NCT04396236CompletedPhase 3
A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)
H8H-MC-LAHV: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Apr 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 205 (actual)
- First submitted
- 21 Feb 2024
- Start date
- 9 Nov 2020
- Lead sponsor
- Eli Lilly & Co.
- Diseases
- Migraine
- NCT number
- NCT04396236
- EU CT number
- 2023-506253-38-00
- EudraCT number
- 2019-004378-24
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 205
- 32 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants must not have any acute, serious, or unstable medical condition
Other
- Participants must not be pregnant or nursing
- Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
Who the study is looking for
- 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)
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (32)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Completed |
| Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Coordinator of this site? Confirm its status | Bad Homburg | Germany | Completed |
| Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital Coordinator of this site? Confirm its status | Bochum | Germany | Completed |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Completed |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Sant Joan De Deu Barcelona Hospital Coordinator of this site? Confirm its status | Esplugues De Llobregat | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Completed |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Completed |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Completed |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Completed |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Completed |
| Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources Coordinator of this site? Confirm its status | Mont-De-Marsan Cedex | France | Completed |
| Trousseau Hospital Coordinator of this site? Confirm its status | Paris | France | Completed |
| Azienda Sanitaria Locale Della Provincia Di Bari Coordinator of this site? Confirm its status | Bari | Italy | Completed |
| Azienda Ospedaliera Universitaria Meyer IRCCS Coordinator of this site? Confirm its status | Florence | Italy | Completed |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Neurological Institute Foundation Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Canisius-Wilhelmina Hospital Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Completed |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Completed |
| Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Coordinator of this site? Confirm its status | Constanța | Romania | Completed |
| Spitalul Clinic De Urgenta Pentru Copii Sfanta Maria Iasi Coordinator of this site? Confirm its status | Jassi | Romania | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.