Suncoast Neuroscience Associates, a dedicated clinical investigational site, is actively recruiting participants for a clinical research study to evaluate an investigational medicine in people diagnosed with Parkinson’s disease exhibiting hallucinations and delusions. Called the SEP361-203 study, the sponsors seek approximately 36 people across 15 clinical research sites in the US that will take part in the study. The study will evaluate how safe the investigational medication is and how well it works.
The study is being conducted at Suncoast Neuroscience Associates by the IRB on May 22, 2019. The study is led by Dr. Alberto Vasquez and his team through Fall 2019 reported Digital Journal.
What is Parkinson’s disease psychosis?
A neurodegenerative condition afflicting Parkinson’s patients where their brain change over time causes problems like losing of how their body moves. They may experience other conditions such as visual hallucinations (seeing things that aren’t actually there), delusions (such as paranoia), or illusions. These symptoms are often referred to as Parkinson’s disease psychosis which is common in people with Parkinson’s disease.
The study is sponsored by commercial biopharma Sunovion. is being managed by a clinical research organization (CRO) IQVIA (Quintiles). It is evaluating an investigational medication for people with Parkinson’s disease with symptoms of psychosis, such as visual hallucinations and /or delusions. The sponsor is seeking 36 participants across 15 sites of which Suncoast Neuroscience Associates is one of them. Participants can sign up for more information here at the IQVIA study research website. The sponsor and site will evaluate the safety and tolerability of SEP363856 in subjects with Parkinson’s disease psychosis. The study is accepting make and female participants 55 years of age or older and who have been diagnosed with Parkinson’s disease. The study will last approximately 21 weeks.
All study-related visits, tests, and study medication will be provided at no cost for the duration of the study. In addition, reimbursement for travel and related expenses may be provided for completed study visits.
What is SEP363856? (the investigational drug)
This investigational drug is a psychotropic agent with a novel, non-D2 mechanism of action, distinct from currently marketed antipsychotics. Sunovion discovered the drug in collaboration with PsychoGenics based in part on a mechanisms-independent approaching using the in vivo phenotypic SmartCube® platform and associated artificial intelligence algorithms. The drug was optimized for antipsychotic activity by Sunovion medical chemists based on quantitative structure-activity relationship analysis, in collaboration with Psychogenic. The drug is jointly owned by Sunovion and PsychoGenics. Sunovion has exclusive rights to develop and commercialize SEP-363856 globally. It is being studied in a global development program for schizophrenia and for Parkinson’s disease psychosis, with additional indications under consideration. Clinical trials to date demonstrate a predictable pharmacokinetic (PK) profile suitable for once daily use.
Suncoast Neuroscience Associates
Suncoast Neuroscience Associates operates in Florida with a team of six neurologists, two clinical research coordinators, a regulatory coordinator and a director of clinical research. They have been conducting Phase II, III and IV trials over 20 years. They have worked on hundreds of studies focusing on Alzheimer’s disease and dementia, memory loss, Parkinson’s disease, multiple sclerosis, stroke, cervical dystonia, tremor, ALS (Lou Gehrig’s disease), migraines/headaches, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, peripheral neuropathy, and other neurological conditions.
The Industry Sponsor: Sunovion
Sunovion Pharmaceuticals, Inc was known until 2010 at Sepracor, Inc. before its acquisition by Sumitomo Dainippon Pharma of Japan. It is a biopharmaceutical company founded in 1984. It is located in Massachusetts and maintains a robust central nervous system (CNS)-focused pipeline.
Call to Action: If there are any patients that are struggling with Parkinson’s disease exhibiting hallucinations and delusions then contact this research site or TrialSite News for more information.
Lead Research/InvestigatorSource: Digital Journal