Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine | Drug: Galcanezumab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 463 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 |
Actual Primary Completion Date : | June 19, 2019 |
Actual Study Completion Date : | September 19, 2019 |
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.
|
Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.
MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.
MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.
MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean percentage across months 1 through 3 of patients with at least a 50% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.
MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.
MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.
MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean percentage across months 1 through 3 of patients with at least a 75% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.
MHD: A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean percentage across months 1 through 3 of patients with 100% reduction in monthly MHDs from baseline using a categorical pseudo likelihood-based repeated measures model for binary responder indicator with fixed, categorical effects of treatment, month, treatment by month, and continuous, fixed covariate of baseline monthly MHD.
Headache Day: A calendar day on which any type of headache occurred (including migraine, probable migraine, and non-migraine headache).
Overall mean is derived from the average of months 1 to 3 from MMRM model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | June 6, 2018 | ||||||||||||||||
First Posted Date ICMJE | June 18, 2018 | ||||||||||||||||
Results First Submitted Date ICMJE | June 19, 2020 | ||||||||||||||||
Results First Posted Date ICMJE | July 8, 2020 | ||||||||||||||||
Last Update Posted Date | July 8, 2020 | ||||||||||||||||
Actual Study Start Date ICMJE | July 31, 2018 | ||||||||||||||||
Actual Primary Completion Date | June 19, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days [ Time Frame: Baseline, Month 1 through Month 3 ] Migraine Headache Day (MHD): A calendar day on which a migraine headache or probable migraine headache occurred.
Overall mean is derived from the average of months 1 to 3 from mixed model repeated measures (MMRM) model. Least square (LS) Mean was calculated using MMRM model with treatment, pooled country, month, treatment by month, baseline, and baseline by month as fixed effects.
|
||||||||||||||||
Original Primary Outcome Measures ICMJE |
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
|
||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||
Original Secondary Outcome Measures ICMJE |
|
||||||||||||||||
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 |
|
||||||||||||||||
Study Arms ICMJE |
|
||||||||||||||||
Publications * |
|
||||||||||||||||
* 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 | Completed | ||||||||||||||||
Actual Enrollment ICMJE |
463 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
420 | ||||||||||||||||
Actual Study Completion Date ICMJE | September 19, 2019 | ||||||||||||||||
Actual Primary Completion Date | June 19, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||
Sex/Gender ICMJE |
|
||||||||||||||||
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, France, Germany, Hungary, Japan, Korea, Republic of, Netherlands, Puerto Rico, Spain, United Kingdom, United States | ||||||||||||||||
Removed Location Countries | Denmark, Italy | ||||||||||||||||
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 |
|
||||||||||||||||
IPD Sharing Statement ICMJE |
|
||||||||||||||||
Responsible Party | Eli Lilly and Company | ||||||||||||||||
Study Sponsor ICMJE | Eli Lilly and Company | ||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||
Investigators ICMJE |
|
||||||||||||||||
PRS Account | Eli Lilly and Company | ||||||||||||||||
Verification Date | October 2019 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |