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

March 6, 2026 updated by: Eli Lilly and Company

Pediatric Options for Migraine Relief: A Randomized, Double-Blind, Placebo-Controlled Study of Lasmiditan for Acute Treatment of Migraine: PIONEER-PEDS1

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
851

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • UZ Brussel
      • Ghent, Belgium, 9000
        • UZ Gent
      • Saint-Nicolas, Belgium, 4460
        • Private Practice - Dr. Sava Simona
  • Canada
      • Kelowna, Canada, V1Y 1Z9
        • OCT Research ULC
      • Sarnia, Canada, N7T 4X3
        • Bluewater Clinical Research Group Inc.
  • France
      • Amiens, France, 80054
        • CHU d'Amiens-Picardie - Hôpital Sud
      • Clermont-Ferrand, France, 63100
        • Centre Hospitalier Universitaire Estaing
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Creteil
      • Lille, France, 59037
        • Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro
      • Mont-de-Marsan, France, 40024
        • Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
      • Toulouse, France, 31059
        • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
  • Germany
      • Bad Homburg, Germany, 61348
        • Private Practice - Dr. Irma Schöll
      • Freiburg im Breisgau, Germany, 79106
        • Universitaetsklinikum Freiburg
  • India
      • Ahmedabad, India, 380005
        • Panchshil Hospital
      • Gūrgaon, India, 122003
        • Artemis Hospital
      • Mangalore, India, 575003
        • Mangala Hospital & Mangala Kidney Foundation
      • Nagpur, India, 440012
        • Getwell Hospital and Research Institute
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, India, 110002
        • G.B. Pant Institute of Postgraduate Medical Education & Research
      • Thane, India, 401107
        • Bhakti Vedanta Hospital and Research Institute
  • Italy
      • Bari, Italy, 70123
        • Ospedale San Paolo Bari
      • Milan, Italy, 20133
        • IRCCS Istituto Neurologico Carlo Besta
      • Napoli, Italy, 80131
        • Università degli studi della Campania Luigi Vanvitelli
      • Pavia, Italy, 27100
        • Fondazione Istituto Neurologico C. Mondino
      • Roma, Italy, 00165
        • Ospedale Pediatrico Bambino Gesù
      • Varese, Italy, 21100
        • Ospedale Filippo del Ponte Varese
  • Japan
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hospital
      • Kagoshima, Japan, 890-0052
        • Tanaka Neurosurgery&Headache Clinic
      • Kai, Japan, 400-0124
        • Nagaseki Headache Clinic
      • Kiryū, Japan, 376-0035
        • Hikita Pediatric Clinic
      • Kobe, Japan, 658-0064
        • Konan Hospital
      • Kochi, Japan, 780-8011
        • Umenotsuji Clinic
      • Kyoto, Japan, 605-0981
        • Japanese Red Cross Kyoto Daiichi Hospital
      • Kyoto, Japan, 600-8811
        • Tatsuoka Neurology Clinic
      • Minato, Japan, 108-0075
        • Shinagawa Strings Clinic
      • Nishinomiya, Japan, 663-8501
        • Hyogo College of Medicine
      • Nishinomiya, Japan, 663-8014
        • Nishinomiya Municipal Central Hospital
      • Nishinomiya, Japan, 663-8204
        • Yamaguchi Clinic
      • Osaka, Japan, 556-0017
        • Tominaga Hospital
      • Sendai, Japan, 982-0014
        • Sendai Headache and Neurology Clinic
      • Shinjuku-ku, Japan, 160-0023
        • Tokyo Medical University Hospital
      • Tokyo, Japan, 151-0051
        • Tokyo Headache Clinic
  • Mexico
      • Aguascalientes, Mexico, 20217
        • Centro de Investigacion Medica Aguascalientes
      • Chihuahua City, Mexico, 31203
        • Unidad de Investigacion en Salud
      • Cuernavaca, Mexico, 1203
        • AGNI Research and Assessment S.C.
      • Guadalajara, Mexico, 44690
        • PanAmerican Clinical Research - Guadalajara
      • Mexico City, Mexico, 6720
        • Hospital Infantil de Mexico Federico Gomez
      • Monterrey, Mexico, 66460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Netherlands
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis
      • Zwolle, Netherlands, 8025 AB
        • Isala, locatie Zwolle
  • Puerto Rico
      • Caguas, Puerto Rico, 00727
        • Dr. Samuel Sanchez PSC
      • Dorado, Puerto Rico, 00646
        • Puerto Rico Health Institute
      • Ponce, Puerto Rico, 00716
        • Ponce Medical School Foundation Inc.
      • Vega Baja, Puerto Rico, 00693
        • Wellness clinical Research Vega Baja
  • Romania
      • Bucharest, Romania, 41914
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
      • Constanța, Romania, 900591
        • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
      • Iași, Romania, 700309
        • Spitalul clinic de urgenta pentru copii Sf. Maria
  • Russia
      • Moscow, Russia, 121467
        • Limited Liability Company University Clinic of headaches
      • Novosibirsk, Russia, 630091
        • Sibneyromed Urban Neurological Center
      • Saint Petersburg, Russia, 194100
        • Saint-Petersburg State Pediatric Medical University
  • Spain
      • Barcelona, Spain, 8035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 8041
        • Hospital de la Santa Creu i Sant Pau
      • Esplugues de Llobregat, Spain, 8950
        • Hospital Sant Joan de Deu
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
      • Sabadell, Spain, 8208
        • Hospital Universitari Parc Tauli
      • Seville, Spain, 41013
        • Hospital Universitario Virgen Del Rocio
      • Valladolid, Spain, 47005
        • Hospital Clinico Universitario de Valladolid
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Royal Hospital for Sick Children
      • Great Yarmouth, United Kingdom, NR31 6LA
        • James Paget University Hospital
      • London, United Kingdom, WC1N 3JH
        • Great Ormond Street Hospital For Children NHS Foundation Trust
      • London, United Kingdom, W1G 9JF
        • Re:Cognition Health - London
      • Nottingham, United Kingdom, NG7 2UH
        • Queen's Medical Centre, Nottingham University Hospitals
      • Stockport, United Kingdom, SK2 7JE
        • Stepping Hill Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates
      • Huntsville, Alabama, United States, 35805
        • Rehabilitation & Neurological Services
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
      • Scottsdale, Arizona, United States, 85254
        • Perseverance Research Center
      • Tucson, Arizona, United States, 85718
        • Center for Neurosciences
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's
    • California
      • Cerritos, California, United States, 90703
        • Core Healthcare Group
      • Exeter, California, United States, 93221
        • Pine Street Pediatrics
      • Imperial, California, United States, 92251
        • Sun Valley Research Center
      • Long Beach, California, United States, 90806
        • Miller Children's & Women's Hospital Long Beach
      • Los Angeles, California, United States, 90006
        • Sensa Health
      • Ontario, California, United States, 91762
        • Orange County Research Institute - Ontario
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Neurological Associates
    • Connecticut
      • New Haven, Connecticut, United States, 06501
        • Yale University School of Medicine
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Jacksonville, Florida, United States, 32207
        • Wolfson Children's Hospital
      • Miami, Florida, United States, 33165
        • New Horizon Research Center
      • Miami, Florida, United States, 33155
        • Biotech Pharmaceutical Group
      • Miami Lakes, Florida, United States, 33015
        • Ezy Medical Research
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
      • Pensacola, Florida, United States, 32503
        • Avanza Medical Research Center
      • Pompano Beach, Florida, United States, 33060
        • Clinical Research Center of Florida
      • Tampa, Florida, United States, 33613
        • Forcare Clinical Research
      • Tampa, Florida, United States, 33612
        • USF Health
      • West Palm Beach, Florida, United States, 33407
        • Palm Beach Neurology
      • Winter Park, Florida, United States, 32789
        • Pediatric Neurology P.A.
    • Georgia
      • Savannah, Georgia, United States, 31406
        • Meridian Clinical Research, LLC
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Hawaii Pacific Neuroscience
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Medical Research Partners
      • Meridian, Idaho, United States, 83642
        • Velocity Clinical Research, Boise
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Chicago Headache Center and Research Institute
      • Naperville, Illinois, United States, 60563
        • Chicago Headache Center and Research Institute - Naperville
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Qualmedica Research, LLC
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Neurological Center - West
      • Indianapolis, Indiana, United States, 46256
        • Josephson Wallack Munshower Neurology, PC
      • Newburgh, Indiana, United States, 47630
        • Deaconess Clinic - Gateway Health Center
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Integrated Clinical Trial Services, Inc.
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Qualmedica Research, LLC
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
      • Owensboro, Kentucky, United States, 42301
        • Qualmedica Research, LLC
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital New Orleans
      • New Orleans, Louisiana, United States, 70119
        • Velocity Clinical Research - New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Pharmasite Research, Inc.
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • ActivMed Practices and Research
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
      • Worcester, Massachusetts, United States, 01601
        • New England Regional headache Center, Inc
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Minneapolis Clinic of Neurology - Burnsville Office
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • Springfield, Missouri, United States, 65807
        • Clinvest Research LLC
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • Statesville, North Carolina, United States, 28625
        • Accellacare - Piedmont
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, United States, 45236
        • Headache Center of Hope
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Frontier Clinical Research, LLC
      • Smithfield, Pennsylvania, United States, 15478
        • Frontier Clinical Research, LLC
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Velocity Clinical Research, Providence
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
    • Texas
      • Austin, Texas, United States, 78726
        • ARC Clinical Research at Wilson Parke
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
      • Houston, Texas, United States, 77054
        • Pain and Headache Centers of Texas
      • Waxahachie, Texas, United States, 75165
        • Clinpoint Trials
    • Utah
      • Layton, Utah, United States, 84041
        • Alliance for Multispecialty Research, LLC
      • Logan, Utah, United States, 84341
        • Medical Research Partners - Logan
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Everett, Washington, United States, 98201
        • Core Clinical Research
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
      • Seattle, Washington, United States, 98105
        • Seattle Clinical Research Center
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Marshall Medical Center
      • Kingwood, West Virginia, United States, 26537
        • Frontier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo administered orally.
Drug: Placebo
Administered orally
Experimental: Lasmiditan High Dose
Lasmiditan administered orally with matching placebo to maintain the blind.
Drug: Placebo
Administered orally
Drug: Lasmiditan
Administered orally
Other Names:
  • LY573144
Experimental: Lasmiditan Mid Dose
Lasmiditan administered orally with matching placebo to maintain the blind.
Drug: Placebo
Administered orally
Drug: Lasmiditan
Administered orally
Other Names:
  • LY573144
Experimental: Lasmiditan Low Dose
Lasmiditan administered orally with matching placebo to maintain the blind.
Drug: Placebo
Administered orally
Drug: Lasmiditan
Administered orally
Other Names:
  • LY573144

