Lasmiditan for Pediatric Migraine

(PIONEER-PEDS1 Trial)

Recruiting at 276 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

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: 4

Duration: 16 weeks

1633 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of lasmiditan, a medication for treating migraines in children aged 6 to 17. The study compares different doses of lasmiditan to determine the most effective one, alongside a placebo group for comparison. Participants must have a history of migraines for over six months, experience two to eight moderate-to-severe attacks per month, and be able to swallow tablets. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking migraine treatment for children.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lasmiditan has been well-tolerated by children with migraines. One study found that a single dose of lasmiditan in children revealed no new safety issues, suggesting the treatment might be safe for those aged 6 to 17. Additionally, the FDA has already approved lasmiditan for treating migraines in adults, which adds confidence about its safety. However, monitoring for any side effects during trials remains crucial to ensure the treatment's safety for younger patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Researchers are excited about lasmiditan for pediatric migraines because it offers a unique approach compared to standard treatments like triptans. Unlike other medications that primarily target blood vessels, lasmiditan works by directly acting on serotonin receptors in the brain, which may reduce the risk of cardiovascular side effects. Additionally, lasmiditan is administered orally in varying doses, providing flexibility in treatment based on individual needs. This new mechanism and administration method could provide a safer, more tailored option for young migraine sufferers.

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

Research has shown that lasmiditan can help treat migraines in children. This trial tests different doses of lasmiditan—low, mid, and high—to determine their effectiveness. Previous studies found that varying the dose affected its efficacy, suggesting that higher doses might work better for some children. Other studies suggest that adjusting the dose based on a child's weight ensures the right amount is administered. Overall, lasmiditan appears promising for effectively managing migraines in children. ^{1 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 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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lasmiditan

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.

How Is the Trial Designed?

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.

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]

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]

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]

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]

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]

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

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 ...

7. 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 Lasmiditan is a medicinal product currently in clinical development for the acute treatment of migraine. A migraine is usually a moderate or ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/211280Orig1s000MedR.pdf

211280Orig1s000 | FDA There do not appear to be safety concerns that would preclude approval. If efficacy is demonstrated and the benefits of lasmiditan outweight the ...

9. researchgate.net researchgate.net/publication/349186658_Pharmacokinetics_Safety_and_Tolerability_of_Lasmiditan_in_Pediatric_Patients_with_Migraine

Pharmacokinetics, Safety, and Tolerability of Lasmiditan in ... Conclusion:The PK results support weight-based dosing of lasmiditan in pediatric patients with migraine and no new safety or tolerability issues ...