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A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS2)

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lasmiditan
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring acute, long-term, open label, safety

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Research AssociatesRecruiting
  • Rehabilitation & Neurological ServicesRecruiting
  • XenoscienceRecruiting
  • Phoenix Children's HospitalRecruiting
  • Perseverance Research CenterRecruiting
  • Velocity Clinical Research, ProvidenceRecruiting
  • Arkansas Children'sRecruiting
  • Core Healthcare GroupRecruiting
  • Sun Valley Research CenterRecruiting
  • Miller Children's & Women's Hospital Long BeachRecruiting
  • Sensa HealthRecruiting
  • Orange County Research Institute - OntarioRecruiting
  • Medical Center for Clinical ResearchRecruiting
  • Children's Hospital ColoradoRecruiting
  • Colorado Springs Neurological AssociatesRecruiting
  • New England Institute for Clinical ResearchRecruiting
  • Wolfson Children's HospitalRecruiting
  • Clinical Neuroscience Solutions, Inc. dba CNS HealthcareRecruiting
  • Accel Research Sites - Maitland Clinical Research UnitRecruiting
  • University of Miami Don Suffer Clinical Research BuildingRecruiting
  • Biotech Pharmaceutical GroupRecruiting
  • New Horizon Research CenterRecruiting
  • Ezy Medical ResearchRecruiting
  • Suncoast Clinical Research, Inc.Recruiting
  • Sensible Healthcare, LLCRecruiting
  • Avanza Medical Research CenterRecruiting
  • Clinical Research Center of Florida
  • USF HealthRecruiting
  • ForCare Clinical ResearchRecruiting
  • Meridian Clinical Research, LLCRecruiting
  • Rophe Adult and Pediatric Medicine/SKYCRNGRecruiting
  • Hawaii Pacific NeuroscienceRecruiting
  • Medical Research PartnersRecruiting
  • St Luke's Meridian Medical CenterRecruiting
  • Velocity Clinical Research, Boise
  • Chicago Headache Center and Research InstituteRecruiting
  • St. Alexius Medical CenterRecruiting
  • Fort Wayne Neurological Center - WestRecruiting
  • Josephson Wallack Munshower Neurology, PCRecruiting
  • Deaconess Clinic - Gateway Health CenterRecruiting
  • Integrated Clinical Trial Services, Inc.Recruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • University of Kentucky Chandler Medical CenterRecruiting
  • Velocity Clinical Research, Metairie
  • Children's Hospital New OrleansRecruiting
  • Pharmasite Research, Inc.Recruiting
  • ActivMed Practices and ResearchRecruiting
  • MedVadis Research CorporationRecruiting
  • New England Regional headache Center, IncRecruiting
  • Great Lakes Research Group, Inc.Recruiting
  • Michigan State UniversityRecruiting
  • Minneapolis Clinic of Neurology - Burnsville OfficeRecruiting
  • Children's Mercy HospitalRecruiting
  • Clinvest Research LLCRecruiting
  • Rochester Clinical Research, Inc.Recruiting
  • Monroe Biomedical ResearchRecruiting
  • Accellacare - Winston-SalemRecruiting
  • Headache Center of HopeRecruiting
  • IPS Research CompanyRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Frontier Clinical Research, LLC
  • Frontier Clinical Research, LLC
  • Velocity Clinical Research, ProvidenceRecruiting
