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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT02969369
• Date of registration: 17/11/2016
• Prospective Registration: Yes
• Primary sponsor: Sunovion
• Public title: A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis
• Scientific 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
• Date of first enrolment: December 31, 2016
• Target sample size: 39
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02969369
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: CNS Medical Director
• Affiliation: Sunovion

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subject, caregiver, and/or legally authorized representative understands and is
willing to sign informed consent to participate in the study.

2. 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.

3. Subject is male or postmenopausal female = 55 years of age.

4. Subject meets established diagnostic criteria for Parkinson's disease of at least one
year duration, consistent with the UK Brain Bank criteria

5. 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.

6. 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.

7. Subject has a Mini-mental status examination (MMSE) score > 21 points out of 30.

8. 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.

9. Subject is taking antiparkinsonian drugs or deep brain stimulation, with a stable
dose/dose regimen and settings for 3 months before enrolment.

10. Female subject must be postmenopausal defined as being amenorrheic for greater than
two years with an appropriate clinical profile.

11. Male subjects with female partner(s) of childbearing potential must agree to avoid
fathering a child and use acceptable methods of birth control from screening until at
least 30 days after the last study drug administration.

12. Subject is, in the opinion of the Investigator, medically stable based on screening
medical history, PE, neurological examination, vital signs, clinical laboratory values
(hematology, serum chemistry, urinalysis, lipid panel, coagulation panel, thyroid
panel, and serum prolactin).

13. Subject has had a stable living arrangement at the time of screening.

Exclusion Criteria:

1. Subject has psychosis secondary to other toxic or metabolic disorders.

2. Subject has atypical Parkinson's disease, Parkinsonism secondary to medication or
other neurodegenerative disorders, such as progressive supranuclear palsy or multiple
system atrophy.

3. Subject has dementia diagnosed concurrent with or before Parkinson's disease, motor
symptoms that began less than one year before the onset of dementia or symptoms
consistent with the diagnosis of lewy body dementia (LBD), or if the psychosis
occurred after ablative stereotaxic surgery.

4. Subject failed 2 or more antipsychotic agents given at adequate doses for at least 4
weeks within 1 year before screening.

5. Subject has had a stroke or other uncontrolled serious medical or neurological illness
within 6 months of baseline.

6. Subject answers "yes" to "Suicidal Ideation" Item 4 (active suicidal ideation with
some intent to act, without specific plan) or Item 5 (active suicidal ideation with
specific plan and intent) on the C SSRS at Screening (ie, in the past one month), or
baseline (ie, since last visit).

7. Subject does not tolerate venipuncture or has poor venous access that would cause
difficulty for collecting blood samples.

8. Subject has participated in an investigational drug study and received investigational
drug within 30 days (or longer if the half-life is known to be = 150 hours) prior to
the screening visit, or who is currently participating in another clinical study.
Subject has previously received SEP 363856.

9. Subject has any clinically significant unstable medical condition or any clinically
significant chronic disease that in the opinion of the Investigator, would limit the
subject's ability to complete and/or participate in the study:

10. Subject has hematological (including deep vein thrombosis) or bleeding disorder,
renal, metabolic, endocrine, pulmonary, gastrointestinal, urological, cardiovascular,
hepatic, neurologic, or allergic disease that is clinically significant or unstable
(except for untreated, asymptomatic, seasonal allergies at time of dosing).

11. Subject has a history of cancer or significant neoplasm.

12. Subject has a disorder or history of a condition or previous gastrointestinal surgery
(eg, cholecystectomy, vagotomy, bowel resection, or any surgical procedure) that may
interfere with drug absorption, distribution, metabolism, excretion, gastrointestinal
motility, or pH, or a clinically significant abnormality of the hepatic or renal
system, or a history of malabsorption.

13. Subject has Alcohol or Substance Abuse Disorder (DSM 5 criteria). The only exceptions
are caffeine or nicotine.

14. Subject has a clinically significant abnormal 12 lead ECG that may jeopardize the
subject's ability to complete the study or a screening 12 lead ECG demonstrating any
one of the following: heart rate > 100 beats per minute, QRS > 120 ms, QT interval
corrected for heart rate using Fridericia's formula (QTcF) > 450 ms (males), QTcF >
470 ms (females), or PR > 220 ms.

15. Subjects with known human immunodeficiency virus (HIV) seropositivity will be
excluded.

16. Female subject who is pregnant or lactating.

17. Subject has a presence or history of a medically diagnosed, clinically significant
psychiatric disorder.

18. Subject is at significant risk of harming him/herself or others according to the
Investigator's judgment.

19. Subject has attempted suicide within 3 months prior to screening.

20. Subject has a history of allergic reaction or suspected sensitivity to any substance
that is contained in the formulation.

21. Subject has any clinically significant abnormal laboratory values (hematology, serum
chemistry, urinalysis, lipid panel, coagulation panel, thyroid panel, serum prolactin,
and urine drug screen(Note: abnormal findings that may be clinically significant or of
questionable significance will be discussed with the Medical Monitor prior to
including subject).

22. Subjects with serum alanine transaminase (ALT) or aspartate transaminase (AST) levels
= 3 times, serum blood urea nitrogen (BUN) or creatine = 1.5 X the upper limit of the
reference ranges provided by the central laboratory require retesting. If on
retesting, the laboratory value remains equal to or above the ULN, the subj


Age minimum: 55 Years
Age maximum: 105 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease Psychosis

Intervention(s)

Drug: Placebo capsule

Drug: SEP-363856

Primary Outcome(s)

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]

Secondary Outcome(s)

Change from Double-blind (DB) Baseline in Mini Mental State Evaluation (MMSE) at Week 6 [Time Frame: Week 0-Week 6]

Change from from Double Blind (DB) Baseline in Neuropsychiatric Inventory (NPI) at Week 6 [Time Frame: week 0-week 6]

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]

Secondary ID(s)

SEP361-203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors