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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03988088
Recruitment Status : Completed
First Posted : June 17, 2019
Results First Posted : September 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Migraine Drug: Lasmiditan Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine
Actual Study Start Date : July 22, 2019
Actual Primary Completion Date : January 19, 2020
Actual Study Completion Date : February 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Lasmiditan
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
Administered orally.
Other Name: LY573144




Primary Outcome Measures :
  1. 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 ]
    Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.

  2. 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 ]
    PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC[0-∞]) of Lasmiditan.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988088


Locations
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United States, Arizona
Perserverance Research Center
Scottsdale, Arizona, United States, 85254
United States, California
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States, 92663
United States, Connecticut
New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, Florida
Meridien Research
Bradenton, Florida, United States, 34201
Meridien Research
Maitland, Florida, United States, 32751
Qps-Mra, Llc
South Miami, Florida, United States, 33143
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States, 33407
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Japan
Kurume Clinical Pharmacology Clinic
Kurume, Fukuoka, Japan, 830-0011
Clinical Research Hospital, Tokyo
Shinjuku-Ku, Tokyo, Japan, 162-0053
Puerto Rico
San Jorge Children and Women's Hospital- Shipping Location
San Juan, Puerto Rico, 00912
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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 Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol: LAHX 05 Protocol  [PDF] March 29, 2019
Statistical Analysis Plan  [PDF] July 15, 2019

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03988088    
Other Study ID Numbers: 16932
H8H-MC-LAHX ( Other Identifier: Eli Lilly and Company )
First Posted: June 17, 2019    Key Record Dates
Results First Posted: September 1, 2020
Last Update Posted: September 1, 2020
Last Verified: May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases