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
|SOURCE MedAvante, Inc.|
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