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Hawaii Pacific Neuroscience | Clinical Research Center

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

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Lilly

Status and phase

Enrolling
Phase 3

Conditions

Migraine

Treatments

Drug: Placebo
Drug: Lasmiditan

Study type

Interventional

Funder types

Industry

Identifiers

NCT04396236
16927
2019-004378-24 (EudraCT Number)
H8H-MC-LAHV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

1,633 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,633 participants in 4 patient groups, including a placebo group

Lasmiditan High Dose
Experimental group
Description:
Lasmiditan administered orally with matching placebo to maintain the blind.
Treatment:
Drug: Lasmiditan
Drug: Placebo
Lasmiditan Mid Dose
Experimental group
Description:
Lasmiditan administered orally with matching placebo to maintain the blind.
Treatment:
Drug: Lasmiditan
Drug: Placebo
Lasmiditan Low Dose
Experimental group
Description:
Lasmiditan administered orally with matching placebo to maintain the blind.
Treatment:
Drug: Lasmiditan
Drug: Placebo
Placebo
Placebo Comparator group
Description:
Placebo administered orally.
Treatment:
Drug: Placebo

Trial contacts and locations

170

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Central trial contact

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

Data sourced from clinicaltrials.gov

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