Trial · NCT02397473
A Study Of Galcanezumab In Participants With Episodic Cluster Headache
NCT02397473, Phase 3, Completed, Eli Lilly and Company; results first posted 2019-03-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Of Galcanezumab In Participants With Episodic Cluster Headache. Trials, record NCT02397473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02397473
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Of Galcanezumab In Participants With Episodic Cluster Headache
- NCT number
- NCT02397473
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 109 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Episodic Cluster Headache
- Interventions
- Galcanezumab, Placebo
- First posted
- 2015-03-25
- Last updated
- 2019-09-09
- Other registries' IDs
- eudract:2015-000149-22
- Results first posted
- 2019-03-13
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks | Baseline, Week 1 through Week 3 | 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. |
| Secondary | Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks | Baseline, Week 3 | 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. |
| Secondary | Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks | Baseline, Week 1 through Week 8 | 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. |
| Secondary | Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) | Week 4 | 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. |
| Secondary | Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) | 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. |
| Secondary | Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks | Baseline, Week 1 through Week 8 | 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. |
| Secondary | Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks | Baseline, Week 1 through Week 8 | 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. |
| Secondary | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | Week 4 | |
| Secondary | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | Week 8 | |
| Secondary | Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab | Baseline through Week 8 | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks | Baseline, Week 1 through Week 3 | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement. | Cluster Headache Attacks per Week | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks | Baseline, Week 3 | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement. | percentage of participants | NUMBER |
| SECONDARY | Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks | Baseline, Week 1 through Week 8 | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement. | Cluster Headache Attacks per Week | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) | Week 4 | All randomized participants who received at least one dose of study drug and had PGI-I measurement at week4. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) | Week 8 | All randomized participants who received at least one dose of study drug and had PGI-I measurement at week 8. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks | Baseline, Week 1 through Week 8 | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks | Baseline, Week 1 through Week 8 | All randomized participants who received at least one dose of study drug and had baseline and at least one post baseline measurement. | percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | Week 4 | All randomized participants who received at least one dose of study drug and had measurable PK samples. | Nanogram per Milliliter (ng/mL) | MEAN |
| SECONDARY | Pharmacokinetics (PK): Serum Concentration of Galcanezumab | Week 8 | All randomized participants who received at least one dose of study drug and had measurable PK samples. | Nanogram per Milliliter (ng/mL) | MEAN |
| SECONDARY | Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab | Baseline through Week 8 | 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. | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks | Placebo | -5.22 | Standard Error 1.33 | Cluster Headache Attacks per Week | |
| Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks | Galcanezumab 300mg | -8.69 | Standard Error 1.42 | Cluster Headache Attacks per Week | |
| Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks | Placebo | 52.63 | percentage of participants | ||
| Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks | Galcanezumab 300mg | 71.43 | percentage of participants | ||
| Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks | Placebo | -9.97 | Standard Error 0.95 | Cluster Headache Attacks per Week | |
| Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks | Galcanezumab 300mg | -10.80 | Standard Error 1.00 | Cluster Headache Attacks per Week | |
| Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) | Placebo | 46.4 | percentage of participants | ||
| Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) | Galcanezumab 300mg | 72.5 | percentage of participants | ||
| Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) | Placebo | 66.1 | percentage of participants | ||
| Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) | Galcanezumab 300mg | 71.9 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | Placebo | 57 | |
| Treatment Phase | STARTED | Galcanezumab 300mg | 52 | |
| Treatment Phase | Received at Least One Dose of Study Drug | Placebo | 57 | |
| Treatment Phase | Received at Least One Dose of Study Drug | Galcanezumab 300mg | 49 | |
| Treatment Phase | COMPLETED | Placebo | 45 | |
| Treatment Phase | COMPLETED | Galcanezumab 300mg | 45 | |
| Treatment Phase | NOT COMPLETED | Placebo | 12 | |
| Treatment Phase | NOT COMPLETED | Galcanezumab 300mg | 7 | |
| Post Treatment Follow-up Phase | STARTED | Placebo | 50 | |
| Post Treatment Follow-up Phase | STARTED | Galcanezumab 300mg | 47 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | Placebo - Treatment Phase | 0 | 57 | 0 |
| other | Injection site pain | General disorders | Galcanezumab 300mg - Treatment Phase | 4 | 49 | 4 |
| other | Injection site pain | General disorders | Placebo - Post Treatment Phase | 0 | 50 | 0 |
| other | Injection site pain | General disorders | Galcanezumab 300mg - Post Treatment Phase | 0 | 47 | 0 |
| other | Nasopharyngitis | Infections and infestations | Placebo - Treatment Phase | 1 | 57 | 1 |
| other | Nasopharyngitis | Infections and infestations | Galcanezumab 300mg - Treatment Phase | 3 | 49 | 3 |
| other | Nasopharyngitis | Infections and infestations | Placebo - Post Treatment Phase | 3 | 50 | 3 |
| other | Nasopharyngitis | Infections and infestations | Galcanezumab 300mg - Post Treatment Phase | 1 | 47 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo - Treatment Phase | 3 | 57 | 3 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Galcanezumab 300mg - Treatment Phase | 0 | 49 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Treatment Phase | 0 | 57 |
| Total, all-cause mortality | Galcanezumab 300mg - Treatment Phase | 0 | 49 |
| Total, all-cause mortality | Placebo - Post Treatment Phase | 0 | 50 |
| Total, all-cause mortality | Galcanezumab 300mg - Post Treatment Phase | 0 | 47 |
| Total, other adverse events | Placebo - Treatment Phase | 4 | 57 |
| Total, other adverse events | Galcanezumab 300mg - Treatment Phase | 7 | 49 |
| Total, other adverse events | Placebo - Post Treatment Phase | 3 | 50 |
| Total, other adverse events | Galcanezumab 300mg - Post Treatment Phase | 1 | 47 |
| Total, serious adverse events | Placebo - Treatment Phase | 0 | 57 |
| Total, serious adverse events | Galcanezumab 300mg - Treatment Phase | 0 | 49 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02397473
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