A study of Lasmiditan in Pediatric Patients with Migraine
- Conditions
- MigraineTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2019-004379-38-IT
- Lead Sponsor
- ELI LILLY & COMPANY, LILLY CORPORATE CENTER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1000
[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:
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
[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