Avanir begins Phase II trial of AVP-786 for neurobehavioral disinhibition from TBI
The Avanir Pharmaceuticals Inc. subsidiary of Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) began a double-blind, placebo-controlled, U.S. Phase II trial to evaluate twice-daily oral AVP-786 (CTP-786) for up to 12 weeks in about 150 patients with neurobehavioral disinhibition, including aggression, agitation and irritability, resulting from traumatic brain injury (TBI).
The trial's primary endpoint is change from baseline to week 12 on a composite of Clinical Impression of Severity scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) subscales of aggression, agitation, and irritability/lability (NPI-C-3). Secondary endpoints include change from baseline to week 12 in modified Clinical Global Impression of Change (mCGI-C) raw scores, NPI-C subscale scores, Frontal Systems Behavior Scale (FrSBe), modified Clinical Global Impression of Severity (mCGI-S), Patient Health Questionnaire-9 (PHQ-9), Zarit Burden Interview (ZBI), Patient Global Impression of Severity (PGI-S), Patient Global Impression of Change (PGI-C) raw scores and Post-Traumatic Headache Assessment Questionnaire and quality of life (QOL)...