Applying a new gel on the skin, over the trigeminal nerve branches, can be a safe and effective alternative treatment for patients suffering from acute migraine, scientists have found.
In a placebo-controlled clinical trial, moderate and severe migraine sufferers were treated with TOPOFEN, also known as ELS-M11, a gel formulation that can permeate human skin rapidly and efficiently.
The study involved 48 screened adults with a history of episodic migraine with and without aura (the warning signs that can precede headache pain in about 20 per cent of sufferers).
Patients were instructed to treat five moderate to severe migraines by applying the TOPOFEN gel on the skin, over the three branches of the trigeminal nerve, and to record their symptoms on an electronic diary.
Compared with placebo, TOPOFEN resulted in greater improvement in pain assessments after study drug application, a faster time to pain response, a reduction of migraine-associated symptoms such as nausea, light and sound hypersensitivity, and greater suppression of pain over the 24-hour period that patients were asked to follow each migraine once they applied the gel.
Of the severe migraine patients, 77 per cent experienced relief of pain and migraine-associated symptoms and 45 per cent had sustained pain relief from two to 24 hours compared to 15 per cent of placebo.
Also 50 per cent of patients who treated their severe pain with TOPOFEN were pain free at 24 hours compared to 25 per cent of placebo-treated patients.
Patients whose severe headaches were treated with TOPOFEN, developed by US-based Achelios Therapeutics, were at least three times as likely to experience complete relief of associated symptoms (nausea and photophobia) versus placebo.
"The results of the study are encouraging, and those of us who treat migraine think it may lead to a meaningful alternative treatment for a substantial number of migraineurs," said researcher Wolfgang Liedtke from Duke University.
"This study showed that it may be possible to affect severe migraine, which can be a debilitating neurological pain condition, with a topical application to facial trigeminal nerve endings, which was unexpected," Liedtke said.
The results of the clinical trial will be presented this week at the American Academy of Neurology annual meeting in Washington, DC.
