Experimental model to induce migraine with IV GTN in adult migraineurs
Research type
Research Study
Full title
Use of Intravenous Glyceryl Trinitrate (GTN) for the Induction of a Migraine-Like Headache in Order to Develop an Experimental Model of Migraine
IRAS ID
223910
Contact name
Dileep Dasyam
Contact email
Sponsor organisation
Early Phase Services Limited
Duration of Study in the UK
0 years, 2 months, 28 days
Research summary
No new compound is being tested during this study. Nitronal, a marketed drug with its active ingredient Glyceryl trinitrate (GTN) will be administered to volunteers who are prone to migraine attacks. The aim is to develop a method of generating a migraine-like headache in a controlled clinical environment. This methodology could potentially be used in future trials to investigate whether new drugs in development can block or reduce migraine attacks.
Migraine is a common condition which affects women more frequently than men. An attack can last between 3 and 72 hours and sufferers are normally well in between the migraines. The precise cause of migraine is unclear, though it is thought that it is due to a combination of the expansion of blood vessels and the release of chemicals, which causes inflammation and pain. When the blood vessels in the brain dilate, they press on nerves nearby causing pain.
Approximately 20 male and female subjects, aged 18-55, with a diagnosis of migraine without aura and who are otherwise healthy will be recruited. GTN or placebo will be administered by infusion to each subject. The infusion will last 20 minutes and will be administered on 4 study visits. The subjects will be split into four groups, each group will receive three 20-minute intravenous infusions of GTN and one 20-minute infusion of placebo. The order of treatments for each group will be random.
REC name
Wales REC 1
REC reference
17/WA/0055
Date of REC Opinion
24 Mar 2017
REC opinion
Further Information Favourable Opinion