Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,338
Countries
7
Sites
32
Migraine
The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 9 Nov 2020 → 12 Nov 2025
- Decision date (initial)
- 2024-04-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506253-38-00
- EudraCT number
- 2019-004378-24
- ClinicalTrials.gov
- NCT04396236
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The reason for this study is to see if lasmiditan is safe and effective in
children aged 6 to 17 with migraine. The study will last up to 20 weeks and
may include up to 4 visits
Conditions and MedDRA coding
Migraine
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002166-PIP01-17
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-506724-85-00 | H8H-MC-LAHW: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine - PIONEER-PEDS2 | Eli Lilly & Co. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Participants must have a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria: o History of migraine attacks for more than 6 months o Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit o Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours o Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
- Participant must be able to swallow a tablet
- For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
- Participants must weigh at least 15 kilograms (kg)
Exclusion criteria 3
- Participants must not be pregnant or nursing
- Participants must not have any acute, serious, or unstable medical condition
- Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of Participants with Pain Freedom (High Dose)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
SUB187183 · Substance
- Active substance
- Lasmiditan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The description on the product packaging and the packaging sites differ from the marketed product, and it also has a different shelf life (60 months) from the marketed product (EMA product number EMEA/H/C/005332)
SUB187183 · Substance
- Active substance
- Lasmiditan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The description on the product packaging and the packaging sites differ from the marketed product, and it also has a different shelf life (60 months) from the marketed product (EMA product number EMEA/H/C/005332)
PRD7107698 · Product
- Active substance
- Lasmiditan
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
PRD10493447 · Product
- Active substance
- Lasmiditan
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107697 · Product
- Active substance
- Lasmiditan
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 5
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
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
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 to match 100mg film coated tablet
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 to match 50mg film coated tablet
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
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Yprime LLC ORG-100042888
|
Malvern, United States | Data management |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Other |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Rebar Interactive LLC ORG-100045545
|
Austin, United States | Other |
| Cogstate Inc. ORG-100045256
|
New Haven, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
Locations
7 EU/EEA countries · 32 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 14 | 3 |
| France | Ended | 10 | 5 |
| Germany | Ended | 20 | 3 |
| Italy | Ended | 32 | 6 |
| Netherlands | Ended | 12 | 2 |
| Romania | Ended | 31 | 3 |
| Spain | Ended | 86 | 10 |
| Rest of world
United States, Canada, Mexico, United Kingdom, Russian Federation, India, Japan
|
— | 1,133 | — |
Investigational sites
Universitair Ziekenhuis Gent
Paediatric Neurology, Corneel Heymanslaan 10, 9000, Gent
UZ Brussel
Paediatric Neurology, Laarbeeklaan 101, 1090, Jette
Ziekenhuis Oost Limburg
Kinderneurologie, Synaps Park 1, 3600, Genk
Trousseau Hospital
Centre de la douleur et de la migraine, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
Centre Hospitalier Intercommunal Creteil
Pédiatrie, 40 Avenue De Verdun, 94000, Creteil
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
Pedriatrie, Avenue Pierre De Coubertin, Bp 417, Mont-De-Marsan Cedex
University Hospital Of Clermont-Ferrand
Pédiatrie neurologie, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Universitaire Amiens Picardie
Pédiatrie neurologie, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
N/A, Lindenallee 3, Dornholzhausen, Bad Homburg
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
N/A, Alexandrinenstraße 5, Nordrhein-Westfalen, Bochum
Medical Center - University Of Freiburg
Zentrum für Kinder- und Jugendmedizin, Klinik für Neuropädiatrie und Muskelerkrankungen, Mathildenstrasse 1, Stuehlinger, Freiburg Im Breisgau
Neurological Institute Foundation Casimiro Mondino
Child Neurology and Psychiatry, Via Casimiro Mondino 2, 27100, Pavia
Azienda Sanitaria Locale Della Provincia Di Bari
Centro Epilessia ed EEG dell'età evolutiva, Via Caposcardicchio Sn, 70132, Bari
Bambino Gesu Childrens Hospital
Neuroscience, Piazza Sant'onofrio 4, 00165, Rome
Azienda Ospedaliera Universitaria Meyer IRCCS
Neurologia, Viale Gaetano Pieraccini 24, 50139, Florence
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOSD Neuropsichiatria Infantile, Via Sergio Pansini 5, 80131, Naples
IRCCS Foundation Istituto Neurologico Carlo Besta
Neuroalgologia - struttura semplice centro cefalee, Via Giovanni Celoria 11, 20133, Milan
Isala Klinieken Stichting
pediatrics, Dokter Van Heesweg 2, 8025 AB, Zwolle
Canisius Wilhelmina Hospital
poli neurologie, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psihiatrie, Soseaua Berceni 4, 041914, Bucharest
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Pediatrie, Bulevardul Tomis Nr 145, 900591, Constanta
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi
Neurologie pediatrica, Strada Vasile Lupu Nr 62, 700309, Jassi
Sant Joan De Deu Barcelona Hospital
Neurology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Parc Tauli Hospital Universitari
Neurology, Parc Del Tauli 1 Edifici Santa Fe Ala Izquierda Planta 2ª, 08208, Sabadell
Hospital Universitari Vall D Hebron
Neurology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Hospital Virgen Del Rocio S.L.
Neurology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Neurology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinico Universitario De Valencia
Neurology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Clinico Universitario De Valladolid
Neurology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital General Universitario Gregorio Maranon
Neurology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital De La Santa Creu I Sant Pau
Neurology, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Quironsalud Madrid
Neurology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
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 | 2020-12-10 | 2025-09-30 | 2021-01-22 | 2025-09-30 | |
| France | 2020-12-04 | 2025-09-30 | 2021-03-25 | 2025-09-30 | |
| Germany | 2021-04-19 | 2025-09-30 | 2022-01-31 | 2025-09-30 | |
| Italy | 2021-04-02 | 2025-09-30 | 2021-04-26 | 2025-09-30 | |
| Netherlands | 2021-04-06 | 2025-09-30 | 2021-06-18 | 2025-09-30 | |
| Romania | 2021-10-20 | 2025-09-30 | 2021-11-25 | 2025-09-30 | |
| Spain | 2020-11-09 | 2025-09-30 | 2020-11-23 | 2025-09-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| H8H-MC-LAHV_Final Summary of Results_2023-506253-38-00 SUM-133072
|
2026-05-08T12:19:52 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| H8H-MC-LAHV_Lay Person Summary of Results_2023-506253-38-00 | 2026-05-08T12:21:52 | Submitted | Laypersons Summary of Results |
Documents 120 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | H8H-MC-LAHV_Lay Person Summary of Results_2023-506253-38-00 | 1 |
| Protocol (for publication) | D1_Protocol_2023-506253-38-00_redacted | 1 |
| Protocol (for publication) | LAHV_Patient Documents Copyright | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements Form_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IT | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Pill Swallowing Brochure_MU DU PILL TRN | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PioneeerPeds1_Poster_ROW | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PIONEER-PEDS1_Brochure_M_NLNL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PIONEER-PEDS1_FamilyBrochure_M_NLNL_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PIONEERPEDS1_Brochure_M_tricolumm | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PioneerPeds1_ClinicalTrialListing | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PIONEERPEDS1_FamilyBrochure_M_tricolumn | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PioneerPeds1_FamilyCaregiverBrochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PIONEERPEDS1_PatientInvitationToTrialLetter_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PioneerPeds1_PatientRecruitmentBrochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PioneerPeds1_PhysicianReferralLetter_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PIONEERPEDS1_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PIONEERPEDS1_Poster_Layout | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PioneerPeds1_RingPocketCard | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PioneerPeds1_RingPocketCard_Layout | 1 |
| Subject information and informed consent form (for publication) | E1E2_LAHV_ICF 16 to less than 18_NLD_Final_Redacted | 4 |
| Subject information and informed consent form (for publication) | E1E2_LAHV_ICF_Older Children Assent Form_NLD_Final_Redacted | 2 |
| Subject information and informed consent form (for publication) | E1E2_LAHV_ICF_Parent_Guardian_NLD_Final_Redacted | 4 |
| Subject information and informed consent form (for publication) | E1E2_LAHV_ICF_Younger Children_Assent Form_NLD_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_Assent Form Kinder 12-15y_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_Assent Form Kinder 6-12y_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Assent Form Older children_IT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_Assent Form Younger children_IT_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_Country Remibursement and Reminder ICF Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_GP Letter_IT_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Kinder 16-17y_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_ICF Kinder die 18 Jahre werden_Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_Parental Consent_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults_IT_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BEDU_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_BEFR_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ENG_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Older Child 12-17 yr_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Older Child 12-17 yr_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Older Child 12-17 yr_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Parents_IT_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Younger Child 06-11 yr_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Younger Child 06-11 yr_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Younger Child 