment arrangements (for publication) CZ_PGI_S_cs N/A
Recruitment arrangements (for publication) CZ_Poster_cs 1.0
Recruitment arrangements (for publication) CZ_PSQI_cs 1.2
Recruitment arrangements (for publication) CZ_Recruitment and Informed consent procedure template_cs 3.0
Recruitment arrangements (for publication) CZ_Retention_Items_Redacted 1.0
Recruitment arrangements (for publication) CZ_SF_36v2_Standard_Screen_Shot_Sample_cs 1.1
Recruitment arrangements (for publication) CZ_SF_36v2_Standard_Single_Item_cs 1.1
Recruitment arrangements (for publication) CZ_Visit_Reminder_Card_cs 1.0
Recruitment arrangements (for publication) DE_Advocacy_Facebook_Post_de_Redacted 1.0
Recruitment arrangements (for publication) DE_Advocacy_Twitter_Post_de_Redacted 1.0
Recruitment arrangements (for publication) DE_Facebook_Post_de_Redacted 1.0
Recruitment arrangements (for publication) DE_Recruitment and Informed consent procedure template N/A
Recruitment arrangements (for publication) DE_Retention_Items_Redacted 1.0
Recruitment arrangements (for publication) HU_Advocacy_FAQ_Sheet_hu 1.0
Recruitment arrangements (for publication) HU_Advocacy_Member_Letter_hu 1.0
Recruitment arrangements (for publication) HU_Advocacy_Study_Fact_Sheet_hu 1.0
Recruitment arrangements (for publication) HU_Advocacy_Study_Letter_hu 1.0
Recruitment arrangements (for publication) HU_Advocacy_Study_Listing_Text_hu 1.0
Recruitment arrangements (for publication) HU_Banner_Ad_1_hu 1.0
Recruitment arrangements (for publication) HU_Banner_Ad_2_hu 1.0
Recruitment arrangements (for publication) HU_Banner_Ad_3_hu 1.0
Recruitment arrangements (for publication) HU_Dr_to_Patient_Letter_Hungary_hu 1.0
Recruitment arrangements (for publication) HU_Flowchart_hu 1.0
Recruitment arrangements (for publication) HU_hu_List of sites N/A
Recruitment arrangements (for publication) HU_Participant_Resource_Guide_hu 1.0
Recruitment arrangements (for publication) HU_Patient_Brochure_Hungary_hu 1.0
Recruitment arrangements (for publication) HU_Poster_hu 1.0
Recruitment arrangements (for publication) HU_Recruitment and Informed consent procedure template N/A
Recruitment arrangements (for publication) HU_Retention_Items_Redacted 1.0
Recruitment arrangements (for publication) HU_Visit_Reminder_Card_hu 1.0
Recruitment arrangements (for publication) K1_BG_Banner Ad_bg 2.0
Recruitment arrangements (for publication) K1_CZ_AutoCruitment_Digital Materials_cs 6.0
Recruitment arrangements (for publication) K1_CZ_AutoCruitment_Phone Screen_cs 5.0
Recruitment arrangements (for publication) K1_CZ_Banner Ad_cs 2.0
Recruitment arrangements (for publication) K1_DE_AutoCruitment_Digital Materials_de 6.0
Recruitment arrangements (for publication) K1_DE_AutoCruitment_Phone Screen_de 5.0
Recruitment arrangements (for publication) K1_DE_Banner Ad_de 2.0
Recruitment arrangements (for publication) K1_PL_Banner Ad_pl 2.0
Recruitment arrangements (for publication) PL_Advocacy_Facebook_Post_pl_Redacted 1.0
Recruitment arrangements (for publication) PL_Advocacy_FAQ_Sheet_pl 1.0
Recruitment arrangements (for publication) PL_Advocacy_Member_Letter_pl 1.0
Recruitment arrangements (for publication) PL_Advocacy_Study_Fact_Sheet_pl 1.0
Recruitment arrangements (for publication) PL_Advocacy_Study_Letter_pl 1.0
Recruitment arrangements (for publication) PL_Advocacy_Study_Listing_Text_pl 1.0
Recruitment arrangements (for publication) PL_Advocacy_Twitter_Post_pl_Redacted 1.0
Recruitment arrangements (for publication) PL_CSFQ_F_pl N/A
Recruitment arrangements (for publication) PL_CSFQ_M_pl N/A
Recruitment arrangements (for publication) PL_Dr_to_Patient_Letter_pl 1.0
Recruitment arrangements (for publication) PL_Facebook_Post_pl_Redacted 1.0
Recruitment arrangements (for publication) PL_Flowchart_pl 1.0
Recruitment arrangements (for publication) PL_Participant_Resource_Guide_pl 1.0
Recruitment arrangements (for publication) PL_Patient_Brochure_pl 1.0
Recruitment arrangements (for publication) PL_PGI_S_pl N/A
Recruitment arrangements (for publication) PL_Poster_pl 1.0
Recruitment arrangements (for publication) PL_PSQI_pl 1.2
Recruitment arrangements (for publication) PL_Recruitment and Informed consent procedure template N/A
