Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGAW | Other Identifier | Eli Lilly and Company | |
| 2018-000600-42 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galcanezumab | Experimental | Galcanezumab administered subcutaneously (SC). |
|
| Placebo | Placebo Comparator | Placebo administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Drug | Administered SC. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days | Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. | Baseline, Month 1 through Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 21st Century Neurology | Phoenix | Arizona | 85004 | United States | ||
| Medical Center for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42327799 | Derived | Lampl C, Lipton RB, Lipsius S, Ford JH, Dell'Agnello G, Viktrup L, Buse DC. Evaluating the relationship between the 4-item migraine interictal burden scale and other patient-reported outcome measures: a post hoc analysis from a phase 3 migraine prevention study. Front Neurol. 2026 Jun 5;17:1808619. doi: 10.3389/fneur.2026.1808619. eCollection 2026. | |
| 37016181 |
| Label | URL |
|---|---|
| A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine | View source |
Not provided
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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo/Galcanezumab 120mg | Participants received matching placebo every month for three months by subcutaneous injection (SC) during double blind treatment phase. Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months by SC injection during open label treatment period. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Treatment Period |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 22, 2018 | Jun 9, 2020 |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Administered SC. |
|
| Baseline, Month 1 through Month 3 |
| Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | Baseline, Month 1 through Month 3 |
| Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | Baseline, Month 1 through Month 3 |
| 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) | MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and 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 that address 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 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. | Baseline, Month 3 |
| 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) in Participants With Episodic Migraine | MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and 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 that address 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 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. | Baseline, Month 3 |
| Percentage of Participants With Episodic Migraine With ≥75% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | Baseline, Month 1 through Month 3 |
| Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | Baseline, Month 1 through Month 3 |
| Percentage of Participants With ≥75% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | Baseline, Month 1 through Month 3 |
| Percentage of Participants With 100% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | Baseline, Month 1 through Month 3 |
| Overall Mean Change From Baseline in the Number of Monthly Days With Acute Headache Medication Use | Overall mean is derived from the average of months 1 to 3 from Mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. | Baseline, Month 1 through Month 3 |
| Overall Mean Change From Baseline in the Number of Monthly Headache Days | Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache). Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. | Baseline, Month 1 through Month 3 |
| Mean Change From Baseline in 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 missed 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. LS mean was calculated using analysis of covariance (ANCOVA) with last observation carried forward (LOCF), with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | Baseline, Month 3 |
| Mean Change From Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4) | MIBS-4 is a self-administered scale that measures the burden related to headache in the time between attacks. The instrument consists of 4 items that address disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty. The questionnaire specifically asks about the effect of the disease over the past 4 weeks on days without a headache attack. Response options include: don't know/not applicable (0), never (0), rarely (1), some of the time (2), much of the time (3), or most or all of the time (3). Each responses associated numerical score are summed across all 4 items resulting in a total score ranging from 0 to 12, and the level of interictal burden being categorized into the following: 0 for none, 1-2 mild, 3-4 moderate, and >5 severe. LS mean was calculated using MMRM model with fixed effects of treatment, pooled country, baseline migraine frequency category, month, treatment by month as fixed effects. | Baseline, Month 3 |
| Mean Change From Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI) | The WPAI Questionnaire is a patient-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores are calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores are calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | Baseline, Month 3 |
| Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) | The PGI-S is a patient-rated instrument that measures illness severity. For this study, the patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" The PGI-S includes a range of possible responses, from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | Baseline, Month 3 |
| Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US) | EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the US algorithm (-0.109 to 1). A higher score indicates better health state. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | Baseline, Month 3 |
| Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK) | EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the UK algorithm (-0.594 to 1). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | Baseline, Month 3 |
| Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score | EQ-5D-5L is a 2-part questionnaire that assesses general health status 'today'. . The second part is assessed using a visual analog scale (VAS) on which the patient rates their perceived health state, ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | Baseline, Month 3 |
| San Diego |
| California |
| 92108 |
| United States |
| Sensible Healthcare | Ocoee | Florida | 34761 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Renstar Medical Research | Wesley Chapel | Florida | 33544 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Michigan Head, Pain and Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| Healthy Perspectives Innovative Mental Health Services, PL | Nashua | New Hampshire | 03060 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| Albuquerque Clinical Trials | Albuquerque | New Mexico | 87102 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| PharmQuest | Greensboro | North Carolina | 27408 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Coastal Carolina Research Center, Inc. | Mt. Pleasant | South Carolina | 29464 | United States |
| Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| Health Research of Hampton Roads Inc | Newport News | Virginia | 23606 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007-4209 | United States |
| Algemeen Ziekenhuis St Jan Brugge | Bruges | 8000 | Belgium |
| Universitair Ziekenhuis Brussel | Brussels | 1090 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | B-9000 | Belgium |
| Okanagan Clinical Trials | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Aggarwal and Associates Ltd | Brampton | Ontario | L6T 0G1 | Canada |
| DIEX Recherche Sherbrooke, Inc | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Clintrial, s.r.o. | Prague | Hl. M. Praha | 100 00 | Czechia |
| Neurologicka ambulance, Neurologie Brno s.r.o. | Brno | 616 00 | Czechia |
| Brain-Soultherapy s.r.o | Kladno | 27201 | Czechia |
| DADO MEDICAL, s.r.o. | Prague | 120 00 | Czechia |
| Neurologicka ordinace | Prague | 160 00 | Czechia |
| Institut Neuropsychiatricke Pece | Prague | 18600 | Czechia |
| CHRU de Lille- Hôpital Roger Salengro | Lille | Cedex | 59037 | France |
| Hôpital de Cimiez | Nice | 06000 | France |
| CHU St Etienne Hopital Nord | Saint-Etienne | 42000 | France |
| DRK-Kliniken Nordhessen | Kassel | Hesse | 34121 | Germany |
| Praxis Dr. Philipp Stude | Bochum | North Rhine-Westphalia | 44787 | Germany |
| Universitätsklinikum Jena | Jena | Thuringia | 07747 | Germany |
| Charité Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| Valeomed Kft. | Esztergom | Komárom-Esztergom | 2500 | Hungary |
| SE Neurologiai Klinika | Budapest | 1083 | Hungary |
| Orszagos Idegtudomanyi Intezet | Budapest | 1145 | Hungary |
| Higashi Sapporo Neurology and Neurosurgery Clinic | Sapporo | Hokkaido | 003-0003 | Japan |
| Medical corporation Shinmatsudakai Atago Hospital | Kochi | Kochi | 780-0051 | Japan |
| Sendai Headache and Neurology Clinic | Sendai | Miyagi | 982-0014 | Japan |
| Takase internal medicine clinic | Toyonaka-shi | Osaka | 560-0012 | Japan |
| Dokkyo Medical University Hospital | Shimotsuga-Gun | Tochigi | 321 0293 | Japan |
| Fukuuchi Pain Clinic | Shinjuku-ku | Tokyo | 160-0017 | Japan |
| Shimoda Neurology Clinic | Tottori-shi | Tottori | 680-0045 | Japan |
| Doi Clinic Internal Medicine Neurology | Hiroshima | 730-0031 | Japan |
| Tanaka neurosurgical clinic | Kagoshima | 892-0844 | Japan |
| Tatsuoka Neurology Clinic | Kyoto | 600-8811 | Japan |
| Tominaga Hospital | Osaka | 5560017 | Japan |
| Ooba Clinic for Neurosurgery & Headache | Ōita | 870-0831 | Japan |
| Canisius-Wilhelmina Ziekenhuis | Nijmegen | Gelderland | 6532 SZ | Netherlands |
| Isala Klinieken | Zwolle | 8025 AB | Netherlands |
| Instituto de Neurologia Dra. Ivonne Fraga | San Juan | PR | 00918 | Puerto Rico |
| Nowon Eulji Medical Center, Eulji University | Seoul | 01830 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hosp | Seoul | 03181 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 120-792 | South Korea |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario Marques De Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitario La Fe de Valencia | Valencia | 46026 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47010 | Spain |
| Hull Royal Infirmary | Hull | East Yorkshire | HU3 2JZ | United Kingdom |
| Kings College Hospital | London | Greater London | SE5 9RS | United Kingdom |
| St Thomas's Hospital | London | SE1 7EH | United Kingdom |
| Ford JH, Ye W, Ayer DW, Mi X, Bhandari S, Buse DC, Lipton RB. Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine. J Patient Rep Outcomes. 2023 Apr 4;7(1):34. doi: 10.1186/s41687-023-00552-4. |
| 35930126 | Derived | Ailani J, Andrews JS, Tockhorn-Heidenreich A, Wenzel R, Rettiganti M. Effect of Galcanezumab on Total Pain Burden in Patients Who Had Previously Not Benefited from Migraine Preventive Medication (CONQUER Trial): A Post Hoc Analysis. Adv Ther. 2022 Oct;39(10):4544-4555. doi: 10.1007/s12325-022-02233-y. Epub 2022 Aug 5. |
| 35076090 | Derived | Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25. |
