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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 : Active, not recruiting
First Posted : November 25, 2015
Results First Posted : January 7, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 23, 2015
First Posted Date  ICMJE November 25, 2015
Results First Submitted Date  ICMJE October 19, 2018
Results First Posted Date  ICMJE January 7, 2019
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE November 30, 2015
Actual Primary Completion Date March 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
Mean Change from Baseline in the Number of Monthly Migraine Headache Days [ Time Frame: Baseline, Month 3 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Percentage of Participants Developing 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.
  • 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.
  • Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Month 3 ]
    Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP).
  • Serum Concentrations of Galcanezumab [ Time Frame: Month 3 ]
    Serum concentrations of Galcanezumab
Original Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
  • Proportion of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days [ Time Frame: Month 3 ]
  • Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire [ Time Frame: Baseline, Month 3 ]
  • 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 3 ]
  • Mean Change from Baseline in the Patient Global Impression of Severity (PGI-S) Score [ Time Frame: Baseline, Month 3 ]
  • Mean Change from Baseline in Headache Hours [ Time Frame: Baseline, Month 3 ]
  • Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score [ Time Frame: Baseline, Month 3 ]
  • Percentage of Participants Developing Anti-drug Antibodies to LY2951742 [ Time Frame: Baseline through Month 3 ]
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY2951742 [ Time Frame: Baseline through Month 3 ]
  • Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through Month 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Galcanezumab in the Prevention of Chronic Migraine
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine - the REGAIN Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Migraine
Intervention  ICMJE
  • Drug: Galcanezumab
    Administered SC
    Other Name: LY2951742
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: Galcanezumab 120 mg

    Galcanezumab 240 mg given as loading dose at first dosing visit followed by 120 mg once a month for 2 months by subcutaneous (SC) injection.

    Participants may be eligible for optional open-label extension at the end of the double blind period with dose level 1 or dose level 2.

    Intervention: Drug: Galcanezumab
  • Experimental: Galcanezumab 240 mg

    Galcanezumab 240 mg given by SC injection once a month for 3 months.

    Participants may be eligible for optional open-label extension at the end of the double blind period with dose level 1 or dose level 2.

    Intervention: Drug: Galcanezumab
  • Placebo Comparator: Placebo

    Placebo given by SC injection once a month for 3 months.

    Participants may be eligible for optional open-label extension at the end of the double blind period with dose level 1 or dose level 2.

    Interventions:
    • Drug: Galcanezumab
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 15, 2018)
1113
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2015)
825
Estimated Study Completion Date  ICMJE May 30, 2021
Actual Primary Completion Date March 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Czechia,   Germany,   Israel,   Italy,   Mexico,   Netherlands,   Puerto Rico,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Brazil,   Czech Republic,   Korea, Republic of
 
Administrative Information
NCT Number  ICMJE NCT02614261
Other Study ID Numbers  ICMJE 15769
I5Q-MC-CGAI ( Other Identifier: Eli Lillly and Company )
2015-001883-21 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date August 17, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP