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A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04396574
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : May 17, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.

Condition or disease Intervention/treatment Phase
Migraine Drug: Lasmiditan Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Lasmiditan

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lasmiditan Dose 1
Lasmiditan administered orally.
 Drug: Lasmiditan
Administered orally
Other Name: LY573144
Experimental: Lasmiditan Dose 2
Lasmiditan administered orally.
 Drug: Lasmiditan
Administered orally
Other Name: LY573144


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack [ Time Frame: Baseline through 12 Months ]
    Percentage of TEAEs by Treated Migraine Attack

  2. Percentage of Participants with Discontinuations Due to Adverse Events (AEs) [ Time Frame: Baseline through 12 Months ]
    Percentage of Participants with Discontinuations Due to AEs


Secondary Outcome Measures :
  1. Percentage of Treated Attacks with Pain Freedom at 2 Hours [ Time Frame: 12 Months ]
    Percentage of Treated Attacks with Pain Freedom at 2 Hours

  2. Percentage of Treated Attacks with Pain Relief at 2 Hours [ Time Frame: 12 Months ]
    Percentage of Treated Attacks with Pain Relief at 2 Hours

  3. Percentage of Treated Attacks with MBS Freedom at 2 Hours [ Time Frame: 12 Months ]
    Percentage of Treated Attacks with Most Bothersome Symptom (MBS) Freedom at 2 Hours


Eligibility Criteria
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Information from the National Library of Medicine

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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 completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
  • Participants must weigh at least 15 kilograms (kg)

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
Contacts and Locations
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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): NCT04396574


Contacts
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Contact: There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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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 Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04396574    
Other Study ID Numbers: 16930
H8H-MC-LAHW ( Other Identifier: Eli Lilly and Company )
2019-004379-38 ( EudraCT Number )
First Posted: May 20, 2020    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
acute
long-term
open label
safety
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Lasmiditan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs