A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
NCT ID: NCT03988088
Last Updated: 2020-09-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2019-07-22
2020-02-24
Brief Summary
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The study will last about 6 weeks, and includes 4 visits.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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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.
Lasmiditan
Administered orally.
Interventions
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Lasmiditan
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Perserverance Research Center
Scottsdale, Arizona, United States
Newport Beach Clinical Research Associates, Inc.
Newport Beach, California, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Meridien Research
Bradenton, Florida, United States
Meridien Research
Maitland, Florida, United States
Qps-Mra, Llc
South Miami, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Kurume Clinical Pharmacology Clinic
Kurume, Fukuoka, Japan
Clinical Research Hospital, Tokyo
Shinjuku-Ku, Tokyo, Japan
San Jorge Children and Women's Hospital- Shipping Location
San Juan, PR, Puerto Rico
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol: LAHX 05 Protocol
Document Type: Statistical Analysis Plan
Document Type: Study Protocol: LAHX Protocol Addendum (1.1)
Related Links
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A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
Other Identifiers
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H8H-MC-LAHX
Identifier Type: OTHER
Identifier Source: secondary_id
16932
Identifier Type: -
Identifier Source: org_study_id
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