Migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [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 - Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours - Patient has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator. Are the trial subjects under 18? yes Number of subjects for this age range: 1633 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [1] Patient is pregnant or breastfeeding. [2] Patient has, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation. [3] Patient has known allergies to lasmiditan, related compounds, or any components of the formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that lasmiditan 200 mg is superior to placebo in the acute treatment of a migraine attack in pediatric patients =6 to <18 years of age;Secondary Objective: - To test the hypothesis that lasmiditan 100 mg is superior to placebo in the acute treatment of a migraine attack in pediatric patients =6 to <18 years of age - To test the hypothesis that lasmiditan 50 mg is superior to placebo in the acute treatment of a migraine attack in pediatric patients =6 to <18 years of age;Primary end point(s): Proportion of patients =6 to <18 years of age with pain freedom (200mg);Timepoint(s) of evaluation of this end point: At 2 hours postdose (200 mg) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients =6 to <18 years of age with pain freedom (100mg) - Proportion of patients =6 to <18 years of age with pain freedom (50mg);Timepoint(s) of evaluation of this end point: - At 2 hours postdose | — |
Countries
Belgium, Canada, France, Germany, India, Italy, Japan, Mexico, Netherlands, Romania, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed