In the Phase IIa clinical trial of 129 migraine patients, significantly more patients taking ADX10059 than those taking placebo (16.7% vs 4.7%, respectively p = 0.039) were pain-free two hours after dosing. ADX10059 administration yielded better pain improvement than placebo at all time points up to two hours after treatment of a migraine attack. In addition, there were trends to superiority for ADX10059 over placebo for migraine pain improvement (mild or no pain) at all time points up to two hours post-dosing.
"Medication is available to prevent migraine but these treatments are often secondary uses of the drug and come with potentially limiting side-effects," noted Dr. Peter Goadsby of the UCSF Headache Center. "New therapies specifically developed for migraine prevention are urgently needed especially for the substantial proportion of migraine sufferers who have frequent attacks and have significant disability in their daily lives. Targeting mGluR5 signaling with ADX10059 is an interesting approach that is showing significant promise in early clinical evaluation."
"The clinical trial data for ADX10059, presented here at AAN, proved the concept that by terminating acute attacks in some patients, mGluR5 inhibition plays a role in migraine pathophysiology. Now we are looking forward to the data from our ongoing Phase IIb migraine prevention study in the first half of 2010," said Charlotte Keywood, chief medical officer.
In December 2008, Addex initiated a Phase IIb trial to study ADX10059 as a prophylactic agent in migraine. The 12-week trial will compare ADX10059 (25mg, 50mg or 100mg) versus placebo in migraine patients who suffer three or more attacks per month. Data from the migraine pr
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