Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,000
Countries
7
Sites
36
Migraine
To evaluate the safety and tolerability of long-term intermittent use of lasmiditan for the acute treatment of migraine in pediatric participants.
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
- 19 Nov 2020 → 5 Dec 2025
- Decision date (initial)
- 2023-09-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506724-85-00
- EudraCT number
- 2019-004379-38
- WHO UTN
- U1111-1294-3227
- ClinicalTrials.gov
- NCT04396574
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate the safety and tolerability of long-term intermittent use of lasmiditan for the acute treatment of migraine in pediatric participants.
Conditions and MedDRA coding
Migraine
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002166-PIP01-17
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV
- 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 2
- Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack
- Percentage of Participants with Discontinuations Due to Adverse Events (AEs)
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
- 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)
PRD10493447 · Product
- Active substance
- Lasmiditan
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- 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
PRD7107698 · Product
- Active substance
- Lasmiditan
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- 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
- Paediatric formulation
- No
- Orphan designation
- No
PRD7107697 · Product
- Active substance
- Lasmiditan
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- 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
- Paediatric formulation
- No
- Orphan designation
- No
SUB187183 · Substance
- Active substance
- Lasmiditan
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- 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)
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 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Yprime LLC ORG-100042888
|
Malvern, United States | Data management |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Data management |
| Cogstate Inc. ORG-100045256
|
New Haven, United States | Data management |
| Rebar Interactive LLC ORG-100045545
|
Austin, United States | Other |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
Locations
7 EU/EEA countries · 36 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 14 | 3 |
| France | Ended | 7 | 9 |
| Germany | Ended | 8 | 3 |
| Italy | Ended | 32 | 6 |
| Netherlands | Ended | 8 | 2 |
| Romania | Ended | 20 | 3 |
| Spain | Ended | 86 | 10 |
| Rest of world
Russian Federation, Japan, India, Mexico, United Kingdom, United States, Canada
|
— | 825 | — |
Investigational sites
Uz Gent
Paediatric Neurology, Corneel Heymanslaan 10, 9000, Gent
Ziekenhuis Oost Limburg
Kinderneurologie, Synaps Park 1, 3600, Genk
UZ Brussel
Paediatric Neurology, Laarbeeklaan 101, 1090, Jette
University Hospital Of Clermont-Ferrand
Pédiatrie neurologie, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Universitaire De Toulouse
Pédiatrie, 1 Place Du Docteur Joseph Baylac, 31300, Toulouse
Trousseau Hospital
Centre de la douleur et de la migraine, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
Les Hopitaux Universitaires De Strasbourg
Pédiatrie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Intercommunal de Mont-de-Marsan et du Pays des Sources
Pédiatrie, Avenue Pierre de Coubertin, 40024, Mont-de-Marsan
Centre Hospitalier Intercommunal Creteil
Pédiatrie, 40 Avenue De Verdun, 94000, Creteil
Centre Hospitalier Universitaire Amiens Picardie
Pédiatrie neurologie, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire De Lille
Neuropediatrie, Avenue Du Professeur Emile Laine, 59037, Lille Cedex
Assistance Publique Hopitaux De Marseille
Centre d'évaluation et de traitement de la douleur, 264 Rue Saint Pierre, 13005, Marseille
St. Josef-Hospital
N/A, Gudrunstrasse 56, Grumme, Bochum
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH
N/A, Lindenallee 3, Dornholzhausen, Bad Homburg
Medical Center - University Of Freiburg
Zentrum für Kinder- und Jugendmedizin, Klinik für Neuropädiatrie und Muskelerkrankungen, Mathildenstrasse 1, Stuehlinger, Freiburg Im Breisgau
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
UOSD Neuropsichiatria Infantile, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliera Universitaria Meyer IRCCS
Neurologia, Viale Gaetano Pieraccini 24, 50139, Florence
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
Neurological Institute Foundation Casimiro Mondino
Child Neurology and Psychiatry, Via Casimiro Mondino 2, 27100, Pavia
IRCCS Foundation Istituto Neurologico Carlo Besta
Neuroalgologia - struttura semplice centro cefalee, Via Giovanni Celoria 11, 20133, Milan
Canisius Wilhelmina Hospital
poli neurologie, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Isala Klinieken Stichting
pediatrics, Dokter Van Heesweg 2, 8025 AB, Zwolle
Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
Psihiatrie, Soseaua Berceni 10, 041915, Bucharest
Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi
Neurologie pediatrica, Strada Vasile Lupu Nr 62, 700309, Jassi
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Pediatrie, Bulevardul Tomis Nr 145, 900591, Constanta
Hospital Clinico Universitario De Valladolid
Neurology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital De La Santa Creu I Sant Pau
Neurology, Carrer De San Quinti 89, 08041, Barcelona
Hospital General Universitario Gregorio Maranon
Neurology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinico Universitario De Valencia
Neurology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Quironsalud Madrid
Neurology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitari Vall D Hebron
Neurology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario 12 De Octubre
Neurology, Bloque D, Avenida De Cordoba Sn, Madrid
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
University Hospital Virgen Del Rocio S.L.
