Lasmiditan for Pediatric Migraine

(PIONEER-PEDS1 Trial)

Recruiting at 275 trial locations

Overseen By Kevin Choi

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Eli Lilly and Company

Disqualifiers: Pregnancy, Unstable medical condition, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on migraine preventive medication, you must have been on a stable treatment plan for at least 3 months before joining the trial.

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

Lasmiditan has been shown to be effective in treating acute migraines in adults, helping to relieve headache pain and other symptoms like sensitivity to light and sound. It works by targeting specific receptors in the brain and has been approved by the FDA based on positive results from clinical trials. ^{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 3 4 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 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.

Inclusion Criteria

I was diagnosed with migraines over 6 months ago.

My child weighs at least 33 pounds.

My child can swallow a tablet.

Exclusion Criteria

I weigh at least 15 kilograms.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lasmiditan or placebo for acute treatment of migraine

16 weeks

Up to 4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lasmiditan (Serotonin (5-HT) 1F Receptor Agonist)

Trial Overview 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.

Participant Groups

Group I: Lasmiditan Mid Dose Experimental Treatment 2 Interventions

Lasmiditan administered orally with matching placebo to maintain the blind.

Group II: Lasmiditan Low Dose Experimental Treatment 2 Interventions

Lasmiditan administered orally with matching placebo to maintain the blind.

Group III: Lasmiditan High Dose Experimental Treatment 2 Interventions

Lasmiditan administered orally with matching placebo to maintain the blind.

Group IV: Placebo Placebo Group 1 Intervention

Placebo administered orally.

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]

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, 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]

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

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

4. 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]

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

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

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

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