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H8H-MC-LAHX

A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients with Migraine

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224864
Enrollment
21
Registered
2019-09-11
Start date
2019-08-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Interventions

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
pharmacokinetics Pharmacokinetics of Lasmiditan in pediatric migraine patients following a single oral dose of lasmiditan.

Secondary

MeasureTime frame
safety other Safety and Tolerability of Lasmiditan in pediatric migraine patients following a single oral dose of lasmiditan.

Countries

Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026