Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

Parkinson's Disease Clinical Trial

Official title:

A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04164758
• Other study ID #: ACP-103-056
• Status: Terminated
• Phase: Phase 2
• Start date: October 23, 2019
• Est. completion date: September 25, 2020

Study information

• Verified date: September 2021
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 25, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Male or female subjects 50 to 85 years of age, inclusive

2. Able to understand the protocol requirements and provide written informed consent

3. Able to complete questions on a handheld device / tablet, is willing to wear an actigraph and can be reliably rated on assessment scales

4. Able to designate an 'informant' (relative, housemate, friend) who can provide information about the subject's well being and attend clinic visits with the subject

5. Is able to swallow the test capsule without difficulty during the Screening visit

6. Has a Mini-Mental State Examination (MMSE) score =19

7. Has a diagnosis of idiopathic Parkinson's disease, without any other known or suspected cause of parkinsonism. Initial diagnosis of PD must have been made more than 1 year prior to Screening.

8. Has non-motor neuropsychiatric symptoms severe enough to warrant treatment with an antipsychotic agent based on investigator judgement and CGI-S score

9. If the subject is on anti-Parkinsonian medication, they must be on a stable regimen for 1 month prior to Baseline and not planning (at the time of the Baseline visit) to make a major change in dose(s)

10. If the subject is female, she must not be pregnant or breastfeeding. She must also be of non-childbearing potential or must agree to use a clinically acceptable method of contraception or be abstinent for at least 1 month prior to the Baseline visit, during the study, and 41 days following completion of double-blind treatment.

Exclusion Criteria:

1. Has atypical parkinsonism or secondary parkinsonism variants such as tardive or medication induced parkinsonism

2. Is in hospice, is receiving end-of-life palliative care, or is bedridden or confined to a wheelchair

3. Has neuropsychiatric symptoms that are primarily attributable to current delirium or substance abuse

4. Has current evidence of an unstable neurological, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical or psychiatric disorder, including cancer or malignancies that, in the judgment of the Investigator, would jeopardize the safe participation of the subject in the study or significantly interfere with the conduct or interpretation of the study

5. Has a known personal or family history of long QT syndrome or family history of sudden cardiac death

6. Has orthostatic hypotension as judged by the investigator and medical monitor

7. Is judged by the Investigator or the Medical Monitor to be inappropriate for the study for any reason, including if the subject is judged to be a danger to self or others

Additional inclusion/exclusion criteria apply. Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all pre-specified entry criteria).

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• Pimavanserin
Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily

Other:
• Placebo
Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily

Drug:
• Quetiapine
Quetiapine 25 mg (provided as 1×25 mg quetiapine encapsulated tablet and 1 × placebo encapsulated tablet), OR 50 mg (provided as 2×25 mg quetiapine encapsulated tablets), OR 100 mg (provided as 2×50 mg quetiapine encapsulated tablets) administered orally as a single dose once daily

Locations

Country	Name	City	State
United States	Dayton Center for Neurological Disorders	Centerville	Ohio
United States	Prisma Health-Upstate	Greenville	South Carolina
United States	Galiz Research	Hialeah	Florida
United States	Hawaii Pacific Neuroscience, LLC.	Honolulu	Hawaii
United States	University of lowa Hospital and Clinics	Iowa City	Iowa
United States	Charter Research, LLC	Lady Lake	Florida
United States	Premier Clinical Research Institute, Inc.	Miami	Florida
United States	SRI International	Plymouth	Michigan
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	Sutter Institute for Medical Research	Sacramento	California
United States	Meridian Clinical Research	Savannah	Georgia
United States	Movement Disorders Center of Arizona	Scottsdale	Arizona
United States	Infinity Clinical Research, LLC	Sunrise	Florida
United States	Bio Behavioral Health	Toms River	New Jersey
United States	Tucson Neuroscience Research	Tucson	Arizona
United States	Charter Research, LLC	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent Adverse Events (TEAEs)	Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.	4-week treatment duration, plus 30 days treatment-free safety follow-up