  • Tribe Clinical Research, LLCRecruiting
  • ARC Clinical Research at Wilson ParkeRecruiting
  • Driscoll Children's HospitalRecruiting
  • Pain and Headache Centers of TexasRecruiting
  • ClinPoint TrialsRecruiting
  • Alliance for Multispecialty Research, LLCRecruiting
  • Northwest Clinical Research CenterRecruiting
  • Core Clinical Research
  • Seattle Children's HospitalRecruiting
  • Seattle Women's: Health, Research, Gynecology
  • Frontier Clinical ResearchRecruiting
  • UZ BrusselRecruiting
  • Ziekenhuis Oost-Limburg, Campus St.-JanRecruiting
  • Private Practice - Dr. Sava Simona
  • CHU Strasbourg-HautepierreRecruiting
  • Centre Hospitalier Général de Mont de Marsan - Hôpital LaynéRecruiting
  • Hôpital Armand TrousseauRecruiting
  • Universitaetsklinikum FreiburgRecruiting
  • Private Practice - Dr. Irma SchöllRecruiting
  • Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-HospitalRecruiting
  • G.B. Pant Institute of Postgraduate Medical Education & ResearchRecruiting
  • Sir Ganga Ram HospitalRecruiting
  • Panchshil hospitalRecruiting
  • Artemis hospitalRecruiting
  • Mangala Hospital & Mangala Kidney FoundationRecruiting
  • Lillestol ResearchRecruiting
  • All India Institute of Medical Sciences (AIIMS) - NagpurRecruiting
  • Deenanath Mangeshkar Hospital & Research CentreRecruiting
  • Bhakti Vedanta Hospital and Research InstituteRecruiting
  • A.O.Universitaria MeyerRecruiting
  • Ospedale Filippo del Ponte VareseRecruiting
  • Konan HospitalRecruiting
  • Nishinomiya Municipal Central HospitalRecruiting
  • Hyogo College of MedicineRecruiting
  • Sendai Headache and Neurology ClinicRecruiting
  • Shinagawa Strings ClinicRecruiting
  • Tokyo Medical University HospitalRecruiting
  • Nagaseki Headache ClinicRecruiting
  • Hiroshima City HospitalRecruiting
  • Tanaka Neurosurgical ClinicRecruiting
  • Umenotsuji ClinicRecruiting
  • Tatsuoka Neurology ClinicRecruiting
  • Japanese Red Cross Kyoto Daiichi HospitalRecruiting
  • Tominaga HospitalRecruiting
  • Tokyo Headache ClinicRecruiting
  • PanAmerican Clinical Research - GuadalajaraRecruiting
  • AGNI Research and Assessment S.C.Recruiting
  • Centro de Investigacion Medica AguascalientesRecruiting
  • Unidad de Investigación en SaludRecruiting
  • Isala, locatie ZwolleRecruiting
  • Dr. Samuel Sanchez PSCRecruiting
  • Puerto Rico Health InstituteRecruiting
  • Ponce Medical School Foundation Inc.Recruiting
  • Wellness clinical Research Vega BajaRecruiting
  • Limited Liability Company University Clinic of headachesRecruiting
  • Saint-Petersburg State Pediatric Medical UniversityRecruiting
  • First Moscow State Medical University I.M. SechenovRecruiting
  • Hospital General Universitario Gregorio MarañonRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario La Paz-NEURORecruiting
  • University Hospital LewishamRecruiting
  • Great Ormond Street Hospital For Children NHS Foundation TrustRecruiting
  • James Paget University HospitalRecruiting
  • Queen's Medical Centre, Nottingham University HospitalsRecruiting
  • Royal Hospital for Sick ChildrenRecruiting
  • Stepping Hill HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lasmiditan Dose 1

