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Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study (EVOLVE-2)

Primary Purpose

Migraine

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Galcanezumab

Placebo

About this trial

This is an interventional treatment trial for Migraine focused on measuring prevention, prophylaxis, headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta version (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 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 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.

Sites / Locations

21st Century Neurology
Arizona Research Center
Axiom Research
Cedars Sinai Medical Center
Catalina Research Institute, LLC
Pacific Research Partners, LLC
Medical Center for Clinical Research
Optimus Medical Group
Schuster Medical Research Institute
IMMUNOe International Research Centers
Clinical Research of South Florida
Sunrise Clinical Research
Westside Center for Clinical Research
Clinical Neuroscience Solutions Inc
Sensible Healthcare
Meridien Research
Atlanta Center of Medical Research
Christie Clinic, LLC
Diamond Headache Clinic
Josephson Wallack Munshower Neurology
Heartland Research Associates
Novex Clinical Research
QUEST Research Institute
Healthcare Research Network - Hazelwood
Nevada Headache Institute
Bio Behavioral Health
Albuquerque Clinical Trials
Regional Clinical Research
SPRI Clinical Trials, LLC.
High Point Clinical Trials Center
Neurology & Neuroscience Associates, Inc.
Univ of Cincinnati College of Medicine
Urgent Care Specialists, LLC
Urgent Care Specialists, LLC
IPS Research Company
Oregon Neurology Associates
Clinical Research of Philadelphia
Mountain View Clinical Research, Inc
Coastal Carolina Research Center, Inc.
FutureSearch Trials
Clinical Trial Network
Clinpoint Trial, LLC
Foothill Family Clinic
Jordan River Family Medicine
Health Research of Hampton Roads Inc
Sentara Neurology Specialists
Northwest Clinical Research Center
Polyclinic
Dean Foundation for Health Research and Education
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Hillel Yaffe
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.
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.
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.
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.
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
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
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.
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
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Cortex, PSC
SomniCare Sleep Institute
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Galcanezumab 120mg

Galcanezumab 240mg

Placebo

Galcanezumab 120mg Maximum Extended Enrollment Cohort

Galcanezumab 240mg Maximum Extended Enrollment Cohort

Placebo Maximum Extended Enrollment Cohort

Arm Description

Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection.

Galcanezumab 240mg given by SC injection once a month for 6 months.

Placebo given by SC injection once a month for 6 months.

Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection.

Galcanezumab 240mg given by SC injection once a month for 6 months.

Placebo given by SC injection once a month for 6 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 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.

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.

Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) Rating

The PGI-S scale is a participant-rated instrument that measures patients 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"). 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.

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.

Mean Change From Baseline in 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.

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.

Pharmacokinetics (PK): Serum Concentrations of Galcanezumab

Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.

Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

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

Full Information

NCT ID

NCT02614196

First Posted

November 23, 2015

Last Updated

June 10, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02614196

Brief Title

Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study

Acronym

EVOLVE-2

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-2 Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

December 4, 2015 (Actual)

Primary Completion Date

March 29, 2017 (Actual)

Study Completion Date

October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

Keywords

prevention, prophylaxis, headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Sponsor is also masked.

Allocation

Randomized

Enrollment

986 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Galcanezumab 120mg

Arm Type

Experimental

Arm Description

Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection.

Arm Title

Galcanezumab 240mg

Arm Type

Experimental

Arm Description

Galcanezumab 240mg given by SC injection once a month for 6 months.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo given by SC injection once a month for 6 months.

Arm Title

Galcanezumab 120mg Maximum Extended Enrollment Cohort

Arm Type

Experimental

Arm Description

Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection.

Arm Title

Galcanezumab 240mg Maximum Extended Enrollment Cohort

Arm Type

Experimental

Arm Description

Galcanezumab 240mg given by SC injection once a month for 6 months.

Arm Title

Placebo Maximum Extended Enrollment Cohort

Arm Type

Placebo Comparator

Arm Description

Placebo given by SC injection once a month for 6 months.

