A Phase 3 interventional study of Galcanezumab and Placebo in Episodic Migraine, sponsored by Eli Lilly and Company. Completed at 40 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The reason for this study is to see if the drug galcanezumab is safe and effective in participants with episodic migraine. The study will last about 53 weeks and may include up to 12 visits.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 520 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* Double-blind treatment phase: Participants received placebo once per month subcutaneously (SC) for 3 months. * Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they received 240 milligram (mg) loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months. * Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Drug: Placebo
* Double-blind treatment phase: Participants received 240 mg loading dose of galcanezumab SC (2 injections of 120 mg) in the first month followed by 120 mg per month for 2 months. * Open-label treatment phase: After completion of double-blind phase, participants could enter open-label treatment phase where they continued to receive 120 mg galcanezumab SC per month for 3 months. * Follow-up phase: After completion or discontinuation from double-blind or open-label treatment phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.
Drug: Galcanezumab
Administered SC
Also known as: LY2951742
Administered SC
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
MHD is a calendar day on which a migraine or probable migraine (a headache missing 1 of the migraine features) occurred. Per International Headache Society \[IHS\] International Classification of Headache Disorders 3rd edition \[ICHD-3\], migraine is defined as a headache, with or without aura, of ≥30 minutes duration with the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Overall mean is derived from the average of months 1 to 3 with Least square (LS) mean change calculated using mixed model repeat measures (MMRM) model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, 3 Months
Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase.
Participant having: * 30% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 30% response rate to treatment or "30% responder." * 50% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 50% response rate to treatment or "50% responder." * 75% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 75% response rate to treatment or "75% responder." * 100% reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 100% response rate to treatment or "100% responder." Overall mean is derived from the average of months 1 to 3 using generalized linear mixed model (GLIMMIX) with the fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariate of baseline value.
Time frame: 3 Months
Overall Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ v2.1) During the Double-blind Treatment Phase.
MSQ v2.1 is a self-administered instrument that was developed to address physical, emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains: Role Function-Restrictive (items 1-7), Role Function- Preventive (items 8-11) and Emotional Function (items 12-14). All item responses ranges from 1 (none of the time) to 6 (all of the time). Total raw scores for each domain is the sum of the raw scores of each item in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, 3 Months
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Headache During the Double-blind Treatment Phase.
Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, 3 Months
Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase.
Number of monthly headache days is the number of calendar days in a 30-day period on which a headache occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, 3 Months
Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase.
Percentage of participants who maintained 50% response rate to treatment in all 3 months of the double-blind treatment phase.
Time frame: Month 1 to Month 3
Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase.
Number of monthly migraine attacks is the number of sets of consecutive days with migraine or probable migraine separated by at least one migraine-free day in a 30-day period day. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, 3 Months
Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase.
Number of monthly migraine headache hours is the total number of headache hours in a 30-day period on days when a migraine or probable migraine occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, 3 Months
Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase.
Number of monthly headache hours is the total number of headache hours in a 30-day period on which a headache occurred. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, 3 Months
Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase.
Severity of Migraine Headache was measured on a headache severity scale ranging from 1 to 3 with 1=mild, 2=moderate, and 3=severe. The mean severity of migraine headache for each month will be calculated as: sum of severity of migraine headache days divided by number of migraine headache days. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, 3 Months
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase.
PGI-S is a 7-point scale that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options range from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean change was calculated using analysis of variance (ANCOVA) model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, Month 3
Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase.
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on migraineurs' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean change was calculated using ANCOVA model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
Time frame: Baseline, Month 3
Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase.
A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer \>= 20.
Time frame: Baseline to Month 3
Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase.
PK: Serum concentration of galcanezumab
Time frame: Month 3
The study was designed to be conducted in three phases: a 3-month double-blind treatment phase, an optional 3-month open-label treatment phase and a 4-month follow-up phase.
| Milestone | Placebo | Galcanezumab 120mg |
|---|---|---|
| Started | 259 | 261 |
| Received at least one dose of study drug | 259 | 261 |
| Completed | 242 | 245 |
| Not completed | 17 | 16 |
| Withdrew: Adverse event | 0 | 6 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Pregnancy | 2 | 1 |
| Withdrew: Withdrawal by subject | 13 | 5 |
| Withdrew: Physician decision | 1 | 3 |
| Milestone | Placebo | Galcanezumab 120mg |
|---|---|---|
| Started | 241 | 243 |
| Completed | 234 | 232 |
| Not completed | 7 | 11 |
| Withdrew: Adverse event | 1 | 2 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Withdrawal by subject | 5 | 7 |
| Withdrew: Pregnancy | 1 | 0 |
| Milestone | Placebo | Galcanezumab 120mg |
|---|---|---|
| Started | 243 | 247 |
| Entered from double-blind treatment phase | 7 | 11 |
| Entered from open-label treatment phase | 236 | 236 |
| Completed | 236 | 238 |
| Not completed | 7 | 9 |
| Withdrew: Withdrawal by subject | 7 | 5 |
| Withdrew: Protocol violation | 0 | 2 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
MHD is a calendar day on which a migraine or probable migraine (a headache missing 1 of the migraine features) occurred. Per International Headache Society \[IHS\] International Classification of Headache Disorders 3rd edition \[ICHD-3\], migraine is defined as a headache, with or without aura, of ≥30 minutes duration with the following required features (A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity (B) During headache at least 1 of the following: Nausea and/or vomiting; Photophobia and phonophobia. Overall mean is derived from the average of months 1 to 3 with Least square (LS) mean change calculated using mixed model repeat measures (MMRM) model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| days per month | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase. | -1.99 ± 0.23 | -3.81 ± 0.23 |
Participant having: * 30% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 30% response rate to treatment or "30% responder." * 50% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 50% response rate to treatment or "50% responder." * 75% or greater reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 75% response rate to treatment or "75% responder." * 100% reduction in the total number of MHDs relative to baseline in a 30-day period is considered to have 100% response rate to treatment or "100% responder." Overall mean is derived from the average of months 1 to 3 using generalized linear mixed model (GLIMMIX) with the fixed categorical effects of treatment, month, and treatment-by-month interaction, as well as the continuous, fixed covariate of baseline value.
| Percentage of participants | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| 30% responder | 50.3 ± 2.4 | 73.0 ± 2.1 |
| 50% responder | 32.9 ± 2.3 | 54.9 ± 2.4 |
| 75% responder | 12.7 ± 1.6 | 29.2 ± 2.1 |
| 100% responder | 3.9 ± 0.9 | 11.9 ± 1.4 |
MSQ v2.1 is a self-administered instrument that was developed to address physical, emotional limitations of specific concern to individuals with migraine. It consists of 14 items that address 3 domains: Role Function-Restrictive (items 1-7), Role Function- Preventive (items 8-11) and Emotional Function (items 12-14). All item responses ranges from 1 (none of the time) to 6 (all of the time). Total raw scores for each domain is the sum of the raw scores of each item in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| score on a scale | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Overall Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire Version 2.1 (MSQ v2.1) During the Double-blind Treatment Phase. | 13.94 ± 0.88 | 21.01 ± 0.85 |
Number of monthly migraine headache days requiring medication for the acute treatment of headache is defined as the number of calendar days in a 30-day period on which migraine or probable migraine occurs and acute medication is used. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| days per month | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Headache During the Double-blind Treatment Phase. | -0.71 ± 0.22 | -2.49 ± 0.22 |
Number of monthly headache days is the number of calendar days in a 30-day period on which a headache occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| days per month | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase. | -2.09 ± 0.24 | -3.91 ± 0.24 |
Percentage of participants who maintained 50% response rate to treatment in all 3 months of the double-blind treatment phase.
| percentage of participants | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase. | 12.4 | 29.6 |
Number of monthly migraine attacks is the number of sets of consecutive days with migraine or probable migraine separated by at least one migraine-free day in a 30-day period day. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| migraine attacks per month | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase. | -1.57 ± 0.12 | -2.46 ± 0.12 |
Number of monthly migraine headache hours is the total number of headache hours in a 30-day period on days when a migraine or probable migraine occurs. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| hours per month | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase. | -12.83 ± 1.98 | -31.72 ± 1.96 |
Number of monthly headache hours is the total number of headache hours in a 30-day period on which a headache occurred. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| hours per month | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase. | -12.94 ± 2.06 | -32.18 ± 2.03 |
Severity of Migraine Headache was measured on a headache severity scale ranging from 1 to 3 with 1=mild, 2=moderate, and 3=severe. The mean severity of migraine headache for each month will be calculated as: sum of severity of migraine headache days divided by number of migraine headache days. Overall mean is derived from the average of months 1 to 3 with LS mean change calculated using MMRM model with fixed categorical effects of treatment, country, month, and treatment-by-month interaction, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| score on a scale | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase. | -0.03 ± 0.03 | -0.19 ± 0.03 |
PGI-S is a 7-point scale that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options range from 1 ("normal, not at all ill") to 7 ("extremely ill"). LS mean change was calculated using analysis of variance (ANCOVA) model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| score on a scale | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase. | -0.610 ± 0.0961 | -0.834 ± 0.0930 |
The MIDAS was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that measures the impact that migraine headaches have on migraineurs' life, including days of work/school missed, days with productivity at work/school reduced to half or more, days with household work missed, days with productivity in household work reduced to half or more, and days missed family/social/leisure activities. Each item has a numeric response range from 0 to 90 days; if days are missed from work/school or household work they are not counted as days with reduced productivity at work/school or household work. The numeric responses are summed to produce a total score ranging from 0 to 270. A higher value is indicative of more disability. LS mean change was calculated using ANCOVA model with fixed categorical effects of treatment, country, and the continuous fixed covariates of baseline value and baseline value-by-visit interaction.
| score on a scale | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase. | -10.181 ± 3.0597 | -22.610 ± 2.9582 |
A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer \>= 20.
