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Study on Lasmiditan for Treating Migraine in Children Aged 6 to 17

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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 effectiveness and safety of a medication called lasmiditan for treating migraine in children aged 6 to 17. Migraines are severe headaches that can cause intense throbbing or pulsing sensations, often accompanied by nausea, vomiting, and sensitivity to light and sound. The study aims to determine if lasmiditan can help relieve these symptoms in young patients.

Participants in the study will be randomly assigned to receive either lasmiditan or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will last up to 20 weeks and may involve up to four visits. During this time, researchers will monitor the participants to see how well the treatment works and if there are any side effects.

The main goal of the study is to see if lasmiditan can provide pain relief for children experiencing migraines. This research is important because it could lead to new treatment options for young people who suffer from these debilitating headaches. The study is conducted in a way that ensures the safety and well-being of all participants throughout the trial period.

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 will be informed about the trial's purpose, which is to evaluate the safety and effectiveness of lasmiditan in children aged 6 to 17 with migraine.

    The study is designed to last up to 20 weeks and may include up to 4 visits.

  2. Step 2

    Medication administration

    Participants will receive lasmiditan in tablet form for oral use. The specific dosage will be determined by the study protocol.

    The medication is intended for the acute treatment of migraine attacks.

  3. Step 3

    Monitoring and visits

    Throughout the study, participants will attend up to 4 visits. These visits are scheduled to monitor the participant's response to the medication and to ensure safety.

    During these visits, participants will be assessed for any changes in their migraine symptoms and overall health.

  4. Step 4

    Evaluation of outcomes

    The primary outcome of the study is to measure the percentage of participants who achieve pain freedom after taking a high dose of lasmiditan.

    This evaluation will help determine the effectiveness of the medication in treating migraine in the pediatric population.

Who can join the trial?

8 criteria

  • Participants must have a history of migraine, which is a type of headache that can cause severe pain, with or without aura. An aura is a visual or sensory disturbance that some people experience before a migraine.
  • Participants should have had migraine attacks for more than 6 months.
  • Participants should report having at least 2 but no more than 8 moderate-to-severe migraine attacks per month in the 2 months before the screening visit.
  • The typical untreated migraine attack should last 3 hours or more, not counting time spent sleeping.
  • Participants should not have had a satisfactory response to previous migraine treatments, according to the investigator's opinion.
  • Participants must be able to swallow a tablet.
  • If participants are taking medication to prevent migraines, their treatment plan should be stable and have been followed for at least 3 months before the screening.
  • Participants must weigh at least 15 kilograms (kg), which is about 33 pounds.

Who cannot join the trial?

7 criteria

  • Children who do not have a diagnosis of migraine cannot participate. A migraine is a type of headache that can cause severe pain, often accompanied by nausea and sensitivity to light and sound.
  • Children younger than 6 years old or older than 17 years old are not eligible.
  • Children who have other medical conditions that might interfere with the study may be excluded.
  • Children who are taking certain medications that could affect the study results might not be able to participate.
  • Children who have had a recent surgery or are planning to have surgery during the study period may be excluded.
  • Children who are unable to attend all required study visits might not be eligible.
  • Children who have participated in another clinical trial recently may not be allowed to join this study.
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Investigated drugs

Lasmiditan is a medication being studied to see if it is safe and effective for treating migraines in children aged 6 to 17. The study aims to determine how well this medication works in relieving migraine symptoms in this age group.

What is already known about the treatment

Lasmiditan – Lasmiditan is administered orally in tablet form and is currently being studied for its safety and effectiveness in treating migraines in children aged 6 to 17. It is in the clinical trial phase, specifically in a study called PIONEER-PEDS1, which is a randomized, double-blind, placebo-controlled trial. The main therapeutic indication for lasmiditan is the acute treatment of migraine. At the molecular level, lasmiditan 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 accompanied by nausea, vomiting, and sensitivity to light and sound. These headaches typically occur on one side of the head and can last from a few hours to several days. Migraine attacks may be preceded by sensory warning symptoms, known as aura, which can include visual disturbances or tingling sensations. The frequency and severity of migraines can vary widely among individuals, with some experiencing chronic migraines that occur frequently. 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 ID2023-506253-38-00Protocol codeH8H-MC-LAHVEstimated enrolment1 338 patientsSponsorEli Lilly & Co.

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