Back to resultsA Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
Primary Purpose
Migraine
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Lasmiditan
Sponsored by
About this trial
This is an interventional basic science trial for Migraine
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
Sites / Locations
- Perserverance Research Center
- Newport Beach Clinical Research Associates, Inc.
- New England Institute for Clinical Research
- Meridien Research
- Meridien Research
- Qps-Mra, Llc
- Premiere Research Institute at Palm Beach Neurology
- Children's Hospital of Philadelphia
- Kurume Clinical Pharmacology Clinic
- Clinical Research Hospital, Tokyo
- San Jorge Children and Women's Hospital- Shipping Location
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lasmiditan
Arm Description
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.
Outcomes
Primary Outcome Measures
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03988088
Brief Title
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
2. Study Status
Record Verification Date
May 1, 2020
Overall Recruitment Status
Completed
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
January 19, 2020 (Actual)
Study Completion Date
February 24, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lasmiditan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lasmiditan
Other Intervention Name(s)
LY573144
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Description
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
Title
PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan
Description
PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan.
Time Frame
0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Perserverance Research Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Newport Beach Clinical Research Associates, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Meridien Research
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
Meridien Research
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Qps-Mra, Llc
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Premiere Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Kurume Clinical Pharmacology Clinic
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Clinical Research Hospital, Tokyo
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-0053
Country
Japan
Facility Name
San Jorge Children and Women's Hospital- Shipping Location
City
San Juan
ZIP/Postal Code
00912
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33565026
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.
Results Reference
derived
Links:
URL
https://www.lillytrialguide.com/en-US/studies/migraine/LAHX#?postal=
Description
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
Learn more about this trial
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
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