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

Primary Purpose

Parkinson's Disease Psychosis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
pimavanserin tartrate
placebo
Sponsored by
Tasly Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease Psychosis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female of 40 years of age or older; A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year; 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; 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; 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; 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; Subject must have had a clear sensorium at study entry (i.e., oriented to time, person, and place); Subject must have been on stable dose of anti-Parkinson's medication for 1 month prior to Day 1 (Baseline) and during the trial; 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; 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; The subject was required to be willing and able to provide consent; Caregiver was required to be willing and able to provide consent and agrees to accompany the subject to all visits. Exclusion Criteria: 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; Subject who was likely to have an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class; Subject who had previously been randomized in any prior clinical study with pimavanserin, and/or received of any other investigational; 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; 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. Subject with atypical Parkinsonism (Parkinson's plus, MSA, PSP), or secondary parkinsonism variants such as tardive or medication induced parkinsonism; Subject who had received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease; Had a score on the Mini-Mental State Examination (MMSE) of <21; Subject who had dementia prior to or concomitantly with the diagnosis of Parkinson's disease that may be inconsistent with a PD diagnosis; Subject who had history of cerebrovascular ischemic syndrome (stroke) that impairs their ability to complete the MMSE; Subject who was using any of the medications prohibited or restricted as described in(Prohibited and Restricted Concomitant Medications-below); 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; 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; 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; Subject who had a myocardial infarction in last six months or who had moderate to severe congestive heart failure (NYHA class III or IV); 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; 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; Subject who was pregnant or breastfeeding.,female subjects of childbearing potential who have positive pregnancy test results; Subject who had any surgery planned during the screening, treatment or follow-up periods; Subject who had participated in any clinical trial and used investigational drug within 4 weeks prior to enrollment; The investigator considered that the subjects had poor compliance or other factors that made it inappropriate to participate in the clinical trial.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical UniversityRecruiting
  • Beijing HospitalRecruiting
  • Xuan Wu HospitalRecruiting
  • Peking University Sixth HospitalRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • Guangdong Provincial Peoples HospitalRecruiting
  • The Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • The Second Hospital of HeBei Medical UniversityRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • The Third Xiangya Hospital of Central South UniversityRecruiting
  • Inner Mongolia Autonomous Region People's HospitalRecruiting
  • Huai'an Second People's HospitalRecruiting
  • Nanjing Drum Tower HospitalRecruiting
  • Zhongda Hospital Southeast UniversityRecruiting
  • The Second Affiliated Hospital of Soochow UniversityRecruiting
  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
  • The Second Affiliated Hospital of Nanchang UniversityRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • The First Hospital of China Medical UniversityRecruiting
  • People's Hospital of Ningxia Hui Autonomous RegionRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Qilu Hospital of Shandong University(Qingdao)Recruiting
  • Ruijin HospitalRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Mianyang Central HospitalRecruiting
  • Tianjin Huanhu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pimavanserin tartrate

