The Phase II, double-blind, placebo-controlled, multi-center trial includes 124 menopausal women with recurrent, moderate to severe hot flashes and is being conducted at eight sites in the US.
The total study treatment duration after screening and baseline will be 13 weeks. Patients have been randomized into one of four treatment arms, which include one placebo and three active groups. The primary endpoints of the trial are the frequency and severity of hot flashes, relative to baseline. The trial will also generate useful safety data. The company expects to report top-line results of this trial in the first quarter of 2008.
Carl Pelzel, president and CEO, said: “We are pleased to have enrolled a total of 124 patients, exceeding our target enrollment and timeline expectations, which, in our view is evidence of a great need for a new therapeutic alternative to hormone therapy for menopausal women in need of treatment for hot flashes. We designed this Phase II trial to establish the relationship between the dose of our proprietary AcuForm formulation of Gabapentin and the clinical effect on hot flashes.”