Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study

Migraine Clinical Trial

— EVOLVE-1  

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-1 Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614183
• Other study ID #: 15767
• Secondary ID: I5Q-MC-CGAG
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2015
• Est. completion date: August 9, 2018

Study information

• Verified date: June 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with episodic migraine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 862
• Est. completion date: August 9, 2018
• Est. primary completion date: March 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have a diagnosis of episodic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 Migraine Headache Days (MHD).

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 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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Galcanezumab
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
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.	Mississauga
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
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.	Sherbrooke
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.	Toronto
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.	Vancouver
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.	Waterloo
Puerto Rico	Office of Dr. Ruddy Guerra	Manati
Puerto Rico	NuFrontiers Clinical Research LLC	Rio Piedras
Puerto Rico	Clinical Research Puerto Rico, Inc.	San Juan
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
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Dent Neurological Institute	Amherst	New York
United States	Community Clinical Research Center	Anderson	Indiana
United States	Michigan Head, Pain and Neurological Institute	Ann Arbor	Michigan
United States	FutureSearch Trials	Austin	Texas
United States	PharmaSite Research Inc	Baltimore	Maryland
United States	Healthcare Research Network - Blue Island	Blue Island	Illinois
United States	Boston Clinical Trials Inc	Boston	Massachusetts
United States	Alpine Clinical Research Center	Boulder	Colorado
United States	Meridien Research	Bradenton	Florida
United States	Advanced Clinical Research	Carmichael	California
United States	Clinical Trials of South Carolina	Charleston	South Carolina
United States	Metrolina Neurological Associates, PA	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	ClinSearch	Chattanooga	Tennessee
United States	Rapid Medical Research Inc	Cleveland	Ohio
United States	MCB Clinical Research Centers	Colorado Springs	Colorado
United States	8 Medical Park	Columbia	South Carolina
United States	Mile High Research Center	Denver	Colorado
United States	Otri-Med Corporation	Edgewood	Kentucky
United States	Investigative Clinical Research of Indiana, LLC	Elwood	Indiana
United States	Pharmacology Research Institute, Newport Beach	Encino	California
United States	Tooraj Joseph Raoof M.D., Inc.	Encino	California
United States	Colorado Neurological Institute	Englewood	Colorado
United States	Advanced Neurosciences Research, LLC	Fort Collins	Colorado
United States	Fullerton Neurology and Headache Center	Fullerton	California
United States	Sarkis Clinical Trials	Gainesville	Florida
United States	Headache Wellness Center	Greensboro	North Carolina
United States	Protenium Clinical Research	Hurst	Texas
United States	Sun Valley Research Center	Imperial	California
United States	Midwest Institute for Clinical Research	Indianapolis	Indiana
United States	Irvine Clinical Research Center	Irvine	California
United States	Clinical Investigation Specialists Inc	Kenosha	Wisconsin
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Arkansas Clinical Research	Little Rock	Arkansas
United States	Pharmacology Research Institute, Newport Beach	Los Alamitos	California
United States	L-Marc Research Center	Louisville	Kentucky
United States	Central New York Clinical Research	Manlius	New York
United States	Advanced Clinical Research LLC	Meridian	Idaho
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Healthy Perspectives Innovative Mental Health Services, PL	Nashua	New Hampshire
United States	Clinical Research Associates	Nashville	Tennessee
United States	Suncoast Clinical Research	New Port Richey	Florida
United States	Fieve Clincial Services	New York	New York
United States	NYU Langone	New York	New York
United States	Deaconess Clinic Inc	Newburgh	Indiana
United States	Pharmacology Research Institute, Newport Beach	Newport Beach	California
United States	Clinical Research Associates of Tidewater	Norfolk	Virginia
United States	Renstar Medical Research	Ocala	Florida
United States	Sensible Healthcare	Ocoee	Florida
United States	Psychiatric Inst of Florida-Clinical Neuroscience Solutions	Orlando	Florida
United States	Compass Research	Oviedo	Florida
United States	Preferred Primary Care Physicians	Pittsburgh	Pennsylvania
United States	Accord Clinical Research, LLC	Port Orange	Florida
United States	Summit Research Network Inc	Portland	Oregon
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	National Clinical Research - Richmond	Richmond	Virginia
United States	Rochester Clinical Research, Inc.	Rochester	New York
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Radiant Research - San Antonio	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Roskamp Institute	Sarasota	Florida
United States	Premier Clinical Research	Spokane	Washington
United States	ClinVest	Springfield	Missouri
United States	Infinity Clinical Reserach . LLC	Sunrise	Florida
United States	Medical College of Ohio at Toledo	Toledo	Ohio
United States	Orange Grove Family Practice	Tucson	Arizona
United States	Territory Neurology & Research Institute	Tucson	Arizona
United States	Healthcare Research Consultant	Tulsa	Oklahoma
United States	Vancouver Clinic	Vancouver	Washington
United States	Omega Medical Research	Warwick	Rhode Island
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Integrated Clinical Trial Services, Inc.	West Des Moines	Iowa
United States	Advanced Clinical Research	West Jordan	Utah
United States	Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida
United States	Abington Neurological Associates	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days	Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred.; Migraine Headache : A headache, with or without aura, of =30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.	Baseline, Month 1 through Month 6
Secondary	Mean Percentage of Participants With Reduction From Baseline =50%, =75% and 100% in Monthly Migraine Headache Days	Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.; Mean is derived from the average of months 1 to 6 from generalized linear mixed model repeated measures. Mean percentages of participants were calculated with a generalized linear mixed model repeated measures method with treatment, month and treatment by month, baseline.	Baseline, Month 1 through Month 6
Secondary	Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain	MSQ v2.1 was developed to address physical & emotional limitations of specific concern to individuals with migraine.; 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.; Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline by month & baseline MHD category as fixed factors.	Baseline, Month 4 through Month 6
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 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed effects.	Baseline, Month 1 through Month 6
Secondary	Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating	The PGI-S scale is a patient-rated instrument that measures patients own global impression of their illness severity. The patient 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"). Mean is derived from the average of months 4 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.	Baseline, Month 4 through Month 6
Secondary	Overall Mean Change From Baseline in Headache Hours	Headache Hours is calculated as the total number of headache hours on which a headache occurred. Overall mean is derived from the average of months 1 to 6 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month and baseline MHD category.	Baseline, Month 1 through Month 6
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 MMRM model with treatment, pooled country, month, treatment by month, baseline, baseline by month, and baseline MHD category as fixed factors.	Baseline, Month 6
Secondary	Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab	Treatment emergent (TE) ADA evaluable participant is considered to be TE ADA+ if the subject 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.	Month 1 through Month 6
Secondary	Pharmacokinetics (PK): Serum Concentrations of Galcanezumab	Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.	Month 6
Secondary	Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)	Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).	Month 6

External Links

•   Click here for more information about this study: Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study