A Study of LY2951742 (Galcanezumab) in Japanese Participa... | NCT02959190 | Trialant
NCT02959190
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 29, 2020Actual
Enrollment
311Actual
Phase
Phase 3
Conditions
Migraine
Interventions
Galcanezumab
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT02959190
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16108
Secondary IDs
ID
Type
Description
Link
I5Q-JE-CGAP
Other Identifier
Eli Lilly and Company
Brief Title
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine
Official Title
A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 (Galcanezumab) in Japanese Patients With Migraine
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 2019
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
Feb 7, 2017Actual
Primary Completion Date
Aug 10, 2019Actual
Completion Date
Aug 10, 2019Actual
First Submitted Date
Nov 7, 2016
First Submission Date that Met QC Criteria
Nov 7, 2016
First Posted Date
Nov 8, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 7, 2020
Results First Submitted that Met QC Criteria
Aug 7, 2020
Results First Posted Date
Aug 24, 2020Actual
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
Sep 8, 2020
Last Update Posted Date
Sep 29, 2020Actual
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 main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.
Detailed Description
Not provided
Conditions Module
Conditions
Migraine
Keywords
prevention
prophylaxis
headache
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
311Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
120mg/120mg Galcanezumab - Episodic Migraine (EM)
Experimental
240 milligram (loading dose) of Galcanezumab at first dosing visit followed by 120 milligram (mg) once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
Drug: Galcanezumab
240mg/240mg Galcanezumab - EM
Experimental
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
Drug: Galcanezumab
Placebo/ 120mg Galcanezumab - EM
Experimental
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
Drug: Galcanezumab
Placebo/ 240mg Galcanezumab - EM
Experimental
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
Drug: Galcanezumab
120mg Galcanezumab - CM
Experimental
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Galcanezumab
Drug
Administered SC
120mg Galcanezumab - CM
120mg/120mg Galcanezumab - Episodic Migraine (EM)
240mg Galcanezumab - CM
240mg/240mg Galcanezumab - EM
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Up To 16 Months
Secondary Outcomes
Measure
Description
Time Frame
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Serum Concentration of Galcanezumab at month 12 is reported.
Month 12: Predose
Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.
Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
Exclusion Criteria:
For Chronic Migraine participants:
Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
Current use or prior exposure to Galcanezumab or other antibodies of calcitonin gene-related peptide (CGRP) or its receptor.
Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.
Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).
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)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Takeshima T, Doi H, Ooba S, Tanji Y, Ozeki A, Komori M. Clinical Evaluation After Discontinuation of Galcanezumab in Japanese Patients with Episodic and Chronic Migraine: Analysis of a Randomized, Placebo-Controlled Trial and Open-label Extension Study. Neurol Ther. 2024 Jun;13(3):697-714. doi: 10.1007/s40120-024-00602-z. Epub 2024 Apr 6.
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 european union (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.
Episodic migraine (EM) participants rolled over from parental Study I5Q-JE-CGAN (CGAN - NCT02959177)), and chronic migraine (CM) participants were newly enrolled in this CGAP study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
120 mg Galcanezumab EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by subcutaneous (SC) injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase.
FG001
Periods
Title
Milestones
Reasons Not Completed
Open Label
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
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: CGAP Protocol
Sep 2, 2016
May 30, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
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
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: Galcanezumab
240mg Galcanezumab - CM
Experimental
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Drug: Galcanezumab
Placebo/ 120mg Galcanezumab - EM
Placebo/ 240mg Galcanezumab - EM
LY2951742
Plasma Concentration of total CGRP at month 12 is reported.
Month 12: Predose
Percentage of Participants Developing Anti-Drug Antibodies (ADA)
Treatment emergent ADA will be defined as any of the following:
A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA.
A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA.
Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days Postdose
Mean Change From Baseline in the Number of Migraine Headache Days (MHDs)
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.
Migraine Headache (EM Participants): A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): 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; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia.
Migraine Headache (CM Participants) : A headache, with or without aura, of greater than or equal to (≥30) minutes duration which meets criteria A and B or meets criterion C: A and B criteria as described above and criteria C) The headache is believed by the participant to be migraine at onset and is relieved by a triptan or ergot derivative.
Baseline, Month 12
Mean Change From Baseline in the Number of Headache Days (HDs)
A headache day is calendar day on which any type of headache occurs,(including migraine headache, probable migraine headache, and non-migraine headache).
