Avanir Pharmaceuticals Clinical Trials
In January 2013 Dr. John H. Fullerton, leader of the Hampton Health, Ltd.™ Clinical Research Division, was chosen to become a Principal Investigator in the Prism II/Phase IV Clinical Trials for Avanir Pharmaceuticals, Inc. in the study of Pseudobulbar affect (PBA), a disorder of disinhibition of emotional expression characterized by uncontrollable episodes of crying or laughing, without an apparent stimulus to trigger the response.
Per the Avanir Prism II Newsletter, Hampton Health, Ltd.™ has proven to be one of the top sites for the AVR 401 study, with Dr. Fullerton providing input and "clarity" for the study proceedings directly with Avanir scientists in Los Angeles.
As Vice President and Co-Chair of the Policy Committee of the CA Chapter of AMDA (American Medical Directors Association), Dr. Fullerton has been actively seeking non-psychoactive “solutions” to behavioral manifestations of dementia, CVA (Stroke) and TBI (Traumatic Brain Injury) and to cut down on the use of controversial psychoactive agents to manage behavior in patients with dementia. “This novel approach to PBA management [through the PRISM II Trial] has the potential to seriously reduce the psychotropic drug usage in one-third of dementia patients with projected PBA behavioral manifestations in our SNF's (Skilled Nursing Facilities) and our dementia units within assisted living facilities across the state and the US."
PBA is the most commonly reported syndrome after a stroke or traumatic brain injury (TBI) and is considered secondary to a number of neurologic conditions. The PRISM study has been the largest observational study to assess PBA symptom prevalence. The continuation of the study with the PHASE IV multi-center, national clinical trial will be to study and evaluate the safety, tolerability and effectiveness of NUEDEXTA for the treatment of Pseudobulbar Affect (PBA) in patients 18 years and above with underlying Dementia, Stroke and Traumatic Brain Injury over a twelve week period.