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Trial record 29 of 4525 for:    Recruiting, Not yet recruiting, Available Studies | "Psychotic Disorders"

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 : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion

Brief Summary:
A study to evaluate the safety and tolerability of SEP363856 in subjects with Parkinson's Disease Psychosis

Condition or disease Intervention/treatment Phase
Parkinson Disease Psychosis Drug: SEP-363856 Drug: Placebo capsule Phase 2

Detailed Description:

This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of SEP-363856 flexibly dosed at 25, 50, or 75 mg/day for 6 weeks 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 Lead-in), Lead-in Period (2 weeks prior to Baseline), Double-blind treatment Period (6 weeks), and Follow-up Period (1 week after last dose) as shown in the following figure. All post-Baseline clinic visits will have a window of ± 2 days relative to the date of the Baseline visit (Visit 3).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-group, Multicenter 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 : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SEP-363856
SEP-363856 (25, 50, or 75mg/day), once daily
Drug: SEP-363856
SEP-363856 (25, 50, or 75mg/day)

Placebo Comparator: Placebo Capsule
Placebo once daily
Drug: Placebo capsule
Placebo once daily




Primary Outcome Measures :
  1. Change from Baseline in total SAPS-PD Score at Week 6 [ Time Frame: week 0-week 6 ]

Secondary Outcome Measures :
  1. Change from Baseline in the CGI S at Week 6. [ Time Frame: week 0-week 6 ]
  2. Change from Baseline in NPI at Week 6 [ Time Frame: week 0-week 6 ]
  3. Change from Baseline in MMSE at Week 6 [ Time Frame: week 0-week 6 ]
  4. The incidence of overall AEs, serious adverse events (SAEs), and AEs (or SAEs) leading to discontinuation. [ Time Frame: Week 0 - week 7 ]
  5. changes from Baseline in clinical laboratory tests (hematology) [ Time Frame: Week 0 - week 7 ]
  6. Absolute values from Baseline in clinical laboratory tests (hematology) [ Time Frame: Week 0 - week 7 ]
  7. changes from Baseline in clinical laboratory tests (serum chemistry) [ Time Frame: Week 0 - week 7 ]
  8. Absolute values from Baseline in clinical laboratory tests (serum chemistry) [ Time Frame: Week 0 - week 7 ]
  9. changes from Baseline in clinical laboratory tests (urinalysis) [ Time Frame: Week 0 - week 7 ]
  10. absolute values from Baseline in clinical laboratory tests (urinalysis) [ Time Frame: Week 0 - week 7 ]
  11. changes from Baseline in clinical evaluations (body weight) [ Time Frame: Week 0 - week 7 ]
  12. absolute values from Baseline in clinical evaluations (body weight) [ Time Frame: Week 0 - week 7 ]
  13. changes from Baseline in clinical evaluations (BMI) [ Time Frame: Week 0 - week 7 ]
  14. absolute values from Baseline in clinical evaluations (BMI) [ Time Frame: Week 0 - week 7 ]
  15. changes from Baseline in clinical evaluations (blood pressure , [supine and standing]) [ Time Frame: Week 0 - week 7 ]
  16. absolute values from Baseline in clinical evaluations (blood pressure , [supine and standing]) [ Time Frame: Week 0 - week 7 ]
  17. changes from Baseline in clinical evaluations (heart rate [supine and standing]) [ Time Frame: Week 0 - week 7 ]
  18. absolute values from Baseline in clinical evaluations (heart rate [supine and standing]) [ Time Frame: Week 0 - week 7 ]
  19. changes from Baseline in clinical evaluations ( 12-lead ECGs) [ Time Frame: Week 0 - week 7 ]
  20. absolute values from Baseline in clinical evaluations ( 12-lead ECGs) [ Time Frame: Week 0 - week 7 ]
  21. Frequency of subjects With suicidal ideation or suicidal behavior using the C-SSRS [ Time Frame: Week 0 - week 7 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 criterion must be met at visits 1 and 3.

    7. Subject has a Mini-mental status examination (MMSE) score > 16 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 and Zarit 22 scale.

    9. Subject is taking antiparkinsonian drugs or deep brain stimulation, with a stable dose/dose regimen and settings for 1 month before screening.

    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. Treatment failure is defined as a complete lack of efficacy. Subjects who had a partial response or who discontinued treatment for reasons of tolerability will be allowed.

    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 interventional study. Observational studies are not exclusionary. 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 as judged by the Investigator 11. Subject has a history of malignancy within 5 years prior to the Screening visit, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.

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

    13. Subject has known or suspected Alcohol or Substance Use Disorder as defined by DSM 5. The only exceptions are caffeine or nicotine.

    14. Subject has a clinically significant abnormal 12 lead ECG that may result in the subject's inability to complete the study, as judged by the Investigator.

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

    16. Female subject who is pregnant or lactating. 17. Subject has an active and unstable psychiatric disorder as judged by the investigator 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 study drug 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 subject will be excluded.

    23. Subjects with a random (non-fasting) blood glucose at screening ≥ 200 mg/dL (11.1 mmol/L) or HbA1c ≥ 7% will be excluded.

    24. Subject has a prolactin concentration > 100 ng/mL at screening or has a history of pituitary adenoma.

    25.. Subject has an abnormal BMI that may result in the subject's inability to complete the study, as judged by the Investigator.

    26. 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.

    27. Subject consumes more than 300 mg of caffeine per day (5 cups of coffee or equivalent in caffeinated beverages).

    28. 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.

    29. Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.


Information from the National Library of Medicine

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


Contacts
Contact: CNS Medical Director 1-866-503-6351

Locations
United States, California
Neuuro-Pain Medical Center Recruiting
Fresno, California, United States, 93710
Contact: Perminder Bhatia, MD    559-437-9700      
Keck School of Medicine of USC/ University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Jennifer Hui, MD    323-442-5710      
United States, Florida
JEM Research Institute Recruiting
Atlantis, Florida, United States, 33462
Contact: Mark Goldstein, MD    561-968-2933      
Parkinson's Disease and Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
Contact: Stuart Isaacson, MD    561-392-1818 ext 6      
Compass Research Recruiting
Orlando, Florida, United States, 32802
Contact: Ira Goodman, MD    407-426-9299      
Neurology Associates of Ormond Beach Active, not recruiting
Ormond Beach, Florida, United States, 32174
University of Florida Parkinson's Disease and Movement Disorder's Center Recruiting
Tampa, Florida, United States, 33613
Contact: Robert Hauser, MD    813-396-0751      
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Rajesh Pahwa, MD    913-588-6782      
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Kevin Black, MD    314-362-5041      
United States, New York
David Kreitzman Withdrawn
Commack, New York, United States, 11725
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Burton Scott, MD, PhD    919-688-6477      
United States, Oklahoma
The Movement Disorder Clinic of Oklahoma Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Kevin Klos, MD    918-392-4530      
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jeffrey Ratliff, MD    215-503-2724      
Sponsors and Collaborators
Sunovion
Investigators
Study Chair: CNS Medical Director Sunovion

Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT02969369     History of Changes
Other Study ID Numbers: SEP361-203
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018

Keywords provided by Sunovion:
Parkinson's Disease Psychosis

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases