MedAvante Central Ratings Selected For Cerecor Investigational MDD Study
HAMILTON, N.J., Dec. 2, 2013 /PRNewswire/ -- MedAvante, Inc., the world's leading provider of centralized assessments and monitoring in clinical trials of treatments for central nervous system (CNS) disorders, announced that biopharmaceutical company Cerecor Inc. will use MedAvante Central Ratings in the phase 2 clinical study of CERC-301, an investigational drug intended for the adjunctive treatment of subjects with major depressive disorder (MDD) who have not adequately responded to their current therapy and report recent suicidal ideation.
"A new treatment with potential for rapid onset of action for severely depressed, treatment resistant patients is urgently needed," said James Vornov, MD, PhD, Cerecor SVP, Clinical Development and Regulatory Affairs.
"In this Phase 2 study of CERC-301, an oral, selective NMDA receptor subunit 2B (NR2B) antagonist, we will use the blinded, independent MedAvante Central Raters to maximize signal detection through objective and standardized outcome measurement," he said.
Central Ratings assessments of study subjects at investigative research sites will be conducted by experienced and continuously trained MedAvante clinicians, confirming symptom severity prior to randomization and administering the trial's primary endpoint measure.
"MedAvante has unique clinical and operational expertise and technology to handle the sensitive requirements of our study," said Dr. Vornov. "They utilize a robust process to standardize the assessments and ensure that the Central Raters are fully blinded to protocol and visit history."
"MedAvante Central Ratings attack the root causes of the intractable problem of a high percentage of CNS trials failing to determine conclusive outcomes," said Paul M. Gilbert, co-founder and CEO of MedAvante. "Because we provide a smaller number of trained clinical raters to perform assessments in place of different raters at every site, we can minimize variability of study data and avoid perception biases which can increase placebo response and reduce observed drug effect," he said. "We are proud to bring these capabilities to the Cerecor study."
About MedAvante, Inc.
MedAvante is the leading global provider of centralized expert psychiatric and neurocognition rating and monitoring services to the pharmaceutical, biotechnology and medical device industries. MedAvante central trial services help sponsors enhance assay sensitivity for increased drug effect and reduced trial failure rates, enabling them to bring better drugs to market faster. Supported by operational teams in the US, Germany, Russia and Japan, MedAvante clinicians located in 31 countries and speaking 26 languages deliver Central Trial Services in 41 countries worldwide.
For more information, please visit www.medavante.com.
About Cerecor Inc.
Cerecor Inc. is a privately held clinical stage biopharmaceutical company developing prescription pharmaceuticals that work in the human nervous system and which address the needs of underserved patient segments of major diseases. We are committed to the development of drugs that improve lives by applying our extensive knowledge and experience in central nervous system disorders. www.cerecor.com
SOURCE MedAvante, Inc.