The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
270
Administered SC
Percentage of Participants Who Discontinued Due to Adverse Event
Adverse Event: Any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A summary of other non-serious AEs, and all SAE's, regardless of causality, is reported in the Adverse Events section.
Time frame: Baseline through Month 12
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab
Time frame: Baseline through Month 12
Serum Concentrations of Galcanezumab
Serum Concentrations of Galcanezumab.
Time frame: Month 12
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Time frame: Month 12
Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab
A Treatment Emergent Anti-drug Antibody (TE ADA) evaluable participant is considered to be TE ADA+ if the participant 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 (treatment-induced). There were 6 participants in the 120 mg arm who discontinued after receiving loading dose of 240mg, these participants were moved to 240mg arm for safety analysis.
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California Medical Clinic for Headache
Santa Monica, California, United States
Encompass Clinical Research
Spring Valley, California, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Sunrise Clinical Research
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Mercy Health Research
St Louis, Missouri, United States
Albuquerque Neurosciences
Albuquerque, New Mexico, United States
PharmQuest
Greensboro, North Carolina, United States
Wilmington Health Associates
Wilmington, North Carolina, United States
Suburban Research Associates
Media, Pennsylvania, United States
...and 17 more locations
Time frame: Month 1 through Month 12
Overall Mean Change From Baseline in the Number of Migraine Headache Days (MHD)
MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 12 from MMRM model. Least squares mean (LSMean) was calculated using mixed model repeated measures (MMRM) model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.
Time frame: Baseline, Month 1 through Month 12
Overall Mean Change From Baseline in the Number of Headache Days
Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache). Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.
Time frame: Baseline, Month 1 through Month 12
Percentage of Participants With Overall Reduction From Baseline ≥50% in Monthly Migraine Headache Days
Migraine Headache Day: A calendar day on which a migraine headache or probable migraine headache occurred. Overall percentage of participants with a given response rate were estimated from the generalized linear mixed models (GLIMMIX) model.
Time frame: Baseline, Month 1 through Month 12
Overall Mean Change From Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches
Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month as fixed effects.
Time frame: Baseline, Month 1 through Month 12
Overall Mean Patient Global Impression-Improvement (PGI-I) Score
The Patient Global Impression of Improvement (PGI -I) scale is a participant-rated instrument that measures the participants own global impression of their symptom improvement. The participant was instructed as follows: "Mark the box that best describes your migraine headache condition since you started taking this medicine." Response options were on a 7-point scale in which a score of 1 indicates that the participant's condition is "very much better," a score of 4 indicates that the participant has experienced "no change," and a score of 7 indicates that the participant is "very much worse." Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline PGI-S, and baseline PGI-S by month as fixed effects.
Time frame: Month 1 through Month 12
Overall Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. Overall mean is derived from the average of months 1 to 12 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled investigative site, month, and treatment by month, baseline, and baseline by month.
Time frame: Baseline, Month 1 through Month 12
Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1
MSQv2.1 is a health status instrument,with a 4-week recall period, developed to address physical \& emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family \& friends, leisure time, productivity, concentration, energy, tiredness \& feelings.It consists of 14 items addressing 3 domains:(1)Role Function-Restrictive (items 1-7);(2)Role Function- Preventive (items 8-11);\&(3)Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6), \& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain.After total raw score is computed for each domain \& total score, they are transformed to a 0-100 scale with higher scores indicating a better health status \& a positive change in scores reflecting functional improvement.
Time frame: Baseline, Month 1 through Month 12
Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
The PSMQ-M is a self-rated scale which measures participants level of satisfaction with study medication.The scale has been modified for use in this study, assessing 3 items related to the clinical trial treatment over the past 4 weeks: satisfaction, preference, and side effects. Satisfaction responses range from "very unsatisfied" to "very satisfied" with the current treatment. Preference compares the current study medication to previous medications, with responses from "much rather prefer my previous medication" to "much rather prefer the medication administered to me during the study".
Time frame: Baseline through Month 12
Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12
The SQAAQ is a self-administered questionnaire that provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of study drug. Participants will respond to questionnaire items using a 7-point Likert scale (from "Strongly Disagree" to "Strongly Agree") shortly after the injection. If a caregiver administers the injection, the participants should be prepared to provide the caregiver's ratings of the questions.strongly agree \& agree are considered as positive responses.
Time frame: Baseline through Month 12