Lead Investigator: Hui Zheng, Chengdu University of Traditional Chinese Medicine
Title of Proposal Research: Predictors of galcanezumab in the preventive treatment of migraine
Vivli Data Request: 8435
Funding Source: The analysis will be funded by the Sicence and Technology Department of Sichuan Province.
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Migraine is a highly prevalent headache disorders and a major public health problem world wide. A project collecting data from nine European countries reported a one-year prevalence as high as 35% after sex adjustment. China was reported with a one-year prevalence of 9%, the lowest in global countries. Migraine is the second leading cause of disability although there has been considerable progress in diagnosis and treatment, and it contributes to 5.6% of the global disease burden.
The preventive treatment of migraine is of great interest to clinical practitioners. Calcitonin gene-related peptide monocolonal antibodies (CGRP mAbs) are a new class of preventive treatment for migraine, and galcanezumab is one of the CGRP mAbs that excert a significantly better treatment effect than placebo. With the generalization of galcanezumab into clinical practice, the practitioners are keen to know the predictive factors for the treatment effect of galcanezumab in order to make clinical decisions in whether a patient should be recommended for the treatment of galcanezumab. Little has been reported about the predictors of the effect of galcanezumab in the treatment of migraine. We therefore aim to review the clinical data from previously published trials of galcanezumab.
Requested Studies:
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adults With Treatment-Resistant Migraine – the CONQUER Study
Data Contributor: Lilly
Study ID: NCT03559257
Sponsor ID: 16670
A Phase 3, Long-Term, Open-Label Safety Study of LY2951742 in Patients With Migraine
Data Contributor: Lilly
Study ID: NCT02614287
Sponsor ID: 15770
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine – the REGAIN Study
Data Contributor: Lilly
Study ID: NCT02614261
Sponsor ID: 15769
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine – the EVOLVE-2 Study
Data Contributor: Lilly
Study ID: NCT02614196
Sponsor ID: 15768
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine – the EVOLVE-1 Study
Data Contributor: Lilly
Study ID: NCT02614183
Sponsor ID: 15767
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients With Episodic Migraine
Data Contributor: Lilly
Study ID: NCT02163993
Sponsor ID: 15414