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, Czech Republic, 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