LY2951742 in Episodic Cluster Headaches (CGAL)
Research type
Research Study
Full title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients with Episodic Cluster Headache
IRAS ID
177910
Contact name
Peter Goadsby
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2015-000149-22
Duration of Study in the UK
1 years, 6 months, 5 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 15180
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 generelated
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 has 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 episodic cluster
headache lasting 6 weeks or greater.
Study assessments will include: Physical examinations, ECGs, questionnaire and daily diary completion and blood
and urine tests, blood tests at three separate visits will be fasting blood glucose tests.REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0703
Date of REC Opinion
12 Jun 2015
REC opinion
Further Information Favourable Opinion