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Parkinson Disease PsychosisPhase 2NCT02969369

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

A Phase 2 study testing SEP-363856 in people with Parkinson Disease Psychosis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 105 years
Conditions the study is for
Parkinson Disease Psychosis
What is being tested?
SEP-363856
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
24 sitesUnited States
Study dates
31 Dec 2016to 20 Apr 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.
  • Female subject who is pregnant or lactating.
  • Subject has a presence or history of a medically diagnosed, clinically significant psychiatric disorder.
  • Subject is at significant risk of harming him/herself or others according to the Investigator's judgment.
  • Subject has attempted suicide within 3 months prior to screening.
  • Subject has a history of allergic reaction or suspected sensitivity to any substance that is contained in the formulation.
  • 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).
  • 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 subject will be excluded.
  • Subjects with a random (non-fasting) blood glucose at screening ≥ 200 mg/dL (11.1 mmol/L) and HbA1c ≥ 6.5% will be excluded.
  • Subject has a prolactin concentration > 100 ng/mL at screening or has a history of pituitary adenoma.
  • Subject's BMI is ≥ 30 mg/kg/m2.
  • Subject has experienced significant blood loss (≥ 473 mL) or donated blood within 60 days prior to first dose of study drug; has donated plasma within 72 hours prior to the first dose of study drug or intends to donate plasma or blood or undergo elective surgery during study participation or within 60 days after the last study visit.
  • Subject consumes more than 300 mg of caffeine per day (5 cups of coffee or equivalent in caffeinated beverages).
  • Subject has used disallowed prescription medications or anticipates the need for any disallowed medication during their participation in this study. Subject is a staff member or the relative of a staff member.
  • Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.
  • Continuation into Open-label Extension Cirteria
  • Subject must have completed the 6-week double-blind treatment.
  • Subject has not taken any medication other than the study drug for the purpose of controlling PDD symptoms
  • . • There has been no clinically significant change in the subject's medical condition or Parkinson's disease, in the opinion of the investigator.
  • Subject has not answered "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 assessment at any time during the DB treatment period.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • JEM Research Institute

    Atlantis, Florida, 33462

  • UHealth at Boca Raton

    Boca Raton, Florida, 33431

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Brian Maddux

    Cincinnati, Ohio, 45212

  • Neuuro-Pain Medical Center

    Fresno, California, 93710

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Keck School of Medicine of USC/ University of Southern California

    Los Angeles, California, 90033

  • University of Miami, Dept. of Neurology

    Miami, Florida, 33136

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Compass Research

    Orlando, Florida, 32802

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pennsylvania, Department of Neurology

    Philadelphia, Pennsylvania, 19107

  • Parkinson's Disease Treatment Center of Southwest Florida

    Port Charlotte, Florida, 33980

  • CiTrials

    Riverside, California, 92521

  • Inland Northwest Research

    Spokane, Washington, 99202

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33713

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

    Tampa, Florida, 33613

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, Oklahoma, 74136

  • Georgetown University Hospial, Research Pharmacy Servcies

    Washington D.C., District of Columbia, 20007

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

Other trials in United States

About this study

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

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.

Read the detailed description

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).

Being tested
SEP-363856, Placebo capsule
Keywords
Parkinson's Disease Psychosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEP-363856Drug

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

  • Placebo capsuleDrug

    Placebo once daily

Study groups in NCT02969369
Study groupRoleWhat they receive
SEP-363856ExperimentalSEP-363856 (25, 50, or 75mg/day), once daily
Receives: Drug: SEP-363856
Placebo CapsulePlacebo comparatorPlacebo once daily
Receives: Drug: Placebo capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (3)

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

    Analysis Method: Mixed Model Repeated Measures (MMRM)

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

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

    The NPI is a 12-item behavior rating scale composed of a structured interview of the caregiver, which assesses psychiatric disturbance. For each subdomain, both the frequency (0 to 3 scale) and the severity (0 to 4 scale) of symptoms is determined. Higher scores represent a worse outcome. The subdomain score is the product of these two measures and ranges from 0 to 12. The combined NPI score is obtained by summing all 12 sub-domain scores and therefore ranges from 0 to 144.

    Analysis Method: Mixed Model Repeated Measures (MMRM)

    Measured: NPI assessments during DB treatment period, Baseline and Week 6

  3. Change From Double-blind (DB) Baseline in Mini Mental State Evaluation (MMSE) at 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 is the sum of all 11 tests.

    Analysis Method: Mixed Model Repeated Measures (MMRM)

    Measured: MMSE assessments during DB treatment period, Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2016 (estimated)
  2. Study start31 Dec 2016
  3. Primary completion20 Apr 2020
  4. Study completion20 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02969369
Sponsor's protocol ID
SEP361-203
Status last verified
Jun 2024
First submitted
17 Nov 2016
Last updated
5 Jul 2024
Data monitoring committee
No
Individual data sharing
Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

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.

    PubMed 37273942

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SEP-363856 in people with Parkinson Disease Psychosis, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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: SAPS-PD assessments during DB treatment period, Baseline and Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02969369, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.

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