Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY2951742 (Galcanezumab) in Japanese Participants With 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02959190
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as Galcanezumab in Japanese participants with migraine.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 (Galcanezumab) in Japanese Patients With Migraine
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : August 10, 2019
Actual Study Completion Date : August 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Dose Level 1 Galcanezumab
Dose level 1 Galcanezumab given subcutaneously (SC) once a month for a year.
Drug: Galcanezumab
Administered SC
Other Name: LY2951742

Experimental: Dose Level 2 Galcanezumab
Dose level 2 Galcanezumab given SC once a month for a year.
Drug: Galcanezumab
Administered SC
Other Name: LY2951742




Primary Outcome Measures :
  1. Percentage of Participants who Discontinue [ Time Frame: Baseline through Month 12 ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Serum Concentration of Galcanezumab [ Time Frame: Baseline through Month 12 ]
  2. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through Month 12 ]
  3. Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab [ Time Frame: Baseline through Month 12 ]
  4. Mean Change from Baseline in the Number of Migraine Headache Days [ Time Frame: Baseline, Month 12 ]
  5. Mean Change from Baseline in the Number of Headache Days [ Time Frame: Baseline, Month 12 ]
  6. Proportion of Participants with Reduction from Baseline ≥50% in Number of Migraine Headache Days [ Time Frame: Month 12 ]
  7. Mean Change from Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches [ Time Frame: Baseline, Month 12 ]
  8. Mean Change from Baseline in the Patient Global Impression of Severity (PGI-S) Score [ Time Frame: Baseline, Month 12 ]
  9. Mean Change from Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine Headache or Headache [ Time Frame: Baseline, Month 12 ]
  10. Mean Change from Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine Headache [ Time Frame: Baseline, Month 12 ]
  11. Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score [ Time Frame: Baseline, Month 12 ]
  12. Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire [ Time Frame: Baseline, Month 12 ]
  13. Patient Satisfaction with Medication Questionnaire-Modified (PSMQ-M) [ Time Frame: Month 12 ]


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:

  • For Episodic Migraine participants: Participants who completed the treatment period of Galcanezumab study CGAN.
  • 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:

  • For Chronic Migraine participants:

    • 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 other antibodies of CGRP or its receptor.
    • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
    • 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.
    • Failure to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months).

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): NCT02959190


Locations
Show Show 44 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: NCT02959190    
Other Study ID Numbers: 16108
I5Q-JE-CGAP ( Other Identifier: Eli Lilly and Company )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 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: https://vivli.org/

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
prophylaxis
headache
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