The objectives of this study are to evaluate the safety of multiple doses of EVP-6124 in this patient population, to investigate potential drug-drug interactions, and to determine the effects of EVP-6124 on sensitive electrophysiology markers (the P50 auditory evoked response and mismatch negativity) in schizophrenia patients.
This trial is enrolling approximately 20 schizophrenia patients treated with a stable dose of an atypical antipsychotic drug. Patients will receive one of two doses of EVP-6124 or a placebo for up to 28 days. Previous Phase I studies have characterized the safety and cognitive effects of single and multiple EVP-6124 doses as low as 0.1 mg/day. Based on these studies, two doses of EVP-6124 within the expected efficacy range are being examined in this ongoing study. The results of this safety and biomarker trial will be used to design larger Phase II studies of EVP-6124 in patients with Schizophrenia. These trials will be initiated later in 2008 or in early 2009.
Kees Been, president and CEO of EnVivo, said: “We already have results that suggest that EVP-6124 is associated with cognitive benefits in learning and memory and we believe we understand the dosing range in which to expect efficacy. This significantly enhances the probability of success of the upcoming biomarker and Phase II studies.”