CGAH: The Evolve-2 Study (Treatment for Episodic Migraine)
Research type
Research Study
Full title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients with Episodic Migraine – the EVOLVE-2 Study
IRAS ID
194241
Contact name
Nicholas Silver
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-001882-17
Duration of Study in the UK
1 years, 7 months, 4 days
Research summary
Migraine is a chronic, debilitating condition.
CGRP is a type of amino acid peptide (a chemical compound that is made from 2 or more amino acids (a type of protein)that are held together by a 'peptide' bond).CGRP is widely found throughout the central and peripheral nervous system and acts as a facilitator for inflammatory processes and pain.
In migraineurs blood concentrations of CGRP have been found to be elevated during migraine attacks. Also, infusions of CGRP to individuals with a history of migraine can trigger migraine attacks. The neutralisation of CGRP with antibodies has been shown to modulate neurological inflammation and pain.
The investigational study drug, LY2951742, is a humanised monoclonal antibody (a type of man made biological therapy)that potently and selectively binds to CGRP preventing and mediating its biological effects.
Study I5Q-MC-CGAH (EVOLVE-2) will enable a more comprehensive clinical assessment of LY2951742 in a patient population for which the medical need is substantial.
To be eligible to participate in this study patients must be aged between 18 and 65 years of age at the time of screening and have a diagnosis of episodic migraine.
Study assessments will include: Physical examinations, ECGs, Questionnaire completion, and blood and urine tests.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0950
Date of REC Opinion
25 Jan 2016
REC opinion
Further Information Favourable Opinion