LY2951742 in Chronic Cluster Headaches (CGAM)
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 with a Long-Term Open-Label Extension in Patients with Chronic Cluster Headache
IRAS ID
180555
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2014-005429-11
Duration of Study in the UK
2 years, 7 months, days
Research summary
Cluster headache is a rare but disabling primary headache disorder characterized by episodic attacks of intense, one sided headache.
Cluster headache attacks can last from 15-180 minutes with severe (often excruciating) head pain. These episodes may happen close to daily or multiple times per day.
The majority of patients who experience cluster headaches rate their pain intensity as near to or at the worst pain imaginable.
There is no curative medical treatment for cluster headache, however, some abortive medications which shorten the overall duration of attack are available.
LY2951742 is a medication which reduces a peptide (a naturally occurring biological molecule) called calcitonin gene-related peptide (CGRP). CGRP is produced in the nerve cells. In studies of patients with spontaneous cluster headache attacks it was found that these patients had elevated levels of CGRP during their attack and therefore treatment with LY2951742 may be effective in managing cluster headache.
LY2951742 is not approved in the UK or by the United States Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However, the FDA and UK regulators have allowed the use of this medicine for research.
To be eligible to participate in this study patients must be aged 18 - 65 years and have a history of chronic cluster headache which is distinguished from episodic cluster headache, occurring without a remission period, or with remissions lasting ≤1 months, for at least one year.
Study assessments will include: Physical examinations, ECGs, questionnaire and daily diary completion and blood and urine tests, blood tests at six separate visits will be fasting blood glucose tests.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0894
Date of REC Opinion
14 Jul 2015
REC opinion
Further Information Favourable Opinion