H8H-MC-LAHV - PIONEER-PEDS1
Research type
Research Study
Full title
Protocol H8H-MC-LAHV Pediatric Options for Migraine Relief: A Randomized,Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
IRAS ID
279837
Contact name
Ishaq Abu-Arafeh
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2019-004378-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 10 months, 24 days
Research summary
Migraines are one of the most common neurological conditions in paediatrics affecting 7.7% of children and adolescents under 20 worldwide. Migraine attacks are associated with intense pain and a range of accompanying symptoms, including headache, vomiting or sensitivity to light. The experience of migraine has a significant impact on quality of life and ability to function. Children with migraine may miss school or other activities.
Currently there are few approved treatment options for migraine in children and adolescents. However, some patients show a poor response to treatment, or experience undesirable side effects from treatments. Therefore, there is a need for additional safe and effective medications for the acute treatment of migraine in the paediatric population. The goal of acute treatment is to treat each attack as it occurs to provide fast pain freedom, and to allow the patient to return to normal activities.
There is evidence that the novel drug “lasmiditan” may act by blocking the pain pathways. It has been shown that lasmiditan could result in pain-freedom 2 hours after dosing, and it has recently been approved for the acute treatment of migraine in adults in the United States.
This is a late phase study to investigate the effect of lasmiditan on treatment of a single migraine attack. Patients must be between 6 and 18 years of age, be able to swallow a tablet and meet the International Classification of Headache Disorders criteria for a diagnosis of migraine. Study participants will receive weight-based doses that correspond to 50 milligrams (mg), 100mg, 200mg of lasmiditan or placebo. Participation in the study will last about 12 weeks. Approximately 1,600 participants will be taking part from around the world including 50 patients from the UK.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
20/EE/0179
Date of REC Opinion
6 Oct 2020
REC opinion
Further Information Favourable Opinion