A Study of Galcanezumab (LY2951742) in Participants With... | NCT03963232 | Trialant
NCT03963232
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Mar 28, 2023Actual
Enrollment
520Actual
Phase
Phase 3
Conditions
Episodic Migraine
Interventions
Galcanezumab
Placebo
Countries
China
India
Russia
Protocol Section
Identification Module
NCT ID
NCT03963232
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
17054
Secondary IDs
ID
Type
Description
Link
I5Q-MC-CGAX
Other Identifier
Eli Lilly and Company
Brief Title
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study
Acronym
PERSIST
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Mar 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 30, 2019Actual
Primary Completion Date
Jul 27, 2021Actual
Completion Date
Mar 11, 2022Actual
First Submitted Date
May 16, 2019
First Submission Date that Met QC Criteria
May 23, 2019
First Posted Date
May 24, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jun 29, 2022
Results First Submitted that Met QC Criteria
Jul 27, 2022
Results First Posted Date
Aug 19, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 1, 2023
Last Update Posted Date
Mar 28, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The reason for this study is to see if the drug galcanezumab is safe and effective in participants with episodic migraine. The study will last about 53 weeks and may include up to 12 visits.
Detailed Description
Not provided
Conditions Module
Conditions
Episodic Migraine
Keywords
prevention
prophylactic
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
520Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Double-blind treatment phase: Participants received placebo once per month subcutaneously (SC) for 3 months.
Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 milligram (mg) loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Drug: Placebo
Galcanezumab 120 mg
Experimental
Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.
Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Drug: Galcanezumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Galcanezumab
Drug
Administered SC
Galcanezumab 120 mg
LY2951742
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
MHD is a calendar day on which a migraine or probable migraine (a headache missing 1 of the migraine features) occurred. Per International Headache Society [IHS] International Classification of Headache Disorders 3rd edition [ICHD-3], migraine is defined as a headache, with or without aura, of ≥30 minutes duration with the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Overall mean is derived from the average of months 1 to 3 with Least square (LS) mean change calculated using mixed model repeat measures (MMRM) model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, 3 Months
Secondary Outcomes
Measure
Description
Time Frame
Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
Participant having:
30% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 30% response rate to treatment or "30% responder."
50% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 50% response rate to treatment or "50% responder."
75% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 75% response rate to treatment or "75% responder."
100% reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 100% response rate to treatment or "100% responder." Overall mean is derived from the average of months 1 to 3 using generalized linear mixed model (GLIMMIX) with the fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariate of baseline value.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participants must have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 (1.1 or 1.2) (ICHD-3 2018) with a history of migraine of at least 1 year prior to screening and migraine onset prior to age 50
Prior to screening, participants must have a history of 4-14 migraine headache days and at least 2 migraine attacks per month on average within the past 3 months
Exclusion Criteria:
Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody
Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (for example, adalimumab, infliximab, trastuzumab, bevacizumab, etc.)
Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab
Women who are pregnant or nursing
History of chronic migraine, daily persistent headache, cluster headache, medication overuse headache, migraine with brainstem aura, or hemiplegic migraine
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Zhou J, Zhong L, Chowdhury D, Skorobogatykh K, Luo G, Yang X, Zhang M, Sun L, Liu H, Qian C, Yu S. Galcanezumab in patients with episodic migraine: results from the open-label period of the phase 3 PERSIST study. J Headache Pain. 2023 Aug 4;24(1):103. doi: 10.1186/s10194-023-01613-1.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
The study was designed to be conducted in three phases: a 3-month double-blind treatment phase, an optional 3-month open-label treatment phase and a 4-month follow-up phase.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Double-blind treatment phase: Participants received placebo once per month SC for 3 months during this phase.
Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Periods
Title
Milestones
Reasons Not Completed
Double-Blind Treatment Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jan 10, 2020
Apr 4, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Placebo
Drug
Administered SC
Placebo
3 Months
Overall Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ v2.1) During the Double-blind Treatment Phase.
MSQ v2.1 is a self-administered instrument that was developed to address physical, emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains: Role Function-Restrictive (items 1-7), Role Function- Preventive (items 8-11) and Emotional Function (items 12-14). All item responses ranges from 1 (none of the time) to 6 (all of the time). Total raw scores for each domain is the sum of the raw scores of each item in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, 3 Months
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Headache During the Double-blind Treatment Phase.
Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, 3 Months
Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase.
Number of monthly headache days is the number of calendar days in a 30-day period on which a headache occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, 3 Months
Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase.
Percentage of participants who maintained 50% response rate to treatment in all 3 months of the double-blind treatment phase.
Month 1 to Month 3
Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase.
Number of monthly migraine attacks is the number of sets of consecutive days with migraine or probable migraine separated by at least one migraine-free day in a 30-day period day. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, 3 Months
Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase.
Number of monthly migraine headache hours is the total number of headache hours in a 30-day period on days when a migraine or probable migraine occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, 3 Months
Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase.
Number of monthly headache hours is the total number of headache hours in a 30-day period on which a headache occurred. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, 3 Months
Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase.
Severity of Migraine Headache was measured on a headache severity scale ranging from 1 to 3 with 1=mild, 2=moderate, and 3=severe. The mean severity of migraine headache for each month will be calculated as: sum of severity of migraine headache days divided by number of migraine headache days. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, 3 Months
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase.
PGI-S is a 7-point scale that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options range from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean change was calculated using analysis of variance (ANCOVA) model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, Month 3
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase.
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on migraineurs' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean change was calculated using ANCOVA model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Baseline, Month 3
Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase.
A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer >= 20.
Baseline to Month 3
Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase.
PK: Serum concentration of galcanezumab
Month 3
Beijing
Beijing Municipality
100853
China
The First Affiliated Hospital Chongqing Medical University
Chongqing
Chongqing Municipality
400016
China
Guangzhou First People's Hospital
Guangzhou
Guangdong
510180
China
The Affiliated Hospital of Guiyang Medical College
Guiyang
Guizhou
550004
China
The First Affiliated Hospital of Zhengzhou Universtiy
Zhengzhou
Henan
450052
China
Wuhan Union Hospital
Wuhan
Hubei
430022
China
Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
Wuhan
Hubei
430030
China
Xiangya Hospital, Central South University
Changsha
Hunan
410008
China
The First Affliated Hospital of Soochow University
Suzhou
Jiangsu
215000
China
Affiliated Hospital of Jiangsu University
Zhenjiang
Jiangsu
212000
China
Pingxiang People's Hospital
Pingxiang
Jiangxi
337000
China
No.2 Hospital Affiliated to Jilin University
Changchun
Jilin
130041
China
Tianjin Huanhu Hospital
Tianjin
Jinnan District
300350
China
Jiangsu Province Hospital
Nanjing
Nanjing
210029
China
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
710061
China
Jinan Central Hospital
Jinan
Shandong
250013
China
People's hospital of Rizhao
Rizhao
Shandong
276826
China
Shanghai East Hospital
Shanghai
Shanghai Municipality
20000
China
Zhongshan Hospital, Fudan University
Shanghai
Shanghai Municipality
200032
China
HuaShan Hospital Affiliated To Fudan University
Shanghai
Shanghai Municipality
20040
China
West China Hospital Sichuan University
Chengdu
Sichuan
610041
China
Tianjin Medical University General Hospital
Tianjin
Tianjin Municipality
300052
China
First Affiliated Hospital of Kunming Medical University
Kunming
Yunnan
650032
China
Zhejiang Hospital
Hangzhou
Zhejiang
310013
China
Bao Tou Central Hospital
Baotou
Zizhiqu
014040
China
Apollo Hospitals International Ltd.
Ahmedabad
Gujarat
382428
India
Artemis Hospital
Gurgaon
Haryana
122001
India
Mangala Hospitals & Mangala Kidney Foundation
Mangalore
Karnataka
575003
India
CHL - Apollo Hospital
Indore
Madh Prad
452008
India
Getwell Hospital & Research Institute
Nagpur
Maharashtra
440012
India
HCG Manavata Cancer Centre
Nashik
Maharashtra
422001
India
Deenanath Mangeshkar Hospital & Research Centre
Pune
Maharashtra
411004
India
All India Institute of Medical Sciences
New Delhi
National Capital Territory of Delhi
110029
India
Sir Ganga Ram Hospital
New Delhi
National Capital Territory of Delhi
110060
India
Gobind Ballabh Pant Hospital
New Delhi
110002
India
First Moscow State Medical University n.a. Sechenov
Moscow
119991
Russia
University Headache Clinic
Moscow
121467
Russia
OOO "Medis"
Nizhny Novgorod
603137
Russia
Academician I.P. Pavlov First St-Petersburg State Medical University
Saint Petersburg
197022
Russia
FG001
Galcanezumab 120mg
Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.
Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
FG000259 subjects
FG001261 subjects
Received at Least One Dose of Study Drug
FG000259 subjects
FG001261 subjects
COMPLETED
FG000242 subjects
FG001245 subjects
NOT COMPLETED
FG00017 subjects
FG00116 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0016 subjects
Protocol Violation
FG0001 subjects
FG0011 subjects
Pregnancy
FG0002 subjects
FG0011 subjects
Withdrawal by Subject
FG00013 subjects
FG0015 subjects
Physician Decision
FG0001 subjects
FG0013 subjects
Open-Label Treatment Phase
Type
Comment
Milestone Data
STARTED
FG000241 subjectsParticipants from double-blind treatment phase had the option to enter the open-label treatment phase or proceed directly to the follow-up phase.
FG001243 subjectsParticipants from double-blind treatment phase had the option to enter the open-label treatment phase or proceed directly to the follow-up phase.
COMPLETED
FG000234 subjects
FG001232 subjects
NOT COMPLETED
FG0007 subjects
FG00111 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
Protocol Violation
FG0000 subjects
FG001
Follow-up Phase
Type
Comment
Milestone Data
STARTED
FG000243 subjectsParticipants from double-blind or open-label treatment phases entered the follow-up phase.
FG001247 subjectsParticipants from double-blind or open-label treatment phases entered the follow-up phase.
Entered From Double-blind Treatment Phase
FG0007 subjects
FG00111 subjects
Entered From Open-Label Treatment Phase
FG000236 subjects
FG001236 subjects
COMPLETED
FG000236 subjects
FG001238 subjects
NOT COMPLETED
FG0007 subjects
FG0019 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0007 subjects
FG0015 subjects
Protocol Violation
FG0000 subjects
FG001
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Double-blind treatment phase: Participants received placebo once per month SC for 3 months during this phase.
Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
BG001
Galcanezumab 120 mg
Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.
Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000259
BG001261
BG002520
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00036.80± 9.83
BG00137.20± 9.33
BG00237.00± 9.57
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG000196
BG001188
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
China
Title
Measurements
BG000198
BG001198
BG002
Monthly Migraine Headache Days (MHD)
Mean
Standard Deviation
days per month
Title
Denominators
Categories
Title
Measurements
BG0008.34± 2.70
BG0018.16± 2.83
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
MHD is a calendar day on which a migraine or probable migraine (a headache missing 1 of the migraine features) occurred. Per International Headache Society [IHS] International Classification of Headache Disorders 3rd edition [ICHD-3], migraine is defined as a headache, with or without aura, of ≥30 minutes duration with the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Overall mean is derived from the average of months 1 to 3 with Least square (LS) mean change calculated using mixed model repeat measures (MMRM) model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Least Squares Mean
Standard Error
days per month
Baseline, 3 Months
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Units
Counts
Participants
OG000258
OG001260
Title
Denominators
Categories
Title
Measurements
OG000-1.99± 0.23
OG001-3.81± 0.23
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
<.0001
LS Mean Difference
-1.82
Standard Error of the Mean
0.26
2-Sided
95
-2.32
-1.32
Superiority
Secondary
Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
Participant having:
30% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 30% response rate to treatment or "30% responder."
50% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 50% response rate to treatment or "50% responder."
75% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 75% response rate to treatment or "75% responder."
100% reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 100% response rate to treatment or "100% responder." Overall mean is derived from the average of months 1 to 3 using generalized linear mixed model (GLIMMIX) with the fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariate of baseline value.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Mean
Standard Error
Percentage of participants
3 Months
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Secondary
Overall Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ v2.1) During the Double-blind Treatment Phase.
