Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
450
Countries
10
Sites
38
Episodic Migraine
To evaluate the safety and efficacy of two doses of atogepant (low and high) when administered daily for the treatment of episodic migraine in pediatric participants 6 to 17 years of age.
Key facts
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 8 Nov 2023 → ongoing
- Decision date (initial)
- 2023-07-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2022-501100-94-00
- ClinicalTrials.gov
- NCT05711394
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacokinetic
To evaluate the safety and efficacy of two doses of atogepant (low and high) when administered daily for the treatment of episodic migraine in pediatric participants 6 to 17 years of age.
Secondary objectives 1
- The secondary efficacy objective of the study is to demonstrate improvement in efficacy for treatment with atogepant when compared to placebo with respect to the secondary endpoints.
Conditions and MedDRA coding
Episodic Migraine
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | LLT | 10082019 | Episodic migraine | 10029205 |
| 20.0 | PT | 10027607 | Migraine with aura | 100000004852 |
| 20.0 | PT | 10052787 | Migraine without aura | 100000004852 |
Study design 4 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening/Baseline Period A 4-week migraine assessment period prior to initial study drug administration.
|
Not Applicable | None | Screening/Baseline Period: A 4-week migraine assessment period prior to initial study drug administration. | |
| 2 | Open-label Pharmacokinetic SubStudy A 2-day open label treatment period where eligible subjects will be administered an open-label single dose of atogepant (dose A or B in 2 sequential cohorts) followed by serial blood sample collection.
|
2 | None | Atogepant Dose A (6-11 yrs): Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period. Atogepant Dose B (6-11 yrs): Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period. |
|
| 3 | Double-Blind Treatment Period A 12-week double-blind treatment period where subjects will be randomized in a 1:1:1 ratio to receive placebo, low-dose atogepant or high-dose atogepant
|
Randomised Controlled | Double | [{"id":175041,"code":4,"name":"Analyst"},{"id":175044,"code":2,"name":"Investigator"},{"id":175043,"code":1,"name":"Subject"},{"id":175045,"code":3,"name":"Monitor"},{"id":175042,"code":5,"name":"Carer"}] | High Dose Atogepant (12-17 yrs): Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks Placebo (12-17 yrs): Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks. Low Dose Atogepant (12-17 yrs): Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks. High Dose Atogepant (6-11 yrs): Participants aged 6 to 11 will receive oral tablets of high dose atogepant once a day for 12 weeks Placebo (6-11 yrs): Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks. Low Dose Atogepant (6-11 yrs): Participants aged 6 to 11 will receive oral tablets of low dose atogepant once a day for 12 weeks. |
| 4 | Follow-Up Period A safety follow-up period of 4 weeks following the last study drug administration
|
Not Applicable | None | Follow-up Period: A safety follow-up period of 4 weeks following the last study drug administration |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- EMA paediatric investigation plan (PIP)
- EMEA-002530-PIP01-18
- Plan to share IPD
- Yes
- IPD plan description
- AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
- History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
- Participant has to have 4 to 14 migraine days and < 15 headache days in the last 28-day baseline period per eDiary.
- To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine and per investigator judgment is appropriate to receive preventive treatment for migraine.
Exclusion criteria 3
- History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
- Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
- Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in mean monthly migraine days across the 12-week treatment period.
Secondary endpoints 6
- Change from baseline in mean monthly headache days across the 12-week treatment period.
- Change from baseline in mean monthly acute medication use days across the 12-week treatment period.
- Achievement of at least a 50% reduction in 3-month average of monthly migraine days.
- Change from baseline in the PedsQL total score at Week 12.
- Change from baseline in the PedMIDAS total score at Week 12.
- Change from baseline in mean monthly headache days of at least moderate severity across the 12-week treatment period.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10064866 · Product
- Active substance
- Atogepant
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALLERGAN SALES, LLC (A SUBSIDIARY OF ABBVIE INC.)
- Paediatric formulation
- No
- Orphan designation
- No
PRD9649619 · Product
- Active substance
- Atogepant
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALLERGAN SALES, LLC (A SUBSIDIARY OF ABBVIE INC.)
