Lead Investigator: Daniel Schachter, Unigranrio
Title of Proposal Research: Efficacy of Calcitonin gene-related peptide (CGRP) monoclonal antibodies for medication overuse headache in chronic migraine patients A systematic review and meta-analysis
Vivli Data Request: 8585
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Medication overuse headache (MOH) is characterized by excessive use of medications to treat acute symptoms of primary headaches, most commonly migraine. MOH has a prevalence of 1-2% of the general population, however, the optimal approach to this condition remains unclear. There is still no consensus in the literature as to which medications are most effective in inducing a decrease in monthly headache days, decreasing the rate of relapse, or the best strategy to decrease acute medication use days.
Anti-calcitonin gene-related peptide (CGRP) receptor monoclonal antibodies (mAb) are a new class of medications that have shown excellent results in the treatment of acute and chronic migraine and are a promising therapy for patients with MOH. During a migraine attack the nerves and blood vessels in the brain release substances including a protein called CGRP, which is known to be involved in the brain processes which cause pain during the attack. Drugs called MAbs are proteins made in laboratories that act like proteins called antibodies (part of the immune system) in our bodies. These new anti-CGRP drugs target CGRP to prevent the migraine developing. There have been no trials designed to evaluate specifically patients with MOH, with data being driven by subgroup analysis of trials on patients with chronic migraine.
Hence, we aim to perform a systematic review and meta-analysis examining the use of CGRP mAb in patients with MOH and chronic migraine, in order to better characterize the efficacy and population who will most benefit from this therapy.
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: NCT03559257/16670
Data Request ID: 00008585
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Chronic Migraine – the REGAIN Study
Data Contributor: Lilly
Study ID: NCT02614261/15769
A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine
Data Contributor: Lundbeck
Study ID: NCT02974153/ALD403-CLIN-011