Intervention Type

Drug

Intervention Name(s)

Galcanezumab

Other Intervention Name(s)

LY2951742

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days

Description

Time Frame

Baseline, Month 1 through Month 6

Secondary Outcome Measure Information:

Title

Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days

Description

Time Frame

Baseline, Month 1 through Month 6

Title

Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Role Function Restrictive Domain

Description

Time Frame

Baseline, Month 4 through Month 6

Title

Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache

Description

Time Frame

Baseline, Month 1 through Month 6

Title

Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) Rating

Description

Time Frame

Baseline, Month 4 through Month 6

Title

Overall Mean Change From Baseline in Headache Hours

Description

Time Frame

Baseline, Month 1 through Month 6

Title

Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score

Description

Time Frame

Baseline, Month 6

Title

Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab

Description

Time Frame

Month 1 through Month 6

Title

Pharmacokinetics (PK): Serum Concentrations of Galcanezumab

Description

Pharmacokinetics (PK): Serum Concentrations of Galcanezumab.

Time Frame

Month 6

Title

Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

Description

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

Time Frame

Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta version (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 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

21st Century Neurology

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

Arizona Research Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

Axiom Research

City

Apple Valley

State/Province

California

ZIP/Postal Code

92307

Country

United States

Facility Name

Cedars Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Catalina Research Institute, LLC

City

Montclair

State/Province

California

ZIP/Postal Code

91763

Country

United States

Facility Name

Pacific Research Partners, LLC

City

Oakland

State/Province

California

ZIP/Postal Code

94607

Country

United States

Facility Name

Medical Center for Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

Facility Name

Optimus Medical Group

City

San Francisco

State/Province

California

ZIP/Postal Code

94102

Country

United States

Facility Name

Schuster Medical Research Institute

City

Sherman Oaks

State/Province

California

ZIP/Postal Code

91403

Country

United States

Facility Name

IMMUNOe International Research Centers

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Clinical Research of South Florida

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Sunrise Clinical Research

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Westside Center for Clinical Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Clinical Neuroscience Solutions Inc

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

Sensible Healthcare

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Meridien Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Facility Name

Atlanta Center of Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Christie Clinic, LLC

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Facility Name

Diamond Headache Clinic

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60642

Country

United States

Facility Name

Josephson Wallack Munshower Neurology

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256

Country

United States

Facility Name

Heartland Research Associates

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

Novex Clinical Research

City

New Bedford

State/Province

Massachusetts

ZIP/Postal Code

02740

Country

United States

Facility Name

QUEST Research Institute

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

Facility Name

Healthcare Research Network - Hazelwood

City

Hazelwood

State/Province

Missouri

ZIP/Postal Code

63042

Country

United States

Facility Name

Nevada Headache Institute

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89113

Country

United States

Facility Name

Bio Behavioral Health

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Albuquerque Clinical Trials

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Regional Clinical Research

City

Binghamton

State/Province

New York

ZIP/Postal Code

13760

Country

United States

Facility Name

SPRI Clinical Trials, LLC.

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11235

Country

United States

Facility Name

High Point Clinical Trials Center

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27265

Country

United States

Facility Name

Neurology & Neuroscience Associates, Inc.

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Facility Name

Univ of Cincinnati College of Medicine

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Urgent Care Specialists, LLC

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Urgent Care Specialists, LLC

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45424

Country

United States

Facility Name

IPS Research Company

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Oregon Neurology Associates

City

Springfield

State/Province

Oregon

ZIP/Postal Code

97477

Country

United States

Facility Name

Clinical Research of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19114

Country

United States

Facility Name

Mountain View Clinical Research, Inc

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Coastal Carolina Research Center, Inc.

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

FutureSearch Trials

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Clinical Trial Network

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Clinpoint Trial, LLC

City

Waxahachie

State/Province

Texas

ZIP/Postal Code

75165

Country

United States

Facility Name

Foothill Family Clinic

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

Country

United States

Facility Name

Jordan River Family Medicine

City

South Jordan

State/Province

Utah

ZIP/Postal Code

84095

Country

United States

Facility Name

Health Research of Hampton Roads Inc

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Sentara Neurology Specialists

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23456

Country

United States

Facility Name

Northwest Clinical Research Center

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007-4209

Country

United States

Facility Name

Polyclinic

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Dean Foundation for Health Research and Education

City

Middleton

State/Province

Wisconsin

ZIP/Postal Code

53562

Country

United States

Facility Name

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.

