Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGBD | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
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The purpose of this study is to assess whether galcanezumab is superior to rimegepant in the prevention of migraine in participants with episodic migraine. The study duration will be approximately 6 months.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galcanezumab | Experimental | Participants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months. 1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding. |
|
| Rimegepant | Active Comparator | Participants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months. 2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Drug | Administered SC. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period. | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 50% reduction in monthly migraine headache days from baseline (50% response rate) 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 migraine headache day. | Baseline, Month 1 through Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 75% Response Rate Across the 3-month Treatment Period. | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 75% reduction in monthly migraine headache days from baseline (75% response rate) 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 migraine headache day. |
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 |
|---|---|---|---|---|---|---|
| Gilbert Neurology | Gilbert | Arizona | 85297 | United States | ||
| Foothills Research Center / CCT Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37948006 | Background | Schwedt TJ, Myers Oakes TM, Martinez JM, Vargas BB, Pandey H, Pearlman EM, Richardson DR, Varnado OJ, Cobas Meyer M, Goadsby PJ. Comparing the Efficacy and Safety of Galcanezumab Versus Rimegepant for Prevention of Episodic Migraine: Results from a Randomized, Controlled Clinical Trial. Neurol Ther. 2024 Feb;13(1):85-105. doi: 10.1007/s40120-023-00562-w. Epub 2023 Nov 10. |
| Label | URL |
|---|---|
| A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine (CHALLENGE-MIG) | 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 European Union (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.
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Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Galcanezumab | Participants received a loading dose of 2 injections of 120 milligrams (mg) galcanezumab subcutaneously (SC) in the first month followed by 120 mg monthly for remaining 2 months. 1 placebo oral disintegrating tablet (ODT) every other day for 3 months was given to preserve blinding. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Nov 2, 2022 | May 8, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Rimegepant | Drug | Administered orally. |
|
| Placebo | Drug | Administered orally. |
|
| Placebo | Drug | Administered SC. |
|
| Baseline, Month 1 through Month 3 |
| Percentage of Participants With 100% Response Rate Across the 3-month Treatment Period. | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 100% reduction in monthly migraine headache days from baseline (100% response rate) 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 migraine headache day. | Baseline, Month 1 through Month 3 |
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Across the 3-month Treatment Period. | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean was derived from the average of month 1 through month 3. Least square (LS) mean was calculated using mixed model for repeated measures (MMRM) model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables. | Baseline, Month 1 through Month 3 |
| Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1 | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables. | Baseline, Month 1 |
| Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2 | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables. | Baseline, Month 2 |
| Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 3 | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables. | Baseline, Month 3 |
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache Across the 3-month Treatment Period. | Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean was derived from the average of month 1 through month 3. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days with acute medications use, and baseline-by-month interaction as continuous variables. | Baseline, Month 1 through Month 3 |
| Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3 | The MSQ v2.1 is a 14-item questionnaire, participant-rated scale with a 4-week recall period that measures 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:
Each item is scored from 1 (none of the time) to 6 (all of the time) and are reverse coded (value 6 to 1). Raw scores for each domain are computed as a sum of item responses, with the collective sum providing a total raw score. These were transformed to a 0-100 scale, with higher scores indicating better quality of life. LS mean was calculated using Analysis of covariance (ANCOVA) with main effects of treatment, the baseline number of migraine headache days category (<8 vs >=8), and the continuous fixed covariate of the baseline endpoint. | Baseline, Month 3 |
| Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 | The MIDAS is a participant-rated scale that measures headache-related disability over a 3-month period. It consists of 5 items that measures number of days of work/school missed or days with productivity at work/school reduced to half or more; days with household work missed or days with productivity in household work reduced to half or more, and days of missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean was calculated using ANCOVA model with main effects of treatment, the baseline number of migraine headache days category (<8 vs >=8), and the continuous fixed covariate of the baseline endpoint. | Baseline, Month 3 |
| Phoenix |
| Arizona |
| 85044 |
| United States |
| Alliance for Multispecialty Research, LLC Tempe | Tempe | Arizona | 85281 | United States |
| Velocity Clinical Research, Banning | Banning | California | 99202 | United States |
| Velocity Clinical Research, Chula Vista | Chula Vista | California | 91911 | United States |
| Wr- Pri, Llc | Encino | California | 91316 | United States |
