Recruiting

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

H8H-MC-LAHV - ClinicalTrials.gov - NCT04396236

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine.
How long will I be in the trial?
The study will last up to 20 weeks and may include up to 4 visits.
Email
Recruiting

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

H8H-MC-LAHV - ClinicalTrials.gov - NCT04396236

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine.
How long will I be in the trial?
The study will last up to 20 weeks and may include up to 4 visits.
Email

Key Requirements

Age :

6-17

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

6-17

Sex

All

Participants must

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)

Participants must NOT

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 Summary

Conditions the trial is for

Migraine, Pediatric Migraine

What the trial is testing?

Lasmiditan

Could I receive a Placebo?

yes

Enrollment Goal

1646

Trial Dates

March 2020 - November 2024

Trial Phase

3

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Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

6-17

Sex

All

Participants must

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)

Participants must NOT

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 Summary

Conditions the trial is for

Migraine, Pediatric Migraine

What the trial is testing?

Lasmiditan

Could I receive a Placebo?

yes

Enrollment Goal

1646

Trial Dates

March 2020 - November 2024

Trial Phase

3

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?