Lasmiditan for Pediatric Migraine
(PIONEER-PEDS1 Trial)
Recruiting in Palo Alto (17 mi)
+275 other locations
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.
12345How 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.
12346Eligibility 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.
+1 more
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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Lasmiditan Mid DoseExperimental Treatment2 Interventions
Lasmiditan administered orally with matching placebo to maintain the blind.
Group II: Lasmiditan Low DoseExperimental Treatment2 Interventions
Lasmiditan administered orally with matching placebo to maintain the blind.
Group III: Lasmiditan High DoseExperimental Treatment2 Interventions
Lasmiditan administered orally with matching placebo to maintain the blind.
Group IV: PlaceboPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Christiana Care Neurology SpecialistsNewark, DE
AMITA Health - Alexian Brothers Neurosciences Institute Clinical ResearchHoffman Estates, IL
University Hospital Cleveland Medical CenterCleveland, OH
ARC Clinical Research William CannonAustin, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Eli Lilly and CompanyLead Sponsor
References
Lasmiditan Is a New Option for Acute Migraine Treatment. [2021]Lasmiditan is a new oral medication for treatment of acute migraine. It was approved by the U.S. Food and Drug Administration in October 2019 and is marketed under the brand name Reyvow (Eli Lilly and Company, Indianapolis, IN). It is the first of its kind in a new drug class called ditans. Lasmiditan has been studied as monotherapy for acute migraine treatment and as an abortive therapy for adults taking chronic migraine preventive medication. Lasmiditan may be an option for individuals who have had no relief with triptans or other acute migraine treatment agents or who are unable to use other migraine treatments because of contraindications.
Lasmiditan: First Approval. [2023]Lasmiditan (REYVOW™; Eli Lilly and Company) is an orally available serotonin (5-HT)1F receptor agonist. In October 2019, the US FDA approved lasmiditan 50 mg and 100 mg tablets for the acute treatment of migraine with or without aura in adults. Approval was based on positive results from two pivotal phase III trials, in which lasmiditan significantly improved the proportions of patients achieving freedom from headache pain and freedom from the most bothersome symptom (photophobia, phonophobia or nausea), relative to placebo, when used to treat a migraine with moderate to severe pain. Lasmiditan is not for use in the preventive treatment of migraine. This article summarizes the milestones in the development of lasmiditan leading to its first approval for the acute treatment of migraine in adults.
Lasmiditan is an effective acute treatment for migraine: A phase 3 randomized study. [2022]To assess the efficacy and safety of lasmiditan in the acute treatment of migraine.
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]Lasmiditan (COL-144) is a novel, centrally acting, highly selective 5-HT(1F) receptor agonist without vasoconstrictor activity that seemed effective when given as an intravenous infusion in a proof-of-concept migraine study. We aimed to assess the efficacy and safety of oral lasmiditan for the acute treatment of migraine.
Lasmiditan: an additional therapeutic option for the acute treatment of migraine. [2022]Introduction: Migraine is currently listed as the second cause of 'years lived with disability' and the sixth cause of global disability. Despite the burden associated to the disease, availability of specific drugs is still limited.Areas covered: The authors have evaluated lasmiditan, the first 'ditan' approved by the Food and Drugs Administration in 2019, from a global perspective: basic chemistry, pharmacodynamic and pharmacokinetic profiles, efficacy in migraine as a 5-HT1F receptor selective agonist, tolerability and clinical safety, and impact on migraine-related disability. Our evaluation considered original papers and review articles published from 2010 to 2020.Expert opinion: Available data point to the efficacy of lasmiditan in reducing migraine pain and the most bothersome symptoms within 2 hours from oral administration. Moreover, lasmiditan has a positive effect on migraine-related disability. Its side effects mostly reflect an involvement of the central nervous system or the vestibular system, while cardiovascular side effects are rare and mild.Lasmiditan can be safely prescribed in patients who have failed non-steroid anti-inflammatory drugs or triptans or with cardiovascular risk factors. Caution is advised in frequent users, due to lack of reliable data on its abuse potential. Further data are necessary to determine the usability of lasmiditan in particular populations, e.g. children and adolescents, pregnancy.
Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Pediatric Patients with Migraine. [2022]Lasmiditan is a selective serotonin (5-HT1F) receptor agonist approved in the US for the acute treatment ofmigraine in adults. This phase I, open-label, two-cohort study assessed the pharmacokinetics (PK), safety, and tolerability of lasmiditan in patients with migraine aged 6 to