| Velocity Clinical Research, San Diego | La Mesa | California | 91942 | United States |
| California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility) | Los Angeles | California | 90067 | United States |
| Pharmacology Research Institute | Newport Beach | California | 92660 | United States |
| Velocity Clinical Research, North Hollywood | North Hollywood | California | 91606 | United States |
| Anderson Clinical Research | Redlands | California | 92374 | United States |
| Center for Clinical Trials of Sacramento | Sacramento | California | 95823 | United States |
| Velocity Clinical Research, Huntington Park | Santa Ana | California | 92704 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| CMR of Greater New Haven, LLC | Hamden | Connecticut | 06517 | United States |
| Innovative Research of West Florida | Clearwater | Florida | 33756 | United States |
| AMR Miami | Coral Gables | Florida | 33134 | United States |
| Accel Research Sites- Clinical Research Unit | DeLand | Florida | 32720 | United States |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | United States |
| Accel Research Sites-LKD CRU | Lakeland | Florida | 33803 | United States |
| Visionary Investigators Network | Miami | Florida | 33176 | United States |
| Visionary Investigators Network | Miami | Florida | 33180 | United States |
| Sensible Healthcare, LLC | Ocoee | Florida | 34761 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Palm Beach Research Center | West Palm Beach | Florida | 33409 | United States |
| DelRicht Research | Atlanta | Georgia | 30329 | United States |
| Better Health Clinical Research | Newnan | Georgia | 30265 | United States |
| Meridian Clinical Research | Savannah | Georgia | 31406 | United States |
| Chicago Headache Center | Chicago | Illinois | 60657 | United States |
| American Health Network of Indiana, LLC - Avon | Avon | Indiana | 46123 | United States |
| Deaconess Clinic | Evansville | Indiana | 47713 | United States |
| Alliance for Multispecialty Research, LLC El Dorado | El Dorado | Kansas | 67042 | United States |
| Alliance for Multispecialty Research, LLC Lexington | Lexington | Kentucky | 40509 | United States |
| L-MARC Research Center | Louisville | Kentucky | 40213 | United States |
| DelRicht Research | Covington | Louisiana | 70433 | United States |
| DelRicht Research | New Orleans | Louisiana | 70124 | United States |
| DelRicht Research | Prairieville | Louisiana | 70769 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Michigan Headache & Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division | Troy | Michigan | 48098 | United States |
| MedPharmics, LLC | Gulfport | Mississippi | 39503 | United States |
| Healthcare Research Network - St. Louis | Hazelwood | Missouri | 63042 | United States |
| Alliance for Multispecialty Research, LLC | Las Vegas | Nevada | 89119 | United States |
| Albuquerque Clinical Trials, Inc. | Albuquerque | New Mexico | 87102 | United States |
| Dent Neurosciences Research Center (Research Facility) | Amherst | New York | 14226 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | United States |
| NeuroScience Research Center, LLC | Canton | Ohio | 44718 | United States |
| Dayton Center for Neurological Disorders | Centerville | Ohio | 45459 | United States |
| Neurology Diagnostics, Inc. | Dayton | Ohio | 45459 | United States |
| Tekton Research | Edmond | Oklahoma | 73013 | United States |
| Lynn Institute of Norman | Norman | Oklahoma | 73072 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| DelRicht Research | Tulsa | Oklahoma | 74133 | United States |
| Tekton Research | Yukon | Oklahoma | 73099 | United States |
| Velocity Clinical Research, Grants Pass (Research Facility) | Grants Pass | Oregon | 97527 | United States |
| Velocity Clinical Research - Medford | Medford | Oregon | 97504 | United States |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | United States |
| Tribe Clinical Research, LLC | Greenville | South Carolina | 29607 | United States |
| Premier Neurology Research, P.C. | Greer | South Carolina | 29650 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37920 | United States |
| Clinical Research Associates | Nashville | Tennessee | 37203 | United States |
| Tekton Research (Research Facility) | Austin | Texas | 78705 | United States |
| FutureSearch Trials of Neurology | Austin | Texas | 78731 | United States |
| ACRC Trials | Austin | Texas | 78735 | United States |
| ACRC Trials | Carrollton | Texas | 75010 | United States |
| Velocity Clinical Research, Austin | Cedar Park | Texas | 78613 | United States |
| Ventavia Research Group | Fort Worth | Texas | 76104 | United States |
| Accurate Clinical Management - Houston | Houston | Texas | 77065 | United States |
| Dynamed Clinical Research, LP d/b/a DM Clinical Research | Humble | Texas | 77064 | United States |
| Ventavia Research Group - Keller | Keller | Texas | 76248 | United States |
| ACRC Trials | Plano | Texas | 75024 | United States |
| Alpine Research Organization | Clinton | Utah | 84015 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| Alliance for Multispecialty Research, LLC - AMR Norfolk | Norfolk | Virginia | 23502 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Rimegepant |
Participants received 75 mg Rimegepant oral disintegrating tablet (ODT) every other day for 3 months. 2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding. |
| Received at Least 1 Dose of the Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Galcanezumab | Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months. 1 placebo ODT every other day for 3 months was given to preserve blinding. |
| BG001 | Rimegepant | Participants received 75 mg Rimegepant ODT every other day for 3 months. 2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding. |
| 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 |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
| |||||||||||||||
| Number of Monthly Migraine Headache Days | A Migraine Headache Day is defined as a calendar day on which a migraine headache or probable migraine headache occurred. | Mean | Standard Deviation | days per month |
|
