A study of Lasmiditan in Pediatric Patients with Migraine

Phase 1

• Conditions: Migraine; MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-004379-38-FR
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-19
• Last Update Posted: 15 September 2020

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

[1] Patient was between 6 and <18 years of age inclusive at the time of enrollment into Study LAHX or Study LAHV.
[2] The patient has a minimum body weight of 15 kg.
[3] The patient is able to swallow a tablet.
[4] For patients taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to Visit 1.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1000
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.
[4] In the opinion of the investigator or sponsor, patient is unsuitable for inclusion in the study.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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<br>- Proportion of discontinuation due to Adverse Events;Timepoint(s) of evaluation of this end point: - At the conclusion of the trial

Secondary Outcome Measures

Name	Time	Method
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