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A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)

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: NCT04396236
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 study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1633 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : June 28, 2024
Estimated Study Completion Date : January 31, 2025

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 High Dose
Lasmiditan administered orally with matching placebo to maintain the blind.
 Drug: Lasmiditan
Administered orally
Other Name: LY573144

Drug: Placebo
Administered orally
Experimental: Lasmiditan Mid Dose
Lasmiditan administered orally with matching placebo to maintain the blind.
 Drug: Lasmiditan
Administered orally
Other Name: LY573144

Drug: Placebo
Administered orally
Experimental: Lasmiditan Low Dose
Lasmiditan administered orally with matching placebo to maintain the blind.
 Drug: Lasmiditan
Administered orally
Other Name: LY573144

Drug: Placebo
Administered orally
Placebo Comparator: Placebo
Placebo administered orally.
 Drug: Placebo
Administered orally


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Pain Freedom (High Dose) [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Freedom (High Dose)


Secondary Outcome Measures :
  1. Percentage of Participants with Pain Freedom (Mid Dose) [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Freedom (Mid Dose)

  2. Percentage of Participants with Pain Freedom (Low Dose) [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Freedom (Low Dose)

  3. Percentage of Participants with Pain Freedom (Age Sub-Groups) [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Freedom (Age Sub-Groups)

  4. Percentage of Participants with Pain Relief [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Relief

  5. Percentage of Participants Most Bothersome Symptom (MBS)-Free [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants MBS-Free

  6. Percentage of Participants Nausea-Free [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants Nausea-Free

  7. Percentage of Participants Photophobia-Free [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants Photophobia-Free

  8. Percentage of Participants Phonophobia-Free [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants Phonophobia-Free

  9. Percentage of Participants with Sustained Pain Freedom [ Time Frame: 24 Hours Postdose ]
    Percentage of Participants with Sustained Pain Freedom

  10. Percentage of Participants with Sustained Pain Freedom [ Time Frame: 48 Hours Postdose ]
    Percentage of Participants with Sustained Pain Freedom

  11. Percentage of Participants Using Additional Medication for Migraine [ Time Frame: 24 Hours Postdose ]
    Percentage of Participants Using Additional Medication for Migraine

  12. Percentage of Participants Using Additional Medication for Migraine [ Time Frame: 48 Hours Postdose ]
    Percentage of Participants Using Additional Medication for Migraine

  13. Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely") [ Time Frame: 2 Hours Postdose ]
    Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely")

  14. Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard" [ Time Frame: 24 Hours Postdose ]
    Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"


Eligibility Criteria
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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 with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria:

    • History of migraine attacks for more than 6 months
    • Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit
    • Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
    • Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator
  • Participant must be able to swallow a tablet
  • For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening
  • 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): NCT04396236


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

Locations
Show Show 175 study locations
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: NCT04396236    
Other Study ID Numbers: 16927
H8H-MC-LAHV ( Other Identifier: Eli Lilly and Company )
2019-004378-24 ( 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
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