Trial · NCT02797951
A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
NCT02797951, Phase 3, Completed, Eli Lilly and Company; results first posted 2022-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache. Trials, record NCT02797951. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02797951
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
- NCT number
- NCT02797951
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 165 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Episodic Cluster Headache, Chronic Cluster Headache
- Interventions
- Galcanezumab
- First posted
- 2016-06-14
- Last updated
- 2022-02-10
- Other registries' IDs
- eudract:2015-005234-21
- Results first posted
- 2022-02-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Baseline through End of Study (Up to 4 Years) | A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase. An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module. |
| Primary | Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | Baseline through End of Study (Up to 4 Years) | C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no). * Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent. * Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide. |
| Secondary | Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab | Baseline through End of Study (Up to 4 Years) | A participant is considered TE-ADA positive if: * ADA "not present" baseline result and any subsequent "present" postbaseline ADA result with a titer of at least 1:20 (treatment-induced), or * ADA "present" baseline result and any subsequent "present" postbaseline ADA result with a 4-fold or greater increase in titer from baseline (treatment-boosted). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Baseline through End of Study (Up to 4 Years) | All participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | Baseline through End of Study (Up to 4 Years) | All participants who received at least one dose of study drug and had at least one postbaseline C-SSRS assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab | Baseline through End of Study (Up to 4 Years) | All participants who received at least one dose of study drug and had baseline and at least one post baseline ADA assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Galcanezumab 300 mg SC | TEAEs | 119 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Galcanezumab 300 mg SC | SAEs | 17 | Participants | |
| Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | Galcanezumab 300 mg SC | Suicidal Ideation | 2 | Participants | |
| Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | Galcanezumab 300 mg SC | Suicidal Behaviour | 0 | Participants | |
| Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab | Galcanezumab 300 mg SC | 8 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Galcanezumab 300 mg SC | 165 | |
| Overall Study | Received at Least One Dose of Study Drug | Galcanezumab 300 mg SC | 164 | |
| Overall Study | COMPLETED | Galcanezumab 300 mg SC | 116 | |
| Overall Study | NOT COMPLETED | Galcanezumab 300 mg SC | 49 |
Source ClinicalTrials.gov
Adverse events21
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 | Bronchitis | Infections and infestations | Galcanezumab 300 mg SC | 10 | 164 | 16 |
| other | Influenza | Infections and infestations | Galcanezumab 300 mg SC | 16 | 164 | 21 |
| other | Nasopharyngitis | Infections and infestations | Galcanezumab 300 mg SC | 36 | 164 | 46 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Galcanezumab 300 mg SC | 11 | 164 | 14 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Galcanezumab 300 mg SC | 11 | 164 | 13 |
| serious | Constipation | Gastrointestinal disorders | Galcanezumab 300 mg SC | 1 | 164 | 1 |
| serious | Chest discomfort | General disorders | Galcanezumab 300 mg SC | 1 | 164 | 1 |
| serious | Sarcoidosis | Immune system disorders | Galcanezumab 300 mg SC | 1 | 164 | 1 |
| serious | Gastroenteritis | Infections and infestations | Galcanezumab 300 mg SC | 1 | 164 | 1 |
| serious | Cartilage injury | Injury, poisoning and procedural complications | Galcanezumab 300 mg SC | 1 | 164 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Galcanezumab 300 mg SC | 1 | 164 |
| Total, other adverse events | Galcanezumab 300 mg SC | 62 | 164 |
| Total, serious adverse events | Galcanezumab 300 mg SC | 17 | 164 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35633025 | DERIVED |
Source PubMed
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/NCT02797951
GET https://conductscience.org/api/trials/v1/NCT02797951/events?page=2