Cluster Headache Patient Prevalence and Prescribed Treatments in the UK Clinical Practice Research Datalink

Date of ISAC Approval: 
28/08/2015
Lay Summary: 
Cluster headache is one of the most painful and intense headaches known to man. It is a rare type of one-sided headache, where pain is focussed around the eye; headaches occur in episodic attacks or clusters which last between 15 minutes and 3 hours. Attacks occur daily and bouts may last weeks or months, they most frequently occur in spring and autumn. Some patients experience chronic cluster headache, with very short (less than one month) breaks from attacks, whereas other patients may have months or years between attacks. Cluster headache occurs more commonly in men than women, and it also tends to first occur in adulthood. There are few effective treatments available for cluster headache. These complex features of cluster headache and its rarity mean that descriptive epidemiological information from large populations is not readily available. This study will count the number of adults and children with cluster headache and examine the treatment they are prescribed to prevent cluster headache attacks. This information will be used by Lilly to support the development of a new medicine for prevention of cluster headache. Thus it is important to public health as there are few available effective treatments to prevent cluster headache attacks.
Technical Summary: 
Cluster headache (CH) is a rare and disabling primary headache disorder characterized by episodic attacks of intense unilateral headache and autonomic symptoms. Cluster periods are separated by attack-free remissions of variable duration, lasting from weeks to years. The average age of onset is 20-40 years and there is a strong male predominance. The rarity of CH, the severity of the illness and the varying patterns of bouts mean that reported estimates of disease prevalence lack precision. The primary objective of this study is to determine a prevalence estimate of cluster headache in adults and children, and to describe the characteristics of CH patients. Lilly is developing a Calcitonin Gene Related Peptide neutralising Antibody (CGRP Ab) for the preventive treatment of CH. Preventive treatment is initiated at the onset of a cluster period but aimed at reducing the overall number of cluster attacks during the cluster period. This analysis will also examine the prevalence of use of CH treatments, with a focus on preventive treatments. This data will be used to provide epidemiological data for submission to regulatory authorities.
Health Outcomes to be Measured: 
First record of cluster headache Use of abortive and preventive cluster headache treatments including analgesics at any time after index date
Collaborators: 

Evelyn M Flahavan - Chief Investigator - Roche
Andrew Ahn - Researcher - Eli Lilly & Co Ltd - US Headquarters
James Michael Martinez - Researcher - Eli Lilly & Co Ltd - US Headquarters
Jonathan Swain - Researcher - Eli Lilly & Co Ltd - US Headquarters
Lucy Mitchell - Researcher - Eli Lilly & Co - UK
Meghan Jones - Researcher - Eli Lilly & Co Ltd - US Headquarters