Clinical investigative Site JEM Research Institute, based in Atlantis, Florida, seeks participants for a clinical trial evaluating an investigational medication in people diagnosed with Parkinson’s disease who are experiencing symptoms such as seeing and hearing things that may not actually be there. The study results will provide information about the safety of the investigational medication and how well it works. Patients who choose to take part in this clinical trial provide a valuable contribution to medical research.
Led by Dr. Mark Goldstein, a Board Certified Neurologist, JEM Research Institute is a participating site in the SEP361-203 Study.
What is the SEP361 Study?
The SEP361 study is sponsored by biopharma company Sunovion. The sponsor and sites including JEM Research seeks to evaluate the safety and tolerability of SEP363856 in participants with Parkinson’s Disease Psychosis. The study is accepting male and female participants 55 years of age and older who have been diagnosed with Parkinson’s disease. The study was planned to be conducted in 24 study centers (sites) in the United States and lasts 21 weeks. The study was planned to end in 2020. JEM Research Institute is one of several sites in Florida.
The Investigative Product: SEP363856
SEP-363856 is a psychotropic agent with a novel, non-D2 mechanism of action, distinct from currently marketed antipsychotics. Sunovion discovered SEP-363856 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube® platform and associated artificial intelligence algorithms. SEP-363856 was optimized for antipsychotic activity by Sunovion medicinal chemists based on quantitative structure-activity relationship analysis, in collaboration with PsychoGenics. SEP-363856 is jointly owned by Sunovion and PsychoGenics. Sunovion has exclusive rights to develop and commercialize SEP-363856 globally.
SEP-363856 is being studied in a global development program for schizophrenia as well as for Parkinson’s disease psychosis, with additional indications under consideration. Clinical trial results to date demonstrate a predictable pharmacokinetic (PK) profile suitable for once daily use.
The Clinical Sponsor: Sunovion
Sunovion Pharmaceuticals, formally called Sepracor, Inc., it was acquired by Japanese pharma company Sumitomo Dainippon Pharma. Founded originally in 1984 by Timothy J. Barberich, Steve Matson, and Bob Bratzler. Originally located in Princeton, NL they relocated to Marlborough, MA.
According to Sunovion’s website, they are one of the fastest growing top 20 pharmaceutical companies. With 1,700 employees worldwide has achieved a number of major milestones including FDA approvals.
What is Parkinson Disease Psychosis?
Parkinson’s disease is a neurodegenerative condition. This means that patients with Parkinson’s disease, have their brain change over time causing problems like losing control of how their body moves. They may also experience other symptoms such as visual hallucinations (seeing things that aren’t actually there), delusions (such as paranoia), or illusions (thinking something is real when it is not). These symptoms are often referred to as ‘Parkinson’s disease psychosis’, which is common in people with Parkinson’s disease.
JEM Research Institute
JEM Research Institute was founded in 2007 by Board Certified Neurologists Dr. Mark Goldstein, Dr. James Goldenberg, and Dr. Eric Kramer. JEM Research Institute is committed to contributing to the advancement and development of innovative treatments with a primary focus in the field of neurology. Our goal is to provide cutting-edge research alternatives for common but debilitating neurological illnesses. Our doctors and research staff are dedicated to conducting clinical trials in a professional and ethical manner, while always showing respect for our patients, our colleagues, and the community.
Lead Research/Investigator (For JEM
Mark Goldstein, MD
Call to Action: If you have a loved one with Parkinson’s disease psychosis and desire to contribute to the science of medicine with an emphasis on investigating possible treatments for psychosis associated with Parkinson’s disease, then it may be worth learning more about this study. It will end within a year.