- Paediatric formulation
- No
- Orphan designation
- No
PRD9649618 · Product
- Active substance
- Atogepant
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ALLERGAN SALES, LLC (A SUBSIDIARY OF ABBVIE INC.)
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
Placebo for Atogepant tablets 60mg
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
Placebo for Atogepant tablets 10mg
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Abbvie Deutschland GmbH & Co. KG
- Sponsor organisation
- Abbvie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- Abbvie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| eResearchTechnology GmbH ORG-100044103
|
Estenfeld, Germany | Other |
| Syneos Health Inc. ORG-100008382
|
Raleigh, United States | Other |
| Signant Health Inc. ORG-100040732
|
Blue Bell, United States | Other, E-data capture |
| Abbvie Bioresearch Center Inc. ORG-100011500
|
North Chicago, United States | Other |
| Labcorp Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| Labcorp Central Laboratory Services S.a.r.l. Meyrin ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Cytel Inc. ORG-100042560
|
Waltham, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
10 EU/EEA countries · 38 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 8 | 2 |
| Denmark | Ongoing, recruiting | 12 | 3 |
| France | Ongoing, recruiting | 8 | 3 |
| Hungary | Ongoing, recruiting | 30 | 6 |
| Italy | Ongoing, recruiting | 10 | 3 |
| Netherlands | Ongoing, recruiting | 15 | 4 |
| Poland | Ongoing, recruiting | 50 | 6 |
| Romania | Ended | 10 | 4 |
| Spain | Ongoing, recruiting | 10 | 5 |
| Sweden | Ongoing, recruiting | 10 | 2 |
| Rest of world
Puerto Rico, Japan, United Kingdom, Canada, United States, Israel
|
— | 287 | — |
Investigational sites
Antwerp University Hospital
Pediatric Neurology, Drie Eikenstraat 655, 2650, Edegem
Az St-Jan Brugge-Oostende A.V.
Paediatrics - paediatrics neurology, Ruddershove 10, 8000, Brugge
Regionshospitalet Godstrup
Born og Unge, Hospitalsparken 15, 7400, Herning
Herlev Hospital
Pediatric Department, Borgmester Ib Juuls Vej 1, 2730, Herlev
Aalborg University Hospital
Department of Pediatric and Adolescent, Reberbansgade 15, 9000, Aalborg
Centre Hospitalier Intercommunal Creteil
Consultation pediatrique, 40 Avenue De Verdun, 94000, Creteil
Centre Hospitalier Universitaire Amiens Picardie
Service de Neurologie pediatrique, 1 Rond Point Du Professeur Christian Cabrol, 80054, Amiens
Centre Hospitalier Universitaire De Toulouse
Pédiatrie - Centre de ressource douleur soins palliatifs pédiatriques, 2 Rue Viguerie, 31300, Toulouse
Semmelweis University
Gyermekgyogyaszati Klinika Bokay utcai Reszleg, Bokay Janos Utca 53, 1083, Budapest VIII
S-Medicon Kft.
Neurologia, Madarasz Viktor utca 47-49, 1138, Budapest
Magyarorszagi Reformatus Egyhaz Bethesda Gyermekkorhaza
Gyermekneurlologiai Osztaly, Bethesda Utca 3, 1146, Budapest Xiv
Semmelweis University
Gyermekgyogyaszati Klinika Tuzolto utcai Reszleg, Tuzolto Utca 7-9, 1094, Budapest
MIND Klinika Kft.
not applicable, Lovohaz Utca 39, Kerulet, Budapest II
Clinexpert Kft.
Clinexpert Obuda Egeszegcentruma, Kaszasdulo Utca 5, 1033, Budapest III
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UOSD Neurofisiopatologia, Via Del Vespro 129, 90127, Palermo
The Foundation Of The Carlo Besta Neurological Institute IRCCS
Headache Center Neuroalgology, Via Giovanni Celoria 11, 20133, Milan
Bambino Gesu Childrens Hospital
Neuroscienze, Piazza Sant'onofrio 4, 00165, Rome
Canisius Wilhelmina Hospital
Neurologie, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
ZorgSaam Ziekenhuis
Neurologie, Wielingenlaan 2, 4535 PA, Terneuzen
Neurologie Centrum Amsterdam
Neurologie, Dintelstraat 60, 1078 VV, Amsterdam
Haga Hospital
Juliana Kinderziekenhuis, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Athleticomed Sp. z o.o.