Lasmiditan Dose 2

Arm Description

Lasmiditan administered orally.

Lasmiditan administered orally.

Outcomes

Primary Outcome Measures

Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack
Percentage of TEAEs by Treated Migraine Attack
Percentage of Participants with Discontinuations Due to Adverse Events (AEs)
Percentage of Participants with Discontinuations Due to AEs

Secondary Outcome Measures

Percentage of Treated Attacks with Pain Freedom at 2 Hours
Percentage of Treated Attacks with Pain Freedom at 2 Hours
Percentage of Treated Attacks with Pain Relief at 2 Hours
Percentage of Treated Attacks with Pain Relief at 2 Hours
Percentage of Treated Attacks with MBS Freedom at 2 Hours
Percentage of Treated Attacks with Most Bothersome Symptom (MBS) Freedom at 2 Hours

Full Information

First Posted
May 18, 2020
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04396574
Brief Title
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
Acronym
PIONEER-PEDS2
Official Title
A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
January 31, 2031 (Anticipated)
Study Completion Date
January 31, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
acute, long-term, open label, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lasmiditan Dose 1
Arm Type
Experimental
Arm Description
Lasmiditan administered orally.
Arm Title
Lasmiditan Dose 2
Arm Type
Experimental
Arm Description
Lasmiditan administered orally.
Intervention Type
Drug
Intervention Name(s)
Lasmiditan
Other Intervention Name(s)
LY573144
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Percentage of Treatment Emergent Adverse Events (TEAEs) by Treated Migraine Attack
Description
Percentage of TEAEs by Treated Migraine Attack
Time Frame
Baseline through 12 Months
Title
Percentage of Participants with Discontinuations Due to Adverse Events (AEs)
Description
Percentage of Participants with Discontinuations Due to AEs
Time Frame
Baseline through 12 Months
Secondary Outcome Measure Information:
Title
Percentage of Treated Attacks with Pain Freedom at 2 Hours
Description
Percentage of Treated Attacks with Pain Freedom at 2 Hours
Time Frame
12 Months
Title
Percentage of Treated Attacks with Pain Relief at 2 Hours
Description
Percentage of Treated Attacks with Pain Relief at 2 Hours
Time Frame
12 Months
Title
Percentage of Treated Attacks with MBS Freedom at 2 Hours
Description
Percentage of Treated Attacks with Most Bothersome Symptom (MBS) Freedom at 2 Hours
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There will be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Central Research Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Henry Johnston
Facility Name
Rehabilitation & Neurological Services
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belinda Savage-Edwards, MD
Facility Name
Xenoscience
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Alta Tobin
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
602-933-2264
First Name & Middle Initial & Last Name & Degree
Robert Little
Facility Name
Perseverance Research Center
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
allan block
Facility Name
Velocity Clinical Research, Providence
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinesh Talwar
Facility Name
Arkansas Children's
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
501-364-1850
First Name & Middle Initial & Last Name & Degree
Aravindhan Veerapandiyan
Facility Name
Core Healthcare Group
City
Cerritos
State/Province
California
ZIP/Postal Code
90703-2751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
562-924-8880
First Name & Middle Initial & Last Name & Degree
Francisco Badar
Facility Name
Sun Valley Research Center
City
Imperial
State/Province
California
ZIP/Postal Code
92251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
760-545-0123
First Name & Middle Initial & Last Name & Degree
Bernardo Ng
Facility Name
Miller Children's & Women's Hospital Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmin Dao
Facility Name
Sensa Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Choi
Facility Name
Orange County Research Institute - Ontario
City
Ontario
State/Province
California
ZIP/Postal Code
91762
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
909-395-9788
First Name & Middle Initial & Last Name & Degree
Rosario Retino MD
Facility Name
Medical Center for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92108-5899
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
619-521-2830
First Name & Middle Initial & Last Name & Degree
Todd Simmons
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcy Yonker
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christen Kutz
Facility Name
New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
203-914-1903
First Name & Middle Initial & Last Name & Degree
Peter McAllister
Facility Name
Wolfson Children's Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
904-697-3665
First Name & Middle Initial & Last Name & Degree
Raj Sheth
Facility Name
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nandita Jones
Facility Name
Accel Research Sites - Maitland Clinical Research Unit
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva-Maria Heurich
Facility Name
University of Miami Don Suffer Clinical Research Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Horn
Facility Name
Biotech Pharmaceutical Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doris Diaz
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lazaro D. Nunez
Facility Name
Ezy Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Paoli-Bruno
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary M Goldstein
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Nanette Taylor
Facility Name
Avanza Medical Research Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randall E Reese
Facility Name
Clinical Research Center of Florida
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Individual Site Status
Completed
Facility Name
USF Health
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kavita Kalidas
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seth Benjamin Forman
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine McNaughton Moretz
Facility Name
Rophe Adult and Pediatric Medicine/SKYCRNG
City
Union City
State/Province
Georgia
ZIP/Postal Code
30291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne L. Smith, MD
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kore Liow
Facility Name
Medical Research Partners