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1046AAQ

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1013AAB

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

City

Kladno

ZIP/Postal Code

27201

Country

Czechia

Facility Name

City

Praha 10

ZIP/Postal Code

100 00

Country

Czechia

Facility Name

City

Praha 2

ZIP/Postal Code

120 00

Country

Czechia

Facility Name

City

Praha 6

ZIP/Postal Code

160 00

Country

Czechia

Facility Name

City

Praha 8

ZIP/Postal Code

182 00

Country

Czechia

Facility Name

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

City

Bielefeld

ZIP/Postal Code

33647

Country

Germany

Facility Name

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

City

Bochum

ZIP/Postal Code

44797

Country

Germany

Facility Name

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

City

Halle

ZIP/Postal Code

06120

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

City

Jena

ZIP/Postal Code

07747

Country

Germany

Facility Name

City

Kassel

ZIP/Postal Code

34121

Country

Germany

Facility Name

City

Königstein

ZIP/Postal Code

61462

Country

Germany

Facility Name

City

Prien

ZIP/Postal Code

83209

Country

Germany

Facility Name

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Hillel Yaffe

City

Hadera

ZIP/Postal Code

38100

Country

Israel

Facility Name

City

Haifa

ZIP/Postal Code

3525408

Country

Israel

Facility Name

City

Kfar Saba

ZIP/Postal Code

4420122

Country

Israel

Facility Name

City

Ramat Gan

ZIP/Postal Code

5266202

Country

Israel

Facility Name

City

Hwaseong-si

ZIP/Postal Code

18450

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

01830

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03181

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

07441

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

City

Aguascalientes

ZIP/Postal Code

20217

Country

Mexico

Facility Name

City

Culiacan

ZIP/Postal Code

80020

Country

Mexico

Facility Name

City

Merida

ZIP/Postal Code

97070

Country

Mexico

Facility Name

City

Mexico City

ZIP/Postal Code

03740

Country

Mexico

Facility Name

City

México City

ZIP/Postal Code

03310

Country

Mexico

Facility Name

City

Amsterdam

ZIP/Postal Code

1078 VV

Country

Netherlands

Facility Name

City

Geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

City

Nijmegen

ZIP/Postal Code

6532 SZ

Country

Netherlands

Facility Name

City

Tilburg

ZIP/Postal Code

5042 AD

Country

Netherlands

Facility Name

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Cortex, PSC

City

Las Piedras

ZIP/Postal Code

00771

Country

Puerto Rico

Facility Name

SomniCare Sleep Institute

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

City

Elda

ZIP/Postal Code

03600

Country

Spain

Facility Name

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

City

Valladolid

ZIP/Postal Code

47005

Country

Spain

Facility Name

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

43761

Country

Taiwan

Facility Name

City

Tainan

ZIP/Postal Code

70142

Country

Taiwan

Facility Name

City

Tainan

ZIP/Postal Code

71004

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

220

Country

Taiwan

Facility Name

City

Glasgow

ZIP/Postal Code

G51 4TF

Country

United Kingdom

Facility Name

City

Hull

ZIP/Postal Code

HU3 2JZ

Country

United Kingdom

Facility Name

City

Liverpool

ZIP/Postal Code

L9 7LJ

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

City

Stoke-on-Trent

ZIP/Postal Code

ST4 6QG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://vivli.org/

Citations:

PubMed Identifier

35076090

Citation

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.

Results Reference

derived

PubMed Identifier

34264500

Citation

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.

Results Reference

derived

PubMed Identifier

34049484

Citation

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.

Results Reference

derived

PubMed Identifier

33950375

Citation

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.

Results Reference

derived

PubMed Identifier

33549036

Citation

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.

Results Reference

derived

PubMed Identifier

33544305

Citation

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.

Results Reference

derived

PubMed Identifier

33143451

Citation

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.

Results Reference

derived

PubMed Identifier

33069214

Citation

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.

Results Reference

derived

PubMed Identifier

32576229

Citation

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.

Results Reference

derived

PubMed Identifier

31952501

Citation

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.

Results Reference

derived

PubMed Identifier

31482569

Citation

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.

Results Reference

derived

PubMed Identifier

31253091

Citation

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.

Results Reference

derived

PubMed Identifier

30942898

Citation

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.

Results Reference

derived

PubMed Identifier

30594122

Citation

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.

Results Reference

derived

PubMed Identifier

30462830

Citation

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.

Results Reference

derived

PubMed Identifier

29848108

Citation

Skljarevski V, Matharu M, Millen BA, Ossipov MH, Kim BK, Yang JY. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalalgia. 2018 Jul;38(8):1442-1454. doi: 10.1177/0333102418779543. Epub 2018 May 31.

Results Reference

derived

Learn more about this trial

Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study

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