Back to resultsA Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine (CHALLENGE-MIG)
Primary Purpose
Migraine, Episodic Migraine
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Galcanezumab
Placebo
Rimegepant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)
Exclusion Criteria:
- Have a known hypersensitivity to rimegepant or galcanezumab, and their excipients, monoclonal antibodies or other therapeutic proteins
- Have acute cardiovascular events and/or serious cardiovascular risk, or have had myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary angioplasty.
- Evidence of significant psychiatric disease by medical history, such as schizophrenia, personality disorders, or other serious mood or anxiety disorders.
- Women who are pregnant or nursing
- Current use or prior exposure to any calcitonin gene related peptide (CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)
Sites / Locations
- Gilbert Neurology
- Foothills Research Center / CCT Research
- Alliance for Multispecialty Research, LLC Tempe
- Velocity Clinical Research, Banning
- Velocity Clinical Research, Chula Vista
- Wr- Pri, Llc
- Velocity Clinical Research, San Diego
- California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility)
- Pharmacology Research Institute
- Velocity Clinical Research, North Hollywood
- Anderson Clinical Research
- Center for Clinical Trials of Sacramento
- Velocity Clinical Research, Huntington Park
- Encompass Clinical Research
- CMR of Greater New Haven, LLC
- Innovative Research of West Florida
- AMR Miami
- Accel Research Sites- Clinical Research Unit
- Velocity Clinical Research, Hallandale Beach
- Accel Research Sites-LKD CRU
- Visionary Investigators Network
- Visionary Investigators Network
- Sensible Healthcare, LLC
- University of South Florida
- Palm Beach Research Center
- DelRicht Research
- Better Health Clinical Research
- Meridian Clinical Research
- Chicago Headache Center
- American Health Network of Indiana, LLC - Avon
- Deaconess Clinic
- Alliance for Multispecialty Research, LLC El Dorado
- Alliance for Multispecialty Research, LLC Lexington
- L-MARC Research Center
- DelRicht Research
- DelRicht Research
- DelRicht Research
- Boston Clinical Trials
- Michigan Headache & Neurological Institute
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
- MedPharmics, LLC
- Healthcare Research Network - St. Louis
- Alliance for Multispecialty Research, LLC
- Albuquerque Clinical Trials, Inc.
- Dent Neurosciences Research Center (Research Facility)
- Rochester Clinical Research, Inc.
- North Carolina Clinical Research
- NeuroScience Research Center, LLC
- Dayton Center for Neurological Disorders
- Neurology Diagnostics, Inc.
- Tekton Research
- Lynn Institute of Norman
- Lynn Health Science Institute
- DelRicht Research
- Tekton Research
- Velocity Clinical Research, Grants Pass (Research Facility)
- Velocity Clinical Research - Medford
- Velocity Clinical Research, Providence
- Tribe Clinical Research, LLC
- Premier Neurology Research, P.C.
- Coastal Carolina Research Center
- Alliance for Multispecialty Research, LLC
- Clinical Research Associates
- Tekton Research (Research Facility)
- FutureSearch Trials of Neurology
- ACRC Trials
- ACRC Trials
- Velocity Clinical Research, Austin
- Ventavia Research Group
- Accurate Clinical Management - Houston
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
- Ventavia Research Group - Keller
- ACRC Trials
- Alpine Research Organization
- Advanced Clinical Research
- Alliance for Multispecialty Research, LLC - AMR Norfolk
- Northwest Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Galcanezumab
Rimegepant
Arm Description
Galcanezumab administered subcutaneously (SC). Placebo for rimegepant will be used for blinding.
Rimegepant administered oral disintegrating tablets (ODT). Placebo for galcanezumab will be used for blinding.
