The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,117
Administered SC
Administered SC
Overall Mean Change From Baseline in the Number of Monthly 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 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
Time frame: Baseline, Month 1 through Month 3
Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days
MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Time frame: Baseline, Month 1 through Month 3
Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain
MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and 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 that address 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 the total raw score is computed for each domain, 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 3
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache
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21st Century Neurology
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Pharmacology Research Institute, Encino
Encino, California, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
Pharmacology Research Institute, Los Alamitos
Los Alamitos, California, United States
Pharmacology Research Institute, Newport Beach
Newport Beach, California, United States
Desert Valley Research
Rancho Mirage, California, United States
Anderson Clinical Research
Redlands, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Medical Center for Clinical Research
San Diego, California, United States
...and 107 more locations
Migraine Headache Day (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 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.
Time frame: Baseline, Month 1 through Month 3
Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
PGI-S scale is a participant-rated instrument that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.
Time frame: Baseline, Month 3
Overall Mean Change From Baseline in Headache Hours
Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.
Time frame: Baseline, Month 1 through Month 3
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. LSMean was calculated using Analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, and baseline value as fixed effects.
Time frame: Baseline, Month 3
Percentage of Participants Developing Treatment Emergent Anti-drug Antibodies (ADA) to Galcanezumab
A Treatment Emergent Anti-Drug Antibodies (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 \>= 20.
Time frame: Month 1 through Month 3
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 3
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
Time frame: Month 3
Serum Concentrations of Galcanezumab
Serum concentrations of Galcanezumab
Time frame: Month 3