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Evaluation of Galcanezumab in the Prevention of Chronic Migraine (REGAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614261
Recruitment Status : Active, not recruiting
First Posted : November 25, 2015
Results First Posted : January 7, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Migraine
Interventions Drug: Galcanezumab
Drug: Placebo
Enrollment 1113
Recruitment Details  
Pre-assignment Details Results reported are for primary outcome, which is the double blind treatment phase up to month 3; data beyond month 3 will be reported after Study Completion final analysis for month 16 results.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description Participants received placebo once a month by subcutaneous injection for 3 months. Participants received loading dose of 240 milligrams (mg) of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months. Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
Period Title: Overall Study
Started 558 278 277
Received at Least One Dose of Study Drug 558 278 277
Completed 509 263 266
Not Completed 49 15 11
Reason Not Completed
Adverse Event             6             3             2
Lack of Efficacy             4             0             0
Lost to Follow-up             10             4             1
Physician Decision             2             1             1
Pregnancy             2             2             0
Protocol Violation             6             1             0
Withdrawal by Subject             19             4             7
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg Total
Hide Arm/Group Description Participants received placebo once a month by subcutaneous injection for 3 months. Participants received loading dose of 240 milligrams (mg) of galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 2 months. Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months. Total of all reporting groups
Overall Number of Baseline Participants 558 278 277 1113
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 558 participants 278 participants 277 participants 1113 participants
41.63  (12.08) 39.66  (11.88) 41.05  (12.40) 40.35  (12.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 558 participants 278 participants 277 participants 1113 participants
Female 483 237 226 946
Male 75 41 51 167
Ethnicity (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 523 participants 261 participants 262 participants 1046 participants
Hispanic or Latino 122 66 70 258
Not Hispanic or Latino 401 195 192 788
Unknown or Not Reported 0 0 0 0
[1]
Measure Analysis Population Description: All randomized participants who received at least one dose of study drug and had baseline ethnicity data.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 558 participants 278 participants 276 participants 1112 participants
American Indian or Alaska Native 4 2 0 6
Asian 26 13 14 53
Native Hawaiian or Other Pacific Islander 1 0 0 1
Black or African American 39 16 17 72
White 432 223 224 879
More than one race 56 24 21 101
Unknown or Not Reported 0 0 0 0
[1]
Measure Analysis Population Description: All randomized participants who received at least one dose of study drug and had non-missing race data.
Migraine Headache Days (MHD)  
Mean (Standard Deviation)
Unit of measure:  Days per Month
Number Analyzed 558 participants 278 participants 277 participants 1113 participants
19.55  (4.59) 19.36  (4.27) 19.17  (4.60) 19.41  (4.52)
1.Primary Outcome
Title Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)
Hide Description

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, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.

Time Frame Baseline, Month 1 through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline value.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg of galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 538 273 274
Least Squares Mean (Standard Error)
Unit of Measure: Migraine Headache Days per Month
-2.74  (0.36) -4.83  (0.44) -4.62  (0.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -2.09
Confidence Interval (2-Sided) 95%
-2.92 to -1.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.42
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -1.88
Confidence Interval (2-Sided) -1.88%
-2.71 to -1.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.42
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
Hide Description MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Time Frame Baseline, Month 1 through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240mg of galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 498 256 262
Measure Type: Count of Participants
Unit of Measure: Participants
≥50% 123 90 97
≥75% 44 34 40
≥100% 8 4 8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments Reduction from Baseline ≥50%,
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .004
Comments [Not Specified]
Method CPRMM
Comments Categorical pseudo likelihood-based repeated measures model (CPRMM)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.623
Confidence Interval (2-Sided) 95%
1.167 to 2.256
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments Reduction from Baseline ≥50%
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method CPRMM
Comments Categorical pseudo likelihood-based repeated measures model (CPRMM)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.788
Confidence Interval (2-Sided) 95%
1.291 to 2.474
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments Reduction from Baseline ≥75%
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .102
Comments [Not Specified]
Method CPRMM
Comments Categorical pseudo likelihood-based repeated measures model (CPRMM)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.498
Confidence Interval (2-Sided) 95%
0.923 to 2.430
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments Reduction from Baseline ≥75%
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .011
Comments [Not Specified]
Method CPRMM
Comments Categorical pseudo likelihood-based repeated measures model (CPRMM)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.819
Confidence Interval (2-Sided) 95%
1.146 to 2.888
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments Reduction from Baseline ≥100%
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.729
Comments [Not Specified]
Method CPRMM
Comments Categorical pseudo likelihood-based repeated measures model (CPRMM)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.761
Confidence Interval (2-Sided) 95%
0.163 to 3.563
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments Reduction from Baseline ≥100%
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .276
Comments [Not Specified]
Method CPRMM
Comments Categorical pseudo likelihood-based repeated measures model (CPRMM)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.897
Confidence Interval (2-Sided) 95%
0.600 to 5.998
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain
Hide Description 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.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.

LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.

Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 494 252 253
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
16.76  (1.18) 21.81  (1.41) 23.05  (1.63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 5.06
Confidence Interval (2-Sided) 95%
2.12 to 7.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.50
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value 6.29
Confidence Interval (2-Sided) 95%
3.03 to 9.55
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.66
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
Hide Description

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 MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.

Time Frame Baseline, Month 1 through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 538 273 274
Least Squares Mean (Standard Error)
Unit of Measure: Days Per Month
-2.23  (0.33) -4.74  (0.40) -4.25  (0.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -2.51
Confidence Interval (2-Sided) 95%
-3.27 to -1.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.38
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -2.01
Confidence Interval (2-Sided) 95%
-2.77 to -1.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.38
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
Hide Description PGI-S scale is a participant-rated instrument 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 were from 1 ("normal, not at all ill") to 7 ("extremely ill"). LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and month 3 measurement.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120 mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 494 252 253
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.62  (0.08) -0.76  (0.10) -0.91  (0.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .181
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.34 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.48 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.10
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Overall Mean Change From Baseline in Headache Hours
Hide Description Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.
Time Frame Baseline, Month 1 through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline & at least one post baseline measurement.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240 mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 538 273 274
Least Squares Mean (Standard Error)
Unit of Measure: Headache Hours per Month
-13.44  (3.91) -36.15  (4.74) -31.53  (4.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -22.71
Confidence Interval (2-Sided) 95%
-31.74 to -13.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -18.09
Confidence Interval (2-Sided) 95%
-27.09 to -9.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.58
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
Hide Description The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using Analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, and baseline value as fixed effects.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 504 254 258
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-11.53  (3.38) -20.27  (4.07) -17.02  (4.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .025
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -8.74
Confidence Interval (2-Sided) 95%
-16.39 to -1.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .157
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LSMean Difference
Estimated Value -5.49
Confidence Interval (2-Sided) 95%
-13.10 to 2.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.88
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab
Hide Description A Treatment Emergent Anti-Drug Antibodies (TE ADA) evaluable participant is considered to be TE ADA+ 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+ if there is at least one post baseline result of ADA Present with titer >= 20.
Time Frame Month 1 through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had at least one non-missing test result for ADA for each of the baseline period and the post baseline period.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 535 264 272
Measure Type: Count of Participants
Unit of Measure: Participants
8 7 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 120mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .263
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Galcanezumab 240mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .290
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
9.Secondary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab
Hide Description Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.
Time Frame Baseline through Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Zero participants analyzed. AUC data was not collected as AUC was not pre-specified in protocol.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Hide Description Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had measurable plasma concentrations.
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received placebo once a month by subcutaneous injection for 3 months.
Participants received loading dose of 240mg galcanezumab at first dosing visit followed by 120mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 30 247 253
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
0.529  (0.612) 4.02  (1.70) 4.85  (1.76)
11.Secondary Outcome
Title Serum Concentrations of Galcanezumab
Hide Description Serum concentrations of Galcanezumab
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of Galcanezumab and had measurable serum concentrations.
Arm/Group Title Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description:
Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by subcutaneous injection for 2 months.
Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
Overall Number of Participants Analyzed 248 254
Mean (Standard Deviation)
Unit of Measure: Nanogram per milliliter (ng/mL)
16900  (7140) 29000  (11300)
Time Frame Up to 171 days
Adverse Event Reporting Description

All randomized participants. There were 5 participants from the 120 mg arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for AE analysis.

Per protocol, AE analysis was planned per treatment regimen received.