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Pain Freedom (High Dose)
Time Frame: 2 Hours Postdose
Percentage of Participants with Pain Freedom (High Dose)
2 Hours Postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Pain Freedom (Mid Dose)
Time Frame: 2 Hours Postdose
Percentage of Participants with Pain Freedom (Mid Dose)
2 Hours Postdose
Percentage of Participants with Pain Freedom (Low Dose)
Time Frame: 2 Hours Postdose
Percentage of Participants with Pain Freedom (Low Dose)
2 Hours Postdose
Percentage of Participants with Pain Freedom (Age Sub-Groups)
Time Frame: 2 Hours Postdose
Percentage of Participants with Pain Freedom (Age Sub-Groups)
2 Hours Postdose
Percentage of Participants with Pain Relief
Time Frame: 2 Hours Postdose
Percentage of Participants with Pain Relief
2 Hours Postdose
Percentage of Participants Most Bothersome Symptom (MBS)-Free
Time Frame: 2 Hours Postdose
Percentage of Participants MBS-Free
2 Hours Postdose
Percentage of Participants Nausea-Free
Time Frame: 2 Hours Postdose
Percentage of Participants Nausea-Free
2 Hours Postdose
Percentage of Participants Photophobia-Free
Time Frame: 2 Hours Postdose
Percentage of Participants Photophobia-Free
2 Hours Postdose
Percentage of Participants Phonophobia-Free
Time Frame: 2 Hours Postdose
Percentage of Participants Phonophobia-Free
2 Hours Postdose
Percentage of Participants with Sustained Pain Freedom
Time Frame: 24 Hours Postdose
Percentage of Participants with Sustained Pain Freedom
24 Hours Postdose
Percentage of Participants with Sustained Pain Freedom
Time Frame: 48 Hours Postdose
Percentage of Participants with Sustained Pain Freedom
48 Hours Postdose
Percentage of Participants Using Additional Medication for Migraine
Time Frame: 24 Hours Postdose
Percentage of Participants Using Additional Medication for Migraine
24 Hours Postdose
Percentage of Participants Using Additional Medication for Migraine
Time Frame: 48 Hours Postdose
Percentage of Participants Using Additional Medication for Migraine
48 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")
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")
2 Hours Postdose
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"
24 Hours Postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16927
  • H8H-MC-LAHV (Other Identifier: Eli Lilly and Company)
  • 2019-004378-24 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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