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Study on the Safety and Tolerability of Lasmiditan for Treating Migraine in Children Aged 6 to 17

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of migraine in children aged 6 to 17. The treatment being tested is a medication called lasmiditan, which is taken as a tablet. The purpose of the study is to evaluate the safety and tolerability of using lasmiditan over a long period for treating migraine attacks in young patients.

Participants in the study will take lasmiditan as needed for their migraine attacks over a 12-month period. The study will monitor how well the medication is tolerated by the participants and will track any side effects that may occur. The study will also look at how many participants stop using the medication due to any adverse effects.

Throughout the study, participants will be closely observed to ensure their safety and to gather information on how lasmiditan works in treating migraines in children. This research aims to provide valuable insights into the long-term use of lasmiditan for managing migraines in pediatric patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant must have completed a previous study and weigh at least 15 kilograms.

    The study is designed for children aged 6 to 17 who experience migraines.

  2. Step 2

    Medication administration

    The participant will receive lasmiditan, which is a medication used for treating migraines.

    The medication is administered in the form of a tablet and is taken orally.

    The use of lasmiditan is intermittent, meaning it is taken as needed for migraine attacks over the course of the study.

  3. Step 3

    Duration of the study

    The study will last for a period of 12 months.

    During this time, the safety and tolerability of lasmiditan will be evaluated.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, the occurrence of any adverse events will be monitored.

    The primary focus is on the percentage of treatment emergent adverse events and any discontinuations due to adverse events.

Who can join the trial?

4 criteria

  • Participants must have completed a previous study, either study H8H-MC-LAHX or study H8H-MC-LAHV. This means they should have been part of one of these studies before joining this one.
  • Participants must weigh at least 15 kilograms (kg). This is about 33 pounds or more.
  • The study is open to both boys and girls.
  • The study includes children, as it is for pediatric participants. Pediatric means it is for children.

Who cannot join the trial?

10 criteria

  • Participants who have any other serious health conditions that could interfere with the study.
  • Participants who are currently taking medications that might interact with the study drug.
  • Participants who have had an allergic reaction to similar medications in the past.
  • Participants who are pregnant or breastfeeding.
  • Participants who have a history of substance abuse or addiction.
  • Participants who are unable to follow the study procedures or attend study visits.
  • Participants who have participated in another clinical trial recently.
  • Participants who have a history of certain heart conditions.
  • Participants who have uncontrolled high blood pressure.
  • Participants who have a history of seizures or epilepsy.
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Investigated drugs

Lasmiditan is a medication being studied for its safety and tolerability in treating migraines in children. It is used to relieve migraine attacks when they occur. This study aims to understand how well children can tolerate this medication over a long period when used occasionally to treat their migraine symptoms.

What is already known about the treatment

Lasmiditan – Lasmiditan is administered orally in tablet form and is currently being studied in clinical trials for its use in treating migraines, specifically in pediatric patients. It is a relatively new medication in the field of migraine treatment, with ongoing research to evaluate its safety and tolerability for long-term use. Lasmiditan is primarily indicated for the acute treatment of migraine attacks. At the molecular level, it works by selectively binding to serotonin receptors in the brain, which helps to alleviate migraine symptoms. It is classified pharmacologically as a serotonin receptor agonist.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. These headaches can be accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine attacks can last for hours to days and may vary in frequency and intensity. Some individuals experience warning symptoms known as aura, which can include visual disturbances or tingling sensations. The exact cause of migraines is not fully understood, but they are believed to involve genetic and environmental factors. Triggers for migraines can include stress, certain foods, hormonal changes, and lack of sleep.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-506724-85-00Protocol codeH8H-MC-LAHWEstimated enrolment1 000 patientsSponsorEli Lilly & Co.

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