A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2
Investigating the Safety and Effectiveness of an Investigational Medication in a Research Study for Migraine in Children
Andrea Haller
Primary Investigator
Brief description of study
This is a 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17.
Detailed description of study
All patients will take lasmiditan (100 mg or 200 mg). The decision to use 100 mg or 200 mg will be based on randomization, like flipping a coin. Lasmiditan is a tablet taken by mouth. You can treat up to 8 migraine attacks a month with study drug. During the treatment period, there will be 4 visits at Months 1, 3, 6 and 9. The study will last about 12 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Migraine
-
Age: 16 years - 17 years
-
Gender: All
Inclusion Criteria:
- Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
- Participants must weigh at least 15 kilograms (kg)
Exclusion Criteria:
- Participants must not be pregnant or nursing
- Participants must not have any acute, serious, or unstable medical condition
- Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
This study investigates the safety and effectiveness of an investigational medication for treating migraine in children aged 6 to 17. Migraine is a condition characterized by severe headaches and other symptoms like nausea and sensitivity to light. The study aims to understand how well the investigational medication works for treating these acute attacks.
Participants in the study will take the investigational medication in tablet form, either 100 mg or 200 mg, determined by randomization. They can use the medication to treat up to 8 migraine attacks per month. The study involves visits at Months 1, 3, 6, and 9 to monitor the participants' health and response to the medication.
- Who can participate: Children aged 6 to 17 who have completed specific prior studies and weigh at least 15 kilograms can participate. Participants must not be pregnant, nursing, or have any serious medical conditions.
- Study details: Participants will take the investigational medication in tablet form, with doses decided by randomization (like flipping a coin to decide). The study involves monitoring participants' health during visits and allows treating up to 8 migraine attacks monthly.
- Study timelines and visits: The study will last 12 months. The study requires 4 visits.
