What side effects are associated with this type of intervention?

Common treatments for migraines, such as triptans (e.g., sumatriptan and zolmitriptan), often have side effects including injection site reactions, chest pressure, flushing, weakness, drowsiness, dizziness, and an unpleasant taste for nasal formulations. Zolmitriptan nasal spray can also cause taste disturbances and nasal discomfort. These medications are generally well-tolerated, with most side effects being mild to moderate.

What prior FDA approvals exist?

The FDA has approved several treatments for migraine, including triptans, which are selective serotonin 5-HT1B/1D receptor agonists. Examples include sumatriptan, zolmitriptan, and rizatriptan, which are commonly used for acute migraine relief. Lasmiditan, a selective serotonin 5-HT1F receptor agonist, represents a newer class of migraine treatments that specifically targets the 5-HT1F receptor, offering an alternative for patients who may not respond well to triptans or have contraindications to their use. Other FDA-approved treatments include ergotamine derivatives like dihydroergotamine, which are used less frequently due to their side effect profile.

What other types of research exist?

Promising novel alternatives to Lasmiditan for migraine treatment in 2024 include CGRP inhibitors such as Erenumab, Galcanezumab, and Eptinezumab. These medications have shown efficacy in both episodic and chronic migraine prevention. Additionally, dual therapy combining CGRP inhibitors with OnabotulinumtoxinA injections is also emerging as an effective treatment option.

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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.

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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:

Select...

I weigh at least 15 kilograms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours postdose

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

Somnolence

Fatigue

Paraesthesia

Nausea

Vomiting

Lethargy

Asthenia

Feeling abnormal

Feeling jittery

Migraine

Anxiety

Euphoric mood

Vertigo

Urinary tract infection

Muscle twitching

Hallucination

Diarrhoea

Upper respiratory tract infection

Back pain

Muscle spasms

Balance disorder

Hypoaesthesia

Restless legs syndrome

Tremor

Insomnia

Restlessness

Muscular weakness

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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.