06-11 yr_ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Migraines_Final-Storyboard_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Migraines_LearnersGuide_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appointment reminder Card_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Migraine Learners Guide_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Migraines_Final Storyboard_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Migraines_Final Storyboard_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Migraines_Final Storyboard_NL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Migraines_Learners Guide_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Migraines_Learners Guide_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Migraines_Learners Guide_NL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card_IT | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Invitation to Trial Letter_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Invitation to Trial Letter_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Invitation to Trial Letter_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Pill Swallowing Brochure_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Pill Swallowing Brochure_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Pill Swallowing Brochure_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Appt Reminder Card Electronic Version_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Appt Reminder Card Electronic_M_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Appt Reminder Card Print_M_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Appt Reminder Card_Print_Layout_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Appt Reminder CardElectronic_M_FRBE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Appt Reminder CardPrint_M_FRBE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Brochure_M_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Brochure_M_FRBE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Family Brochure_M_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Family Brochure_M_FRBE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Family Care Brochure_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Patient Recruitment Brochure_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Poster_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Poster_M_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Poster_M_FRBE | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Visit Guide Layout_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Visit Guide_M_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PIONEER-PEDS1_Visit Guide_M_FRBE_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Placebo Learners Guide_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Placebo Peds_Final Storyboard_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Placebo Peds_Final Storyboard_FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Placebo Peds_Final Storyboard_NL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Placebo Peds_Learners Guide_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Placebo Peds_Learners Guide_FR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Placebo Peds_Learners Guide_NL | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Swallowing Brochure_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you Card_IT | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Guide_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patientenkarten | 1 |
| Subject information and informed consent form (for publication) | L2_PioneerPeds1_ApptReminderCardElectronic | 1 |
| Subject information and informed consent form (for publication) | L2_PioneerPeds1_ApptReminderCardPrint | 1 |
| Subject information and informed consent form (for publication) | L2_PioneerPeds1_Brochure_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_PioneerPeds1_FamilyBrochure_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_PioneerPeds1_PatientInvitationToTrialLetter_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_PioneerPeds1_Poster | 1 |
| Subject information and informed consent form (for publication) | L2_PioneerPeds1_VisitGuide_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Placebo Peds_Final-Storyboard_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Placebo Peds_LearnersGuide | 1 |
| Subject information and informed consent form (for publication) | L2_Tabletten Schlucken Brochure | 1 |
| Summary of results (for publication) | H8H-MC-LAHV_Final Summary of Results_2023-506253-38-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2023-506253-38-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR_2023-506253-38-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT 2023-506253-38-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDE_2023-506253-38-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEDU_2023-506253-38-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BEFR_2023-506253-38-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_English_2023-506253-38-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Ro_2023-506253-38-00_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_Netherlands_2023-506253-38-00_Redacted | 1.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-21 | Spain | Acceptable 2024-03-22
|
2024-03-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-04 | Spain | Acceptable 2024-09-24
|
2024-09-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-20 | Acceptable | 2025-03-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-23 | Acceptable | 2025-01-31 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-19 | Acceptable | 2025-04-03 |