City
Ammon
State/Province
Idaho
ZIP/Postal Code
83406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Reed Moore
Facility Name
St Luke's Meridian Medical Center
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Smith
Facility Name
Velocity Clinical Research, Boise
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Completed
Facility Name
Chicago Headache Center and Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley Torphy
Facility Name
St. Alexius Medical Center
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdul Mazin
Facility Name
Fort Wayne Neurological Center - West
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Haller
Facility Name
Josephson Wallack Munshower Neurology, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keith R Ridel
Facility Name
Deaconess Clinic - Gateway Health Center
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R Michelle Galen
Facility Name
Integrated Clinical Trial Services, Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Coggi
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy Ray Klein
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharoon Qaiser
Facility Name
Velocity Clinical Research, Metairie
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert J Jeanfreau
Facility Name
Children's Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Gautreaux
Facility Name
Pharmasite Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Herts
Facility Name
ActivMed Practices and Research
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Shoeck
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02154
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David DiBenedetto
Facility Name
New England Regional headache Center, Inc
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605 0160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
508-890-5633
First Name & Middle Initial & Last Name & Degree
Herbert Markley
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Potts
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
517-884-8922
First Name & Middle Initial & Last Name & Degree
Suad Khalil
Facility Name
Minneapolis Clinic of Neurology - Burnsville Office
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajiv Aggarwal
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Jones
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Gregory True
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Gilruth Davis
Facility Name
Monroe Biomedical Research
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Awawu Igbinadolor
Facility Name
Accellacare - Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Gareth Isaac
Facility Name
Headache Center of Hope
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hope O'Brien
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louise M. Thurman
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaitlin Greene
Facility Name
Frontier Clinical Research, LLC
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Michael Pluto
Facility Name
Frontier Clinical Research, LLC
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcy Jo Goisse
Facility Name
Velocity Clinical Research, Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
401-739-9350
First Name & Middle Initial & Last Name & Degree
David Fried
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Robert Dobson, MD
Facility Name
ARC Clinical Research at Wilson Parke
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Chantal Caviness
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos Valdez
Facility Name
Pain and Headache Centers of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Ummat
Facility Name
ClinPoint Trials
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peggy Linguist
Facility Name
Alliance for Multispecialty Research, LLC
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig K. Julien
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007-4209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
425-453-0404
First Name & Middle Initial & Last Name & Degree
Arifulla Khan, MD
Facility Name
Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidi Blume
Facility Name
Seattle Women's: Health, Research, Gynecology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Completed
Facility Name
Frontier Clinical Research
City
Kingwood
State/Province
West Virginia
ZIP/Postal Code
26537
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Coral Daniel
Facility Name
UZ Brussel
City
Brussels
State/Province
Bruxelles-Capitale, Région De
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Regal
Facility Name
Ziekenhuis Oost-Limburg, Campus St.-Jan
City
Genk
State/Province
Vlaams Gewest
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
Phone
3289321423
First Name & Middle Initial & Last Name & Degree
Leen Wouters
Facility Name
Private Practice - Dr. Sava Simona
City
Saint-Nicolas
State/Province
Wallonne, Région
ZIP/Postal Code
4460
Country
Belgium
Individual Site Status
Completed
Facility Name
CHU Strasbourg-Hautepierre
City
Strasbourg
State/Province
Bas-Rhin
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Aude Spitz
Facility Name
Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
City
Mont-de-Marsan
State/Province
Landes
ZIP/Postal Code
40024
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadège BACHERE
Facility Name
Hôpital Armand Trousseau
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Dugué
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg im Breisgau
State/Province
Baden-Württemberg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janbernd Kirschner
Facility Name
Private Practice - Dr. Irma Schöll
City
Bad Homburg
State/Province
Hessen
ZIP/Postal Code
61348
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elvira Steidl
Facility Name
Klinik für Kinder- und Jugendmedizin der Ruhr-Universität Bochum im St. Josef-Hospital
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Luecke
Facility Name
G.B. Pant Institute of Postgraduate Medical Education & Research
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debashish Chowdhury
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohtagi Anshu
Facility Name
Panchshil hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380005
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddharth Shah
Facility Name
Artemis hospital
City
Gurugram
State/Province
Haryana
ZIP/Postal Code
122003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumit Singh
Facility Name
Mangala Hospital & Mangala Kidney Foundation
