Trial Outcomes & Findings for A Study Of Galcanezumab In Participants With Episodic Cluster Headache (NCT NCT02397473)
NCT ID: NCT02397473
Last Updated: 2019-09-09
Results Overview
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 3 from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.
COMPLETED
PHASE3
109 participants
Baseline, Week 1 through Week 3
2019-09-09
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo once a month for 2 months by subcutaneous (SC) injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
Participants received Galcanezumab 300mg once a month for two months by subcutaneous (SC) injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Treatment Phase
STARTED
|
57
|
52
|
|
Treatment Phase
Received at Least One Dose of Study Drug
|
57
|
49
|
|
Treatment Phase
COMPLETED
|
45
|
45
|
|
Treatment Phase
NOT COMPLETED
|
12
|
7
|
|
Post Treatment Follow-up Phase
STARTED
|
50
|
47
|
|
Post Treatment Follow-up Phase
COMPLETED
|
47
|
45
|
|
Post Treatment Follow-up Phase
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo once a month for 2 months by subcutaneous (SC) injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
Participants received Galcanezumab 300mg once a month for two months by subcutaneous (SC) injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Treatment Phase
Adverse Event
|
1
|
2
|
|
Treatment Phase
Lack of Efficacy
|
8
|
1
|
|
Treatment Phase
Lost to Follow-up
|
1
|
0
|
|
Treatment Phase
Withdrawal by Subject
|
2
|
1
|
|
Treatment Phase
Protocol Violation(did not receive drug)
|
0
|
3
|
|
Post Treatment Follow-up Phase
Lack of Efficacy
|
1
|
1
|
|
Post Treatment Follow-up Phase
Lost to Follow-up
|
1
|
0
|
|
Post Treatment Follow-up Phase
Protocol Violation
|
1
|
0
|
|
Post Treatment Follow-up Phase
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study Of Galcanezumab In Participants With Episodic Cluster Headache
Baseline characteristics by cohort
| Measure |
Placebo
n=57 Participants
Participants received placebo once a month for 2 months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=49 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.40 years
STANDARD_DEVIATION 11.32 • n=93 Participants
|
47.49 years
STANDARD_DEVIATION 10.74 • n=4 Participants
|
46.37 years
STANDARD_DEVIATION 11.05 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
88 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
86 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Greece
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
Belgium
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Region of Enrollment
Finland
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
Denmark
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
11 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Weekly Cluster Headache Attacks
|
17.30 Cluster Headache Attacks per week
STANDARD_DEVIATION 10.05 • n=93 Participants
|
17.82 Cluster Headache Attacks per week
STANDARD_DEVIATION 10.12 • n=4 Participants
|
17.54 Cluster Headache Attacks per week
STANDARD_DEVIATION 10.04 • n=27 Participants
|
|
Lifetime suicidal ideation prior to screening
|
5 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Lifetime suicidal behavior prior to screening
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 1 through Week 3Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 3 from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=49 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
|
-5.22 Cluster Headache Attacks per Week
Standard Error 1.33
|
-8.69 Cluster Headache Attacks per Week
Standard Error 1.42
|
SECONDARY outcome
Timeframe: Baseline, Week 3Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Percentage of participants with 50% or greater reduction from baseline at week 3 was analyzed using Koch's nonparametric randomization-based analysis of covariance method. This method adjusted for pooled investigative site by including it as a stratification variable. It also adjusted for sex and baseline value.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=49 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks
|
52.63 percentage of participants
|
71.43 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1 through Week 8Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 8 from MMRM analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=49 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks
|
-9.97 Cluster Headache Attacks per Week
Standard Error 0.95
|
-10.80 Cluster Headache Attacks per Week
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants who received at least one dose of study drug and had PGI-I measurement at week4.
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Outcome measures
| Measure |
Placebo
n=49 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=44 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
|
46.4 percentage of participants
|
72.5 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 8.
PGI-I requests participants to mark the box that best describes their cluster headache condition since they started taking the medicine. The options in the displayed boxes are represented on a 7-point scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Percentage of participants were derived with a generalized linear mixed model repeated measures method with treatment, sex, baseline cluster headache attack category, month, and treatment by month as fixed effects.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=38 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)
|
66.1 percentage of participants
|
71.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1 through Week 8Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures method with treatment, sex, week, treatment by week, and baseline as fixed effects.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=49 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks
|
70.4 percentage of participants
|
69.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 1 through Week 8Population: All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement.
Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Mean percentage of participants is derived from the average of weeks 1 to 8 from generalized linear mixed model repeated measures with treatment, sex, week, treatment by week and baseline as fixed effects.
Outcome measures
| Measure |
Placebo
n=57 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=49 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks
|
78.9 percentage of participants
|
77.7 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: All randomized participants who received at least one dose of study drug and had measurable PK samples.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
|
20200 Nanogram per Milliliter (ng/mL)
Standard Deviation 6880
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: All randomized participants who received at least one dose of study drug and had measurable PK samples.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Pharmacokinetics (PK): Serum Concentration of Galcanezumab
|
26400 Nanogram per Milliliter (ng/mL)
Standard Deviation 11200
|
—
|
SECONDARY outcome
Timeframe: Baseline through Week 8Population: All randomized participants who received at least one dose of study drug and had non-missing baseline ADA result, and at least one non-missing post baseline ADA result.
Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject 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 \>= 1: 20.
Outcome measures
| Measure |
Placebo
n=53 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=48 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal ideation: a "yes" answer to any of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=49 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Month 1 through Month 6Population: All randomized participants who received at least one dose of study drug and had at least one post baseline C-SSRS assessment.
C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. Some questions are binary responses (yes/no) and some are on a scale of 1 (low severity) to 5 (high severity). Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Outcome measures
| Measure |
Placebo
n=54 Participants
Participants received placebo once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
Galcanezumab 300mg
n=49 Participants
Participants received Galcanezumab 300mg once a month for two months by SC injection.
Participants did not receive any intervention during post treatment follow-up phase.
|
|---|---|---|
|
Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Placebo - Treatment Phase
Galcanezumab 300mg - Treatment Phase
Placebo - Post Treatment Phase
Galcanezumab 300mg - Post Treatment Phase
Serious adverse events
| Measure |
Placebo - Treatment Phase
n=57 participants at risk
Participants received placebo once a month for two months by SC injection.
|
Galcanezumab 300mg - Treatment Phase
n=49 participants at risk
Participants received Galcanezumab 300mg once a month for two months by SC injection.
|
Placebo - Post Treatment Phase
n=50 participants at risk
Participants didn't receive any intervention.
|
Galcanezumab 300mg - Post Treatment Phase
n=47 participants at risk
Participants didn't receive any intervention.
|
|---|---|---|---|---|
|
Nervous system disorders
Cluster headache
|
0.00%
0/57 • 6 Months
|
0.00%
0/49 • 6 Months
|
2.0%
1/50 • Number of events 1 • 6 Months
|
0.00%
0/47 • 6 Months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/57 • 6 Months
|
0.00%
0/49 • 6 Months
|
2.0%
1/50 • Number of events 1 • 6 Months
|
0.00%
0/47 • 6 Months
|
Other adverse events
| Measure |
Placebo - Treatment Phase
n=57 participants at risk
Participants received placebo once a month for two months by SC injection.
|
Galcanezumab 300mg - Treatment Phase
n=49 participants at risk
Participants received Galcanezumab 300mg once a month for two months by SC injection.
|
Placebo - Post Treatment Phase
n=50 participants at risk
Participants didn't receive any intervention.
|
Galcanezumab 300mg - Post Treatment Phase
n=47 participants at risk
Participants didn't receive any intervention.
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
0.00%
0/57 • 6 Months
|
8.2%
4/49 • Number of events 4 • 6 Months
|
0.00%
0/50 • 6 Months
|
0.00%
0/47 • 6 Months
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/57 • Number of events 1 • 6 Months
|
6.1%
3/49 • Number of events 3 • 6 Months
|
6.0%
3/50 • Number of events 3 • 6 Months
|
2.1%
1/47 • Number of events 1 • 6 Months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
3/57 • Number of events 3 • 6 Months
|
0.00%
0/49 • 6 Months
|
0.00%
0/50 • 6 Months
|
0.00%
0/47 • 6 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All information provided to Investigator \&/or Institution by Lilly or Lilly-designated representatives, or generated by Investigator \&/or institution in connection with Study, will be kept in confidence and not used for any purpose not expressly provided in the Agreement for at least 5 years after termination or conclusion of Study, except to the extent that Lilly gives Investigator \&/or Institution written permission or particular information is required by laws or regulations to be disclosed.
- Publication restrictions are in place
Restriction type: OTHER