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Serotonin (5-HT) 1F Receptor Agonist

Lasmiditan for Pediatric Migraine (PIONEER-PEDS2 Trial)

Phase 3
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must weigh at least 15 kilograms (kg)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

PIONEER-PEDS2 Trial Summary

This trial is testing if a drug is safe and effective for treating migraines in children aged 6-17. It will last 12 months and include up to 7 visits.

Who is the study for?
This trial is for children aged 6 to 17 who suffer from migraines and have previously completed certain related studies. They must weigh at least 15 kilograms and not be pregnant, nursing, or have serious medical conditions or significant suicide risk.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of a drug called Lasmiditan for treating migraines in kids when they occur. Over about a year, participants will visit up to seven times as part of this open-label study.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones may include dizziness, fatigue, nausea, sleepiness which are generally associated with migraine medications like Lasmiditan.

PIONEER-PEDS2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 15 kilograms.

PIONEER-PEDS2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Discontinuations Due to Adverse Events (AEs)
Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack
Secondary outcome measures
Percentage of Treated Attacks with MBS Freedom at 2 Hours
Percentage of Treated Attacks with Pain Freedom at 2 Hours
Percentage of Treated Attacks with Pain Relief at 2 Hours

Side effects data

From 2019 Phase 3 trial • 2171 Patients • NCT02565186
16%
Dizziness
8%
Somnolence
5%
Fatigue
5%
Paraesthesia
4%
Nausea
2%
Vomiting
2%
Lethargy
2%
Asthenia
1%
Migraine
1%
Feeling abnormal
1%
Feeling jittery
1%
Anxiety
1%
Euphoric mood
1%
Vertigo
1%
Urinary tract infection
1%
Muscle twitching
1%
Hallucination
1%
Diarrhoea
1%
Upper respiratory tract infection
1%
Back pain
1%
Muscle spasms
1%
Balance disorder
1%
Hypoaesthesia
1%
Restless legs syndrome
1%
Tremor
1%
Insomnia
1%
Restlessness
1%
Muscular weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lasmiditan 100mg
Lasmiditan 200mg

PIONEER-PEDS2 Trial Design

2Treatment groups
Experimental Treatment
Group I: Lasmiditan Dose 2Experimental Treatment1 Intervention
Lasmiditan administered orally.
Group II: Lasmiditan Dose 1Experimental Treatment1 Intervention
Lasmiditan administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lasmiditan
2017
Completed Phase 3
~5240

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,215,599 Total Patients Enrolled
26 Trials studying Migraine
9,528 Patients Enrolled for Migraine
Study DirectorEli Lilly and Company
3 Previous Clinical Trials
2,001 Total Patients Enrolled
1 Trials studying Migraine
1,633 Patients Enrolled for Migraine

Media Library

Lasmiditan (Serotonin (5-HT) 1F Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04396574 — Phase 3
Migraine Research Study Groups: Lasmiditan Dose 1, Lasmiditan Dose 2
Migraine Clinical Trial 2023: Lasmiditan Highlights & Side Effects. Trial Name: NCT04396574 — Phase 3
Lasmiditan (Serotonin (5-HT) 1F Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04396574 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this age group fall outside of the scope for this research?

"Children aged 6 to 17 years old can participate in this trial, which is one of 34 trials for patients under the age of 18. There are 120 other trials for people over 65 years old."

Answered by AI

Are there any other existing clinical trials that test the efficacy of Lasmiditan?

"There are currently 2 Lasmiditan clinical trials ongoing, with 500 different Hoffman Estates locations participating."

Answered by AI

Has Lasmiditan been cleared by the FDA?

"Lasmiditan has received a score of 3 on Power's safety scale. This is due to the fact that Lasmiditan is currently in Phase 3 trials, meaning there is evidence suggesting it is effective as well as data collected from multiple rounds supporting its safety."

Answered by AI

I am interested in enrolling as a test subject, how can I sign up?

"This clinical trial, which seeks to study the effects of a new migraine medication, is looking for 1000 participants that are currently suffering from migraines and fall in the age range of 6-17."

Answered by AI

How many hospitals in the country are participating in this trial?

"One hundred hospitals are participating in this study, with locations spanning from Huntington to Worcester. If you choose to enroll, try and select a location close to you to limit travel time commitments."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Ohio
Other
North Carolina
How old are they?
18 - 65
What site did they apply to?
PMG Research of Piedmont Healthcare
Sensa Health
Other
Accellacare - Winston-Salem
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
2020. "A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04396574.
All > Migraine Headaches > Migraine
~333 spots leftby Mar 2026
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