MSQ v2.1 is a self-administered instrument that was developed to address physical, emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains: Role Function-Restrictive (items 1-7), Role Function- Preventive (items 8-11) and Emotional Function (items 12-14). All item responses ranges from 1 (none of the time) to 6 (all of the time). Total raw scores for each domain is the sum of the raw scores of each item in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, 3 Months
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Secondary
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Headache During the Double-blind Treatment Phase.
Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Least Squares Mean
Standard Error
days per month
Baseline, 3 Months
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Secondary
Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase.
Number of monthly headache days is the number of calendar days in a 30-day period on which a headache occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Least Squares Mean
Standard Error
days per month
Baseline, 3 Months
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Units
Counts
Participants
Secondary
Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase.
Percentage of participants who maintained 50% response rate to treatment in all 3 months of the double-blind treatment phase.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Number
percentage of participants
Month 1 to Month 3
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Units
Counts
Participants
OG000
Secondary
Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase.
Number of monthly migraine attacks is the number of sets of consecutive days with migraine or probable migraine separated by at least one migraine-free day in a 30-day period day. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Least Squares Mean
Standard Error
migraine attacks per month
Baseline, 3 Months
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Units
Counts
Secondary
Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase.
Number of monthly migraine headache hours is the total number of headache hours in a 30-day period on days when a migraine or probable migraine occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Least Squares Mean
Standard Error
hours per month
Baseline, 3 Months
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Units
Counts
Secondary
Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase.
Number of monthly headache hours is the total number of headache hours in a 30-day period on which a headache occurred. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Least Squares Mean
Standard Error
hours per month
Baseline, 3 Months
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Units
Counts
Participants
Secondary
Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase.
Severity of Migraine Headache was measured on a headache severity scale ranging from 1 to 3 with 1=mild, 2=moderate, and 3=severe. The mean severity of migraine headache for each month will be calculated as: sum of severity of migraine headache days divided by number of migraine headache days. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline value.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, 3 Months
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Secondary
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase.
PGI-S is a 7-point scale that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options range from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean change was calculated using analysis of variance (ANCOVA) model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline value, non-missing post baseline value at month 3.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 3
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Secondary
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase.
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on migraineurs' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean change was calculated using ANCOVA model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
All randomized participants who received at least one dose of study drug and had baseline value, non-missing post baseline value at month 3.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Month 3
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Secondary
Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase.
A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer >= 20.
All randomized participants who received at least one dose of study drug and had baseline, at least one non-missing post baseline ADA value.
Posted
Number
percentage of participants
Baseline to Month 3
ID
Title
Description
OG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months.
OG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Units
Counts
Participants
Secondary
Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase.
PK: Serum concentration of galcanezumab
All randomized participants who received at least one dose of galcanezumab and had evaluable serum concentrations.
Posted
Mean
Standard Deviation
Nanogram per milliliter (ng/mL)
Month 3
ID
Title
Description
OG000
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
Units
Counts
Participants
OG000
Time Frame
Baseline to Follow-up (Up To 10 months)
Description
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Per protocol, AE analysis was planned per treatment regimen received in each study phase
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo - Double-Blind Treatment Phase
Participants received placebo once per month SC for 3 months during this phase.
0
259
3
259
29
259
EG001
Galcanezumab 120mg - Double-Blind Treatment Phase
Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
After completion of Placebo double-blind phase, participants had an option to enter open-label treatment phase where they received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months.
After completion of Galcanezumab 120mg double-blind phase, participants had an option to enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months.
0
243
3
243
7
243
EG004
Placebo - Follow-up
Participants entered follow-up phase from Placebo double-blind treatment phase and were observed for 4 months. No treatments administered.
0
7
0
7
0
7
EG005
Galcanezumab 120mg - Follow-up
Participants entered follow-up phase from Galcanezumab 120mg double-blind treatment phase and were observed for 4 months. No treatments administered.
0
11
0
11
0
11
EG006
Placebo/Galcanezumab 120mg - Follow-up
Participants entered follow-up phase from Placebo/Galcanezumab 120 mg open-label treatment phase and were observed for 4 months. No treatments administered.
0
236
3
236
0
236
EG007
Galcanezumab 120mg/Galcanezumab 120mg - Follow-up
Participants entered follow-up phase from Galcanezumab 120mg/Galcanezumab 120mg open-label treatment phase and were observed for 4 months. No treatments administered.