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Trial record 17 of 22 for:    pediatric migraine | Recruiting Studies | Child

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 : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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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 : November 3, 2025
Estimated Study Completion Date : November 3, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine

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




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



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 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

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
Show Show 172 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
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: November 18, 2020
Last Verified: November 2020
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