Recruitment arrangements (for publication) PL_Retention_Items_Redacted 1.0
Recruitment arrangements (for publication) PL_SF_36v2_Standard_Screen_Shot_Sample_pl 1.1
Recruitment arrangements (for publication) PL_SF_36v2_Standard_Single_Item_pl 1.1
Recruitment arrangements (for publication) PL_Visit_Reminder_Card_pl 1.0
Subject information and informed consent form (for publication) BG_eConsent Screenshots_FBR ICF_bg 1.0
Subject information and informed consent form (for publication) BG_eConsent Screenshots_Main ICF_bg 1.0
Subject information and informed consent form (for publication) BG_Emergency Card 1.1.0
Subject information and informed consent form (for publication) BG_Emergency Card_bg 1.1.0
Subject information and informed consent form (for publication) BG_ICF_Main_redlined 2.1.0
Subject information and informed consent form (for publication) BG_ICF_Main_redlined_bg 2.1.0
Subject information and informed consent form (for publication) BG_ICF_Optional_FBR 2.1.0
Subject information and informed consent form (for publication) BG_ICF_Optional_FBR_bg 2.1.0
Subject information and informed consent form (for publication) BG_ICF_Optional_FBR_redlined 2.1.0
Subject information and informed consent form (for publication) BG_ICF_Optional_FBR_redlined_bg 2.1.0
Subject information and informed consent form (for publication) BG_ICF_Pregnant Participant Partner_bg 1.1.0
Subject information and informed consent form (for publication) CZ_cs_ICF_Optional FBR 2.3.0
Subject information and informed consent form (for publication) CZ_cs_ICF_Optional FBR_highlighted for ongoing patients 2.3.0
Subject information and informed consent form (for publication) CZ_cs_ICF_Pregnant_Partner 2.3.0
Subject information and informed consent form (for publication) CZ_cs_ICF_Pregnant_Partner_highlighted for ongoing patients 2.3.0
Subject information and informed consent form (for publication) CZ_cs_ICF_Pregnant_Partner_Privacy notice 2.3.0
Subject information and informed consent form (for publication) CZ_cs_ICF_Pregnant_Partner_Privacy notice_highlighted ongoing pt 2.3.0
Subject information and informed consent form (for publication) CZ_Dear_Investigator_Letter 1.0
Subject information and informed consent form (for publication) CZ_eConsent Screenshots_FBR ICF_cs 1.0
Subject information and informed consent form (for publication) CZ_eConsent Screenshots_Main ICF_cs 1.0
Subject information and informed consent form (for publication) CZ_Emergency Card_cs 1.1.0
Subject information and informed consent form (for publication) CZ_ICF_Main_ redline_cs 2.1.0
Subject information and informed consent form (for publication) CZ_ICF_Main_Privacy_Notice_redlined_cs 2.1.0
Subject information and informed consent form (for publication) CZ_ICF_Optional FBR_redlined_cs 2.1.0
Subject information and informed consent form (for publication) CZ_ICF_Pregnant_Partner_Privacy notice_redlined_cs 2.1.0
Subject information and informed consent form (for publication) CZ_ICF_Pregnant_Partner_redlined_cs 2.1.0
Subject information and informed consent form (for publication) DE_de_Pregnancy ICF 1.2.0
Subject information and informed consent form (for publication) DE_eConsent Screenshots_FBR ICF_de 1.0
Subject information and informed consent form (for publication) DE_eConsent Screenshots_Main ICF_de 1.0
Subject information and informed consent form (for publication) DE_Emergency Card_de 1.1.0
Subject information and informed consent form (for publication) DE_ICF_Main_redlined_de 2.1.0
Subject information and informed consent form (for publication) DE_ICF_Optional_FBR_redlined_de 2.1.0
Subject information and informed consent form (for publication) HU_eConsent Screenshots_FBR ICF_hu 1.0
Subject information and informed consent form (for publication) HU_eConsent Screenshots_Main ICF_hu 1.0
Subject information and informed consent form (for publication) HU_Emergency Card_hu 1.1.0
Subject information and informed consent form (for publication) HU_hu_Optional FBR ICF 2.2.0
Subject information and informed consent form (for publication) HU_hu_Optional FBR PIS 2.2.0
Subject information and informed consent form (for publication) HU_ICF_Main_ redlined_hu 2.1.0
Subject information and informed consent form (for publication) HU_ICF_Optional_FBR_redlined_hu 2.1.0
Subject information and informed consent form (for publication) HU_ICF_PGx_hu 2.1.0
Subject information and informed consent form (for publication) HU_ICF_PGx_redlined_hu 2.1.0
Subject information and informed consent form (for publication) HU_ICF_Pregnant Participant Partner_hu 1.1.0
Subject information and informed consent form (for publication) HU_PIS_Optional_FBR_redlined_hu 2.1.0
Subject information and informed consent form (for publication) HU_PIS_PGx_hu 2.1.0
Subject information and informed consent form (for publication) HU_PIS_PGx_redlined_hu 2.1.0
Subject information and informed consent form (for publication) ICF_Main 3.0
Subject information and informed consent form (for publication) L1_BG_ICF_Main 7.1.0
Subject information and informed consent form (for publication) L1_BG_ICF_Main_bg_redacted 8.1.0
Subject information and informed consent form (for publication) L1_CZ_ICF_Main_cs 8.1.0
Subject information and informed consent form (for publication) L1_CZ_ICF_Main_for ongoing patients_cs 8.1.0
Subject information and informed consent form (for publication) L1_CZ_ICF_Privacy notice_cs 4.1.0
Subject information and informed consent form (for publication) L1_CZ_ICF_Privacy notice_ongoing patients_cs 4.1.0
Subject information and informed consent form (for publication) L1_DE_ICF_Main_de_redacted V8.1.0
Subject information and informed consent form (for publication) L1_DE_ICF_Optional FBR_de 2.3.0
Subject information and informed consent form (for publication) L1_HU_ICF_Main_hu_redacted 8.2.0
Subject information and informed consent form (for publication) L1_PL_ICF_Main_pl 8.1.0
Subject information and informed consent form (for publication) PL_eConsent Screenshots_FBR ICF_pl 1.0
Subject information and informed consent form (for publication) PL_eConsent Screenshots_Main ICF_pl 1.0
Subject information and informed consent form (for publication) PL_Emergency Card_pl 1.1.0
Subject information and informed consent form (for publication) PL_ICF_Main_redlined_pl 2.1.0
Subject information and informed consent form (for publication) PL_ICF_Optional_FBR_pl 2.1.0
Subject information and informed consent form (for publication) PL_ICF_Optional_FBR_redlined_pl 2.1.0
Subject information and informed consent form (for publication) PL_ICF_Pregnant Participant Partner_pl 1.1.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis 382-201-00001 Amendment 5_Redacted 5.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis 382-201-00001_bg_Amendment 5_Redacted 5.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis 382-201-00001_cs_Amendment 5_Redacted 5.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis 382-201-00001_hu_Amendment 5_Redacted 5.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis 382-201-00001_pl_Amendment 5_Redacted 5.0

Application history

15 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-10-17 Poland Acceptable
2023-02-20
 2023-02-22
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-02-28 Acceptable
2023-02-20
 2023-02-28
3 SUBSTANTIAL MODIFICATION SM-1 2023-03-21 Poland Acceptable
2023-06-26
 2023-06-27
4 SUBSTANTIAL MODIFICATION SM-2 2023-07-07 Acceptable 2023-08-11
5 NON SUBSTANTIAL MODIFICATION NSM-2 2023-08-22 Poland Acceptable 2023-08-22
6 NON SUBSTANTIAL MODIFICATION NSM-3 2023-08-28 Poland Acceptable 2023-08-28
7 SUBSTANTIAL MODIFICATION SM-5 2023-09-15 Poland Acceptable
2023-12-18
 2023-12-19
8 SUBSTANTIAL MODIFICATION SM-7 2024-03-28 Poland Acceptable
2024-07-08
 2024-07-09
9 NON SUBSTANTIAL MODIFICATION NSM-5 2024-08-01 Poland Acceptable
2024-07-08
 2024-08-01
10 SUBSTANTIAL MODIFICATION SM-8 2024-08-16 Acceptable 2024-09-30
11 NON SUBSTANTIAL MODIFICATION NSM-6 2024-10-01 Poland Acceptable 2024-10-01
12 NON SUBSTANTIAL MODIFICATION NSM-7 2024-10-29 Poland Acceptable 2024-10-29
13 SUBSTANTIAL MODIFICATION SM-10 2024-12-06 Poland Acceptable
2025-02-24
 2025-02-25
14 SUBSTANTIAL MODIFICATION SM-11 2025-05-08 Poland Acceptable with conditions
2025-07-28
 2025-07-29
15 SUBSTANTIAL MODIFICATION SM-12 2025-09-10 Poland Acceptable
2025-11-07
 2025-11-10