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Serotonin (5-HT) 1F Receptor Agonist

Lasmiditan for Pediatric Migraine (PIONEER-PEDS1 Trial)

Verified 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
Were you diagnosed with migraines more than 6 months ago?
Does your child have 2-8 migraines a month?
Must not have
Participants must weigh at least 15 kilograms (kg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours postdose
Awards & highlights

PIONEER-PEDS1 Trial Summary

This trial will test the safety and effectiveness of lasmiditan in treating migraines in children aged 6-17. Up to 4 visits over 20 weeks may be required.

Who is the study for?
This study is for children aged 6 to 17 who have been diagnosed with migraines at least 6 months ago, experience 2-8 migraines a month, weigh more than 33 pounds (15 kg), and can swallow tablets.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a medication called Lasmiditan in treating migraines in children. Participants will either receive Lasmiditan or a placebo during the study which lasts up to 20 weeks with up to four visits.See study design
What are the potential side effects?
Possible side effects of Lasmiditan may include dizziness, fatigue, tingling sensations, sleepiness, and nausea. These are based on known side effects in adults as specific child-related side effects are being studied.

PIONEER-PEDS1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with migraines over 6 months ago.
Select...
My child experiences 2-8 migraines monthly.
Select...
My child weighs at least 33 pounds.
Select...
My child can swallow a tablet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I weigh at least 15 kilograms.

PIONEER-PEDS1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours postdose 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 Pain Freedom (High Dose)
Secondary outcome measures
Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"
Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely")
Percentage of Participants Most Bothersome Symptom (MBS)-Free
+9 more

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%
Vertigo
1%
Urinary tract infection
1%
Muscle twitching
1%
Hallucination
1%
Diarrhoea
1%
Feeling abnormal
1%
Feeling jittery
1%
Upper respiratory tract infection
1%
Back pain
1%
Muscle spasms
1%
Balance disorder
1%
Hypoaesthesia
1%
Migraine
1%
Restless legs syndrome
1%
Tremor
1%
Anxiety
1%
Euphoric mood
1%
Insomnia
1%
Restlessness
1%
Muscular weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lasmiditan 100mg
Lasmiditan 200mg

PIONEER-PEDS1 Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Lasmiditan Mid DoseExperimental Treatment2 Interventions
Lasmiditan administered orally with matching placebo to maintain the blind.
Group II: Lasmiditan Low DoseExperimental Treatment2 Interventions
Lasmiditan administered orally with matching placebo to maintain the blind.
Group III: Lasmiditan High DoseExperimental Treatment2 Interventions
Lasmiditan administered orally with matching placebo to maintain the blind.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Lasmiditan
2017
Completed Phase 3
~5240

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,197,722 Total Patients Enrolled
26 Trials studying Migraine
8,895 Patients Enrolled for Migraine
Study DirectorEli Lilly and Company
3 Previous Clinical Trials
1,368 Total Patients Enrolled
1 Trials studying Migraine
1,000 Patients Enrolled for Migraine

Media Library

Lasmiditan (Serotonin (5-HT) 1F Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04396236 — Phase 3
Migraine Research Study Groups: Lasmiditan Low Dose, Lasmiditan High Dose, Lasmiditan Mid Dose, Placebo
Migraine Clinical Trial 2023: Lasmiditan Highlights & Side Effects. Trial Name: NCT04396236 — Phase 3
Lasmiditan (Serotonin (5-HT) 1F Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04396236 — Phase 3

Frequently Asked Questions

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

When will Lasmiditan be available for public use?

"Lasmiditan has been given a safety score of 3 by our analysts at Power. This is because Lasmiditan is in a Phase 3 clinical trial, meaning that there is some evidence of efficacy as well as multiple rounds of data supporting safety."

Answered by AI

If somebody is under 40 years old, can they participate in this clinical trial?

"This study is enrolling participants that are aged 6-17 years old."

Answered by AI

What does the current research tell us about Lasmiditan?

"There are currently 2 Phase 3 trials underway investigating the efficacy of lasmiditan. However, this is not the full extent of research being conducted as there are 500 different clinical trial sites operating around the world."

Answered by AI

How many willing participants are being recruited for this experiment?

"In order to carry out this study, 1633 participants that meet the pre-specified inclusion criteria are required. These potential patients can be recruited from various locations, such as AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research in Hoffman Estates, Illinois and University Hospital Cleveland Medical Center in Cleveland, Ohio."

Answered by AI

Are there a lot of these research programs taking place in city?

"There are 4 main enrolling locations for this trial, which are AMITA Health - Alexian Brothers Neurosciences Institute Clinical Research in Hoffman Estates, Illinois, University Hospital Cleveland Medical Center in Cleveland, Ohio, and New England Institute for Clinical Research in Stamford, Connecticut. In addition, there are 100 other sites where this trial is taking place."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
North Carolina
New York
Other
How old are they?
18 - 65
What site did they apply to?
Yale New Haven Children's Hospital
Integrated Clinical Trial Services, Inc.
Pmg Research of Winston-Salem
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
~983 spots leftby Nov 2029