Lasmiditan for Pediatric Migraine

(PIONEER-PEDS2 Trial)

Recruiting at 306 trial locations

Overseen By Kevin Choi

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Disqualifiers: Pregnancy, Unstable medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 12 months

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial organizers or your doctor.

What data supports the effectiveness of the drug Lasmiditan for treating migraines?

Lasmiditan has been shown to effectively reduce migraine pain and symptoms like sensitivity to light and sound within 2 hours of taking it, based on studies in adults. It is a new type of migraine medication that works differently from other treatments and is especially helpful for those who haven't found relief with other migraine drugs. ^{1 2 3 4 5}

How is the drug Lasmiditan different from other migraine treatments?

Lasmiditan is unique because it is the first drug in a new class called ditans, which works by targeting a specific serotonin receptor (5-HT1F) without causing blood vessel constriction, making it suitable for people who cannot use other migraine medications due to heart-related issues. ^{1 2 4 5 6}

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for children aged 6 to 17 who suffer from migraines and have previously completed certain related studies. They must weigh at least 15 kilograms and not be pregnant, nursing, or have serious medical conditions or significant suicide risk.

Inclusion Criteria

Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)

I weigh at least 15 kilograms.

Exclusion Criteria

Participants must not be pregnant or nursing

Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator

I do not have any serious or unstable health conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lasmiditan for the intermittent acute treatment of migraine

12 months

Up to 7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lasmiditan

Trial Overview The study tests the safety and effectiveness of a drug called Lasmiditan for treating migraines in kids when they occur. Over about a year, participants will visit up to seven times as part of this open-label study.

Participant Groups

Group I: Lasmiditan Dose 2 Experimental Treatment 1 Intervention

Lasmiditan administered orally.

Group II: Lasmiditan Dose 1 Experimental Treatment 1 Intervention

Lasmiditan administered orally.

Lasmiditan is already approved in United States, European Union for the following indications:

Approved in United States as Reyvow for:

• Acute treatment of migraine with or without aura

Approved in European Union as Reyvow for:

• Acute treatment of migraine with or without aura

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Lasmiditan, approved by the FDA in October 2019, is a new oral medication specifically designed for the acute treatment of migraines, representing a novel class of drugs called ditans.

This medication is particularly beneficial for patients who do not respond to traditional treatments like triptans or have contraindications that prevent them from using other migraine therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasmiditan Is a New Option for Acute Migraine Treatment. Blakely, KK., Stallworth, K.[2021]

Lasmiditan, a serotonin (5-HT)1F receptor agonist, was approved by the US FDA in October 2019 for the acute treatment of migraines, showing significant efficacy in relieving headache pain and associated symptoms in two pivotal phase III trials.

The drug is specifically indicated for treating migraines with moderate to severe pain and is not intended for preventive use, highlighting its targeted mechanism of action for acute migraine relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasmiditan: First Approval. Lamb, YN.[2023]

Lasmiditan, approved by the FDA in 2019, is effective in reducing migraine pain and related symptoms within 2 hours of oral administration, making it a promising option for patients with migraines.

It is generally safe for patients who have not responded to traditional treatments like NSAIDs or triptans, with rare and mild cardiovascular side effects, although caution is advised for frequent users due to potential abuse concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasmiditan: an additional therapeutic option for the acute treatment of migraine. Martinelli, D., Bitetto, V., Tassorelli, C.[2022]

In a study involving 1,856 adult patients with migraine, lasmiditan at doses of 200 mg and 100 mg significantly increased the likelihood of being headache pain-free at 2 hours after treatment compared to placebo, with 32.2% and 28.2% of patients respectively achieving this outcome.

Lasmiditan was well tolerated, with most adverse events being mild or moderate, making it a safe option for acute migraine treatment, especially in patients with high cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasmiditan is an effective acute treatment for migraine: A phase 3 randomized study. Kuca, B., Silberstein, SD., Wietecha, L., et al.[2022]

Oral lasmiditan is effective for the acute treatment of migraine, with a clear dose-response relationship observed in a study of 512 patients, where all doses significantly improved headache relief compared to placebo.

While lasmiditan showed efficacy, the incidence of treatment-emergent adverse events increased with higher doses, with most being mild to moderate, indicating a need for further studies to evaluate its safety profile in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Färkkilä, M., Diener, HC., Géraud, G., et al.[2022]

Lasmiditan, a selective serotonin receptor agonist, was found to be safe and well-tolerated in a study of 18 pediatric patients (ages 6 to < 18) with migraine, with no serious adverse events reported.

The pharmacokinetics of lasmiditan support weight-based dosing for children, showing that the drug's exposure was similar across different weight cohorts, which suggests it could be an effective treatment option for migraines in younger patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Pediatric Patients with Migraine. Tsai, M., Nery, ESM., Kerr, L., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lasmiditan Is a New Option for Acute Migraine Treatment. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Lasmiditan: First Approval. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Lasmiditan: an additional therapeutic option for the acute treatment of migraine. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Lasmiditan is an effective acute treatment for migraine: A phase 3 randomized study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Pediatric Patients with Migraine. [2022]