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The trial is taking place at:
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Hawaii Pacific Neuroscience | Clinical Research Center

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A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS2)

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Migraine

Treatments

Drug: Lasmiditan

Study type

Interventional

Funder types

Industry

Identifiers

NCT04396574
16930
2019-004379-38 (EudraCT Number)
H8H-MC-LAHW (Other Identifier)

Details and patient eligibility

About

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

Enrollment

1,000 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,000 participants in 2 patient groups

Lasmiditan Dose 1
Experimental group
Description:
Lasmiditan administered orally.
Treatment:
Drug: Lasmiditan
Lasmiditan Dose 2
Experimental group
Description:
Lasmiditan administered orally.
Treatment:
Drug: Lasmiditan

Trial contacts and locations

171

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Central trial contact

There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)

Data sourced from clinicaltrials.gov

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