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
Interventional
Phase 3
Eli Lilly and Company (Voir sur ClinicalTrials)
juin 2020
novembre 2026
02 octobre 2025
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 | ||
Critères
Tous
- 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)
Exclusion Criteria:
- 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