Early Phase CNS Studies

By Johan A. den Boer, Director of Scientific Affairs, Early Development Services, PRA Health Sciences

PRA Health Sciences’ (PRA) Early Development Services (EDS) group has a long-standing track record of early clinical development work in various CNS indications through our global clinical facilities. PRA EDS in the Netherlands (Groningen) has built up extensive experience in CNS-targeted drug development by performing over 130 Phase I and Phase IIa clinical studies with CNS-active agents in the last decade. The Groningen clinic has dedicated and well-established collaborations with various departments at the University Medical Center Groningen (UMCG), and with other external partners for highly specialized clinical assessments in the field of neuroimaging, including positron emission tomography and functional- or pharmaco-MRI.

PRA’s Clinical Research Centers at Marlton, NJ; Philadelphia, PA; Salt Lake City, UT; and Lenexa, KS offer additional expertise in CNS early phase trials. These sites have supported 160 Phase I studies and enrolled nearly 3,100 subjects from 2009 to 2013. Approximately 520 studies for later-phase CNS studies have been conducted across our sites in the US since 2004.

At PRA-US sites, several studies have been performed on experimental drugs for Alzheimer’s disease. A full spectrum of clinical tests is available for the measurement of efficacy in psychiatric disorders, addiction, human abuse liability, and in acute and chronic pain. The Salt Lake City clinic collaborates with several neuroimaging providers located within 20 minutes of the facility. These collaborating centers are The Brain Institute at the University of Utah, Neuroimaging Institute, US-MRI and Kings Open Imaging.

This document summarizes our experience in assessing clinical efficacy and safety of CNS active agents.