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

NCT02969369 | Completed Phase 2 Results

• 1 other identifier: SEP361-203
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 24

Brief 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.

Conditions

Parkinson Disease Psychosis

Keywords

Parkinson's Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Change From Double Blind (DB) Baseline in Total Scale for Assessment of Positive Symptoms - Parkinson's Disease ( SAPS-PD) Score at 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), so that higher values represent a worse outcome. Total score is 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. The primary analysis of the primary efficacy variable will use a mixed model for repeated measures (MMRM).

  SAPS-PD assessments during DB treatment period, Baseline and Week 6

Secondary Outcomes (3)

• Change From Double Blind (DB) Baseline in the Clinical Global Impression-Severity of Illness (CGI-S) at Week 6.

  CGI-S assessments during DB treatment period, Baseline and Week 6

• Change From Double Blind (DB) Baseline in Neuropsychiatric Inventory (NPI) at Week 6

  NPI assessments during DB treatment period, Baseline and Week 6

• Change From Double-blind (DB) Baseline in Mini Mental State Evaluation (MMSE) at Week 6

  MMSE assessments during DB treatment period, Baseline and Week 6

Study Arms (2)

SEP-363856

EXPERIMENTAL

SEP-363856 (25, 50, or 75mg/day), once daily

Drug: SEP-363856

Placebo Capsule

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo capsule

Interventions

SEP-363856 DRUG

SEP-363856 (25, 50, or 75mg/day)

SEP-363856

Placebo capsule DRUG

Placebo once daily

Placebo Capsule

Eligibility Criteria

• Age: 55 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 an appropriate clinical profile.
• 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.
• 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).
• Subject has had a stable living arrangement at the time of screening.

You may not qualify if:

• Subject has psychosis secondary to other toxic or metabolic disorders.
• Subject has atypical Parkinson's disease, Parkinsonism secondary to medication or other neurodegenerative disorders, such as progressive supranuclear palsy or multiple system atrophy.
• 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.
• Subject failed 2 or more antipsychotic agents given at adequate doses for at least 4 weeks within 1 year before screening.
• Subject has had a stroke or other uncontrolled serious medical or neurological illness within 6 months of baseline.
• 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).
• Subject does not tolerate venipuncture or has poor venous access that would cause difficulty for collecting blood samples.
• 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.
• 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:
• 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).
• Subject has a history of cancer or significant neoplasm.
• 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.
• Subject has Alcohol or Substance Abuse Disorder (DSM 5 criteria). The only exceptions are caffeine or nicotine.
• 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.
• Subjects with known human immunodeficiency virus (HIV) seropositivity will be excluded.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (24)

Neuuro-Pain Medical Center

Fresno, California, 93710, United States

Location

Keck School of Medicine of USC/ University of Southern California

Los Angeles, California, 90033, United States

Location

CiTrials

Riverside, California, 92521, United States

Location

Georgetown University Hospial, Research Pharmacy Servcies

Washington D.C., District of Columbia, 20007, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

UHealth at Boca Raton

Boca Raton, Florida, 33431, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Miami, Dept. of Neurology

Miami, Florida, 33136, United States

Location

Compass Research

Orlando, Florida, 32802, United States

Location

Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

Location

Parkinson's Disease Treatment Center of Southwest Florida

Port Charlotte, Florida, 33980, United States

Location

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, 33713, United States

Location

University of Florida Parkinson's Disease and Movement Disorder's Center

Tampa, Florida, 33613, United States

Location

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Henry Ford West Bloomfield Hospital

West Bloomfield, Michigan, 48322, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Brian Maddux

Cincinnati, Ohio, 45212, United States

Location

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pennsylvania, Department of Neurology

Philadelphia, Pennsylvania, 19107, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

Related Publications (1)

• 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.

  PMID: 37273942 DERIVED

MeSH Terms

Interventions

SEP-363856

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sunovion Pharmaceuticals Inc.

clinicaltraildisclosure@sunovion.com

1-866-503-6351

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 21, 2016
• Study Start: December 31, 2016
• Primary Completion: April 20, 2020
• Study Completion: April 20, 2020
• Last Updated: July 5, 2024
• Results First Posted: June 5, 2023

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (24)