NA, Ul. Fordonska 144, 85-752, Bydgoszcz
MIGRE Polskie Centrum Leczenia Migreny
NA, ul. Lubinowa 12/7, 52-210, Wroclaw
Clinical Research Center Sp. z o.o. Medic-R sp.k.
NA, Ul. Feliksa Nowowiejskiego 5, 61-731, Poznan
Indywidualna Specjalistyczna Praktyka Lekarska
NA, ul. Onyksowa 12 Lubelskie, 20-582, Lublin
OHA-Med Sp. z o.o.
NA, Lok 5u-80, Ul. Wolnosc 2, Warsaw
Specjalistyczne Gabinety Sp. z o.o.
NA, Pl. Lasoty 4, 30-539, Cracow
Delta Health Care S.R.L.
Pediatric Neurology Department, Str Nicolae Caramfil Nr 85a Sector 1, 014146, Bucharest
Spitalul Clinic de Psihiatrie “Dr. Gheorghe Preda” Sibiu
Paediatric Neurology Department, Str. Dr. D. Bagdasar nr. 12, 550082, Sibiu
Spitalul Clinic de Urgenta pentru Copii Cluj Napoca
Pediatric Neurology, Str. Victor Babes nr. 43, 400012, Cluj Napoca
Spitalul Clinic de Copii “Dr. Victor Gomoiu”
Pediatric Neurology, Bulevardul Basarabia nr. 21, 022102, Bucuresti
Hospital Clinico San Carlos
Pediatric Department, Calle Del Profesor Martin Lagos S/n, 28040, Madrid
University Hospital Virgen Del Rocio S.L.
Department of Neurology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Y Politecnico La Fe
Neurology Department, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario 12 De Octubre
Paediactric Neurology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitari Vall D Hebron
Neurology Department, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Vastra Gotalandsregionen
Molnlycke Pediatric Clinic, Regionens Hus, 462 80, Vänersborg
Soedersjukhuset AB
Sach's Children and Youth Hospital, Sjukhusbacken 10, 118 83, STOCKHOLM
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 |
|---|---|---|---|---|---|
| Belgium | 2024-02-27 | 2024-05-27 | |||
| Denmark | 2023-12-18 | 2024-02-05 | |||
| France | 2023-12-06 | 2024-01-22 | |||
| Hungary | 2023-11-13 | 2023-11-20 | |||
| Italy | 2024-01-09 | 2024-05-07 | |||
| Netherlands | 2023-11-16 | 2023-12-07 | |||
| Poland | 2023-11-28 | 2023-12-12 | |||
| Romania | 2024-02-19 | ||||
| Spain | 2023-11-13 | 2023-12-04 | |||
| Sweden | 2023-11-08 | 2023-11-29 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-16417
- Halt date
- 2024-02-26
- Member states concerned
- Hungary
- Publication date
- 2024-03-08
- Reason
- Sponsor decision
- Explanation
- In order to conduct the M21-201 study full subject date of birth collection is required, and Hungary has stricter regulations on this matter. Temporary Screening Halt applied in the country until we receive guidance and approval from authorities on the collection of full date of birth.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Corrective measures 2 · Art. 77 CTR
Corrective measure CM-HU-0001
- Member state
- Hungary
- Publication date
- 2024-07-12
- Type
- 4
- Reason
- 5
- Immediate action required
- No
- Justification
- associated notification: ad hoc assessment FR-0000000010; Justification: New identified risk
Corrective measure CM-IT-0001
- Member state
- Italy
- Publication date
- 2025-07-09
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-07-09
- Immediate action required
- Yes
- Notes
- Reverted (2025-07-09)
- Justification
- Dear Applicant,
It was ascertained that the CET (Ethic Committee) due to technical issue/ did not assess / have full visibility of/ the documentation submitted for the SM-2 EU CT 2022-501100-94-00 procedure (AIFA authorization provision n° 0082024-25/06/2025-AIFA-AIFA_USC-P).
