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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
165
Administered SC
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)
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)
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mayo Clinic Hospital
Phoenix, Arizona, United States
Stanford University Hospital
Palo Alto, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
Colorado Neurological Institute
Englewood, Colorado, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
University of South Florida
Tampa, Florida, United States
Atlanta Center of Medical Research
Atlanta, Georgia, United States
Michigan Head, Pain and Neurological Institute
Ann Arbor, Michigan, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Clinical Trials of South Carolina
Charleston, South Carolina, United States
...and 30 more locations
Time frame: Baseline through End of Study (Up to 4 Years)