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出境医 / 临床实验 / A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine

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

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.


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

Study Design
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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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE June 12, 2019
First Posted Date  ICMJE June 17, 2019
Results First Submitted Date  ICMJE August 14, 2020
Results First Posted Date  ICMJE September 1, 2020
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE July 22, 2019
Actual Primary Completion Date January 19, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 12, 2019)
  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan [ Time Frame: 30 Minutes Postdose through 24 Hours Postdose ]
    PK: Cmax of Lasmiditan
  • PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan [ Time Frame: 30 Minutes Postdose through 24 Hours Postdose ]
    PK: AUC[0-∞] of Lasmiditan
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
Official Title  ICMJE A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Pediatric Patients With Migraine
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Migraine
Intervention  ICMJE Drug: Lasmiditan
Administered orally.
Other Name: LY573144
Study Arms  ICMJE 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.
Intervention: Drug: Lasmiditan
Publications * 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 Feb 10. doi: 10.1007/s40262-020-00966-z. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 4, 2020) 		18
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2019) 		21
Actual Study Completion Date  ICMJE February 24, 2020
Actual Primary Completion Date January 19, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03988088
Other Study ID Numbers  ICMJE 16932
H8H-MC-LAHX ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 1, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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