| 35041159 | Derived | Tepper SJ, Ailani J, Ford JH, Nichols RM, Li LQ, Kemmer P, Hand AL, Tockhorn-Heidenreich A. Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER). Clin Drug Investig. 2022 Mar;42(3):263-275. doi: 10.1007/s40261-021-01115-5. Epub 2022 Jan 18. |
| 34592919 | Derived | Okonkwo R, Tockhorn-Heidenreich A, Stroud C, Paget MA, Matharu MS, Tassorelli C. Efficacy of galcanezumab in patients with migraine and history of failure to 3-4 preventive medication categories: subgroup analysis from CONQUER study. J Headache Pain. 2021 Sep 30;22(1):113. doi: 10.1186/s10194-021-01322-7. |
| 34542830 | Derived | Reuter U, Lucas C, Dolezil D, Hand AL, Port MD, Nichols RM, Stroud C, Tockhorn-Heidenreich A, Detke HC. Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial. Adv Ther. 2021 Nov;38(11):5465-5483. doi: 10.1007/s12325-021-01911-7. Epub 2021 Sep 20. |
| 34264500 | Derived | Citrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15. |
| 33892641 | Derived | Kuruppu DK, Tobin J, Dong Y, Aurora SK, Yunes-Medina L, Green AL. Efficacy of galcanezumab in patients with migraine who did not benefit from commonly prescribed preventive treatments. BMC Neurol. 2021 Apr 23;21(1):175. doi: 10.1186/s12883-021-02196-7. |
| 33765912 | Derived | Schwedt TJ, Kuruppu DK, Dong Y, Standley K, Yunes-Medina L, Pearlman E. Early onset of effect following galcanezumab treatment in patients with previous preventive medication failures. J Headache Pain. 2021 Mar 25;22(1):15. doi: 10.1186/s10194-021-01230-w. |
| 32949542 | Derived | Mulleners WM, Kim BK, Lainez MJA, Lanteri-Minet M, Pozo-Rosich P, Wang S, Tockhorn-Heidenreich A, Aurora SK, Nichols RM, Yunes-Medina L, Detke HC. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020 Oct;19(10):814-825. doi: 10.1016/S1474-4422(20)30279-9. Epub 2020 Sep 16. |
| Galcanezumab 120mg |
Participants received initial loading dose of 240mg of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection during double blind treatment period. Participants received 120mg of galcanezumab every month for three months by SC injection during open label treatment period. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-label Treatment Period |
|
|
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo/Galcanezumab 120mg | Participants received matching placebo every month for three months by subcutaneous injection (SC) during double blind treatment phase. Participants received initial loading dose of 240mg galcanezumab followed by 120mg every month for two months by SC injection during open label treatment period. |
| BG001 | Galcanezumab 120mg | Participants received initial loading dose of 240mg of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection during double blind treatment period. Participants received 120mg of galcanezumab every month for three months by SC injection during open label treatment period. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Monthly Migraine Headache Days | Mean | Standard Deviation | Days |
|
| 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 | Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Least Squares Mean | Standard Error | Days | Baseline, Month 1 through Month 3 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. | All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Least Squares Mean | Standard Error | Days | Baseline, Month 1 through Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline, Month 1 through Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline, Month 1 through Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) | MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and 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 that address 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 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. | All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3. LS Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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) in Participants With Episodic Migraine | MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and 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 that address 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 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. | All randomized episodic migraine participants who received at least one dose of study drug and had a post baseline value at Month 3. LS Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Episodic Migraine With ≥75% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline, Month 1 through Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | All randomized episodic migraine participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline, Month 1 through Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With ≥75% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline, Month 1 through Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With 100% Reduction From Baseline in Monthly Migraine Headache Days | MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline, Month 1 through Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Mean Change From Baseline in the Number of Monthly Days With Acute Headache Medication Use | Overall mean is derived from the average of months 1 to 3 from Mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Least Squares Mean | Standard Error | Days | Baseline, Month 1 through Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Mean Change From Baseline in the Number of Monthly Headache Days | Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache). Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects. | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value. | Posted | Least Squares Mean | Standard Error | Days | Baseline, Month 1 through Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in 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 missed 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. LS mean was calculated using analysis of covariance (ANCOVA) with last observation carried forward (LOCF), with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4) | MIBS-4 is a self-administered scale that measures the burden related to headache in the time between attacks. The instrument consists of 4 items that address disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty. The questionnaire specifically asks about the effect of the disease over the past 4 weeks on days without a headache attack. Response options include: don't know/not applicable (0), never (0), rarely (1), some of the time (2), much of the time (3), or most or all of the time (3). Each responses associated numerical score are summed across all 4 items resulting in a total score ranging from 0 to 12, and the level of interictal burden being categorized into the following: 0 for none, 1-2 mild, 3-4 moderate, and >5 severe. LS mean was calculated using MMRM model with fixed effects of treatment, pooled country, baseline migraine frequency category, month, treatment by month as fixed effects. | All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI) | The WPAI Questionnaire is a patient-reported instrument developed to measure the impact on work productivity and regular activities attributable to a specific health problem (migraine). Recall period is the past 7 days. It contains 6 items that measure: 1) employment status, 2) hours missed from work due to the specific health problem, 3) hours missed from work for other reasons, 4) hours actually worked, 5) degree health affected productivity while working, and 6) degree health affected productivity in regular unpaid activities. Four scores are calculated from the responses to these 6 items: absenteeism, presenteeism, work productivity loss, and activity impairment. Scores are calculated as impairment percentages (0-100%), with higher numbers indicating greater impairment and less productivity, i.e, worse outcomes. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) | The PGI-S is a patient-rated instrument that measures illness severity. For this study, the patient was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" The PGI-S includes a range of possible responses, from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US) | EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the US algorithm (-0.109 to 1). A higher score indicates better health state. LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK) | EQ-5D-5L is a 2-part questionnaire that assesses general health status for 'today'. The first part is comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using country-specific algorithms, with scores ranging from less than 0 (where zero is a health state equivalent to death; negative values are valued as worse than dead) to 1 (perfect health). Index values were calculated using the UK algorithm (-0.594 to 1). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score | EQ-5D-5L is a 2-part questionnaire that assesses general health status 'today'. . The second part is assessed using a visual analog scale (VAS) on which the patient rates their perceived health state, ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine). LS mean was calculated using ANCOVA with LOCF with baseline, pooled country, baseline migraine frequency category, and treatment as fixed effects. | All randomized participants who received at least one dose of study drug and had a post baseline value at Month 3. | Posted | Least Squares Mean | Standard Error | mm | Baseline, Month 3 |
|
|
Up to 6 months
Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
Not provided
| 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 matching placebo every month for three months by SC injection. | 0 | 230 | 2 | 230 | 31 | 230 |
| EG001 | Galcanezumab 120mg - Double-Blind Treatment Phase | Participants received initial loading dose of 240 milligrams (mg) of Galcanezumab followed by 120mg Galcanezumab every month for two months by SC injection. | 0 | 232 | 2 | 232 | 21 | 232 |
| EG002 | Placebo/Galcanezumab 120mg - Open-Label Treatment Phase | Participants received initial loading dose of 240mg Galcanezumab followed by 120mg every month for two months by SC injection. | 0 | 225 | 6 | 225 | 19 | 225 |
| EG003 | Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment | Participants received 120mg of Galcanezumab every month for three months by SC injection. | 0 | 224 | 3 | 224 | 13 | 224 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Hemiplegia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Behcet's syndrome | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2019 | Jun 9, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628360 | galcanezumab |
Not provided
Not provided
Not provided
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Physician Decision |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| OG001 | Galcanezumab 120mg - Double-Blind Treatment Phase | Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection. |
|
|
|
| OG001 | Galcanezumab 120mg - Double-Blind Treatment Phase | Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection. |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
|
|
|
Participants received initial loading dose of 240 milligrams (mg) of galcanezumab followed by 120mg galcanezumab every month for two months by SC injection.
|
|
|
| Participants |
|
|
|
|
|
|
|
|
|
| Participants |
|
|
|