H8H-MC-LAHV - ClinicalTrials.gov - NCT04396236
H8H-MC-LAHV - ClinicalTrials.gov - NCT04396236
Key Requirements
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Participants must
Participants must have a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria: - History of migraine attacks for more than 6 months, - Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit, - Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours, - Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
Participant must be able to swallow a tablet
For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
Participants must weigh at least 15 kilograms (kg)
Participants must NOT
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
Trial Summary
Conditions the trial is for
Migraine, Pediatric Migraine
What the trial is testing?
Lasmiditan
Could I receive a Placebo?
yes
Enrollment Goal
1646
Trial Dates
June 2020 - November 2024
Trial Phase
3
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Participants must
Participants must have a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria: - History of migraine attacks for more than 6 months, - Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit, - Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours, - Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
Participant must be able to swallow a tablet
For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
Participants must weigh at least 15 kilograms (kg)
Participants must NOT
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
Trial Summary
Conditions the trial is for
Migraine, Pediatric Migraine
What the trial is testing?
Lasmiditan
Could I receive a Placebo?
yes
Enrollment Goal
1646
Trial Dates
June 2020 - November 2024
Trial Phase
3
Trial Locations
Hide locations not currently recruiting