A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

Phase 3RecruitingNCT04396574

Eli Lilly and Company1,000 enrolled

Overview

The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Migraine

Interventions

LasmiditanDRUG

Administered orally

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined) * 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

Locations (133)

Outcomes

Primary Outcomes

Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack

Percentage of TEAEs by Treated Migraine Attack

Time frame: Baseline through 12 Months

Percentage of Participants with Discontinuations Due to Adverse Events (AEs)

Percentage of Participants with Discontinuations Due to AEs

Time frame: Baseline through 12 Months

Secondary Outcomes

Percentage of Treated Attacks with Pain Freedom at 2 Hours

Time frame: 12 Months

Percentage of Treated Attacks with Pain Relief at 2 Hours

Time frame: 12 Months

Percentage of Treated Attacks with MBS Freedom at 2 Hours

Percentage of Treated Attacks with Most Bothersome Symptom (MBS) Freedom at 2 Hours

Time frame: 12 Months

Central Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Central Research Associates

Birmingham, Alabama, United States

COMPLETED

Rehabilitation & Neurological Services

Huntsville, Alabama, United States

RECRUITING

Phoenix Children's Hospital

Phoenix, Arizona, United States

NOT_YET_RECRUITING

Perseverance Research Center

Scottsdale, Arizona, United States

RECRUITING

Center for Neurosciences

Tucson, Arizona, United States

RECRUITING

Arkansas Children's

Little Rock, Arkansas, United States

COMPLETED

Core Healthcare Group

Cerritos, California, United States

COMPLETED

Miller Children's & Women's Hospital Long Beach

Long Beach, California, United States

NOT_YET_RECRUITING

Sensa Health

Los Angeles, California, United States

NOT_YET_RECRUITING

Orange County Research Institute - Ontario

Ontario, California, United States

RECRUITING

...and 123 more locations