Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03559257
Recruitment Status : Active, not recruiting
First Posted : June 18, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 6, 2018
First Posted Date  ICMJE June 18, 2018
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE July 31, 2018
Estimated Primary Completion Date June 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03559257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2018)
  • 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
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
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 Adults With Treatment-Resistant Migraine
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine - the CONQUER Study
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.
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 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
Actual Enrollment  ICMJE
 (submitted: April 2, 2019)
465
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2018)
420
Estimated Study Completion Date  ICMJE September 23, 2019
Estimated Primary Completion Date June 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 Belgium,   Canada,   Czechia,   Denmark,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Puerto Rico,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03559257
Other Study ID Numbers  ICMJE 16670
I5Q-MC-CGAW ( Other Identifier: Eli Lilly and Company )
2018-000600-42 ( EudraCT Number )
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
IPD Sharing Statement  ICMJE
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.

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 2019

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