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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
Pivotal Trial

Summary

This trial is testing if lasmiditan is safe and effective for children aged 6 to 17 with migraines. The medication aims to block brain signals that cause migraine pain. The study will last several months and may include a few visits. Lasmiditan has been shown to be effective in treating acute migraine attacks in adults and is noted for its safety profile, particularly due to its lack of vasoconstrictive effects.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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My child can swallow a tablet.

Exclusion Criteria

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants with Pain Freedom (High Dose)
Secondary study objectives
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%
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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Lasmiditan
2017
Completed Phase 3
~5240
Placebo
1995
Completed Phase 3
~2670

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Migraine treatments work through various mechanisms to alleviate symptoms and prevent attacks. Lasmiditan, a selective serotonin 5-HT1F receptor agonist, targets specific serotonin receptors to reduce migraine pain without causing vasoconstriction, making it safer for patients with cardiovascular risks. Triptans, another common class, act as serotonin 5-HT1B/1D receptor agonists, leading to vasoconstriction and inhibition of pro-inflammatory neuropeptides. NSAIDs like ibuprofen reduce inflammation and pain by inhibiting cyclooxygenase enzymes. Antiemetics such as metoclopramide help manage nausea and enhance gastric motility. Understanding these mechanisms is crucial for tailoring treatments to individual patient needs, optimizing efficacy, and minimizing side effects.
Evaluation of 2-Hour Post-Dose Efficacy of Lasmiditan for the Acute Treatment of Difficult-to-Treat Migraine Attacks.Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,464,110 Total Patients Enrolled
26 Trials studying Migraine
8,888 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
~0 spots leftby Jan 2025