Phase 1 N=18 Basic Science

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

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT03988088 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan — 362; 426 nanograms per milliliter (ng/mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Lasmiditan (Drug)
Age: Pediatric · 6+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan	362; 426	—
PRIMARY PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan	2050; 2590	—

Summary

The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine. The study will last about 6 weeks, and includes 4 visits.

Eligibility Criteria

Inclusion Criteria

Participants must have a history of migraine headaches for more than 6 months
Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months
Participants must weigh between 15 and 55 kilograms (kg)
Participants must not have a migraine headache on the day of lasmiditan administration

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
Participants must not be on a medicine that acts in the brain and spinal cord

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03988088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.