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A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis

Sponsor
Tasly Pharmaceutical Group Co., Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06068465
Collaborator
(none)
248
Enrollment
27
Locations
2
Arms
27.2
Anticipated Duration (Months)
9.2
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of 34 mg pimavanserin compared to placebo in patients with Parkinson's disease psychosis (PDP).

Condition or Disease Intervention/Treatment Phase
  • Drug: pimavanserin tartrate
  • Drug: placebo
 Phase 3

Detailed Description

Not provided

Study Design

Study Type:
Interventional
Anticipated Enrollment :
248 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease
Anticipated Study Start Date :
Sep 27, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pimavanserin tartrate

Pimavanserin, 34 mg, capsule,once daily by mouth for 6 weeks Interventions

Drug: pimavanserin tartrate
pimavanserin tartrate, 34 mg, capsule, once daily by mouth for 6 weeks
Placebo Comparator: Placebo

Placebo, capsule, once daily by mouth for 6 weeks

Drug: placebo
placebo, capsule, once daily by mouth for 6 weeks

Outcome Measures

Primary Outcome Measures

  1. Antipsychotic Efficacy [Study Days 1 and 43]

    Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement. Analysis Method: Analysis of Covariance,ANCOVA

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Male or female of 40 years of age or older;

  2. A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year;

  3. Subjects must have had psychotic symptoms that developed after the diagnosis of Parkinson's disease was established. These symptoms must have included visual hallucinations and/or auditory hallucinations, and/or delusions；

  4. Psychotic symptoms were to have been present for at least one month and the subject must have been actively experienced psychotic symptoms each week during the month prior to the Screening visit;

  5. Symptoms severe enough to warrant treatment with an antipsychotic agent; documented at screening by items A and B of the NPI, and defined as a score of 4 or greater on either the Hallucinations (Frequency x Severity) or Delusions (Frequency x Severity) scales OR a total combined score of 6 or greater;

  6. At the baseline visit, subject must have had a SAPS Hallucinations or Delusions global item (H7 or D13) score ≥3 AND a score >3 on at least one other non-global item using the modified 9-item SAPS Hallucinations and Delusions domains;

  7. Subject must have had a clear sensorium at study entry (i.e., oriented to time, person, and place);

  8. Subject must have been on stable dose of anti-Parkinson's medication for 1 month prior to Day 1 (Baseline) and during the trial;

  9. If a Subject had received stereotaxic surgery for sub-thalamic nucleus deep brain stimulation they must have been at least 6 months post-surgery and the stimulator settings must have been stable for at least 1 month prior to Day 1 (Baseline) and must remain stable during the trial;

  10. Subjects of reproductive age (male/female) must have agreed to use a clinically acceptable method of contraception for at least one month prior to randomization, during the study, and one month following completion of the study;

  11. The subject was required to be willing and able to provide consent;

  12. Caregiver was required to be willing and able to provide consent and agrees to accompany the subject to all visits.

Exclusion Criteria:

  1. Subject with psychotic symptoms (hallucinations and delusions) which could be better explained as a part of a toxic, metabolic or infection-induced delirium /encephalopathy , psychosis due to substance abuse, psychosis associated with schizophrenia, bipolar disorder or psychotic depression;

  2. Subject who was likely to have an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class;

  3. Subject who had previously been randomized in any prior clinical study with pimavanserin, and/or received of any other investigational;

  4. Subject with a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder;

  5. Subjects had a significant risk of excitability or committing suicide based on the investigator's judgement; Any suicidal behavior in the year prior to or during screening; Subjects with a Columbia-Suicide Severity Rating Scale (C-SSRS) positive response to suicidal ideation items 4, or 5 are not eligible during the screening period.

