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Evaluation of Galcanezumab in the Prevention of Chronic Migraine (REGAIN)

Primary Purpose

Chronic Migraine

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Galcanezumab

Placebo

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Main Study:

Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

Israel addendum:

Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered.
Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine.

Exclusion Criteria:

Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.
Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.

Sites / Locations

21st Century Neurology
Arizona Research Center
Pharmacology Research Institute, Encino
Fullerton Neurology and Headache Center
Pharmacology Research Institute, Los Alamitos
Pharmacology Research Institute, Newport Beach
Desert Valley Research
Anderson Clinical Research
Artemis Institute for Clinical Research
Medical Center for Clinical Research
Optimus Medical Group
Colorado Neurological Institute
Advanced Neurosciences Research, LLC
Associated Neurologists of Southern Connecticut
Avail Clinical Research LLC
Clinical Neuroscience Solutions Inc
|Renstar Medical Research
Psychiatric Inst of Florida-Clinical Neuroscience Solutions
Compass Research
Premiere Research Institute at Palm Beach Neurology
Northwest Clinical Trials
Christie Clinic, LLC
Robbins Headache Clinic
Midwest Institute for Clinical Research
Phoenix Medical Research, Inc
Heartland Research Associates
PharmaSite Research Inc
Boston Clinical Trials Inc
Michigan Head, Pain and Neurological Institute
Clinical Research Institute
Healthcare Research Network - Hazelwood
ClinVest
Albuquerque Clinical Trials
Dent Neurological Institute
Island Neuro Associates,PC
Univ of Cincinnati College of Medicine
Healthcare Research Consultant
Preferred Primary Care Physicians
Abington Neurological Associates
Clinical Trials of South Carolina
University of South Carolina
Coastal Carolina Research Center, Inc.
BG Neurology
ClinSearch
FutureSearch Trials of Neurology and Sleep Lab
Headache Medicine Specialist of North Texas
Foothill Family Clinic
Health Research of Hampton Roads Inc
Sentara Neurology Specialists
Northwest Clinical Research Center
Premier Clinical Research
Dean Foundation for Health Research and Education
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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.
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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.
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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.
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.
Office of Dr. Ruddy Guerra
GCM Medical Group PSC
Instituto de Neurologia Dra. Ivonne Fraga
Neuro GI Wellness Center
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 Type

Placebo Comparator

Experimental

Arm Label

Placebo

Galcanezumab 120 mg

Galcanezumab 240 mg

Israel Addendum

Arm Description

Double-blind treatment phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they receive 240 milligram (mg) galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.

Double-blind treatment phase: Participants received loading dose of 240 mg of galcanezumab at first dosing visit followed 120 mg galcanezumab once a month by SC injection for 2 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.

Double-blind treatment phase: Participants received 240 mg of galcanezumab once a month by subcutaneous injection for 3 months. Open-label extension phase: After completion of double-blind phase, participants had an option to enter open-label extension phase where they received 240mg galcanezumab SC at first month, 120mg at second month followed by 120mg or 240mg once a month (at the discretion of the investigator) for the remaining 7 months. Follow-up phase: After completion or discontinuation from double-blind or open-label extension phases, participants entered follow-up phase where they were observed for 4 months. No treatments administered.

Eligible participants from main study were enrolled in Israel addendum. Participants received 120mg or 240mg galcanezumab SC once a month, at the discretion of the investigator, for up to 3 years or until Israel's Ministry of Health's conditions for continued access cease to be met, whichever occurs first.

Outcomes

Primary Outcome Measures

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

MHD: A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square(LS) Mean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.

Secondary Outcome Measures

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

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

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

MSQ v2.1 is a health status instrument, with a 4-week recall period, developed to address physical and emotional limitations of specific concern to individuals with migraine. Addressing the impact of migraine on work or daily activities, relationships with family & friends, leisure time, productivity, concentration, energy, tiredness & feelings. It consists of 14 items that address 3 domains:(1) Role Function-Restrictive (items 1-7);(2) Role Function- Preventive (items 8-11);&(3) Emotional Function (items 12-14).Response options range from "none of the time" (value 1) to "all of the time" (value 6),& are reverse-recoded (value 6 to 1) before the domain scores are calculated. Total raw scores for each domain is the sum of the final item value for all of the items in that domain. After the total raw score is computed for each domain, they are transformed to a 0-100 scale with higher scores indicating a better health status & a positive change in scores reflecting functional improvement.

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

Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.

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

PGI-S scale is a participant-rated instrument that measures participants own global impression of their illness severity. The participant was instructed as follows: "Considering migraine as a chronic condition, how would you rate your level of illness?" Response options were from 1 ("normal, not at all ill") to 7 ("extremely ill"). LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month, baseline, and baseline by month as fixed effects.

Overall Mean Change From Baseline in Headache Hours

Overall mean is derived from the average of months 1 to 3 from MMRM model. LSMean was calculated using MMRM model with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, month, treatment by month,baseline, and baseline by month as fixed effects.

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

The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of five items that reflect the number of days reported as missing or with reduced productivity at work or home, and the number of days of missed social events. Each item has a numeric response range from 0 to 90 days, if days are missed from work or home they are not counted as days with reduced productivity at work or home. The numeric responses are summed to produce a total score ranging from 0 to 270, in which a higher value is indicative of more disability. LSMean was calculated using Analysis of covariance (ANCOVA) model with last observation carried forward (LOCF) with treatment, pooled country, baseline medication overuse, concurrent prophylaxis use, and baseline value as fixed effects.

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

A Treatment Emergent Anti-Drug Antibodies (TE ADA) evaluable participant is considered to be TE ADA+ if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer >= 20.

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.

Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

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

Serum Concentrations of Galcanezumab

Serum concentrations of Galcanezumab

Full Information

NCT ID

NCT02614261

First Posted

November 23, 2015

Last Updated

April 25, 2022

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02614261

Brief Title

Evaluation of Galcanezumab in the Prevention of Chronic Migraine

Acronym

REGAIN

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

November 30, 2015 (Actual)

Primary Completion Date

March 16, 2017 (Actual)

Study Completion Date

July 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

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

Chronic Migraine

Keywords

prevention, prophylaxis, headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Galcanezumab 120 mg

Arm Type

Experimental

Arm Description

Arm Title

Galcanezumab 240 mg

Arm Type

Experimental

Arm Description

Arm Title

Israel Addendum

Arm Type

Experimental

Arm Description

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 (MHD)

Description

Time Frame

Baseline, Month 1 through Month 3

Secondary Outcome Measure Information:

Title

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

Description

MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

Time Frame

Baseline, Month 1 through Month 3

Title

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

Description

Time Frame

Baseline, Month 3

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 3

Title

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

Description

Time Frame

Baseline, Month 3

Title

Overall Mean Change From Baseline in Headache Hours

Description

Time Frame

Baseline, Month 1 through Month 3

Title

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

Description

Time Frame

Baseline, Month 3

Title

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

Description

Time Frame

Month 1 through Month 3

Title

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab

Description

Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.

Time Frame

Baseline through Month 3

Title

Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

Description

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

Time Frame

Month 3

Title

Serum Concentrations of Galcanezumab

Description

Serum concentrations of Galcanezumab

Time Frame

Month 3

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: Main Study: Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50. Israel addendum: Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered. Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine. Exclusion Criteria: Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product. Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody. Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab. History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.

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

Pharmacology Research Institute, Encino

City

Encino

State/Province

California

ZIP/Postal Code

91316

Country

United States

Facility Name

Fullerton Neurology and Headache Center

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Pharmacology Research Institute, Los Alamitos

City

Los Alamitos

State/Province

California

ZIP/Postal Code

90720

Country

United States

Facility Name

Pharmacology Research Institute, Newport Beach

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

Desert Valley Research

City

Rancho Mirage

State/Province

California

ZIP/Postal Code

92270

Country

United States

Facility Name

Anderson Clinical Research

City

Redlands

State/Province

California

ZIP/Postal Code

92374

Country

United States

Facility Name

Artemis Institute for Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92103

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

Colorado Neurological Institute

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Advanced Neurosciences Research, LLC

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Associated Neurologists of Southern Connecticut

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Avail Clinical Research LLC

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Facility Name

Clinical Neuroscience Solutions Inc

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32256

Country

United States

Facility Name

|Renstar Medical Research

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Psychiatric Inst of Florida-Clinical Neuroscience Solutions

City

Orlando

State/Province

Florida

ZIP/Postal Code

32801

Country

United States

Facility Name

Compass Research

City

Oviedo

State/Province

Florida

ZIP/Postal Code

32765

Country

United States

Facility Name

Premiere Research Institute at Palm Beach Neurology

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

Northwest Clinical Trials

City

Boise

State/Province

Idaho

ZIP/Postal Code

83704

Country

United States

Facility Name

Christie Clinic, LLC

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Facility Name

Robbins Headache Clinic

City

Riverwoods

State/Province

Illinois

ZIP/Postal Code

60015

Country

United States

Facility Name

Midwest Institute for Clinical Research

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Phoenix Medical Research, Inc

City

Prairie Village

State/Province

Kansas

ZIP/Postal Code

66208

Country

United States

Facility Name

Heartland Research Associates

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

PharmaSite Research Inc

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21208

Country

United States

Facility Name

Boston Clinical Trials Inc

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02131

Country

United States

Facility Name

Michigan Head, Pain and Neurological Institute

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48104

Country

United States

Facility Name

Clinical Research Institute

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Healthcare Research Network - Hazelwood

City

Hazelwood

State/Province

Missouri

ZIP/Postal Code

63042

Country

United States

Facility Name

ClinVest

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Albuquerque Clinical Trials

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Dent Neurological Institute

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Island Neuro Associates,PC

City

Plainview

State/Province

New York

ZIP/Postal Code

11803

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

Healthcare Research Consultant

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Preferred Primary Care Physicians

City

Pleasant Hills

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

Abington Neurological Associates

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

Clinical Trials of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

University of South Carolina

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29203

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

BG Neurology

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29307

Country

United States

Facility Name

ClinSearch

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

FutureSearch Trials of Neurology and Sleep Lab

City

Austin

State/Province

Texas

ZIP/Postal Code

78731

Country

United States

Facility Name

Headache Medicine Specialist of North Texas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Foothill Family Clinic

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84109

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

Premier Clinical Research

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

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

Buenos Aires

ZIP/Postal Code

C1056ABJ

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

C1046AAQ

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1128AAF

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1204AAD

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1428AQK

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1430EGF

Country

Argentina

Facility Name

City

Cordoba

ZIP/Postal Code

X5000EDC

Country

Argentina

Facility Name

City

Cordoba

ZIP/Postal Code

X5021FPQ

Country

Argentina

Facility Name

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.

City

Brampton

ZIP/Postal Code

L6T 0G1

Country

Canada

Facility Name

City

Kelowna

ZIP/Postal Code

V1Y 1Z9

Country

Canada

Facility Name

City

Montreal

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

City

Ottawa

ZIP/Postal Code

K2G 6E2

Country

Canada

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

1790 12

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

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20246

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

City

Hadera

ZIP/Postal Code

38100

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

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

City

Bologna

ZIP/Postal Code

40139

Country

Italy

Facility Name

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

City

Modena

ZIP/Postal Code

40124

Country

Italy

Facility Name

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

City

Roma

ZIP/Postal Code

00163

Country

Italy

Facility Name

City

Aguascalientes

ZIP/Postal Code

20217

Country

Mexico

Facility Name

City

Culiacan

ZIP/Postal Code

80020

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

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

City

Nijmegen

ZIP/Postal Code

6532 SZ

Country

Netherlands

Facility Name

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Office of Dr. Ruddy Guerra

City

Manati

ZIP/Postal Code

00674

Country

Puerto Rico

Facility Name

GCM Medical Group PSC

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

Instituto de Neurologia Dra. Ivonne Fraga

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

Neuro GI Wellness Center

City

San Juan

ZIP/Postal Code

00926

Country

Puerto Rico

Facility Name

City

Barcelona

ZIP/Postal Code

08028

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

City

Pamplona

ZIP/Postal Code

31008

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

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

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

35392739

Citation

Pozo-Rosich P, Detke HC, Wang S, Dolezil D, Li LQ, Aurora SK, Reuter U. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022 May;38(5):731-742. doi: 10.1080/03007995.2022.2059975. Epub 2022 Apr 15.

Results Reference

derived

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

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

32930994

Citation

Ford J, Tassorelli C, Leroux E, Wang S, Ayer D, Nichols R, Detke H. Changes in patient functioning and disability: results from a phase 3, double-blind, randomized, placebo-controlled clinical trial evaluating galcanezumab for chronic migraine prevention (REGAIN). Qual Life Res. 2021 Jan;30(1):105-115. doi: 10.1007/s11136-020-02623-1. Epub 2020 Sep 15.

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

31104507

Citation

Ruff DD, Ford JH, Tockhorn-Heidenreich A, Sexson M, Govindan S, Pearlman EM, Wang SJ, Khan A, Aurora SK. Efficacy of galcanezumab in patients with chronic migraine and a history of preventive treatment failure. Cephalalgia. 2019 Jul;39(8):931-944. doi: 10.1177/0333102419847957. Epub 2019 May 19.

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

30446596

Citation

Detke HC, Goadsby PJ, Wang S, Friedman DI, Selzler KJ, Aurora SK. Galcanezumab in chronic migraine: The randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018 Dec 11;91(24):e2211-e2221. doi: 10.1212/WNL.0000000000006640. Epub 2018 Nov 16.

Results Reference

derived

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/FnCyu97viesEckigw4wmc

Description

A Study of LY2951742 in the Prevention of Chronic Migraine (REGAIN)

Learn more about this trial

Evaluation of Galcanezumab in the Prevention of Chronic Migraine

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