NCT03988088

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_1

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 22, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

September 1, 2020

Completed
Last Updated

September 1, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

June 12, 2019

Results QC Date

August 14, 2020

Last Update Submit

August 14, 2020

Conditions

Migraine

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan

    Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.

    0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose

  • PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan

    PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC\[0-∞\]) of Lasmiditan.

    0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose

Study Arms (1)

Lasmiditan

EXPERIMENTAL

Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 milligrams (mg) Lasmiditan in Cohort 1 and higher body weight (\>40 to ≤55 kg) participants received single oral dose of 200 mg Lasmiditan in Cohort 2.

Drug: Lasmiditan

Interventions

LasmiditanDRUG

Administered orally.

Also known as: LY573144
Lasmiditan

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Perserverance Research Center

Scottsdale, Arizona, 85254, United States

Location

Newport Beach Clinical Research Associates, Inc.

Newport Beach, California, 92663, United States

Location

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Meridien Research

Bradenton, Florida, 34201, United States

Location

Meridien Research

Maitland, Florida, 32751, United States

Location

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, 33407, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Kurume Clinical Pharmacology Clinic

Kurume, Fukuoka, 830-0011, Japan

Location

Clinical Research Hospital, Tokyo

Shinjuku-Ku, Tokyo, 162-0053, Japan

Location

San Jorge Children and Women's Hospital- Shipping Location

San Juan, PR, 00912, Puerto Rico

Location

Related Publications (1)

  • 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.

    PMID: 33565026DERIVED

Related Links

MeSH Terms

Conditions

Migraine Disorders

Interventions

lasmiditan

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 17, 2019

Study Start

July 22, 2019

Primary Completion

January 19, 2020

Study Completion

February 24, 2020

Last Updated

September 1, 2020

Results First Posted

September 1, 2020

Record last verified: 2020-05-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)PR(1)US(8)