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 was between 6 and =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. [4] In the opinion of the investigator or sponsor, patient is unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of long-term intermittent use of lasmiditan for the acute treatment of migraine in pediatric patients;Secondary Objective: To evaluate the efficacy of intermittently dosed lasmiditan in the treatment of multiple migraine attacks over time in pediatric patients;Primary end point(s): - Nature, proportion, and severity of Treatment-Emergent Adverse Events by treated attack - Proportion of discontinuation due to Adverse Events;Timepoint(s) of evaluation of this end point: - At the conclusion of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of treated attacks with pain freedom, pain relief and MBS-freedom;Timepoint(s) of evaluation of this end point: - 2 hours after dosing for each 3-month period | — |
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