Outcomes
Primary Outcome Measures
Mean Monthly Percentage of Participants with a 50% Response Rate
The mean monthly percentage of participants will be an average of month 1 through month 3 response percentages where response is defined with ≥50% reduction from baseline in monthly migraine headache days
Secondary Outcome Measures
Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Overall mean change from baseline in the number of monthly migraine headache days
Mean Monthly Percentage of Participants with a 75% Response Rate
The mean monthly percentage of participants will be an average of month 1 through month 3 response percentages where response is defined with ≥75% reduction from baseline in monthly migraine headache days
Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Mean change from baseline in the number of monthly migraine headache days
Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Mean change from baseline in the number of monthly migraine headache days
Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Mean change from baseline in the number of monthly migraine headache days
Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
Overall mean change from baseline in the number of monthly migraine headache days requiring medication for the acute treatment of migraine or headache
Mean Change from Baseline in the Role Function-Restrictive (RF-R) Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Mean Change from Baseline in the Role Function-Restrictive (RF-R) domain score of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)
Mean Monthly Percentage of Participants with a 100% Response Rate
The mean monthly percentage of participants will be an average of month 1 through month 3 response percentages where response is defined with 100% reduction from baseline in monthly migraine headache days
Change from Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Total Score
Change from baseline in MSQ v2.1 total score
Change from baseline in Role Function-Preventive (RF-P) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Change from baseline in RF-P Domain Score of MSQ v2.1
Change from Baseline in Emotional Function (EF) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Change from baseline in EF domain score of MSQ v2.1
Change from Baseline in MIDAS (Migraine Disability Assessment) Total Score
Change from baseline in MIDAS total score
Full Information
NCT ID
NCT05127486
First Posted
November 3, 2021
Last Updated
August 22, 2023
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT05127486
Brief Title
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
Acronym
CHALLENGE-MIG
Official Title
A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants With Episodic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
May 23, 2023 (Actual)
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
No
5. Study Description
Brief Summary
The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. The study duration will be approximately 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine, Episodic Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
587 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Galcanezumab
Arm Type
Experimental
Arm Description
Galcanezumab administered subcutaneously (SC).
Placebo for rimegepant will be used for blinding.
Arm Title
Rimegepant
Arm Type
Active Comparator
Arm Description
Rimegepant administered oral disintegrating tablets (ODT).
Placebo for galcanezumab will be used for blinding.
Intervention Type
Drug
Intervention Name(s)
Galcanezumab
Other Intervention Name(s)
LY2951742
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered ODT
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Intervention Description
Administered ODT
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Mean Monthly Percentage of Participants with a 50% Response Rate
Description
The mean monthly percentage of participants will be an average of month 1 through month 3 response percentages where response is defined with ≥50% reduction from baseline in monthly migraine headache days
Time Frame
Month 1 through Month 3
Secondary Outcome Measure Information:
Title
Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Description
Overall mean change from baseline in the number of monthly migraine headache days
Time Frame
Baseline, Month 1 through Month 3
Title
Mean Monthly Percentage of Participants with a 75% Response Rate
Description
The mean monthly percentage of participants will be an average of month 1 through month 3 response percentages where response is defined with ≥75% reduction from baseline in monthly migraine headache days
Time Frame
Month 1 through Month 3
Title
Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Description
Mean change from baseline in the number of monthly migraine headache days
Time Frame
Baseline, 1 Month
Title
Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Description
Mean change from baseline in the number of monthly migraine headache days
Time Frame
Baseline, 2 Months
Title
Mean Change from Baseline in the Number of Monthly Migraine Headache Days
Description
Mean change from baseline in the number of monthly migraine headache days
Time Frame
Baseline, 3 Months
Title
Overall Mean Change from Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
Description
Overall mean change from baseline in the number of monthly migraine headache days requiring medication for the acute treatment of migraine or headache
Time Frame
Baseline, Month 1 through Month 3
Title
Mean Change from Baseline in the Role Function-Restrictive (RF-R) Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Description
Mean Change from Baseline in the Role Function-Restrictive (RF-R) domain score of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)
Time Frame
Baseline, 3 Months
Title
Mean Monthly Percentage of Participants with a 100% Response Rate
Description
The mean monthly percentage of participants will be an average of month 1 through month 3 response percentages where response is defined with 100% reduction from baseline in monthly migraine headache days
Time Frame
Month 1 through Month 3
Title
Change from Baseline in Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) Total Score
Description
Change from baseline in MSQ v2.1 total score
Time Frame
Baseline, 3 Months
Title
Change from baseline in Role Function-Preventive (RF-P) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Description
Change from baseline in RF-P Domain Score of MSQ v2.1
Time Frame
Baseline, 3 Months
Title
Change from Baseline in Emotional Function (EF) Domain Score of Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1)
Description
Change from baseline in EF domain score of MSQ v2.1
Time Frame
Baseline, 3 Months
Title
Change from Baseline in MIDAS (Migraine Disability Assessment) Total Score
Description
Change from baseline in MIDAS total score
Time Frame
Baseline, 3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of migraine, with or without aura, as determined by the study investigator and in consideration of International Headache Society International Classification of Headache Disorders - 3rd edition guidelines (ICHD-3 2018)
Exclusion Criteria:
Have a known hypersensitivity to rimegepant or galcanezumab, and their excipients, monoclonal antibodies or other therapeutic proteins
Have acute cardiovascular events and/or serious cardiovascular risk, or have had myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary angioplasty.
Evidence of significant psychiatric disease by medical history, such as schizophrenia, personality disorders, or other serious mood or anxiety disorders.
Women who are pregnant or nursing
Current use or prior exposure to any calcitonin gene related peptide (CGRP) antagonist (small molecule or antibody) for any indication, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antagonist (small molecule or antibody)
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 Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Gilbert Neurology
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Foothills Research Center / CCT Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC Tempe
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Velocity Clinical Research, Banning
City
Banning
State/Province
California
ZIP/Postal Code
99202
Country
United States
Facility Name
Velocity Clinical Research, Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Wr- Pri, Llc
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Velocity Clinical Research, San Diego
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Velocity Clinical Research, North Hollywood
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Center for Clinical Trials of Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Velocity Clinical Research, Huntington Park
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
CMR of Greater New Haven, LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
Innovative Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
AMR Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Accel Research Sites- Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Velocity Clinical Research, Hallandale Beach
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Accel Research Sites-LKD CRU
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33803
Country
United States
Facility Name
Visionary Investigators Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Visionary Investigators Network
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Sensible Healthcare, LLC
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
DelRicht Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Better Health Clinical Research
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Meridian Clinical Research
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Chicago Headache Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
American Health Network of Indiana, LLC - Avon
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
Deaconess Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
L-MARC Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
DelRicht Research
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
DelRicht Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
Country
United States
Facility Name
DelRicht Research
City
Prairieville
State/Province
Louisiana
ZIP/Postal Code
70769
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Michigan Headache & Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
MedPharmics, LLC
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
Healthcare Research Network - St. Louis
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Dent Neurosciences Research Center (Research Facility)
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
NeuroScience Research Center, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Dayton Center for Neurological Disorders
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Neurology Diagnostics, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Tekton Research
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Lynn Institute of Norman
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
DelRicht Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Tekton Research
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Velocity Clinical Research, Grants Pass (Research Facility)
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Facility Name
Velocity Clinical Research - Medford
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Velocity Clinical Research, Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Premier Neurology Research, P.C.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tekton Research (Research Facility)
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
ACRC Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
ACRC Trials
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Velocity Clinical Research, Austin
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Ventavia Research Group
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Accurate Clinical Management - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
Dynamed Clinical Research, LP d/b/a DM Clinical Research
City
Humble
State/Province
Texas
ZIP/Postal Code
77064
Country
United States
Facility Name
Ventavia Research Group - Keller
City
Keller
State/Province
Texas
ZIP/Postal Code
76248
Country
United States
Facility Name
ACRC Trials
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Alpine Research Organization
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC - AMR Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
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 European Union (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/muhFfaGNSBYar2xzfLSZR
Description
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine (CHALLENGE-MIG)
Learn more about this trial
A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine
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