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

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ClinicalTrials.gov Identifier: NCT04396236
Recruitment Status : Recruiting
First Posted : May 20, 2020
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 18, 2020
First Posted Date  ICMJE May 20, 2020
Last Update Posted Date July 16, 2021
Actual Study Start Date  ICMJE March 12, 2020
Estimated Primary Completion Date November 4, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
Percentage of Participants with Pain Freedom (High Dose) [ Time Frame: 2 Hours Postdose ]
Percentage of Participants with Pain Freedom (High Dose)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
  • Percentage of Participants with Pain Freedom (Mid Dose) [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Freedom (Mid Dose)
  • Percentage of Participants with Pain Freedom (Low Dose) [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Freedom (Low Dose)
  • Percentage of Participants with Pain Freedom (Age Sub-Groups) [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Freedom (Age Sub-Groups)
  • Percentage of Participants with Pain Relief [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Relief
  • Percentage of Participants Most Bothersome Symptom (MBS)-Free [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants MBS-Free
  • Percentage of Participants Nausea-Free [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants Nausea-Free
  • Percentage of Participants Photophobia-Free [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants Photophobia-Free
  • Percentage of Participants Phonophobia-Free [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants Phonophobia-Free
  • Percentage of Participants with Sustained Pain Freedom [ Time Frame: 24 Hours Postdose ]
    Percentage of Participants with Sustained Pain Freedom
  • Percentage of Participants with Sustained Pain Freedom [ Time Frame: 48 Hours Postdose ]
    Percentage of Participants with Sustained Pain Freedom
  • Percentage of Participants Using Additional Medication for Migraine [ Time Frame: 24 Hours Postdose ]
    Percentage of Participants Using Additional Medication for Migraine
  • Percentage of Participants Using Additional Medication for Migraine [ Time Frame: 48 Hours Postdose ]
    Percentage of Participants Using Additional Medication for Migraine
  • 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")
  • 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"
Original Secondary Outcome Measures  ICMJE Same as current
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) Treatment in Children Aged 6 to 17 With Migraine
Official Title  ICMJE Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Lasmiditan
    Administered orally
    Other Name: LY573144
  • Drug: Placebo
    Administered orally
Study Arms  ICMJE
  • Experimental: Lasmiditan High Dose
    Lasmiditan administered orally with matching placebo to maintain the blind.
    Interventions:
    • Drug: Lasmiditan
    • Drug: Placebo
  • Experimental: Lasmiditan Mid Dose
    Lasmiditan administered orally with matching placebo to maintain the blind.
    Interventions:
    • Drug: Lasmiditan
    • Drug: Placebo
  • Experimental: Lasmiditan Low Dose
    Lasmiditan administered orally with matching placebo to maintain the blind.
    Interventions:
    • Drug: Lasmiditan
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Placebo administered orally.
    Intervention: Drug: Placebo
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2020)
1646
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 4, 2024
Estimated Primary Completion Date November 4, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States,   Belgium,   Canada,   France,   Germany,   India,   Italy,   Japan,   Mexico,   Netherlands,   Puerto Rico,   Romania,   Russian Federation,   Spain,   United Kingdom
Removed Location Countries Czechia
 
Administrative Information
NCT Number  ICMJE NCT04396236
Other Study ID Numbers  ICMJE 16927
H8H-MC-LAHV ( Other Identifier: Eli Lilly and Company )
2019-004378-24 ( EudraCT Number )
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: 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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
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 Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date July 1, 2021

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