Therefore, in compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 155 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_m21201-protocol-adminchange-redacted | 2 |
| Protocol (for publication) | D1_m21201-protocol-redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents-PedMIDAS-allMS-public | 1 |
| Protocol (for publication) | D4_Patient facing documents-PedsQL Core Parent-Proxy Children 8-12-allMS-public | 1 |
| Protocol (for publication) | D4_Patient facing documents-PedsQL Core Parent-Proxy Young Children 5-7-allMS-public | 1 |
| Protocol (for publication) | D4_Patient facing documents-PedsQL Core Self Report Teens 13-18-allMS-public | 1 |
| Protocol (for publication) | D4_Patient facing documents-Today Headache Diary Adolescent 12-17-allMS-public | 7.0 |
| Protocol (for publication) | D4_Patient facing documents-Today Headache Diary Pediatric 6-11-allMS-public | 4.0 |
| Protocol (for publication) | D4_Patient facing documents-Yesterday Headache Diary Adolescent 12-17-allMS-public | 7.0 |
| Protocol (for publication) | D4_Patient facing documents-Yesterday Headache Diary Pediatric 6-11-allMS-public | 6.0 |
| Recruitment arrangements (for publication) | K1_M21-201 BE Recruitment and ICF Procedures_public | 2 |
| Recruitment arrangements (for publication) | K1_M21-201 FR Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M21-201 IT Recruitment and ICF Procedures clean_public | 3.0 |
| Recruitment arrangements (for publication) | K1_M21-201 NL Recruitment and ICF procedure_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M21-201 PL Recruitment and ICF Procedures_Public | 1 |
| Recruitment arrangements (for publication) | K1_M21-201 SE Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M21-201_DK-Recruitment and ICF Procedures_public | 3 |
| Recruitment arrangements (for publication) | K1_M21-201_ES_GP to GP Letter_Public | 5 |
| Recruitment arrangements (for publication) | K1_M21-201_ES_Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M21-201_HU_Recruitment and ICF Procedures_clean_Public | 2.0 |
| Recruitment arrangements (for publication) | K1_M21-201_RO_Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M21-201 BE Participant Letters GP to Parent Dutch_public | 4 |
| Recruitment arrangements (for publication) | K2_M21-201 BE Participant Letters GP to Parent English_public | 4 |
| Recruitment arrangements (for publication) | K2_M21-201 BE Participant Letters GP to Parent French_public | 4 |
| Recruitment arrangements (for publication) | K2_M21-201 IT Dr to Patient Letter clean_public | 4.0 |
| Recruitment arrangements (for publication) | K2_M21-201 Participants Letters GP to Parent_Public | 4.0 |
| Recruitment arrangements (for publication) | K2_M21-201 PL Participant Letters GP to Parent_Public | 2 |
| Recruitment arrangements (for publication) | K2_M21-201 SE Recruitment Material _Public | 1 |
| Recruitment arrangements (for publication) | K2_M21-201_DK- Participant Letters GP to Parent_public | 3 |
| Recruitment arrangements (for publication) | K2_M21-201_ES_GP to Patient letter_Public | 4.0 |
| Recruitment arrangements (for publication) | K2_M21-201_FR Participants Letters GP to Patient Letter V2_Public | 2 |
| Recruitment arrangements (for publication) | K2_M21-201_HU_GP to Parent or Guardian Letter_Clean_Public | 4.0 |
| Recruitment arrangements (for publication) | K2_M21-201_RO_Dr to Dr Letter_public | 4 |
| Recruitment arrangements (for publication) | K2_M21-201_RO_Dr to Patient Letter_public | 4 |
| Recruitment arrangements (for publication) | K2_M21-201-SE Participant Letters GP to Parent_Public | 2 |
| Recruitment arrangements (for publication) | M21-201_BE-Recruitment letters GP to GP Dutch_public | 1 |
| Recruitment arrangements (for publication) | M21-201_BE-Recruitment letters GP to GP English_public | 2 |
| Recruitment arrangements (for publication) | M21-201_BE-Recruitment letters GP to GP French_public | 1 |
| Recruitment arrangements (for publication) | M21-201_DK-Recruitment letters GP to GP English_public | 2 |
| Recruitment arrangements (for publication) | M21-201_FR-Participants Letters GP to GP Letter_public | 1 |
| Recruitment arrangements (for publication) | M21-201_HU-Recruitment letters GP to GP_public | 2 |
| Recruitment arrangements (for publication) | M21-201_IT-Participant Letters GP to GP_English_public | 2 |
| Recruitment arrangements (for publication) | M21-201_PL-Participant Letter_GP to GP_public | 1 |
| Subject information and informed consent form (for publication) | L1 M21-201 SE ICF Assent 12-17_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 M21-201 SE ICF Parent-Guardian_Public_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE Assent PK Sub-Study 6-11y Dutch Public | 4 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE Assent PK Sub-Study 6-11y English Public | 4 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE Assent PK Sub-Study 6-11y French Public | 4 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE Child Assent Form Age 12-17 Dutch Public_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE Child Assent Form Age 12-17 English Public_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE Child Assent Form Age 12-17 French Public_redacted | 6 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE Main ICF Parent and 18 plus Dutch Public_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE Main ICF Parent and 18 plus English Public_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE Main ICF Parent and 18 plus French Public_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE PK Sub-study Parent ICF Dutch Public_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE PK Sub-study Parent ICF English Public_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_M21-201 BE PK Sub-study Parent ICF French Public_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_M21-201 FR ICF Assent 12-17_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 FR ICF Main_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 FR ICF Parent_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 HU_Main PIS_ICF_over 18ys_clean_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 NL ICF Optional 16 plus_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 NL ICF Optional Assent 12-15_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 NL ICF Optional Parents_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201 PL ICF Main Assent 13-17_Public | 6 |
| Subject information and informed consent form (for publication) | L1_M21-201 PL ICF Main_Public redacted | 6 |
| Subject information and informed consent form (for publication) | L1_M21-201 PL ICF Optional Assent 13-17_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M21-201 PL ICF Optional_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M21-201 PL ICF Parents Main_Public redatced | 6 |
| Subject information and informed consent form (for publication) | L1_M21-201 PL ICF Parents Optional_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M21-201 PL ICF Pregnancy_Public | 3 |
| Subject information and informed consent form (for publication) | L1_M21-201_DK- ICF Assent 15-17_public_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_M21-201_DK-ICF Assent 12-14_public | 4 |
| Subject information and informed consent form (for publication) | L1_M21-201_DK-ICF Main Parent and 18 plus_public_redacted | 4 |
| Subject information and informed consent form (for publication) | L1_M21-201_DK-ICF Optional Parent and 18 plus_public | 2 |
| Subject information and informed consent form (for publication) | L1_M21-201_ES_ICF 12-17yrs optional parents_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_ES_ICF assent 12-17 yrs_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_ES_ICF main_parents_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_ES_ICF main_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_ES_ICF optional_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_ES_ICF PK 6-11yrs optional parents_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_List of submitted ICFs_clean_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Main PIS_Assent_12-17ys_clean_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Main PIS_ICF_Parent_clean_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Optional PGenetic Assent_12-17ys_clean_Public Only | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Optional PGenetic ICF_over 18_clean_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Optional PGenetic ICF_Parent_clean_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Optional PGenetic PIS_12-17ys_clean_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Optional PGenetic PIS_Parent_clean_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Optional PGenetic_PIS_over 18_clean_Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Optional PK Substudy_PIS_ICF_Assent_6-11ys_clean_Public redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_HU_Optional PK Substudy_PIS_ICF_Parent_clean_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_IT_Assent 12-17 clean_public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_IT_Assent Optional Research 6-11 yo clean_public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_IT_ICF for pregnancy_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_IT_Optional ParentGuardian clean_public redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_IT_ParentGuardian ICF clean_public redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_NL_ICF Main 16 plus_Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_M21-201_NL_ICF Main Assent 12-15_Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_M21-201_NL_ICF Main Parents_Public | 4.1 |
| Subject information and informed consent form (for publication) | L1_M21-201_NL_ICF PK Substudy Assent 6-11_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_NL_ICF PK Substudy Parents_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_NL_ICF Pregnant Subject_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_RO_ICF Assent 12-17_public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_RO_ICF Assent 12-17_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_RO_ICF Combined Parent and 18 plus_public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_RO_ICF Combined Parent and 18 plus_public | 2 |