  6. Subject with atypical Parkinsonism (Parkinson's plus, MSA, PSP), or secondary parkinsonism variants such as tardive or medication induced parkinsonism;

  7. Subject who had received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease;

  8. Had a score on the Mini-Mental State Examination (MMSE) of <21;

  9. Subject who had dementia prior to or concomitantly with the diagnosis of Parkinson's disease that may be inconsistent with a PD diagnosis;

  10. Subject who had history of cerebrovascular ischemic syndrome (stroke) that impairs their ability to complete the MMSE;

  11. Subject who was using any of the medications prohibited or restricted as described in(Prohibited and Restricted Concomitant Medications-below);

  12. Subject who was on medications of antidepressant/anxiety known to prolong the QT interval, the dose of medication cannot be maintained for 21 days before the baseline period;

  13. Subject who was on medications of acetylcholinesterase inhibitors，the dose of medication was not guaranteed to remain constant between the first 21 days of the baseline period and the last visit；

  14. Subject who had current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies,which would affect the subject's ability to participate in the study;

  15. Subject who had a myocardial infarction in last six months or who had moderate to severe congestive heart failure (NYHA class III or IV);

  16. Subject who had a screening and baseline electrocardiogram (ECG) with Bazett's corrected QT (QTcB) of greater than 460 msec if male or 470 msec if female or Subject who was known history or symptoms of long QT syndrome;

  17. Alanine aminotransferase (ALT) or glutamic aminotransferase (AST) or total bilirubin (TBiL) in laboratory tests were higher than 2 times the upper limit of normal during screening or baseline. Or severe impairment of renal function (defined as creatinine clearance Ccr < 30 ml/min. Creatinine clearance was calculated according to the Cockcroft-Gault formula); or other abnormal indicators in laboratory tests have clinical significance and are judged by the investigators to have safety risks;

  18. Subject who was pregnant or breastfeeding.，female subjects of childbearing potential who have positive pregnancy test results；

  19. Subject who had any surgery planned during the screening, treatment or follow-up periods;

  20. Subject who had participated in any clinical trial and used investigational drug within 4 weeks prior to enrollment；

  21. The investigator considered that the subjects had poor compliance or other factors that made it inappropriate to participate in the clinical trial.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Anhui Medical University Hefei Anhui China 230061
2 Beijing Hospital Beijing Beijing China 100005
3 Xuan Wu Hospital Beijing Beijing China 100053
4 Peking University Sixth Hospital Beijing Beijing China 100191
5 The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing China 400016
6 The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350005
7 Guangdong Provincial Peoples Hospital Guangzhou Guangdong China 510000
8 The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou China 550001
9 The Second Hospital of HeBei Medical University Shijiazhuang Hebei China 050005
10 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052
11 The Third Xiangya Hospital of Central South University Changsha Hunan China 410013
12 Inner Mongolia Autonomous Region People's Hospital Hohhot Inner Mongolia Autonomous Region China 010000
13 Huai'an Second People's Hospital Huaian Jiangsu China 223022
14 Nanjing Drum Tower Hospital Nanjing Jiangsu China 210008
15 Zhongda Hospital Southeast University Nanjing Jiangsu China 210009
16 The Second Affiliated Hospital of Soochow University Suzhou Jiangsu China 215004
17 The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu China 221004
18 The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330008
19 The First Hospital of Jilin University Changchun Jilin China 130021
20 The First Hospital of China Medical University Shenyang Liaoning China 110002
21 People's Hospital of Ningxia Hui Autonomous Region Yinchuan Ningxia Hui Autonomous Region China 750002
22 Qilu Hospital of Shandong University Jinan Shandong China 250012
23 Qilu Hospital of Shandong University(Qingdao) Qingdao Shandong China 266035
24 Ruijin Hospital Shanghai Shanghai China 200025
25 West China Hospital of Sichuan University Chengdu Sichuan China 610041
26 Mianyang Central Hospital Mianyang Sichuan China 621099
27 Tianjin Huanhu Hospital Tianjin Tianjin China 300222

Sponsors and Collaborators

  • Tasly Pharmaceutical Group Co., Ltd

Investigators

  • Study Director: Rui Liu, Tianjin Tasly Sants Pharmaceutical Co., Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tasly Pharmaceutical Group Co., Ltd
ClinicalTrials.gov Identifier:
NCT06068465
Other Study ID Numbers:
  • TSL-CM-JSSPMFSL-Ⅲ
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Parkinson Disease
Psychotic Disorders
Mental Disorders
Pimavanserin

Study Results

No Results Posted as of Oct 5, 2023