Clinical trial NCT03988088: A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
Official title: A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-06-17
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine.

The study will last about 6 weeks, and includes 4 visits.


Eligibility criteria: Inclusion Criteria:

* Participants must have a history of migraine headaches for more than 6 months
* Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months
* Participants must weigh between 15 and 55 kilograms (kg)
* Participants must not have a migraine headache on the day of lasmiditan administration

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
* Participants must not be on a medicine that acts in the brain and spinal cord

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
measure: PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Perserverance Research Center
state: Arizona
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Bradenton
country: United States
facility: Meridien Research
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Kurume
country: Japan
facility: Kurume Clinical Pharmacology Clinic
state: Fukuoka
city: Shinjuku-Ku
country: Japan
facility: Clinical Research Hospital, Tokyo
state: Tokyo
city: San Juan
country: Puerto Rico
facility: San Jorge Children and Women's Hospital- Shipping Location
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Tsai M, Nery ESM, Kerr L, Khanna R, Komori M, Dennehy EB, Wilbraham D, Winner P. Pharmacokinetics, Safety, and Tolerability of Lasmiditan in Pediatric Patients with Migraine. Clin Pharmacokinet. 2021 Jun;60(6):819-828. doi: 10.1007/s40262-020-00966-z. Epub 2021 Feb 10.