Neurology, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 | 2021-06-04 | 2025-09-30 | ||
| France | 2020-12-04 | 2022-01-07 | 2025-09-30 | ||
| Germany | 2021-05-19 | 2022-03-22 | 2025-09-30 | ||
| Italy | 2021-04-02 | 2021-09-07 | 2025-09-30 | ||
| Netherlands | 2021-04-06 | 2021-08-12 | 2025-09-30 | ||
| Romania | 2021-10-20 | 2022-04-09 | 2025-09-30 | ||
| Spain | 2020-11-19 | 2021-07-26 | 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-LAHW_Final Summary of Results_2023-506724-85-00 SUM-136619
|
2026-05-29T13:06:09 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| H8H-MC-LAHW_Lay Person Summary of Results_2023-506724-85-00 | 2026-05-29T13:08:25 | Submitted | Laypersons Summary of Results |
Documents 67 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-LAHW_Lay Person Summary of Results_2023-506724-85-00 | 1 |
| Protocol (for publication) | D4_Patient facing documents Patient Documents Copyright | 1 |
| Protocol (for publication) | LY573144 LAHW_c Clinical Protocol_Redacted | 1 |
| Recruitment arrangements (for publication) | Blank document | 1.0 |
| Recruitment arrangements (for publication) | Blank document | 1.0 |
| Recruitment arrangements (for publication) | Blank document | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_04 Oct 2023 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ApptReminderCardElectronic_BEFR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ApptReminderCardElectronic_NLBE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ApptReminderCardPrint_BEFR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ApptReminderCardPrint_NLBE | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_BEDU-PILL-TRN | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_BEFR-PILL-TRN | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_M_FRBE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_M_NLBE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FamilyBrochure_M_FRBE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_FamilyBrochure_M_NLBE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_VisitGuide_M_FRBE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_VisitGuide_M_NLBE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_22178_PIONEERPEDS2_Family Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Country Subject Retention Materials_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Pill Swallowing Brochure_MU-DU-PILL-TRN | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_simpleshow_Qualifying Migraines_Learner Guide | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_simpleshow_Qualifying Migraines_Video Storyboard_Script | 1 |
| Recruitment arrangements (for publication) | K3_List of Planned Sites_Belgium_ENG_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Adults_BEDU_Final Clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Adults_BEFR_Final Clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Adults_ENG_Final Clean_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Older Child 12-17 yr_BEDU_Final Clean_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Older Child 12-17 yr_BEFR_Final Clean_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Older Child 12-17 yr_ENG_Final Clean_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Participant_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Participant_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Participant_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Younger Child 6-11 yr_BEDU_Final Clean_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Younger Child 6-11 yr_BEFR_Final Clean_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Younger Child 6-11 yr_ENG_Final Clean_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adults_IT_25 May 2022_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GP Letter_IT_01 Jun 22_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Older children_IT_04 Aug 2021_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parents_IT_25 May 2022_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Younger children_IT_04 Aug 2021_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1. Subject Information & Informed Consent Form_16 to less than 18_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1. Subject Information & Informed Consent Form_Older Children Assent_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1. Subject Information & Informed Consent Form_Parent_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1. Subject Information & Informed Consent Form_Younger Children Assent_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Consent Procedure_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient card_IT_13 Sep 2013 | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject information material_Study Participant Contact Cards | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you card_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing materials_ Appointment Reminder Card_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient facing materials_VisitGuide_IT_Redacted | 1 |
| Summary of results (for publication) | H8H-MC-LAHW_Final Summary of Results_2023-506724-85-00 | 1 |
| Synopsis of the protocol (for publication) | D1_H8H-MC-LAHW Protocol synopsis amendment_c_DE_Redacted | c |
| Synopsis of the protocol (for publication) | D1_H8H-MC-LAHW Protocol synopsis amendment_c_FR_BE_Redacted | c |
| Synopsis of the protocol (for publication) | D1_H8H-MC-LAHW Protocol synopsis amendment_c_NL_BE_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis c_ITA_2023-506724-85-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis c_RO_2023-506724-85-00_clean_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NLD_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis_SP_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | LY573144 LAHW c Clinical Protocol Synopsis FR_Redacted | c |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-02 | Germany | Acceptable 2023-09-07
|
2023-09-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-06 | Germany | Acceptable 2023-11-15
|
2023-11-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-27 | Germany | Acceptable 2024-02-08
|
2024-02-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-07-04 | Germany | Acceptable 2024-09-17
|
2024-09-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-20 | Acceptable | 2025-02-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-06 | Acceptable | 2025-03-05 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-02-19 | Acceptable | 2025-04-17 |