Children's National

A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

Purpose

The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

Condition

Migraine

Eligibility

Eligible Ages: Between 6 Years and 17 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Participants must have 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 - Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator - Participant must be able to swallow a tablet - For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening - Participants must weigh at least 15 kilograms (kg)

Exclusion Criteria

Participants must not be pregnant or nursing - Participants must not have any acute, serious, or unstable medical condition - Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Lasmiditan High Dose	Lasmiditan administered orally with matching placebo to maintain the blind.	Drug: Lasmiditan Administered orally Other names: LY573144 Drug: Placebo Administered orally
Experimental Lasmiditan Mid Dose	Lasmiditan administered orally with matching placebo to maintain the blind.	Drug: Lasmiditan Administered orally Other names: LY573144 Drug: Placebo Administered orally
Experimental Lasmiditan Low Dose	Lasmiditan administered orally with matching placebo to maintain the blind.	Drug: Lasmiditan Administered orally Other names: LY573144 Drug: Placebo Administered orally
Placebo Comparator Placebo	Placebo administered orally.	Drug: Placebo Administered orally

Recruiting Locations

Children's National and nearby locations

Children's National Medical Center
Washington, District of Columbia 20010

More Details

NCT ID: NCT04396236
Status: Recruiting
Sponsor: Eli Lilly and Company

Study Contact

There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.