Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 75 of 179 for:    DCLRE1C

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03963232
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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
Estimated Study Start Date : July 31, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

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




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



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.


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

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): NCT03963232


Contacts
Layout table for location contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Clinicaltrials.gov@lilly.com

  Show 41 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

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03963232     History of Changes
Other Study ID Numbers: 17054
I5Q-MC-CGAX ( Other Identifier: Eli Lilly and Company )
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 15, 2019
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: http://www.clinicalstudydatarequest.com/

Layout table for additional information
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

Keywords provided by Eli Lilly and Company:
prevention
prophylactic

Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases