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

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

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

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Galcanezumab

• Study Type: Interventional
• Enrollment (Actual): 862
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Brampton, Canada, L6T 0G1
    • 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, V1Y 1Z9
    • 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, L4Y 2N8
    • 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, H3A 2B4
    • 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, K2G 6E2
    • 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, J1H1Z1
    • 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, M9W 4L6
    • 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, V6Z 2E8
    • 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, Canada, N2J 1C4
    • 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.
• Puerto Rico
  • Manati, Puerto Rico, 00674
    • Office of Dr. Ruddy Guerra
  • Rio Piedras, Puerto Rico, 00923
    • NuFrontiers Clinical Research LLC
  • San Juan, Puerto Rico, 00909
    • GCM Medical Group PSC
  • San Juan, Puerto Rico, 00909
    • Clinical Research Puerto Rico, Inc.
  • San Juan, Puerto Rico, 00918
    • Instituto De Neurologia Dra. Ivonne Fraga
  • San Juan, Puerto Rico, 00926
    • Neuro GI Wellness Center
• United States
  • Arizona
    • Tucson, Arizona, United States, 85704
      • Territory Neurology & Research Institute
    • Tucson, Arizona, United States, 85741
      • Orange Grove Family Practice
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Arkansas Clinical Research
  • California
    • Carmichael, California, United States, 95608
      • Advanced Clinical Research
    • Encino, California, United States, 91316
      • Pharmacology Research Institute, Newport Beach
    • Encino, California, United States, 91436
      • Tooraj Joseph Raoof M.D., Inc.
    • Fullerton, California, United States, 92835
      • Fullerton Neurology and Headache Center
    • Imperial, California, United States, 92251
      • Sun Valley Research Center
    • Irvine, California, United States, 92618
      • Irvine Clinical Research Center
    • Los Alamitos, California, United States, 90720
      • Pharmacology Research Institute, Newport Beach
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute, Newport Beach
    • Rancho Mirage, California, United States, 92270
      • Desert Valley Research
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Alpine Clinical Research Center
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers
    • Denver, Colorado, United States, 80218
      • Mile High Research Center
    • Englewood, Colorado, United States, 80113
      • Colorado Neurological Institute
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research, Llc
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Bradenton, Florida, United States, 34201
      • Meridien Research
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research
    • Ocala, Florida, United States, 34471
      • Renstar Medical Research
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare
    • Orlando, Florida, United States, 32801
      • Psychiatric Inst of Florida-Clinical Neuroscience Solutions
    • Oviedo, Florida, United States, 32765
      • Compass Research
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Sarasota, Florida, United States, 34243
      • Roskamp Institute
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Reserach . LLC
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute at Palm Beach Neurology
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research LLC
  • Illinois
    • Blue Island, Illinois, United States, 60406
      • Healthcare Research Network - Blue Island
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Community Clinical Research Center
    • Elwood, Indiana, United States, 46036
      • Investigative Clinical Research of Indiana, LLC
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic Inc
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Integrated Clinical Trial Services, Inc.
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Phoenix Medical Research, Inc
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Otri-Med Corporation
    • Louisville, Kentucky, United States, 40213
      • L-MARC Research Center
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research Inc
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials Inc
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head, Pain and Neurological Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Clinvest
  • New Hampshire
    • Nashua, New Hampshire, United States, 03060
      • Healthy Perspectives Innovative Mental Health Services, PL
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurological Institute
    • Manlius, New York, United States, 13104
      • Central New York Clinical Research
    • New York, New York, United States, 10016
      • NYU Langone
    • New York, New York, United States, 10168
      • Fieve Clincial Services
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Metrolina Neurological Associates, PA
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center
  • Ohio
    • Cleveland, Ohio, United States, 44122
      • Rapid Medical Research Inc
    • Toledo, Ohio, United States, 43614
      • Medical College of Ohio at Toledo
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • Healthcare Research Consultant
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network Inc
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Lehigh Center for Clinical Research
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Neurological Associates
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Columbia, South Carolina, United States, 29203
      • 8 Medical Park
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
    • Nashville, Tennessee, United States, 37203
      • Clinical Research Associates
  • Texas
    • Austin, Texas, United States, 78731
      • FutureSearch Trials
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78229
      • Radiant Research - San Antonio
  • Utah
    • West Jordan, Utah, United States, 84088
      • Advanced Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
    • Norfolk, Virginia, United States, 23507
      • Clinical Research Associates of Tidewater
    • Richmond, Virginia, United States, 23294
      • National Clinical Research - Richmond
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research
    • Vancouver, Washington, United States, 98664
      • Vancouver Clinic
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Clinical Investigation Specialists Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Galcanezumab 240mg; Galcanezumab 240mg given by SC injection once a month for 6 months.	Drug: Galcanezumab; Administered SC; Other Names: LY2951742
Placebo Comparator: Placebo; Placebo given by SC injection once a month for 6 months.	Drug: Placebo; Administered SC
Experimental: Galcanezumab 120mg; Galcanezumab given by subcutaneous (SC) injection at 120mg dose once a month for 6 months. Participants received a loading dose of 240mg (2 injections of 120mg each) was administered at visit 3 only.	Drug: Galcanezumab; Administered SC; Other Names: LY2951742

