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

NCT06068465 | Completed Phase 3

• 1 other identifier: TSL-CM-JSSPMFSL-Ⅲ
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 27

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).

Conditions

Parkinson's Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• The primary outcome is change in total SAPS-PD score from baseline to day 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

  Assessments are done at baseline and days 15,29 and 43.

Study Arms (2)

Pimavanserin tartrate

EXPERIMENTAL

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

Drug: pimavanserin tartrate

Placebo

PLACEBO COMPARATOR

Placebo, capsule, once daily by mouth for 6 weeks

Drug: placebo

Interventions

placebo DRUG

placebo, capsule, once daily by mouth for 6 weeks

Placebo

pimavanserin tartrate DRUG

pimavanserin tartrate, 34 mg, capsule, once daily by mouth for 6 weeks

Also known as: NUPLAZID®

Pimavanserin tartrate

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (27)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230061, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100005, China

Location

Xuan Wu Hospital

Beijing, Beijing Municipality, 100053, China

Location

Peking University Sixth Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, 510000, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, China

Location

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, 050005, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, 010000, China

Location

Huai'an Second People's Hospital

Huaian, Jiangsu, 223022, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221004, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330008, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110002, China

Location

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750002, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Qilu Hospital of Shandong University(Qingdao)

Qingdao, Shandong, 266035, China

Location

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, 621099, China

Location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300222, China

Location

MeSH Terms

Interventions

pimavanserin

Study Officials

• Rui Liu

  Tianjin Tasly Sants Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 28, 2023
• First Posted: October 5, 2023
• Study Start: September 27, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (27)