A Study of Lasmiditan (LY573144) Treatment in Children Ag... | NCT04396236

ID	Type	Description	Link
H8H-MC-LAHV	Other Identifier	Eli Lilly and Company
2019-004378-24	EudraCT Number

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated due to strategic business decision

Expanded Access Info

Start Date

Jun 15, 2020Actual

Primary Completion Date

Nov 12, 2025Actual

Completion Date

Nov 12, 2025Actual

First Submitted Date

May 18, 2020

First Submission Date that Met QC Criteria

May 18, 2020

First Posted Date

May 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2026

Last Update Posted Date

Mar 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

851Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lasmiditan High Dose	Experimental	Lasmiditan administered orally with matching placebo to maintain the blind.	Drug: Lasmiditan Drug: Placebo
Lasmiditan Mid Dose	Experimental	Lasmiditan administered orally with matching placebo to maintain the blind.	Drug: Lasmiditan Drug: Placebo
Lasmiditan Low Dose	Experimental	Lasmiditan administered orally with matching placebo to maintain the blind.	Drug: Lasmiditan Drug: Placebo
Placebo	Placebo Comparator	Placebo administered orally.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lasmiditan	Drug	Administered orally	Lasmiditan High Dose Lasmiditan Low Dose Lasmiditan Mid Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Pain Freedom (High Dose)	Percentage of Participants with Pain Freedom (High Dose)	2 Hours Postdose

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants with Pain Freedom (Mid Dose)	Percentage of Participants with Pain Freedom (Mid Dose)	2 Hours Postdose
Percentage of Participants with Pain Freedom (Low Dose)	Percentage of Participants with Pain Freedom (Low Dose)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Research Associates		Birmingham	Alabama	35205	United States
Rehabilitation & Neurological Services

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

IPD Sharing Statement Module

Plan to Share IPD

Yes

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.

Types

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/

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 8, 2026			Jun 3, 2026	99
Jun 25, 2026

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases