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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02614261
Recruitment Status : Completed
First Posted : November 25, 2015
Results First Posted : January 7, 2019
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: Galcanezumab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : March 16, 2017
Actual Study Completion Date : July 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
  • 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.
 Drug: Galcanezumab
Administered SC
Other Name: LY2951742

Drug: Placebo
Administered SC
Experimental: Galcanezumab 120 mg
  • 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.
 Drug: Galcanezumab
Administered SC
Other Name: LY2951742
Experimental: Galcanezumab 240 mg
  • 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.
 Drug: Galcanezumab
Administered SC
Other Name: LY2951742
Experimental: Israel Addendum
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.
 Drug: Galcanezumab
Administered SC
Other Name: LY2951742


Outcome Measures
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Primary Outcome Measures :
  1. Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD) [ Time Frame: Baseline, Month 1 through Month 3 ]

    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 :
  1. Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days [ Time Frame: Baseline, Month 1 through Month 3 ]
    MHD: A calendar day on which a migraine headache or probable migraine headache occurred.

  2. Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain [ Time Frame: Baseline, Month 3 ]
    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.

  3. Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache [ Time Frame: Baseline, Month 1 through Month 3 ]

    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.


  4. Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score [ Time Frame: Baseline, Month 3 ]
    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.

  5. Overall Mean Change From Baseline in Headache Hours [ Time Frame: Baseline, Month 1 through Month 3 ]
    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.

  6. Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score [ Time Frame: Baseline, Month 3 ]
    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.

  7. Percentage of Participants Developing Treatment Emergent Anti-drug Antibodies (ADA) to Galcanezumab [ Time Frame: Month 1 through Month 3 ]
    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.

  8. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab [ Time Frame: Baseline through Month 3 ]
    Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab.

  9. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Month 3 ]
    Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).

  10. Serum Concentrations of Galcanezumab [ Time Frame: Month 3 ]
    Serum concentrations of Galcanezumab


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614261


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] January 22, 2016
Statistical Analysis Plan  [PDF] April 25, 2017

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02614261    
Other Study ID Numbers: 15769
I5Q-MC-CGAI ( Other Identifier: Eli Lillly and Company )
2015-001883-21 ( EudraCT Number )
First Posted: November 25, 2015    Key Record Dates
Results First Posted: January 7, 2019
Last Update Posted: May 18, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Keywords provided by Eli Lilly and Company:
prevention
prophylaxis
headache
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases