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MigrainePhase 3EVOLVE-1NCT02614183

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

A Phase 3 study testing Galcanezumab in people with Migraine, run by Eli Lilly and Company at 95 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine
What is being tested?
Galcanezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
862 participants
Where
95 sitesin 3 countries
Study dates
30 Nov 2015to 9 Aug 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

95 sites in 3 countries.

95 sites in 3 countries

United States80 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Dent Neurological Institute

    Amherst, New York, 14226

  • Community Clinical Research Center

    Anderson, Indiana, 46011

  • Michigan Head, Pain and Neurological Institute

    Ann Arbor, Michigan, 48104

  • FutureSearch Trials

    Austin, Texas, 78731

  • PharmaSite Research Inc

    Baltimore, Maryland, 21208

  • Healthcare Research Network - Blue Island

    Blue Island, Illinois, 60406

  • Boston Clinical Trials Inc

    Boston, Massachusetts, 02131

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301

  • Meridien Research

    Bradenton, Florida, 34201

  • Advanced Clinical Research

    Carmichael, California, 95608

  • Clinical Trials of South Carolina

    Charleston, South Carolina, 29406

  • Metrolina Neurological Associates, PA

    Charlotte, North Carolina, 28210

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • ClinSearch

    Chattanooga, Tennessee, 37421

  • Rapid Medical Research Inc

    Cleveland, Ohio, 44122

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910

  • 8 Medical Park

    Columbia, South Carolina, 29203

  • Mile High Research Center

    Denver, Colorado, 80218

  • Otri-Med Corporation

    Edgewood, Kentucky, 41017

  • Investigative Clinical Research of Indiana, LLC

    Elwood, Indiana, 46036

  • Pharmacology Research Institute, Newport Beach

    Encino, California, 91316

  • Tooraj Joseph Raoof M.D., Inc.

    Encino, California, 91436

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Advanced Neurosciences Research, LLC

    Fort Collins, Colorado, 80528

  • Fullerton Neurology and Headache Center

    Fullerton, California, 92835

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

  • Protenium Clinical Research

    Hurst, Texas, 76054

  • Sun Valley Research Center

    Imperial, California, 92251

  • Midwest Institute for Clinical Research

    Indianapolis, Indiana, 46260

  • Irvine Clinical Research Center

    Irvine, California, 92618

  • Clinical Investigation Specialists Inc

    Kenosha, Wisconsin, 53142

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • Pharmacology Research Institute, Newport Beach

    Los Alamitos, California, 90720

  • L-Marc Research Center

    Louisville, Kentucky, 40213

  • Central New York Clinical Research

    Manlius, New York, 13104

  • Advanced Clinical Research LLC

    Meridian, Idaho, 83642

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Healthy Perspectives Innovative Mental Health Services, PL

    Nashua, New Hampshire, 03060

  • Clinical Research Associates

    Nashville, Tennessee, 37203

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • NYU Langone

    New York, New York, 10016

  • Fieve Clincial Services

    New York, New York, 10168

  • Deaconess Clinic Inc

    Newburgh, Indiana, 47630

  • Pharmacology Research Institute, Newport Beach

    Newport Beach, California, 92660

  • Clinical Research Associates of Tidewater

    Norfolk, Virginia, 23507

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Sensible Healthcare

    Ocoee, Florida, 34761

  • Psychiatric Inst of Florida-Clinical Neuroscience Solutions

    Orlando, Florida, 32801

  • Compass Research

    Oviedo, Florida, 32765

  • Preferred Primary Care Physicians

    Pittsburgh, Pennsylvania, 15236

  • Accord Clinical Research, LLC

    Port Orange, Florida, 32129

  • Summit Research Network Inc

    Portland, Oregon, 97210

  • Phoenix Medical Research, Inc

    Prairie Village, Kansas, 66206

  • Desert Valley Research

    Rancho Mirage, California, 92270

  • Anderson Clinical Research

    Redlands, California, 92374

  • National Clinical Research - Richmond

    Richmond, Virginia, 23294

  • Rochester Clinical Research, Inc.

