I5Q-MC-CGAW
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults with Treatment-Resistant Migraine - The CONQUER Study
IRAS ID
247688
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2018-000600-42
Duration of Study in the UK
1 years, 2 months, days
Research summary
Migraine is one of the top 10 causes of disability worldwide. Preventative medications are available, but many patients do not respond to them or are unable to tolerate them. If migraine is not adequately managed, it can result in a negative impact on patient functioning and an overall decrease in quality of life. New treatment options are needed, particularly for patients who have previously failed multiple preventative medications.
Study I5Q-MC-CGAW is a multicentre, randomised, double-blind, placebo-controlled Phase 3 trial of galcanezumab. This study is being conducted to find out if galcanezumab is better than placebo in reducing migraine headache frequency in patients who have previously failed multiple migraine preventative treatments and to monitor any side effects patients may have when they take galcanezumab.
The study will include about 420 participants worldwide, including about 14 participants in the UK. Men and women aged 18-75 years old with a diagnosis of migraine and a history of migraines of at least 1 year will be included in this study.
Study participants will initially receive galcanezumab injection or placebo injection once a month for 3 months. The placebo will look the same as galcanezumab but will not contain any medicine. There will be a 50:50 chance of receiving either galcanezumab or placebo. Neither the study participant nor the study doctor will know which treatment the study participant has been randomly assigned to receive. Participants who complete the initial 3-month treatment period will have the option to enter another 3-month treatment period, during which all participants will receive galcanezumab once monthly.
Participants are expected to be in the study for about 8 months. Study assessments will include questionnaires, blood and urine tests, physical and neurological examinations and ECGs (electrical tracings of the heart rhythm). Participants will also be required to complete a daily headache diary.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1237
Date of REC Opinion
9 Oct 2018
REC opinion
Further Information Favourable Opinion