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出境医 / 临床实验 / A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine (PERSIST)

A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine (PERSIST)

Study Description
Brief Summary:
The reason for this study is to see if the drug galcanezumab is safe and effective in participants with episodic migraine. The study will last about 53 weeks and may include up to 12 visits.

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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 486 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 the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : February 28, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Galcanezumab
Galcanezumab administered subcutaneously (SC).
 Drug: Galcanezumab
Administered SC
Other Name: LY2951742
Placebo Comparator: Placebo
Placebo administered SC.
 Drug: Placebo
Administered SC
Outcome Measures
Primary Outcome Measures :
  1. Mean Change from Baseline in the Number of Monthly Migraine Headache Days (MHDs) [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in the Number of Monthly MHDs


Secondary Outcome Measures :
  1. Percentage of Participants with Reduction from Baseline ≥30% in Monthly MHDs [ Time Frame: 3 Months ]
    Percentage of Participants with Reduction from Baseline ≥30% in Monthly MHDs

  2. Percentage of Participants with Reduction from Baseline ≥50% in Monthly MHDs [ Time Frame: 3 Months ]
    Percentage of Participants with Reduction from Baseline ≥50% in Monthly MHDs

  3. Percentage of Participants with Reduction from Baseline ≥75% in Monthly MHDs [ Time Frame: 3 Months ]
    Percentage of Participants with Reduction from Baseline ≥75% in Monthly MHDs

  4. Percentage of Participants with Reduction from Baseline 100% in Monthly MHDs [ Time Frame: 3 Months ]
    Percentage of Participants with Reduction from Baseline 100% in Monthly MHDs

  5. Mean Change from Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire version 2.1 (MSQ v2.1) [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in the Role Function-Restrictive Domain Score of the MSQ v2.1

  6. Mean Change from Baseline in the Number of Monthly MHDs Taking Medication for the Acute Treatment of Headache [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in the Number of Monthly MHDs Taking Medication for the Acute Treatment of Headache

  7. Mean Change from Baseline in the Number of Monthly Headache Days [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in the Number of Monthly Headache Days

  8. Time to First Occurrence of a ≥50% Reduction from Baseline in the Number of Monthly MHDs [ Time Frame: Baseline through 3 Months ]
    Time to First Occurrence of a ≥50% Reduction from Baseline in the Number of Monthly MHDs

  9. Percentage of Participants who Maintain 50% Response Criteria for all 3 Months of Double-Blind Treatment [ Time Frame: 3 Months ]
    Percentage of Participants who Maintain 50% Response Criteria for all 3 Months of Double-Blind Treatment

  10. Mean Change from Baseline in Number of Migraine Attacks [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in Number of Migraine Attacks

  11. Mean Change from Baseline in Number of Migraine Headache Hours [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in Number of Migraine Headache Hours

  12. Mean Change from Baseline in Number of Headache Hours [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in Number of Headache Hours

  13. Mean Change from Baseline in Severity of Remaining Migraines [ Time Frame: Baseline, 3 Months ]
    Participant rated response options for headache severity were 1 (mild), 2 (moderate), and 3 (severe)

  14. Mean Change from Baseline in the Patient Global Impression of Severity (PGI-S) [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in the PGI-S

  15. Mean Change from Baseline on the Migraine Disability Assessment test (MIDAS) Total Score [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline on the MIDAS Total Score

  16. Percentage of Participants Developing Anti-Drug Antibodies [ Time Frame: 3 Months ]
    Percentage of Participants Developing Anti-Drug Antibodies

  17. Pharmacokinetics (PK): Serum Concentration of Galcanezumab [ Time Frame: 3 Months ]
    PK: Serum concentration of galcanezumab


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 (1.1 or 1.2) (ICHD-3 2018) with a history of migraine of at least 1 year prior to screening and migraine onset prior to age 50
  • Prior to screening, participants must have a history of 4-14 migraine headache days and at least 2 migraine attacks per month on average within the past 3 months

Exclusion Criteria:

  • Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody
  • Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (for example, adalimumab, infliximab, trastuzumab, bevacizumab, etc.)
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab
  • Women who are pregnant or nursing
  • History of chronic migraine, daily persistent headache, cluster headache, medication overuse headache, migraine with brainstem aura, or hemiplegic migraine
Contacts and Locations

Locations
Show Show 40 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 24, 2019
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE July 30, 2019
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		Mean Change from Baseline in the Number of Monthly Migraine Headache Days (MHDs) [ Time Frame: Baseline, 3 Months ]
Mean Change from Baseline in the Number of Monthly MHDs
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019)
  • Percentage of Participants with Reduction from Baseline ≥30% in Monthly MHDs [ Time Frame: 3 Months ]
    Percentage of Participants with Reduction from Baseline ≥30% in Monthly MHDs
  • Percentage of Participants with Reduction from Baseline ≥50% in Monthly MHDs [ Time Frame: 3 Months ]
    Percentage of Participants with Reduction from Baseline ≥50% in Monthly MHDs
  • Percentage of Participants with Reduction from Baseline ≥75% in Monthly MHDs [ Time Frame: 3 Months ]
    Percentage of Participants with Reduction from Baseline ≥75% in Monthly MHDs
  • Percentage of Participants with Reduction from Baseline 100% in Monthly MHDs [ Time Frame: 3 Months ]
    Percentage of Participants with Reduction from Baseline 100% in Monthly MHDs
  • Mean Change from Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality-of-Life Questionnaire version 2.1 (MSQ v2.1) [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in the Role Function-Restrictive Domain Score of the MSQ v2.1
  • Mean Change from Baseline in the Number of Monthly MHDs Taking Medication for the Acute Treatment of Headache [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in the Number of Monthly MHDs Taking Medication for the Acute Treatment of Headache
  • Mean Change from Baseline in the Number of Monthly Headache Days [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in the Number of Monthly Headache Days
  • Time to First Occurrence of a ≥50% Reduction from Baseline in the Number of Monthly MHDs [ Time Frame: Baseline through 3 Months ]
    Time to First Occurrence of a ≥50% Reduction from Baseline in the Number of Monthly MHDs
  • Percentage of Participants who Maintain 50% Response Criteria for all 3 Months of Double-Blind Treatment [ Time Frame: 3 Months ]
    Percentage of Participants who Maintain 50% Response Criteria for all 3 Months of Double-Blind Treatment
  • Mean Change from Baseline in Number of Migraine Attacks [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in Number of Migraine Attacks
  • Mean Change from Baseline in Number of Migraine Headache Hours [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in Number of Migraine Headache Hours
  • Mean Change from Baseline in Number of Headache Hours [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in Number of Headache Hours
  • Mean Change from Baseline in Severity of Remaining Migraines [ Time Frame: Baseline, 3 Months ]
    Participant rated response options for headache severity were 1 (mild), 2 (moderate), and 3 (severe)
  • Mean Change from Baseline in the Patient Global Impression of Severity (PGI-S) [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline in the PGI-S
  • Mean Change from Baseline on the Migraine Disability Assessment test (MIDAS) Total Score [ Time Frame: Baseline, 3 Months ]
    Mean Change from Baseline on the MIDAS Total Score
  • Percentage of Participants Developing Anti-Drug Antibodies [ Time Frame: 3 Months ]
    Percentage of Participants Developing Anti-Drug Antibodies
  • Pharmacokinetics (PK): Serum Concentration of Galcanezumab [ Time Frame: 3 Months ]
    PK: Serum concentration of galcanezumab
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Galcanezumab in Patients With Episodic Migraine-the Persist Study
Brief Summary The reason for this study is to see if the drug galcanezumab is safe and effective in participants with episodic migraine. The study will last about 53 weeks and may include up to 12 visits.
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 Episodic Migraine
Intervention  ICMJE
  • Drug: Galcanezumab
    Administered SC
    Other Name: LY2951742
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: Galcanezumab
    Galcanezumab administered subcutaneously (SC).
    Intervention: Drug: Galcanezumab
  • Placebo Comparator: Placebo
    Placebo administered SC.
    Intervention: Drug: Placebo
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019) 		486
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 (1.1 or 1.2) (ICHD-3 2018) with a history of migraine of at least 1 year prior to screening and migraine onset prior to age 50
  • Prior to screening, participants must have a history of 4-14 migraine headache days and at least 2 migraine attacks per month on average within the past 3 months

Exclusion Criteria:

  • Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody
  • Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (for example, adalimumab, infliximab, trastuzumab, bevacizumab, etc.)
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab
  • Women who are pregnant or nursing
  • History of chronic migraine, daily persistent headache, cluster headache, medication overuse headache, migraine with brainstem aura, or hemiplegic migraine
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 China,   India,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03963232
Other Study ID Numbers  ICMJE 17054
I5Q-MC-CGAX ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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: http://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 April 2021

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

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