A study of Lasmiditan in Pediatric Patients for acute treatment of migraine

Phase 1

• Conditions: Migraine; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-004378-24-IT
• Lead Sponsor: ELI LILLY & COMPANY, LILLY CORPORATE CENTER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-06
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1633

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:
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

[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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- 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)