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Pharmacokinetics (PK): Serum Concentrations of Galcanezumab	Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.	Month 6
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)	Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).	Month 6
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.
• Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7. Erratum In: BMC Neurol. 2020 Mar 13;20(1):90.
• Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.
• Ailani J, Kuruppu DK, Rettiganti M, Oakes T, Schroeder K, Wietecha L, Port M, Blumenfeld AM. Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials. Headache. 2022 Feb;62(2):198-207. doi: 10.1111/head.14257. Epub 2022 Jan 25.
• Citrome L, Sanchez Del Rio M, Dong Y, Nichols RM, Tockhorn-Heidenreich A, Foster SA, Stauffer VL. Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm. Adv Ther. 2021 Aug;38(8):4442-4460. doi: 10.1007/s12325-021-01848-x. Epub 2021 Jul 15.
• Jedynak J, Eross E, Gendolla A, Rettiganti M, Stauffer VL. Shift from high-frequency to low-frequency episodic migraine in patients treated with Galcanezumab: results from two global randomized clinical trials. J Headache Pain. 2021 May 28;22(1):48. doi: 10.1186/s10194-021-01222-w.
• Pozo-Rosich P, Samaan KH, Schwedt TJ, Nicholson RA, Rettiganti M, Pearlman EM. Galcanezumab Provides Consistent Efficacy Throughout the Dosing Interval Among Patients with Episodic and Chronic Migraine: A Post Hoc Analysis. Adv Ther. 2021 Jun;38(6):3154-3165. doi: 10.1007/s12325-021-01708-8. Epub 2021 May 5.
• Ament M, Day K, Stauffer VL, Skljarevski V, Rettiganti M, Pearlman E, Aurora SK. Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine. J Headache Pain. 2021 Feb 6;22(1):6. doi: 10.1186/s10194-021-01215-9. Erratum In: J Headache Pain. 2021 Aug 26;22(1):100.
• Dodick DW, Doty EG, Aurora SK, Ruff DD, Stauffer VL, Jedynak J, Dong Y, Pearlman EM. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021 Mar;41(3):340-352. doi: 10.1177/0333102420966658. Epub 2020 Nov 3.
• Ailani J, Andrews JS, Rettiganti M, Nicholson RA. Impact of galcanezumab on total pain burden: findings from phase 3 randomized, double-blind, placebo-controlled studies in patients with episodic or chronic migraine (EVOLVE-1, EVOLVE-2, and REGAIN trials). J Headache Pain. 2020 Oct 17;21(1):123. doi: 10.1186/s10194-020-01190-7.
• Silberstein SD, Stauffer VL, Day KA, Lipsius S, Wilson MC. Galcanezumab in episodic migraine: subgroup analyses of efficacy by high versus low frequency of migraine headaches in phase 3 studies (EVOLVE-1 & EVOLVE-2). J Headache Pain. 2019 Jun 28;20(1):75. doi: 10.1186/s10194-019-1024-x. Erratum In: J Headache Pain. 2019 Dec 27;20(1):118.
• Stauffer VL, Wang S, Voulgaropoulos M, Skljarevski V, Kovacik A, Aurora SK. Effect of Galcanezumab Following Treatment Cessation in Patients With Migraine: Results From 2 Randomized Phase 3 Trials. Headache. 2019 Jun;59(6):834-847. doi: 10.1111/head.13508. Epub 2019 Apr 3.
• Forderreuther S, Zhang Q, Stauffer VL, Aurora SK, Lainez MJA. Preventive effects of galcanezumab in adult patients with episodic or chronic migraine are persistent: data from the phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. J Headache Pain. 2018 Dec 29;19(1):121. doi: 10.1186/s10194-018-0951-2.
• Nichols R, Doty E, Sacco S, Ruff D, Pearlman E, Aurora SK. Analysis of Initial Nonresponders to Galcanezumab in Patients With Episodic or Chronic Migraine: Results From the EVOLVE-1, EVOLVE-2, and REGAIN Randomized, Double-Blind, Placebo-Controlled Studies. Headache. 2019 Feb;59(2):192-204. doi: 10.1111/head.13443. Epub 2018 Nov 21.
• Kuruppu DK, North JM, Kovacik AJ, Dong Y, Pearlman EM, Hutchinson SL. Onset, Maintenance, and Cessation of Effect of Galcanezumab for Prevention of Migraine: A Narrative Review of Three Randomized Placebo-Controlled Trials. Adv Ther. 2021 Mar;38(3):1614-1626. doi: 10.1007/s12325-021-01632-x. Epub 2021 Feb 5.
• Stauffer VL, Dodick DW, Zhang Q, Carter JN, Ailani J, Conley RR. Evaluation of Galcanezumab for the Prevention of Episodic Migraine: The EVOLVE-1 Randomized Clinical Trial. JAMA Neurol. 2018 Sep 1;75(9):1080-1088. doi: 10.1001/jamaneurol.2018.1212. Erratum In: JAMA Neurol. 2019 Jul 1;76(7):872.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2015
• Primary Completion (Actual): March 22, 2017
• Study Completion (Actual): August 9, 2018

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 25, 2015

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 10, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: prevention; prophylaxis; headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 15767; I5Q-MC-CGAG (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)