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Clinical trial

A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)

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Last updated:8th May 2023
Status: Recruiting
Identifier: NCT04396236
A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)


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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 1633 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
Actual Study Start Date: June 15, 2020
Estimated Primary Completion Date: June 28, 2024
Estimated Study Completion Date: January 31, 2025

Arms:
- Experimental: Lasmiditan High Dose
- Experimental: Lasmiditan Mid Dose
- Experimental: Lasmiditan Low Dose
- Placebo Comparator: Placebo

Category Value
Study type(s) Interventional
Estimated enrolment 1663
Actual Study start date 15 June 2020
Estimated study completion date 31 January 2025

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