Recruiting

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

H8H-MC-LAHW - ClinicalTrials.gov - NCT04396574

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.
How long will I be in the trial?
The study will last about 12 months and may include up to 7 visits.
Email
Recruiting

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

H8H-MC-LAHW - ClinicalTrials.gov - NCT04396574

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.
How long will I be in the trial?
The study will last about 12 months and may include up to 7 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 completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT04396236)

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?

no

Enrollment Goal

1000

Trial Dates

June 2020 - November 2025

Trial Phase

3

Enter your postal code to find the nearest site

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 completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT04396236)

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?

no

Enrollment Goal

1000

Trial Dates

June 2020 - November 2025

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?