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Trial record 6 of 25 for:    Lilly | Recruiting, Not yet recruiting Studies | Utah, United States

A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine (CONQUER)

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ClinicalTrials.gov Identifier: NCT03559257
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study
Actual Study Start Date : July 31, 2018
Estimated Primary Completion Date : July 10, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache 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 [ Time Frame: Baseline, Month 3 ]
    Mean change from baseline in the number of monthly migraine headache days


Secondary Outcome Measures :
  1. Mean Change from Baseline in the Number of Monthly Migraine Headache Days in Participants with Episodic Migraine [ Time Frame: Baseline, Month 3 ]
    Mean change from baseline in the number of monthly migraine headache days in participants with episodic migraine

  2. Percentage of Participants with ≥50% Reduction from Baseline in Monthly Migraine Headache Days [ Time Frame: Month 3 ]
    Percentage of participants with ≥50% reduction from baseline in monthly migraine headache days

  3. 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, Month 3 ]
    Mean change from baseline in the role function-restrictive domain score of the MSQ v2.1.

  4. Percentage of Participants with ≥75% Reduction from Baseline in Monthly Migraine Headache Days [ Time Frame: Month 3 ]
    Percentage of participants with ≥75% reduction from baseline in monthly migraine headache days

  5. Percentage of Participants with 100% Reduction from Baseline in Monthly Migraine Headache Days [ Time Frame: Month 3 ]
    Percentage of participants with 100% reduction from baseline in monthly migraine headache days

  6. Mean Change from Baseline in the Number of Monthly Days with Acute Headache Medication Use [ Time Frame: Baseline, Month 3 ]
    Mean change from baseline in the number of monthly days with acute headache medication use

  7. Mean Change from Baseline in the Number of Monthly Headache Days [ Time Frame: Baseline, Month 3 ]
    Mean change from baseline in the number of monthly headache days

  8. Mean Change from Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score [ Time Frame: Baseline, Month 3 ]
    Mean change from baseline in the MIDAS total score

  9. Mean Change from Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) [ Time Frame: Baseline, Month 3 ]
    Mean change from baseline in the EQ-5D-5L

  10. Mean Change from Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4) [ Time Frame: Baseline, Month 3 ]
    Mean change from baseline in the MIBS-4

  11. Mean Change from Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI) [ Time Frame: Baseline, Month 3 ]
    Mean change from baseline in the WPAI

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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of migraine or chronic migraine.
  • History of migraine headaches at least 1 year prior to screening, with onset prior to age 50.
  • Have failed previous migraine preventive medications in the past 10 years due to inadequate efficacy or tolerability.

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.
  • 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).
  • Pregnant or nursing.

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): NCT03559257


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 80 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03559257     History of Changes
Other Study ID Numbers: 16670
I5Q-MC-CGAW ( Other Identifier: Eli Lilly and Company )
2018-000600-42 ( EudraCT Number )
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 17, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
prevention
prophylaxis
headache
treatment-resistant
treatment resistant

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