NL-OMON54273
Recruiting
Phase 3
Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1 - H8H-MC-LAHV (PIONEER-PEDS1)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Headache
- Sponsor
- Eli Lilly
- Enrollment
- 4
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Type of Patient and Disease Characteristics
- •\[1] Patient is at least 6 and less than 18 years of age at Screening (Visit 1\).
- •\[2] Patient must have a minimum body weight of 15 kg.
- •\[3] Patient has 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
Exclusion Criteria
- •Medical Conditions
- •\[10] Patient has a history or clinical evidence of congenital heart disease,
- •or confirmed.
- •\[11] ECG showing abnormalities compatible with acute cardiovascular events,
- •serious cardiovascular disease risk, or both.
- •\[12] Within 6 months of screening, patient had
- •\- myocardial infarction
- •\- unstable angina
- •\- percutaneous coronary intervention, and
- •\- coronary artery bypass graft.
Outcomes
Primary Outcomes
Not specified
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