A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis

Summary

A study to evaluate the safety and tolerability of SEP-363856 in subjects with Parkinson's Disease Psychosis. This study is accepting male and female participants 55 years of age and older who have been diagnosed with Parkinson's Disease. This study will be conducted in 24 study centers in the United States. The study will last approximately 21 weeks.

Timeline

Start

2016-12-31

Primary completion

2020-04-20

Completion

2020-04-20

Outcome

Missed primary endpoint

paper Least squares mean (95% confidence interval) difference in change from baseline at week 6 was -1.1 (-6.5, 4.3, p = 0.681). PMID 37273942 ↗

Publications

• Isaacson SH, Goldstein M, Pahwa R, Singer C, Klos K, Pucci M, Zhang Y, Crandall D, Koblan KS, Navia B; Parkinson's Psychosis TAAR1 Study Group. Ulotaront, a Trace Amine-Associated Receptor 1/Serotonin 5-HT1A Agonist, in Patients With Parkinson Disease Psychosis: A Pilot Study. Neurol Clin Pract. 2023 Aug;13(4):e200175. doi: 10.1212/CPJ.0000000000200175. Epub 2023 May 25.

Drugs

Indications