A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis
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|ClinicalTrials.gov Identifier: NCT02969369|
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease Psychosis||Drug: SEP-363856 Drug: Placebo capsule||Phase 2|
This is a multicenter, randomized, parallel-group, placebo-controlled study evaluating the efficacy, safety, and tolerability of double-blind SEP-363856 flexibly dosed at 25, 50, or 75 mg/day for 6 weeks followed by 12 weeks of open-label extension of SEP-363856 flexibly-dosed at 25, 50, or 75 mg/day in male and female subjects ≥ 55 years of age with a clinical diagnosis of PDP. The study will randomize approximately 36 subjects to 2 treatment groups in a 2:1 ratio (approximately 24 subjects to SEP-363856 and 12 to placebo). The study will consist of 4 periods: Screening/Washout Period (up to 14 days prior to Double-blind Treatment), Double-blind Treatment Period (6 weeks), Open-label SEP-363856 Treatment Period (12 weeks), and Follow-up Period (1 week after last dose) as shown in the following figure. All postBaseline clinic visits will have a window of ± 2 days relative to the date of the Baseline visit (Visit 3).
Treatment with SEP-363856 in subjects with PDP will result in a significant reduction in the Scale for Assessment of Positive Symptoms - Parkinson's Disease (SAPS-PD) total score at Week 6 when compared to placebo. Let μSEP and μPBO represent the mean changes from Baseline at Week 6 in SAPS-PD total score for the SEP-363856 and placebo arms, respectively. The following hypothesis will be tested to compare the mean change values between the SEP-363856 group and placebo group at Week 6: H0: μSEP = μPBO versus H1: μSEP ≠ μPBO
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis|
|Actual Study Start Date :||December 31, 2016|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
SEP-363856 (25, 50, or 75mg/day), once daily
SEP-363856 (25, 50, or 75mg/day)
Placebo Comparator: Placebo Capsule
Placebo once daily
Drug: Placebo capsule
Placebo once daily
- Change from Double Blind (DB) Baseline in total Scale for Assessment of Positive Symptoms - Parkinson's Disease ( SAPS-PD) Score at Week 6 [ Time Frame: week 0-week 6 ]
There are seven items assessing individual symptoms (four items for hallucinations and three items for delusions), a global hallucinations item and a global delusions item. Separate items are rated from 0 (absent) to 5 (severe). Total score will be equal to the sum of the seven items plus the global hallucinations, plus the global delusions. Therefore a total possible score on the SAPS-PD ranges from 0 to 45.
Higher values represent a worse outcome: 0 (absent) to 5 (severe).
Ttotal score will be equal to the sum of the seven items plus the global hallucinations, plus the global delusions.
- Change from from Double Blind (DB) Baseline in the Clinical Global Impression-Severity of Illness (CGI S) at Week 6. [ Time Frame: week 0-week 6 ]The CGI-S score is a single value, clinician-rated assessment of illness severity and ranges from 1= 'Normal, not at all ill' to 7= 'Among the most extremely ill patients'. A higher score is associated with greater illness severity.
- Change from from Double Blind (DB) Baseline in Neuropsychiatric Inventory (NPI) at Week 6 [ Time Frame: week 0-week 6 ]The Neuropsychiatric Inventory (NPI) is a 12-item behavior rating scale composed of a structured interview of the caregiver, which assess psychiatric disturbance. Both the frequency and the severity of each behavior are determined. NPI score is obtained by summing all the 12 sub-domain scores.
- Change from Double-blind (DB) Baseline in Mini Mental State Evaluation (MMSE) at Week 6 [ Time Frame: Week 0-Week 6 ]The Mini Mental State Examination (MMSE) for Cognition is a brief instrument, used to assess cognitive function, consisting of 11 tests including orientation, memory (recent and immediate), concentration, language, and praxis. Scores range from 0 to 30, with lower scores indicating greater cognitive impairment. MMSE, the total score will also be summing scores of all 11 tests.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969369
|Contact: CNS Medical Director||1-866-503-6351|
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|Study Chair:||CNS Medical Director||Sunovion|