LY2951742 in Patients with Episodic or Chronic Cluster Headache
Research type
Research Study
Full title
A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (galcanezumab) in Patients with Episodic or Chronic Cluster Headache
IRAS ID
199180
Contact name
Suzanne Wright
Contact email
Sponsor organisation
Eli Lilly Site Activation
Eudract number
2015-005234-21
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Galcanezumab is a humanized monoclonal antibody (a type of antibody made in the laboratory by combining a human antibody with a small part of monoclonal antibody.) that selectively binds to and neutralizes calcitonin gene-related peptide (CGRP) that has been identified for clinical development in pain conditions relevant to the CGRP pathway such as migraine and cluster headache. The similarities between migraine and cluster headache, the role of CGRP in both disorders, and the clinical efficacy observed with galcanezumab to date for the preventive treatment of migraine support the evaluation of galcanezumab for the treatment of cluster headache.
The aim of this study is to assess the long-term safety and tolerability of galcanezumab 300 mg administered up to once monthly in episodic or chronic cluster headache patients who have completed Study I5Q-MC-CGAL (CGAL) or Study I5Q-MC-CGAM (CGAM).
Safety will be assessed using treatment emergent adverse events (TEAEs), serious adverse events.
The study will consist of 2 study phases (SP): SP I is the screening phase to confirm patients meet the inclusion/exclusion criteria, and SP II is the open-label treatment phase during which patients can receive galcanezumab 300 mg administered subcutaneously (SC) up to once a month. Within the paradigm of a once-monthly dosing regimen, the decision to dose at each monthly interval will be determined by the investigator.REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/1354
Date of REC Opinion
15 Nov 2016
REC opinion
Further Information Favourable Opinion