| Subject information and informed consent form (for publication) | L1_M21-201_RO_ICF Optional PK Assent 6-11_public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_RO_ICF Optional PK Assent 6-11_public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M21-201_RO-ICF Assent 6-11_public | 1 |
| Subject information and informed consent form (for publication) | L1_M21-201_RO-ICF Optional PK Parent_public | 2.0 |
| Subject information and informed consent form (for publication) | M21-201 BE Child Assent Form Age 6-11 Dutch_public | 2 |
| Subject information and informed consent form (for publication) | M21-201 BE Child Assent Form Age 6-11 English_public | 2 |
| Subject information and informed consent form (for publication) | M21-201 BE Child Assent Form Age 6-11 French_public | 2 |
| Subject information and informed consent form (for publication) | M21-201 BE ICF Optional Parent and 18 plus Dutch_public_Redacted | 1 |
| Subject information and informed consent form (for publication) | M21-201_BE-ICF Optional Parent and 18 plus English_public_Redacted | 1 |
| Subject information and informed consent form (for publication) | M21-201_BE-ICF Optional Parent and 18 plus French_public_Redacted | 1 |
| Subject information and informed consent form (for publication) | M21-201_BE-ICF Pregnant Partner Dutch_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_BE-ICF Pregnant Partner English_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_BE-ICF Pregnant Partner French_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_DK- ICF DTP IP and Supplies_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_DK-EC required for subject participating in clinical trial_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_DK-ICF Assent 6-11_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_DK-ICF Pregnant Partner_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_DK-Other Information Given to Subjects_Danish__public | 1 |
| Subject information and informed consent form (for publication) | M21-201_DK-POA Main and Optional 18 plus_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_DK-POA Main and Optional Parent_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_DK-POA Parent to Parent_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_ES-ICF Optional PK Parent_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_ES-ICF Pregnant Partner_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_FR-ICF Assent 6-11_public | 1.1 |
| Subject information and informed consent form (for publication) | M21-201_FR-ICF PregPart_public | 1.1 |
| Subject information and informed consent form (for publication) | M21-201_HU-Description of submitted ICFs_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_HU-ICF Assent 6-11_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_HU-ICF Optional PharmacoGenetic Assent 6-11_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_HU-ICF Pregnant Partner_public | 1.1 |
| Subject information and informed consent form (for publication) | M21-201_HU-PIS Optional PharmacoGenetic Assent 6-11_public_Redacted | 1 |
| Subject information and informed consent form (for publication) | M21-201_HU-Subject Participation Card_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_IT-ICF Assent 6-11_public | 2 |
| Subject information and informed consent form (for publication) | M21-201_NL-ICF Assent Main children under 12_public | 1.2 |
| Subject information and informed consent form (for publication) | M21-201_PL-ICF Assent under 13 years_public | 2 |
| Subject information and informed consent form (for publication) | M21-201_RO-ICF Pregnant Partner_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_SE_ICF PregPart_public | 1 |
| Subject information and informed consent form (for publication) | M21-201_SE-ICF Assent Swedish 6-11_public | 1 |
| Synopsis of the protocol (for publication) | D_m21201-euctr-synopsis-de-be | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-en-en | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-es-es | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-fr-be | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-fr-fr | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-hu-hu | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-it-it | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-nl-be | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-nl-nl | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-pl-pl | 1 |
| Synopsis of the protocol (for publication) | D1_m21201-euctr-synopsis-sv-se | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-03 | Hungary | Acceptable with conditions 2023-07-31
|
2023-07-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-22 | Acceptable with conditions 2023-07-31
|
2023-08-22 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-26 | Hungary | Acceptable 2024-09-23
|
2024-09-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-04 | Hungary | Acceptable 2025-06-23
|
2025-06-23 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-31 | Hungary | Acceptable 2026-01-06
|
2026-01-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-01 | Hungary | Acceptable 2026-05-11
|
2026-05-12 |