Migraine Clinical Trial
Official title:
A Multinational, Multi-centre, Randomised, Double-blind, Placebo-controlled, 3-way Crossover Study in Migraine Patients, Treated With Two Doses of BGC20-1531 and Placebo
The study is being conducted to explore the safety and effectiveness of a new chemical entity, BGC20-1531, in subjects with a history of migraine. In this study subjects will treat a total of three migraine attacks with two different doses of BGC20-1531 and placebo, with at least one week wash out period between doses.
Migraine headache is estimated to affect 10-20% of the world population and is listed by the World Health Organisation in the top 20 causes of disabling conditions, and in the top four neurological disabling conditions. The most common therapies for acute migraine are non-steroidal anti-inflammatory drugs (NSAIDs) and triptans. However, many migraine sufferers do not experience sufficient relief from these treatments or cannot tolerate their gastrointestinal, cardiovascular and other side-effects. Prostaglandin PGE2-induced sensory nerve sensitisation, neuropeptide release and cerebral vascular dilatation is thought to underlie migraine pain, particularly via activation of the EP4 receptor subtype. BGC20-1531 is an orally available EP4 receptor antagonist which inhibits prostaglandin-induced vasodilation of cranial blood vessels via a selective blockade of EP4 receptors reducing inflammation and migraine pain. As EP4 receptors are discretely localised, the overall safety profile of EP4 receptor antagonists may be improved compared to triptans and NSAIDs. ;
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