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

Phase 3TerminatedNCT04396236

Eli Lilly and Company851 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

851

Conditions

Migraine

Interventions

LasmiditanDRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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) 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

Locations (152)

Outcomes

Primary Outcomes

Percentage of Participants with Pain Freedom (High Dose)

Time frame: 2 Hours Postdose

Secondary Outcomes

Percentage of Participants with Pain Freedom (Mid Dose)

Time frame: 2 Hours Postdose

Percentage of Participants with Pain Freedom (Low Dose)

Time frame: 2 Hours Postdose

Percentage of Participants with Pain Freedom (Age Sub-Groups)

Time frame: 2 Hours Postdose

Percentage of Participants with Pain Relief

Time frame: 2 Hours Postdose

Percentage of Participants Most Bothersome Symptom (MBS)-Free

Percentage of Participants MBS-Free

Time frame: 2 Hours Postdose

Percentage of Participants Nausea-Free

Time frame: 2 Hours Postdose

Percentage of Participants Photophobia-Free

Time frame: 2 Hours Postdose

Data from ClinicalTrials.gov

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