Chronic Migraine Clinical Trial
— REGAINOfficial title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study
| Verified date | April 2022 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.
| Status | Completed |
| Enrollment | 1117 |
| Est. completion date | July 14, 2021 |
| Est. primary completion date | March 16, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: Main Study: - Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50. Israel addendum: - Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered. - Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine. Exclusion Criteria: - Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. - Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody. - Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab. - History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Buenos Aires | |
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ciudad Autonoma de Buenos Aire | |
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ciudad Autonoma de Buenos Aire | |
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ciudad Autonoma de Buenos Aire | |
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ciudad Autonoma de Buenos Aire | |
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ciudad Autonoma de Buenos Aire | |
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ciudad Autonoma de Buenos Aire | |
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ciudad Autonoma de Buenos Aire | |
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cordoba | |
| Argentina | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Cordoba | |
| Canada | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Brampton | |
| Canada | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Kelowna | |
| Canada | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Montreal | |
| Canada | For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician. | Ottawa | |
| Czechia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brno | |
| Czechia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kladno | |
| Czechia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Praha 10 | |
| Czechia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Praha 2 | |
| Czechia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Praha 6 | |
| Czechia | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Praha 8 | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Berlin | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bielefeld | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bochum | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Essen | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamburg | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kassel | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Königstein | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Prien | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tübingen | |
| Israel | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hadera | |
| Israel | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kfar Saba | |
| Israel | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ramat Gan | |
| Israel | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tel Aviv | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bologna | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Firenze | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Modena | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pavia | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Roma | |
| Mexico | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aguascalientes | |
| Mexico | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Culiacan | |
| Mexico | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | México City | |
| Netherlands | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Amsterdam | |
| Netherlands | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leiden | |
| Netherlands | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nijmegen | |
| Netherlands | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Zwolle | |
| Puerto Rico | Office of Dr. Ruddy Guerra | Manati | |
| Puerto Rico | GCM Medical Group PSC | San Juan | |
| Puerto Rico | Instituto de Neurologia Dra. Ivonne Fraga | San Juan | |
| Puerto Rico | Neuro GI Wellness Center | San Juan | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Barcelona | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pamplona | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Santander | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valencia | |
| Spain | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Valladolid | |
| Taiwan | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Kaohsiung | |
| Taiwan | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tainan | |
| Taiwan | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tainan | |
| Taiwan | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taipei | |
| Taiwan | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Taipei | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Glasgow | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hull | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | London | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stoke-on-Trent | |
| United States | Albuquerque Clinical Trials | Albuquerque | New Mexico |
| United States | Dent Neurological Institute | Amherst | New York |
| United States | Michigan Head, Pain and Neurological Institute | Ann Arbor | Michigan |
| United States | FutureSearch Trials of Neurology and Sleep Lab | Austin | Texas |
| United States | PharmaSite Research Inc | Baltimore | Maryland |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Northwest Clinical Trials | Boise | Idaho |
| United States | Boston Clinical Trials Inc | Boston | Massachusetts |
| United States | Christie Clinic, LLC | Champaign | Illinois |
| United States | Clinical Trials of South Carolina | Charleston | South Carolina |
| United States | ClinSearch | Chattanooga | Tennessee |
| United States | Univ of Cincinnati College of Medicine | Cincinnati | Ohio |
| United States | University of South Carolina | Columbia | South Carolina |
| United States | Headache Medicine Specialist of North Texas | Dallas | Texas |
| United States | Avail Clinical Research LLC | DeLand | Florida |
| United States | Pharmacology Research Institute, Encino | Encino | California |
| United States | Colorado Neurological Institute | Englewood | Colorado |
| United States | Associated Neurologists of Southern Connecticut | Fairfield | Connecticut |
| United States | Advanced Neurosciences Research, LLC | Fort Collins | Colorado |
| United States | Fullerton Neurology and Headache Center | Fullerton | California |
| United States | Healthcare Research Network - Hazelwood | Hazelwood | Missouri |
| United States | Midwest Institute for Clinical Research | Indianapolis | Indiana |
| United States | Clinical Neuroscience Solutions Inc | Jacksonville | Florida |
| United States | Pharmacology Research Institute, Los Alamitos | Los Alamitos | California |
| United States | Dean Foundation for Health Research and Education | Middleton | Wisconsin |
| United States | Clinical Research Institute | Minneapolis | Minnesota |
| United States | Coastal Carolina Research Center, Inc. | Mount Pleasant | South Carolina |
| United States | Pharmacology Research Institute, Newport Beach | Newport Beach | California |
| United States | Health Research of Hampton Roads Inc | Newport News | Virginia |
| United States | |Renstar Medical Research | Ocala | Florida |
| United States | Psychiatric Inst of Florida-Clinical Neuroscience Solutions | Orlando | Florida |
| United States | Compass Research | Oviedo | Florida |
| United States | 21st Century Neurology | Phoenix | Arizona |
| United States | Arizona Research Center | Phoenix | Arizona |
| United States | Island Neuro Associates,PC | Plainview | New York |
| United States | Preferred Primary Care Physicians | Pleasant Hills | Pennsylvania |
| United States | Phoenix Medical Research, Inc | Prairie Village | Kansas |
| United States | Desert Valley Research | Rancho Mirage | California |
| United States | Anderson Clinical Research | Redlands | California |
| United States | Robbins Headache Clinic | Riverwoods | Illinois |
| United States | Foothill Family Clinic | Salt Lake City | Utah |
| United States | Artemis Institute for Clinical Research | San Diego | California |
| United States | Medical Center for Clinical Research | San Diego | California |
| United States | Optimus Medical Group | San Francisco | California |
| United States | BG Neurology | Spartanburg | South Carolina |
| United States | Premier Clinical Research | Spokane | Washington |
| United States | ClinVest | Springfield | Missouri |
| United States | Healthcare Research Consultant | Tulsa | Oklahoma |
| United States | Sentara Neurology Specialists | Virginia Beach | Virginia |
| United States | Premiere Research Institute at Palm Beach Neurology | West Palm Beach | Florida |
| United States | Heartland Research Associates | Wichita | Kansas |
| United States | Abington Neurological Associates | Willow Grove | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Argentina, Canada, Czechia, Germany, Israel, Italy, Mexico, Netherlands, Puerto Rico, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
Baseline, Month 1 through Month 3 | |
| Secondary | 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. | Baseline, Month 1 through Month 3 | |
| Secondary | 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. | Baseline, Month 3 | |
| Secondary | Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache | 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. |
Baseline, Month 1 through Month 3 | |
| Secondary | 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. | Baseline, Month 3 | |
| Secondary | 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. | Baseline, Month 1 through Month 3 | |
| Secondary | 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. | Baseline, Month 3 | |
| Secondary | 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. | Month 1 through Month 3 | |
| Secondary | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab | Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab. | Baseline through Month 3 | |
| Secondary | Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) | Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP). | Month 3 | |
| Secondary | Serum Concentrations of Galcanezumab | Serum concentrations of Galcanezumab | Month 3 |
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