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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
Must not have
Participants must not have any acute, serious, or unstable medical condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any serious or unstable health conditions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants with Discontinuations Due to Adverse Events (AEs)
Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack
Secondary study objectives
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%
Feeling abnormal
1%
Feeling jittery
1%
Migraine
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2,680 Previous Clinical Trials
3,465,384 Total Patients Enrolled
26 Trials studying Migraine
9,521 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
~206 spots leftby Mar 2026
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