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Parkinson's Disease PsychosisPhase 3NCT06068465

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

A Phase 3 study testing pimavanserin tartrate in people with Parkinson's Disease Psychosis, run by Tasly Pharmaceutical Group Co., Ltd at 60 sites in China.

Completed

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

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Parkinson's Disease Psychosis
What is being tested?
pimavanserin tartrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
60 sitesChina
Study dates
27 Sep 2023to 1 Feb 2026
Phase
Phase 3
Are there results?
None posted in the registry

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

China60 sites

  • Guang'anmen Hospital Baoding, China Academy of Chinese Medical Sciences (Baoding No.1 Hospital of TCM)

    Baoding, Hebei, 071000

  • Beijing Hospital

    Beijing, Beijing Municipality, 100005

  • Xuan Wu Hospital

    Beijing, Beijing Municipality, 100053

  • Peking University Sixth Hospital

    Beijing, Beijing Municipality, 100191

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510000

  • Guangzhou Red Cross Hospital (Affiliated to Jinan University, Guangzhou Emergency Hospital)

    Guangzhou, Guangdong, 510220

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550001

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • The Second People's Hospital of Hefei (Hefei Hospital Affiliated to Anhui Medical University)

    Hefei, Anhui, 230011

  • The First Affiliated Hospital of Anhui University of Chinese Medicine (Anhui Provincial Hospital of Traditional Chinese Medicine)

    Hefei, Anhui, 230031

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230061

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan, 421001

  • Inner Mongolia Autonomous Region People's Hospital

    Hohhot, Inner Mongolia, 010000

  • Huai'an Second People's Hospital

    Huaian, Jiangsu, 223022

  • The Second Hospital of Jiaxing

    Jiaxing, Zhejiang, 314000

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Gansu Provincial Hospital of Traditional Chinese Medicine

    Lanzhou, Gansu, 730050

  • Linyi People's Hospital (Affiliated Hospital of Shandong Second Medical University)

    Linyi, Shandong, 276002

  • The First People's Hospital of Luoyang

    Luoyang, Henan, 471002

  • The Third People's Hospital of Luoyang

    Luoyang, Henan, 471002

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621099

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330008

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, 637000

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • Nantong First People's Hospital

    Nantong, Jiangsu, 226001

  • Nanshi Hospital of Nanyang (Nanshi Hospital Affiliated to Henan University)

    Nanyang, Henan, 473010

  • Ningbo Medical Center Lihuili Hospital (The Affiliated Lihuili Hospital of Ningbo University)

    Ningbo, Zhejiang, 315040

  • Qilu Hospital of Shandong University(Qingdao)

    Qingdao, Shandong, 266035

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

  • The First People's Hospital of Shangqiu (Affiliated to Henan University of Medical Sciences)

    Shangqiu, Henan, 476100

  • The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning, 110000

  • The First People's Hospital of Shenyang

    Shenyang, Liaoning, 110002

  • The Affiliated Central Hospital of Shenyang Medical College

    Shenyang, Liaoning, 110024

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518035

  • The Second Hospital of HeBei Medical University

    Shijiazhuang, Hebei, 050005

  • The Second Affiliated Hospital of Soochow University

    Suqian, Jiangsu, 215004

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215004

  • The Second Affiliated Hospital of Shandong First Medical University

    Tai’an, Shandong, 271000

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300222

  • Renmin Hospital of Wuhan University (Hubei General Hospital)

    Wuhan, Hubei, 430060

  • The Second Affiliated Hospital (Tangdu Hospital) of Air Force Medical University

    Xi'an, Shaanxi, 710038

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

  • Xinxiang Central Hospital

    Xinxiang, Henan, 453004

  • Xuchang Central Hospital (Affiliated Hospital of Henan University of Science and Technology)

    Xuchang, Henan, 461000

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221004

  • Yancheng First People's Hospital

    Yancheng, Jiangsu, 224006

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia, 750002

  • Yuncheng Central Hospital (The Eighth Clinical Medical College of Shanxi Medical University)

    Yuncheng, Shanxi, 044000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

  • Zibo Hospital of Traditional Chinese Medicine

    Zibo, Shandong, 255300

Other trials in China

About this study

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

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).

Being tested
pimavanserin tartrate, placebo

What participants receive

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

  • pimavanserin tartrateDrug

    Also called NUPLAZID®

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

  • placeboDrug

    placebo, capsule, once daily by mouth for 6 weeks

Study groups in NCT06068465
Study groupRoleWhat they receive
Pimavanserin tartrateExperimentalPimavanserin, 34 mg, capsule,once daily by mouth for 6 weeks Interventions
Receives: Drug: pimavanserin tartrate
PlaceboPlacebo comparatorPlacebo, capsule, once daily by mouth for 6 weeks
Receives: Drug: placebo

What is being measured

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

  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

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

Timeline

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

  1. First posted5 Oct 2023
  2. Study start27 Sep 2023
  3. Primary completion1 Feb 2026
  4. Study completion1 Feb 2026

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06068465
Sponsor's protocol ID
TSL-CM-JSSPMFSL-Ⅲ
Status last verified
Feb 2026
First submitted
28 Sep 2023
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pimavanserin tartrate in people with Parkinson's Disease Psychosis, run by Tasly Pharmaceutical Group Co., Ltd at 60 sites in China.

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 12 inclusion and 21 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary outcome is change in total SAPS-PD score from baseline to day 43. (time frame: Assessments are done at baseline and days 15,29 and 43.). 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 NCT06068465.

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 2 Nov 2026.

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