 
Arm/Group Title Placebo Galcanezumab 120mg Galcanezumab 240mg
Hide Arm/Group Description Participants received placebo once a month by subcutaneous injection for 3 months. Participants received loading dose of 240mg galcanezumab at first dosing visit followed 120mg galcanezumab once a month by subcutaneous injection for 2 months. Participants received 240mg of galcanezumab once a month by subcutaneous injection for 3 months.
All-Cause Mortality
Placebo Galcanezumab 120mg Galcanezumab 240mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/558 (0.00%)      0/273 (0.00%)      0/282 (0.00%)    
Hide Serious Adverse Events
Placebo Galcanezumab 120mg Galcanezumab 240mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/558 (1.25%)      5/273 (1.83%)      8/282 (2.84%)    
Blood and lymphatic system disorders       
Iron deficiency anaemia  1  1/558 (0.18%)  1 0/273 (0.00%)  0 0/282 (0.00%)  0
Cardiac disorders       
Acute myocardial infarction  1  0/558 (0.00%)  0 0/273 (0.00%)  0 1/282 (0.35%)  1
Angina unstable  1  0/558 (0.00%)  0 0/273 (0.00%)  0 1/282 (0.35%)  1
Cardiac failure congestive  1  0/558 (0.00%)  0 0/273 (0.00%)  0 1/282 (0.35%)  1
Myocardial infarction  1  1/558 (0.18%)  1 0/273 (0.00%)  0 0/282 (0.00%)  0
Gastrointestinal disorders       
Alcoholic pancreatitis  1  1/558 (0.18%)  1 0/273 (0.00%)  0 0/282 (0.00%)  0
Gastritis  1  1/558 (0.18%)  1 0/273 (0.00%)  0 0/282 (0.00%)  0
Pancreatitis acute  1  0/558 (0.00%)  0 0/273 (0.00%)  0 1/282 (0.35%)  1
Hepatobiliary disorders       
Cholelithiasis  1  0/558 (0.00%)  0 1/273 (0.37%)  1 0/282 (0.00%)  0
Infections and infestations       
Cellulitis  1  1/558 (0.18%)  1 0/273 (0.00%)  0 0/282 (0.00%)  0
Osteomyelitis  1  1/558 (0.18%)  1 0/273 (0.00%)  0 0/282 (0.00%)  0
Pyelonephritis  1  0/558 (0.00%)  0 1/273 (0.37%)  1 0/282 (0.00%)  0
Injury, poisoning and procedural complications       
Laceration  1  0/558 (0.00%)  0 1/273 (0.37%)  1 0/282 (0.00%)  0
Road traffic accident  1  0/558 (0.00%)  0 1/273 (0.37%)  1 0/282 (0.00%)  0
Metabolism and nutrition disorders       
Hypokalaemia  1  0/558 (0.00%)  0 0/273 (0.00%)  0 1/282 (0.35%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  0/558 (0.00%)  0 1/273 (0.37%)  1 0/282 (0.00%)  0
Squamous cell carcinoma  1  0/558 (0.00%)  0 1/273 (0.37%)  1 0/282 (0.00%)  0
Nervous system disorders       
Migraine  1  1/558 (0.18%)  1 0/273 (0.00%)  0 0/282 (0.00%)  0
Seizure  1  0/558 (0.00%)  0 1/273 (0.37%)  1 1/282 (0.35%)  1
Renal and urinary disorders       
Nephrolithiasis  1  0/558 (0.00%)  0 0/273 (0.00%)  0 1/282 (0.35%)  1
Renal colic  1  0/558 (0.00%)  0 0/273 (0.00%)  0 1/282 (0.35%)  1
Respiratory, thoracic and mediastinal disorders       
Epistaxis  1  1/558 (0.18%)  1 0/273 (0.00%)  0 0/282 (0.00%)  0
Pulmonary embolism  1  0/558 (0.00%)  0 0/273 (0.00%)  0 1/282 (0.35%)  1
Skin and subcutaneous tissue disorders       
Urticaria  1  0/558 (0.00%)  0 0/273 (0.00%)  0 1/282 (0.35%)  1
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Galcanezumab 120mg Galcanezumab 240mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/558 (9.50%)      37/273 (13.55%)      42/282 (14.89%)    
General disorders       
Injection site pain  1  24/558 (4.30%)  32 17/273 (6.23%)  30 20/282 (7.09%)  31
Injection site reaction  1  10/558 (1.79%)  16 8/273 (2.93%)  13 15/282 (5.32%)  20
Infections and infestations       
Nasopharyngitis  1  26/558 (4.66%)  29 17/273 (6.23%)  19 9/282 (3.19%)  9
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02614261    
Other Study ID Numbers: 15769
I5Q-MC-CGAI ( Other Identifier: Eli Lillly and Company )
2015-001883-21 ( EudraCT Number )
First Submitted: November 23, 2015
First Posted: November 25, 2015
Results First Submitted: October 19, 2018
Results First Posted: January 7, 2019
Last Update Posted: September 13, 2019