    Rochester, New York, 14609

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Radiant Research - San Antonio

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Medical Center for Clinical Research

    San Diego, California, 92108

  • Roskamp Institute

    Sarasota, Florida, 34243

  • Premier Clinical Research

    Spokane, Washington, 99202

  • ClinVest

    Springfield, Missouri, 65807

  • Infinity Clinical Reserach . LLC

    Sunrise, Florida, 33351

  • Medical College of Ohio at Toledo

    Toledo, Ohio, 43614

  • Territory Neurology & Research Institute

    Tucson, Arizona, 85704

  • Orange Grove Family Practice

    Tucson, Arizona, 85741

  • Healthcare Research Consultant

    Tulsa, Oklahoma, 74135

  • Vancouver Clinic

    Vancouver, Washington, 98664

  • Omega Medical Research

    Warwick, Rhode Island, 02886

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Integrated Clinical Trial Services, Inc.

    West Des Moines, Iowa, 50265

  • Advanced Clinical Research

    West Jordan, Utah, 84088

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Canada9 sites

  • 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, 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, 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, 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, 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, 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, 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, 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, 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, N2J 1C4

Other trials in Canada

Puerto Rico6 sites

  • Office of Dr. Ruddy Guerra

    Manati, 00674

  • NuFrontiers Clinical Research LLC

    Rio Piedras, 00923

  • Clinical Research Puerto Rico, Inc.

    San Juan, 00909

  • GCM Medical Group PSC

    San Juan, 00909

  • Instituto de Neurologia Dra. Ivonne Fraga

    San Juan, 00918

  • Neuro GI Wellness Center

    San Juan, 00926

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Migraine
Being tested
Galcanezumab, Placebo
Keywords
prevention, prophylaxis, headache
Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalcanezumabDrug

    Also called LY2951742

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT02614183
Study groupRoleWhat they receive
Galcanezumab 120mgExperimentalGalcanezumab 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.
Receives: Drug: Galcanezumab
Galcanezumab 240mgExperimentalGalcanezumab 240mg given by SC injection once a month for 6 months.
Receives: Drug: Galcanezumab
PlaceboPlacebo comparatorPlacebo given by SC injection once a month for 6 months.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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):

    1. 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.

    Measured: Baseline, Month 1 through Month 6

Secondary outcomes (9)

  1. 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.

    Measured: Baseline, Month 1 through Month 6

  2. 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.

    Measured: Baseline, Month 4 through Month 6

  3. 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.

    Measured: Baseline, Month 1 through Month 6

  4. 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.

    Measured: Baseline, Month 4 through Month 6

  5. 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.

    Measured: Baseline, Month 1 through Month 6

  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.

    Measured: Baseline, Month 6

  7. 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.

    Measured: Month 1 through Month 6

  8. Pharmacokinetics (PK): Serum Concentrations of Galcanezumab

    Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.

    Measured: Month 6

  9. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

    Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2015 (estimated)
  2. Study start30 Nov 2015
  3. Primary completion22 Mar 2017
  4. Study completion9 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
862 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02614183
Sponsor's protocol ID
15767
Other IDs
I5Q-MC-CGAG
Acronym
EVOLVE-1
Status last verified
Jun 2020
First submitted
23 Nov 2015
Last updated
17 Jun 2020
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 35076090

  • 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.

    PubMed 34264500

  • 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.

    PubMed 34049484

  • 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.

    PubMed 33950375

  • 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.

    PubMed 33549036

  • 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.

    PubMed 33544305

  • 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.

    PubMed 33143451

  • 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.

    PubMed 33069214

  • 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.

    PubMed 32576229

  • 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.

    PubMed 31952501

  • 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.

    PubMed 31482569

  • 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.

    PubMed 31253091

  • 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.

    PubMed 30942898

  • 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.

    PubMed 30594122

  • 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.

    PubMed 30462830

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Galcanezumab in people with Migraine, run by Eli Lilly and Company at 95 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (time frame: Baseline, Month 1 through Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02614183, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.

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