Phase 2 Trial of Parkinson’s Psychosis Therapy Enrolling Across U.S.

A Phase 2 clinical trial of SEP-363856, an oral treatment candidate for patients with Parkinson’s psychosis, is recruiting participants throughout the U.S.

The Sunovion-funded SEP361-203 study (NCT02969369) will be conducted at 24 U.S. sites and will include approximately 36 participants, 24 on SEP-363856 and 12 on placebo.

Trial locations and their contacts can be found here.

Eligible patients are at least 55 years old, received a Parkinson’s diagnosis at least one year prior to the study and have been experiencing symptoms such as visual hallucinations (to see, hear or feel things that do not exist) and/or delusions, which refers to holding false and typically paranoid beliefs.

Women may be eligible if they are postmenopausal. All participants need to have a caregiver able to attend all study visits. Full details on inclusion and exclusion criteria are given here.

Following a screening/washout period lasting up to two weeks, Sunovion’s SEP361-203 will be given in oral capsules at 25, 50, or 75 mg once daily for six weeks, followed by 12 weeks of an open-label extension phase and one week of follow-up.

The study will test the safety, tolerability and effectiveness of SEP-363856, via changes in the Scale for Assessment of Positive Symptoms – Parkinson’s Disease (SAPS-PD) total score, which addresses hallucinations and delusions.

Other assessments include the Clinical Global Impression-Severity of Illness (a measure of disease severity), the Neuropsychiatric Inventory (composed of an interview of the caregiver), and the Mini Mental State Evaluation of cognitive function, which measures memory, orientation, concentration, and language. Blood and urine tests also will be performed.

All study visits, tests and trial-related medication will be provided at no cost. Participants also may be reimbursed for travel and other expenses. The study is expected to be completed by May 2020.

Parkinson’s psychosis is one the non-motor symptoms of the disease. Its most common manifestations are hallucinations and delusions, but illusions (misinterpreting existing things), panic attacks, and vivid dreams also may occur.

Currently, Nuplazid (pimavanserin), developed by Acadia, is the only U.S. Food and Drug Administration (FDA)–approved medication for treating hallucinations and delusions associated with Parkinson’s disease.

Suncoast Neuroscience Associates in St. Petersburg, Florida is one of the locations enrolling participants for the SEP361-203 study. Patient care there is led by Alberto Vasquez, MD, a neurologist and lead principal investigator at Suncoast. To contact the researchers at Suncoast, click here.