| 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 | Percentage of Participants With 50% Response Rate Across the 3-month Treatment Period. | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 50% reduction in monthly migraine headache days from baseline (50% response rate) 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 migraine headache day. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Number | percentage of participants | Baseline, Month 1 through Month 3 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With 75% Response Rate Across the 3-month Treatment Period. | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 75% reduction in monthly migraine headache days from baseline (75% response rate) 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 migraine headache day. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Number | percentage of participants | Baseline, Month 1 through Month 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With 100% Response Rate Across the 3-month Treatment Period. | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean percentage across months 1 through 3 of participants with at least a 100% reduction in monthly migraine headache days from baseline (100% response rate) 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 migraine headache day. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Number | percentage of participants | Baseline, Month 1 through Month 3 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Across the 3-month Treatment Period. | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. Overall mean was derived from the average of month 1 through month 3. Least square (LS) mean was calculated using mixed model for repeated measures (MMRM) model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | days per month | Baseline, Month 1 through Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 1 | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | days per month | Baseline, Month 1 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 2 | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | days per month | Baseline, Month 2 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Number of Monthly Migraine Headache Days at Month 3 | A migraine headache day is a calendar day on which a migraine headache or probable migraine headache occurred. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days, and baseline-by-month interaction as continuous variables. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | days per month | Baseline, Month 3 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache Across the 3-month Treatment Period. | Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean was derived from the average of month 1 through month 3. LS mean was calculated using MMRM model with treatment, month, and treatment-by-month interaction as fixed effects and baseline number of migraine headache days with acute medications use, and baseline-by-month interaction as continuous variables. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | days per month | Baseline, Month 1 through Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) at Month 3 | The MSQ v2.1 is a 14-item questionnaire, participant-rated scale with a 4-week recall period that measures 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:
Each item is scored from 1 (none of the time) to 6 (all of the time) and are reverse coded (value 6 to 1). Raw scores for each domain are computed as a sum of item responses, with the collective sum providing a total raw score. These were transformed to a 0-100 scale, with higher scores indicating better quality of life. LS mean was calculated using Analysis of covariance (ANCOVA) with main effects of treatment, the baseline number of migraine headache days category (<8 vs >=8), and the continuous fixed covariate of the baseline endpoint. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 | The MIDAS is a participant-rated scale that measures headache-related disability over a 3-month period. It consists of 5 items that measures number of days of work/school missed or days with productivity at work/school reduced to half or more; days with household work missed or days with productivity in household work reduced to half or more, and days of missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean was calculated using ANCOVA model with main effects of treatment, the baseline number of migraine headache days category (<8 vs >=8), and the continuous fixed covariate of the baseline endpoint. | All randomized participants who received at least one dose of study drug and had non-missing baseline value and at least one non-missing post-baseline value for this outcome. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Month 3 |
|
Baseline up to Month 3
All randomized participants who received at least 1 dose of the study drug. As per the planned safety analyses, AE data was reported per treatment regimen received.
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 | Galcanezumab | Participants received a loading dose of 2 injections of 120 mg galcanezumab SC in the first month followed by 120 mg monthly for remaining 2 months. 1 placebo ODT every other day for 3 months was given to preserve blinding. | 0 | 287 | 0 | 287 | 28 | 287 |
| EG001 | Rimegepant | Participants received 75 mg Rimegepant ODT every other day for 3 months. 2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding. | 0 | 293 | 1 | 293 | 28 | 293 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 25.1 | 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 | May 19, 2023 | May 8, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628360 | galcanezumab |
| C578443 | rimegepant sulfate |
Not provided
Not provided
Not provided
| 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 |
|
| Units | Counts |
|---|---|
| Participants |
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|
|
| Units | Counts |
|---|---|
| Participants |
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|
|
| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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| Participants |
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| OG001 |
| Rimegepant |
Participants received 75 mg Rimegepant ODT every other day for 3 months. 2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding. |
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| Rimegepant |
Participants received 75 mg Rimegepant ODT every other day for 3 months. 2 placebo SC injections loading dose, then 1 placebo SC injection monthly for remaining 2 months was given to preserve blinding. |
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