Lasmiditan in Paediatric Patients with Migraine - PIONEER-PEDS2
Research type
Research Study
Full title
A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients with Migraine – PIONEER-PEDS2
IRAS ID
280560
Contact name
Ishaq Abu-Arafeh
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2019-004379-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Migraine is one of the most common neurological conditions in the paediatrics population, affecting 7.7% of children and adolescents under the age of 20 worldwide. Migraine has a negative impact on function and quality of life. Patients can have bothersome symptoms, such as headache, vomiting or sensitivity to light. Severe attacks could result in children not being able to carry out day to day activities or attend school.
Currently, there are few approved treatments for migraine in children and adolescents. Some patients show poor response to existing treatments, or experience undesirable side effects from treatments. Therefore, there is a need for additional safe and effective medication for the acute treatment of migraine in the paediatric patients. The goal of acute treatment is to treat each attack as it occurs, provide fast pain freedom and allow for the return to normal activities.
The novel drug “lasmiditan” was developed specifically for the treatment of acute migraine and evidence suggests lasmiditan may act by blocking 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 safety of lasmiditan when used for treatment of up to 8 migraine attacks per month in paediatric patients. Patients must be between 6 and 18 years of age, have successfully completed the first lasmiditan study (PIONEER-PEDS1) and be able to swallow a tablet. Study participants will receive weight-based doses that correspond to 100 milligrams (mg) or 200mg of lasmiditan, and can reduce dose one time for tolerability. Participation in the study will last about 12 months. Approximately 1000 participants from around the world will take part in this study including 50 patients from the UK.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
20/EE/0183
Date of REC Opinion
6 Oct 2020
REC opinion
Further Information Favourable Opinion