Baseline, Month 12
Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval.
Month 12
Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache
Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.
Baseline, Month 12
Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache
Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache: Calendar days on which headache, migraine or probable migraine occurs, requiring acute medication.
Baseline, Month 12
Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill").
Baseline, Month 12
Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability.
Baseline, Month 12
Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
MSQ version 2.1 is a health status instrument,with a 4-week recall period,developed to address physical & emotional limitations of specific concern to individuals with migraine.Addressing the impact of migraine on work or daily activities,relationships with family & friends,leisure time,productivity,concentration, energy,tiredness & feelings.It consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.
Baseline, Month 12
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects.Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment (5 categories). Preference compared the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study" (5 categories). The side effects responses range from "significantly less side effects" to "significantly more side effects" (5 categories). Positive responses for each item were defined as follows: Satisfaction: "Very Satisfied" or "Somewhat Satisfied"; Preference: "Much Prefer Study Medication" or "Prefer Study Medication"; Side Effects: "Much-Less Side Effects" or "Less Side Effects".
Month 12
Japan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fukui
918 8503
Japan
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Fukuoka
816 0824
Japan
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Higashiosaka
578-8588
Japan
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Hiroshima
730-0031
Japan
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Ibaraki
300-1206
Japan
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Iruma-Gun
350-0495
Japan
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Kagawa
769-0103
Japan
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Kagoshima
892-0842
Japan
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Kagoshima
892-0844
Japan
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Kaisho
400-0124
Japan
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Kanoya
893-0032
Japan
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Kasaoka-shi
714-0043
Japan
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Kasuga-shi
816-0802
Japan
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Kobe
658-0064
Japan
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Kochi
780-0051
Japan
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Kochi
780-8011
Japan
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Kyoto
600-8811
Japan
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Kyoto
606-0851
Japan
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Minatoku
108-8642
Japan
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Morioka
020-0034
Japan
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Morioka
020-8505
Japan
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Narashino-shi
275-0026
Japan
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Nishinomiya
663-8014
Japan
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Nishinomiya
663-8204
Japan
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Okayama
700-8557
Japan
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Osaka
556-0015
Japan
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Ota-shi
373-8585
Japan
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Ōita
870-0831
Japan
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Ōsaka
560-0012
Japan
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Ōta-ku
145-0063
Japan
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Saijo-shi
793-0030
Japan
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Saitama
338-8577
Japan
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Sapporo
003-0003
Japan
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Sapporo
060-8570
Japan
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Sendai
Japan
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Shibuya-ku
151-0051
Japan
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Shinjuku-ku
160-0017
Japan
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Shizuoka
420-0853
Japan
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Tachikawa-shi
190-8531
Japan
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Tochigi
321-0207
Japan
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Tochigi
321-0293
Japan
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Tokyo
160-8582
Japan
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Yamaguchi
754-0002
Japan
Derived
Hirata K, Takeshima T, Sakai F, Tatsuoka Y, Suzuki N, Igarashi H, Nakamura T, Ozeki A, Yamazaki H, Skljarevski V. A long-term open-label safety study of galcanezumab in Japanese patients with migraine. Expert Opin Drug Saf. 2021 Jun;20(6):721-733. doi: 10.1080/14740338.2021.1866536. Epub 2021 Jan 4.
240 mg Galcanezumab EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab or placebo. Participants did not receive any intervention during post-treatment follow-up phase.
FG002
120 mg Galcanezumab CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase.
FG003
240 mg Galcanezumab CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled. Participants did not receive any intervention during post-treatment follow-up phase.
FG000120 subjects
FG001126 subjects
FG00232 subjects
FG00333 subjects
Received at Least 1 Dose of Study Drug
FG000120 subjects
FG001126 subjects
FG00232 subjects
FG00333 subjects
120mg/120mg Galcanezumab - EM
FG00058 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
240mg/240mg Galcanezumab - EM
FG0000 subjects
FG00162 subjects
FG0020 subjects
FG0030 subjects
Placebo/ 120mg Galcanezumab - EM
FG00062 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Placebo/ 240mg Galcanezumab - EM
FG0000 subjects
FG00164 subjects
FG0020 subjects
FG0030 subjects
COMPLETED
FG000113 subjects
FG001110 subjects
FG00228 subjects
FG00327 subjects
NOT COMPLETED
FG0007 subjects
FG00116 subjects
FG0024 subjects
FG0036 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0017 subjects
FG0023 subjects
FG0034 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
Withdrawal by Subject
FG0002 subjects
FG0018 subjects
FG0020 subjects
FG0030 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
Post Treatment Follow Up
Type
Comment
Milestone Data
STARTED
FG000117 subjectsParticipants who discontinued open-label treatment phase had an option to enter post treatment phase
FG001120 subjectsParticipants who discontinued open-label treatment phase had an option to enter post treatment phase
FG00232 subjectsParticipants who discontinued open-label treatment phase had an option to enter post treatment phase
FG00332 subjectsParticipants who discontinued open-label treatment phase had an option to enter post treatment phase
COMPLETED
FG000114 subjects
FG001119 subjects
FG00231 subjects
FG00332 subjects
NOT COMPLETED
FG0003 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG003
All participants who were randomized and received at least 1 dose of the study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
BG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
BG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
BG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
BG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
BG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00058
BG00162
BG00262
BG00364
BG00432
BG00533
BG006311
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
BG00044.95± 10.04
BG00145.47± 9.79
BG00245.35± 10.69
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00048
BG00152
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
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
Japan
Title
Measurements
BG00058
BG00162
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
Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
All participants who were randomized and received at least 1 dose of the study drug.
Posted
Number
participants
Up To 16 Months
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab..
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00058
OG00162
OG00262
OG003
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00054
OG00156
OG00254
OG003
Secondary
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
Serum Concentration of Galcanezumab at month 12 is reported.
All participants who were randomized and received at least 1 dose of the study drug and had evaluable galcanezumab PK data.
Posted
Mean
Standard Deviation
nanogram/milliliter (ng/mL)
Month 12: Predose
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
OG003
Placebo/ 240mg Galcanezumab - EM
Secondary
Pharmacodynamics (PD): Plasma Concentration of Total Calcitonin Gene-Related Peptide (CGRP)
Plasma Concentration of total CGRP at month 12 is reported.
All participants who were randomized and received at least 1 dose of the study drug and had measurable CGRP concentrations.
Posted
Mean
Standard Deviation
ng/mL
Month 12: Predose
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
OG003
Placebo/ 240mg Galcanezumab - EM
Secondary
Percentage of Participants Developing Anti-Drug Antibodies (ADA)
Treatment emergent ADA will be defined as any of the following:
A negative baseline result and a positive post-baseline ADA result with a titer ≥20. This is also called treatment-induced ADA.
A positive baseline result and a positive post-baseline ADA result with a ≥4-fold increase in titers (for example, baseline titer of 10 increasing to ≥40 post-baseline). This is called treatment-boosted ADA.
All participants who were randomized and received at least 1 dose of the study drug and had evaluable immunogenicity data.
Posted
Number
percentage of participants
Month 0, 1, 2, 3, 6, 9, 12 and 16: Predose; Month 0 and 14 days Postdose
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
Secondary
Mean Change From Baseline in the Number of Migraine Headache Days (MHDs)
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.
Migraine Headache (EM Participants): A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): 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; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia.
Migraine Headache (CM Participants) : A headache, with or without aura, of greater than or equal to (≥30) minutes duration which meets criteria A and B or meets criterion C: A and B criteria as described above and criteria C) The headache is believed by the participant to be migraine at onset and is relieved by a triptan or ergot derivative.
All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Posted
Mean
Standard Deviation
MHDs
Baseline, Month 12
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
Secondary
Mean Change From Baseline in the Number of Headache Days (HDs)
A headache day is calendar day on which any type of headache occurs,(including migraine headache, probable migraine headache, and non-migraine headache).
All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Posted
Mean
Standard Deviation
Headache days (HDs)
Baseline, Month 12
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
OG003
Secondary
Percentage of Participants With Meeting Criteria for Reductions From Baseline Greater Than or Equal to (≥) 50% in Number of Migraine Headache Days
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. A 50% responder in a particular month is any participant who has a ≥50% reduction from baseline in the monthly number of migraine headache attacks in a 30-day interval.
