Lasmiditan for Pediatric Migraine

(PIONEER-PEDS2 Trial)

Recruiting at 312 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called lasmiditan to determine its safety and effectiveness in treating migraines in children. The goal is to assess how well it stops migraines when they occur. Researchers are testing two different doses, and the study will last about a year, with up to seven visits. Children who have participated in specific related studies and weigh at least 33 pounds might be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new migraine treatment for children.

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.

Is there any evidence suggesting that lasmiditan is likely to be safe for children with migraines?

Research has shown that lasmiditan is generally safe for children. In earlier studies, dizziness was the most common side effect. No new safety issues emerged in children aged 6 to 17. The studies used weight-based doses to ensure the medication's safety for younger patients. Overall, the results are promising for those considering joining a trial for lasmiditan. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about lasmiditan for pediatric migraine because it offers a new approach to managing migraines, especially for younger patients. Unlike traditional treatments like triptans, which primarily target serotonin receptors to constrict blood vessels, lasmiditan works by selectively activating the 5-HT1F receptor, which does not cause vasoconstriction. This unique mechanism could potentially reduce the risk of cardiovascular side effects, making it a safer option for children. Moreover, lasmiditan's oral administration is convenient, providing a straightforward way for young patients to manage their migraines effectively.

What evidence suggests that lasmiditan might be an effective treatment for pediatric migraine?

Research has shown that lasmiditan effectively treats migraines quickly. In a study with 512 patients, oral lasmiditan proved more effective as the dose increased. This trial will test two different doses of lasmiditan to find the most effective dose for treating migraines in children. The study also supports adjusting the dose based on a child's weight, making the treatment more suitable for them. Overall, the evidence strongly suggests that lasmiditan reduces migraine symptoms. ^{2 6 7 8 9}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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, 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8195962/

Pharmacokinetics, Safety, and Tolerability of Lasmiditan in ... The PK results support weight-based dosing of lasmiditan in pediatric patients with migraine aged 6 to < 18 years. Safety and tolerability were ...

2. withpower.com withpower.com/trial/phase-3-migraine-disorders-2-2020-37a89

Lasmiditan for Pediatric Migraine (PIONEER-PEDS1 Trial) 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7042942/

Efficacy, Safety, and Acceptability of Pharmacologic ... According to our results, prophylactic pharmacologic treatments have little evidence supporting efficacy for pediatric migraine. We advise to carefully ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824677

Preventive Medications in Pediatric Migraine Secondary outcomes included a 50% or greater responder rate, headache duration, headache intensity, and disability (assessed by pediatrics ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1610384

Trial of Amitriptyline, Topiramate, and Placebo for Pediatric ... The primary outcome was a relative reduction of 50% or more in the number of headache days in the comparison of the 28-day baseline period with ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03988088?tab=results

A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...

7. yalemedicine.org yalemedicine.org/clinical-trials/pioneer-peds1-1

A Study of Lasmiditan (LY573144) Treatment in Children ... The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may ...

8. io.nihr.ac.uk io.nihr.ac.uk/wp-content/uploads/2022/01/6824-Lasmiditan-for-Migraine-V1.0-JAN2020-NON-CONF.pdf

Lasmiditan for acute treatment of migraine See trial record for full list of other outcomes. Results ... Results (safety). • The most common adverse events were dizziness and ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03988088

A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 ... The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine. The study will last about 6 weeks, and ...