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shankara Nellikunja
Facility Name
Lillestol Research
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prafulla Keshaorao Shembalkar
Facility Name
All India Institute of Medical Sciences (AIIMS) - Nagpur
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
441108
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meenakshi Girish
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
91204023000
First Name & Middle Initial & Last Name & Degree
Rahul Kulkarni
Facility Name
Bhakti Vedanta Hospital and Research Institute
City
Thane
State/Province
Maharashtra
ZIP/Postal Code
401107
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omkar Hajirnis
Facility Name
A.O.Universitaria Meyer
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renzo Guerrini
Facility Name
Ospedale Filippo del Ponte Varese
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiano Termine
Facility Name
Konan Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
658-0064
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigekazu Kitamura
Facility Name
Nishinomiya Municipal Central Hospital
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8014
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Maeda
Facility Name
Hyogo College of Medicine
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideki Shimomura
Facility Name
Sendai Headache and Neurology Clinic
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
982-0014
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuhiko Matsumori
Facility Name
Shinagawa Strings Clinic
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoko Sanno
Facility Name
Tokyo Medical University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaku Yamanaka
Facility Name
Nagaseki Headache Clinic
City
Kai
State/Province
Yamanashi
ZIP/Postal Code
400-0124
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshishige Nagaseki
Facility Name
Hiroshima City Hospital
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kentaro Kuwabara
Facility Name
Tanaka Neurosurgical Clinic
City
Kagoshima
ZIP/Postal Code
892-0844
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shigeya Tanaka
Facility Name
Umenotsuji Clinic
City
Kochi
ZIP/Postal Code
780-8011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Yamada
Facility Name
Tatsuoka Neurology Clinic
City
Kyoto
ZIP/Postal Code
600-8811
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshihisa Tatsuoka
Facility Name
Japanese Red Cross Kyoto Daiichi Hospital
City
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akira Nishimura
Facility Name
Tominaga Hospital
City
Osaka
ZIP/Postal Code
556-0017
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81120023812
First Name & Middle Initial & Last Name & Degree
Takao Takeshima
Facility Name
Tokyo Headache Clinic
City
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazutaka Shimizu
Facility Name
PanAmerican Clinical Research - Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44690
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ixiu del Carmen Cabrales Guerra
Facility Name
AGNI Research and Assessment S.C.
City
Cuernavaca
State/Province
Morelos
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
7771339434
First Name & Middle Initial & Last Name & Degree
Alejandro Olmos López
Facility Name
Centro de Investigacion Medica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20116
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarug Reyes Morales
Facility Name
Unidad de Investigación en Salud
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avril Molina Garcia
Facility Name
Isala, locatie Zwolle
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jolita Bekhof
Facility Name
Dr. Samuel Sanchez PSC
City
Caguas
ZIP/Postal Code
727
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Cruz
Facility Name
Puerto Rico Health Institute
City
Dorado
ZIP/Postal Code
00646
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elham Shana Ghorbani
Facility Name
Ponce Medical School Foundation Inc.
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odette Olivieri Ramos
Facility Name
Wellness clinical Research Vega Baja
City
Vega Baja
ZIP/Postal Code
00694
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Rafael Albizu Angulo
Facility Name
Limited Liability Company University Clinic of headaches
City
Moscow
State/Province
Moskva
ZIP/Postal Code
121467
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirill Skorobogatykh
Facility Name
Saint-Petersburg State Pediatric Medical University
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
194100
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vyacheslav Chasnyk
Facility Name
First Moscow State Medical University I.M. Sechenov
City
Moscow
ZIP/Postal Code
123317
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergeev Alexey
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estibaliz Barredo Valderrama
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34913908626
First Name & Middle Initial & Last Name & Degree
Noemi Nunez Enamorado
Facility Name
Hospital Universitario La Paz-NEURO
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34917277444
First Name & Middle Initial & Last Name & Degree
Manuel Lara Lara
Facility Name
University Hospital Lewisham
City
London
State/Province
London, City Of
ZIP/Postal Code
SE13 6LH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Nyirenda
Facility Name
Great Ormond Street Hospital For Children NHS Foundation Trust
City
Bloomsbury
State/Province
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
Phone
4420740592000182
First Name & Middle Initial & Last Name & Degree
Prab Prabhakar
Facility Name
James Paget University Hospital
City
Great Yarmouth
State/Province
Norfolk
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
john chapman
Facility Name
Queen's Medical Centre, Nottingham University Hospitals
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Whitehouse
Facility Name
Royal Hospital for Sick Children
City
Glagow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ishaq Abu-Arafeh
Facility Name
Stepping Hill Hospital
City
Stockport
ZIP/Postal Code
SK2 7JE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chris cooper

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/F62T11Ido5SUiPl26NA8f
Description
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS2)

Learn more about this trial

A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

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