All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Posted
Number
Percentage of participants
Month 12
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
Secondary
Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache
Migraine Headache Day (MHD) with Acute Medication Use: Calendar days on which migraine or probable migraine occurs, requiring acute medication.
All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Posted
Mean
Standard Deviation
MHDs with medication use
Baseline, Month 12
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
Secondary
Mean Change From Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache
Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache: Calendar days on which headache, migraine or probable migraine occurs, requiring acute medication.
All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Posted
Mean
Standard Deviation
MHDs and HDs with medication use
Baseline, Month 12
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
Secondary
Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill").
All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Month 12
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
Secondary
Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability.
All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Month 12
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Secondary
Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
MSQ version 2.1 is a health status instrument,with a 4-week recall period,developed to address physical & emotional limitations of specific concern to individuals with migraine.Addressing the impact of migraine on work or daily activities,relationships with family & friends,leisure time,productivity,concentration, energy,tiredness & feelings.It consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), & are reverse-recoded (value 6 to 1) before the domain scores are calculated.Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After total raw score is computed for each domain & total score, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.
All participants who were randomized and received at least 1 dose of the study drug and had baseline and at least one post baseline value.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Month 12
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
Secondary
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects.Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment (5 categories). Preference compared the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study" (5 categories). The side effects responses range from "significantly less side effects" to "significantly more side effects" (5 categories). Positive responses for each item were defined as follows: Satisfaction: "Very Satisfied" or "Somewhat Satisfied"; Preference: "Much Prefer Study Medication" or "Prefer Study Medication"; Side Effects: "Much-Less Side Effects" or "Less Side Effects".
All participants who were randomized and received at least 1 dose of the study drug and had month 12 PSMQ-M measurement.
Posted
Number
Percentage of participants
Month 12
ID
Title
Description
OG000
120mg/120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
OG001
Time Frame
Up To 16 Months
Description
All participants who were randomized and received at least 1 dose of the study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants (pts) rolled over from CGAN (NCT02959177) 120 mg Galcanezumab.
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
0
62
0
62
56
62
EG002
Placebo/ 120mg Galcanezumab - Open-Label Treatment - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected48 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Amnesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Cerebral arteriosclerosis
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected58 at risk
EG0010 events0 affected62 at risk
EG0022 events2 affected62 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Head discomfort
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0012 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Intracranial aneurysm
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Migraine
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Occipital neuralgia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0012 events1 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Syncope
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Thunderclap headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected48 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Frustration tolerance decreased
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Middle insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Stress
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cervical polyp
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected48 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Menopausal disorder
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected48 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Menopausal symptoms
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected48 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected48 at risk
EG0010 events0 affected52 at risk
EG0021 events1 affected51 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected48 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected48 at risk
EG0011 events1 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Allergic bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Choking sensation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0022 events2 affected62 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0012 events2 affected62 at risk
EG0022 events2 affected62 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Asteatosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Cold urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0023 events1 affected62 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected58 at risk
EG0012 events2 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Eczema nummular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Erythema annulare
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Haemorrhage subcutaneous
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0012 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Nail bed bleeding
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Onychalgia
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Onychomadesis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0002 events1 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0005 events1 affected58 at risk
EG0014 events4 affected62 at risk
EG0023 events3 affected62 at risk
EG003
Urticaria chronic
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Urticaria thermal
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Appendicectomy
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Bone graft
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Cervical polypectomy
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected48 at risk
EG0010 events0 affected52 at risk
EG0020 events0 affected51 at risk
EG003
Cholecystectomy
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Endodontic procedure
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Haemorrhoid operation
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Intervertebral disc operation
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Ligament operation
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Lipectomy
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Mastectomy
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Polypectomy
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Removal of foreign body
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Sinus operation
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Skin cyst excision
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Tendon sheath incision
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0010 events0 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Tooth extraction
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0011 events1 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Wisdom teeth removal
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected58 at risk
EG0010 events0 affected62 at risk
EG0020 events0 affected62 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected58 at risk
EG0012 events2 affected62 at risk
EG0021 events1 affected62 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The sponsor can review the study result with PIs prior to public release and can embargo a communication about it until the public release by the contract with Investigator sites.
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00056
OG00153
OG00258
OG00357
OG00428
OG00527
Title
Denominators
Categories
Title
Measurements
OG00021100± 6120
OG00146000± 15300
OG00221000± 7290
OG00342200± 12400
OG00420100± 8550
OG00539600± 13600
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00056
OG00153
OG00258
OG00357
OG00428
OG00527
Title
Denominators
Categories
Title
Measurements
OG0004.51± 1.26
OG0015.87± 1.45
OG0024.69± 1.45
OG0035.59± 1.45
OG0044.37± 1.40
OG0055.19± 1.52
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00058
OG00162
OG00262
OG00364
OG00432
OG00533
Title
Denominators
Categories
Title
Measurements
OG00012.07
OG0019.68
OG00216.13
OG00310.94
OG00412.50
OG00518.18
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00056
OG00153
OG00258
OG00357
OG00428
OG00527
Title
Denominators
Categories
Title
Measurements
OG000-1.82± 2.96
OG001-1.49± 4.11
OG002-4.29± 4.07
OG003-3.23± 5.81
OG004-9.44± 6.16
OG005-8.97± 8.06
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00056
OG00153
OG00258
OG00357
OG00428
OG00527
Title
Denominators
Categories
Title
Measurements
OG000-2.37± 3.62
OG001-1.75± 4.57
OG002-5.04± 4.71
OG003-4.00± 5.14
OG004-9.30± 6.83
OG005-9.42± 8.37
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00047
OG00146
OG00255
OG00356
OG00428
OG00527
Title
Denominators
Categories
Title
Measurements
OG00048.9
OG00145.7
OG00252.7
OG00346.4
OG00435.7
OG00551.9
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00056
OG00153
OG00258
OG00357
OG00428
OG00527
Title
Denominators
Categories
Title
Measurements
OG000-1.40± 2.54
OG001-1.00± 3.59
OG002-3.87± 3.84
OG003-3.01± 5.76
OG004-8.36± 6.29
OG005-7.43± 7.89
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00056
OG00153
OG00258
OG00357
OG00428
OG00527
Title
Denominators
Categories
Title
Measurements
OG000-1.62± 3.21
OG001-1.17± 3.89
OG002-4.47± 4.81
OG003-3.43± 5.53
OG004-8.21± 6.84
OG005-7.48± 8.21
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00056
OG00153
OG00258
OG00357
OG00428
OG00527
Title
Denominators
Categories
Title
Measurements
OG000-0.29± 0.76
OG001-0.04± 0.76
OG002-0.02± 0.66
OG0030.11± 0.77
OG004-0.07± 1.59
OG005-0.81± 1.14
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00056
OG00153
OG00258
OG00357
OG00428
OG00527
Title
Denominators
Categories
Title
Measurements
OG000-0.38± 8.99
OG001-0.42± 15.94
OG002-8.67± 17.39
OG003-4.60± 12.77
OG004-20.71± 32.66
OG005-15.48± 32.26
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.
Units
Counts
Participants
OG00056
OG00153
OG00258
OG00357
OG00428
OG00527
Title
Denominators
Categories
Total Score
Title
Measurements
OG0001.02± 8.68
OG0010.38± 11.97
OG0027.51± 10.58
OG0034.56± 11.22
OG00419.23± 12.57
OG00518.31± 15.67
Role Function-Restrictive Domain
Title
Measurements
OG0001.68± 9.77
OG0010.22± 13.75
OG0028.77± 12.74
OG003
Role Function-Preventive Domain
Title
Measurements
OG0000.09± 9.70
OG0010.75± 13.17
OG0027.16± 10.18
OG003
Emotional Function Domain
Title
Measurements
OG0000.71± 10.54
OG0010.25± 11.47
OG0025.06± 11.47
OG003
240mg/240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) 240 mg Galcanezumab.
OG002
Placebo/ 120mg Galcanezumab - EM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. EM participants rolled over from CGAN (NCT02959177) placebo.
OG003
Placebo/ 240mg Galcanezumab - EM
240 mg Galcanezumab given SC once a month for a year. EM participants rolled over from CGAN (NCT02959177) Placebo.
OG004
120mg Galcanezumab - CM
240 mg (loading dose) of Galcanezumab at first dosing visit followed by 120 mg once a month for a year by SC injection. Participants with CM were enrolled.
OG005
240mg Galcanezumab - CM
240 mg Galcanezumab given SC once a month for a year. Participants with CM were enrolled.