Informations générales (source: ClinicalTrials.gov)
Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1 (PIONEER-PEDS1)
Interventional
Phase 3
Eli Lilly and Company (Voir sur ClinicalTrials)
juin 2020
janvier 2025
17 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Julien NGO | 29/03/2024 01:29:15 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone - 13385 - Marseille - Bouches-du-Rhône - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Général de Mont de Marsan - Hôpital Layné - 40024 - Mont-de-Marsan - Landes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro - 59037 - Lille - Nord-Pas-de-Calais - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan - 31059 - Toulouse - Haute-Garonne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Estaing - 63100 - Clermont-Ferrand - Puy-de-Dôme - France | Contact (sur clinicalTrials) | ||||
| CHU d'Amiens-Picardie - Hôpital Sud - 80054 - Amiens - Somme - France | Contact (sur clinicalTrials) | ||||
| CHU Strasbourg-Hautepierre - 67098 - Strasbourg - Bas-Rhin - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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:
- History of migraine attacks for more than 6 months
- Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per
month in the 2 months prior to screening visit
- Duration of a typical untreated migraine attack (excluding sleep) is greater
than or equal to 3 hours
- 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)
- 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:
- History of migraine attacks for more than 6 months
- Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per
month in the 2 months prior to screening visit
- Duration of a typical untreated migraine attack (excluding sleep) is greater
than or equal to 3 hours
- 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)
- 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