Chronic Cluster Headache, Episodic Cluster Headache
Conditions
Keywords
cluster headache, headache, brain diseases, central nervous system diseases, headache disorders, headache disorders, primary, nervous system diseases, neurologic manifestations, pain, trigeminal autonomic cephalalgias
Brief summary
The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).
Interventions
DRUGGalcanezumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who participated in and completed either study CGAL or study CGAM. * Investigator judges the participant as reliable to follow all study procedures, keep all study visits, and be compliant with study requirements.
Exclusion criteria
* Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device (with the exception of Study CGAL or Study CGAM). * Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF) (with the exception of Study CGAL or Study CGAM). * A history of migraine variants that could implicate or could be confused with ischemia. * Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins. * A history or presence of other medical illness that indicates a medical problem that would preclude study participation. * Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator. * Women who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants who completed one of the parent studies I5Q-MC-CGAL (NCT02397473) or I5Q-MC-CGAM (NCT02438826) were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Galcanezumab 300 mg SC Participants received 300 mg Galcanezumab administered SC up to once a month. | 164 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 19 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Physician Decision | 6 |
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | Galcanezumab 300 mg SC |
|---|---|
| Age, Continuous | 48.30 years STANDARD_DEVIATION 9.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 117 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 140 Participants |
| Region of Enrollment Belgium | 17 Participants |
| Region of Enrollment Canada | 7 Participants |
| Region of Enrollment Denmark | 4 Participants |
| Region of Enrollment Finland | 5 Participants |
| Region of Enrollment France | 23 Participants |
| Region of Enrollment Germany | 25 Participants |
| Region of Enrollment Greece | 2 Participants |
| Region of Enrollment Italy | 24 Participants |
| Region of Enrollment Netherlands | 8 Participants |
| Region of Enrollment Spain | 17 Participants |
| Region of Enrollment United Kingdom | 4 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 164 |
| other Total, other adverse events | 62 / 164 |
| serious Total, serious adverse events | 17 / 164 |
Outcome results
Primary
Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
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.
Time frame: Baseline through End of Study (Up to 4 Years)
Population: All participants who received at least one dose of study drug and had at least one postbaseline C-SSRS assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Galcanezumab 300 mg SC | Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 2 Participants |
| Galcanezumab 300 mg SC | Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) | Suicidal Behaviour | 0 Participants |
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
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.
Time frame: Baseline through End of Study (Up to 4 Years)
Population: All participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Galcanezumab 300 mg SC | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | TEAEs | 119 Participants |
| Galcanezumab 300 mg SC | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | SAEs | 17 Participants |
Secondary
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab
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).
Time frame: Baseline through End of Study (Up to 4 Years)
Population: All participants who received at least one dose of study drug and had baseline and at least one post baseline ADA assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Galcanezumab 300 mg SC | Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab | 8 Participants |