| percentage of participants | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|---|
| Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase. | 1.2 | 9.3 |
PK: Serum concentration of galcanezumab
| Nanogram per milliliter (ng/mL) | Galcanezumab 120mg - Double-Blind Treatment Phase |
|---|---|
| Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase. | 14696 ± 5675 |
Collected over Baseline to Follow-up (Up To 10 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo - Double-Blind Treatment Phase | 0/259 (0%) | 3/259 (1.2%) | 29/259 (11.2%) |
| Galcanezumab 120mg - Double-Blind Treatment Phase | 0/261 (0%) | 2/261 (0.8%) | 32/261 (12.3%) |
| Placebo/Galcanezumab 120mg - Open-Label Treatment Phase | 0/241 (0%) | 9/241 (3.7%) | 12/241 (5%) |
| Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment Phase | 0/243 (0%) | 3/243 (1.2%) | 7/243 (2.9%) |
| Placebo - Follow-up | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Galcanezumab 120mg - Follow-up | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Placebo/Galcanezumab 120mg - Follow-up | 0/236 (0%) | 3/236 (1.3%) | 0/236 (0%) |
| Galcanezumab 120mg/Galcanezumab 120mg - Follow-up | 0/236 (0%) | 4/236 (1.7%) | 0/236 (0%) |
| Event | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase | Placebo/Galcanezumab 120mg - Open-Label Treatment Phase | Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment Phase | Placebo - Follow-up | Galcanezumab 120mg - Follow-up | Placebo/Galcanezumab 120mg - Follow-up | Galcanezumab 120mg/Galcanezumab 120mg - Follow-up |
|---|---|---|---|---|---|---|---|---|
| Uterine polypReproductive system and breast disorders | 0/196 | 0/188 | 0/180 | 1/175 | 0/7 | 0/8 | 0/177 | 0/173 |
| Ectopic pregnancyPregnancy, puerperium and perinatal conditions | 0/196 | 0/188 | 1/180 | 0/175 | 0/7 | 0/8 | 0/177 | 0/173 |
| Abortion threatenedPregnancy, puerperium and perinatal conditions | 1/196 | 0/188 | 0/180 | 0/175 | 0/7 | 0/8 | 0/177 | 0/173 |
| Thymic cystBlood and lymphatic system disorders | 0/259 | 0/261 | 0/241 | 0/243 | 0/7 | 0/11 | 1/236 | 0/236 |
| UveitisEye disorders | 0/259 | 0/261 | 0/241 | 0/243 | 0/7 | 0/11 | 0/236 | 1/236 |
| AppendicitisInfections and infestations | 0/259 | 0/261 | 0/241 | 0/243 | 0/7 | 0/11 | 1/236 | 0/236 |
| MastitisInfections and infestations | 0/259 | 0/261 | 0/241 | 0/243 | 0/7 | 0/11 | 1/236 | 0/236 |
| PharyngitisInfections and infestations | 0/259 | 0/261 | 0/241 | 0/243 | 0/7 | 0/11 | 0/236 | 1/236 |
| MigraineNervous system disorders | 0/259 | 0/261 | 1/241 | 0/243 | 0/7 | 0/11 | 0/236 | 1/236 |
| Thoracic outlet syndromeNervous system disorders | 0/259 | 0/261 | 0/241 | 0/243 | 0/7 | 0/11 | 0/236 | 1/236 |
| Event | Placebo - Double-Blind Treatment Phase | Galcanezumab 120mg - Double-Blind Treatment Phase | Placebo/Galcanezumab 120mg - Open-Label Treatment Phase | Galcanezumab 120mg/Galcanezumab 120mg - Open-Label Treatment Phase | Placebo - Follow-up | Galcanezumab 120mg - Follow-up | Placebo/Galcanezumab 120mg - Follow-up | Galcanezumab 120mg/Galcanezumab 120mg - Follow-up |
|---|---|---|---|---|---|---|---|---|
| Injection site painGeneral disorders | 16/259 | 19/261 | 6/241 | 0/243 | 0/7 | 0/11 | 0/236 | 0/236 |
| Upper respiratory tract infectionInfections and infestations | 13/259 | 14/261 | 6/241 | 7/243 | 0/7 | 0/11 | 0/236 | 0/236 |
All randomized participants.
| Age, Continuous(years) | Placebo | Galcanezumab 120 mg | Total |
|---|---|---|---|
| Mean | 36.80 ± 9.83 | 37.20 ± 9.33 | 37.00 ± 9.57 |
| Sex: Female, Male(Participants) | Placebo | Galcanezumab 120 mg | Total |
|---|---|---|---|
| Female | 196 | 188 | 384 |
| Male | 63 | 73 | 136 |
| Race (NIH/OMB)(Participants) | Placebo | Galcanezumab 120 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 239 | 239 | 478 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 20 | 22 | 42 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Placebo | Galcanezumab 120 mg | Total |
|---|---|---|---|
| China | 198 | 198 | 396 |
| India | 41 | 41 | 82 |
| Russia | 20 | 22 | 42 |
| Monthly Migraine Headache Days (MHD)(days per month) | Placebo | Galcanezumab 120 mg | Total |
|---|---|---|---|
| Mean | 8.34 ± 2.70 | 8.16 ± 2.83 | 8.25 ± 2.76 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Csr
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