A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinso… (NCT02969369) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis
United States39 participantsStarted 2016-12-31
Plain-language 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.
Who can participate
Age range55 Years – 105 Years
SexALL
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Inclusion Criteria:
* Subject, caregiver, and/or legally authorized representative understands and is willing to sign informed consent to participate in the study.
* Subject must be willing and able to comply with the study procedures and visit schedules and must be able to follow verbal and written instructions.
* Subject is male or postmenopausal female ≥ 55 years of age.
* Subject meets established diagnostic criteria for Parkinson's disease of at least one year duration, consistent with the UK Brain Bank criteria
* Subject has psychotic symptoms that began after the diagnosis of PD for at least one month, occurring at least weekly in the month prior to screening (according to subject or caregiver), and severe enough to warrant treatment with antipsychotics.
* Subject has a combined score of at least 6 or an individual score of at least 4 on the neuropsychiatric inventory (NPI) Item A (delusions) and/or Item B (hallucinations). This crieterion must be met at Visit 1 and Visit 3.
* Subject has a Mini-mental status examination (MMSE) score \> 21 points out of 30.
* Subject has a caregiver (spouse or family member) who will be required to attend all visits and is able to provide study information on various scales such as the NPI.
* Subject is taking antiparkinsonian drugs or deep brain stimulation, with a stable dose/dose regimen and settings for 3 months before enrolment.
* Female subject must be postmenopausal defined as being amenorrheic for greater than two years with a…
What they're measuring
1
Change From Double Blind (DB) Baseline in Total Scale for Assessment of Positive Symptoms - Parkinson's Disease ( SAPS-PD) Score at Week 6
Timeframe: SAPS-PD assessments during DB treatment period, Baseline and Week 6
Trial details
NCT IDNCT02969369
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.