Placebo

Arm Description

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

Placebo, capsule, once daily by mouth for 6 weeks

Outcomes

Primary Outcome Measures

Antipsychotic Efficacy
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

Secondary Outcome Measures

Full Information

First Posted
September 28, 2023
Last Updated
September 28, 2023
Sponsor
Tasly Pharmaceutical Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06068465
Brief Title
A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
Detailed Description
Not provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease Psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pimavanserin tartrate
Arm Type
Experimental
Arm Description
Pimavanserin, 34 mg, capsule,once daily by mouth for 6 weeks Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, capsule, once daily by mouth for 6 weeks
Intervention Type
Drug
Intervention Name(s)
pimavanserin tartrate
Intervention Description
pimavanserin tartrate, 34 mg, capsule, once daily by mouth for 6 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo, capsule, once daily by mouth for 6 weeks
Primary Outcome Measure Information:
Title
Antipsychotic Efficacy
Description
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
Time Frame
Study Days 1 and 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female of 40 years of age or older; A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year; 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; 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; 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; 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; Subject must have had a clear sensorium at study entry (i.e., oriented to time, person, and place); Subject must have been on stable dose of anti-Parkinson's medication for 1 month prior to Day 1 (Baseline) and during the trial; 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; 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; The subject was required to be willing and able to provide consent; Caregiver was required to be willing and able to provide consent and agrees to accompany the subject to all visits. Exclusion Criteria: 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; Subject who was likely to have an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class; Subject who had previously been randomized in any prior clinical study with pimavanserin, and/or received of any other investigational; 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; 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. Subject with atypical Parkinsonism (Parkinson's plus, MSA, PSP), or secondary parkinsonism variants such as tardive or medication induced parkinsonism; Subject who had received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease; Had a score on the Mini-Mental State Examination (MMSE) of <21; Subject who had dementia prior to or concomitantly with the diagnosis of Parkinson's disease that may be inconsistent with a PD diagnosis; Subject who had history of cerebrovascular ischemic syndrome (stroke) that impairs their ability to complete the MMSE; Subject who was using any of the medications prohibited or restricted as described in(Prohibited and Restricted Concomitant Medications-below); 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; 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; 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; Subject who had a myocardial infarction in last six months or who had moderate to severe congestive heart failure (NYHA class III or IV); 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; 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; Subject who was pregnant or breastfeeding.,female subjects of childbearing potential who have positive pregnancy test results; Subject who had any surgery planned during the screening, treatment or follow-up periods; Subject who had participated in any clinical trial and used investigational drug within 4 weeks prior to enrollment; The investigator considered that the subjects had poor compliance or other factors that made it inappropriate to participate in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Liu
Phone
022-86343626
Email
liurui2@tasly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Liu
Organizational Affiliation
Tianjin Tasly Sants Pharmaceutical Co., Ltd
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai Wang
Email
wangkai1964@126.com
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haibo Chen
Email
chenhbneuro@263.net
Facility Name
Xuan Wu Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Sun
Email
sallysunhong@163.com
Facility Name
Peking University Sixth Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinyu Sun
Email
sunxinyu@bjmu.edu.cn
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oumei Chen
Email
chengoumei@cqmu.edu.cn
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Wang
Email
26354378@qq.com
Facility Name
Guangdong Provincial Peoples Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijuan Wang
Email
wljgd68@163.com
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lijun Cai
Email
cailijunj@126.com
Facility Name
The Second Hospital of HeBei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaling Liu
Email
lyldoctor@163.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuming Xu
Email
13903711125@126.com
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lifang Lei
Email
525837843@qq.com
Facility Name
Inner Mongolia Autonomous Region People's Hospital
City
Hohhot
State/Province
Inner Mongolia Autonomous Region
ZIP/Postal Code
010000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Runxiu Zhu
Email
zhurunxiu@163.com
Facility Name
Huai'an Second People's Hospital
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liandong Zhao
Email
zldong@163.com
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yun Xu
Email
xuyun20042001@aliyun.com
Facility Name
Zhongda Hospital Southeast University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baoyu Yuan
Email
Yuanby1978@163.com
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunfeng Liu
Email
liucf20@163.com
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiyun Cui
Email
cuiguiyun-js@163.com
Facility Name
The Second Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Huang
Email
13677080198@163.com
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yin Zhang
Email
rose19700@sina.com
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuansheng Zhao
Email
cszhao@cmu.edu.cn
Facility Name
People's Hospital of Ningxia Hui Autonomous Region
City
Yinchuan
State/Province
Ningxia Hui Autonomous Region
ZIP/Postal Code
750002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Wu
Email
jluwuyuan@163.com
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiming Liu
Email
Liuym@sdu.edu.cn
Facility Name
Qilu Hospital of Shandong University(Qingdao)
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cuiping Zhao
Email
zhaocuipingzsu@126.com
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengdi Chen
Email
ruijincsd@126.com
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huifang Shang
Email
hfshang2002@163.com
Facility Name
Mianyang Central Hospital
City
Mianyang
State/Province
Sichuan
ZIP/Postal Code
621099
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufeng Tang
Email
dryufeng@126.com
Facility Name
Tianjin Huanhu Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300222
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Chen
Email
halo1881@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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