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

Sponsor
ACADIA Pharmaceuticals Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04164758
Collaborator
(none)
11
Enrollment
16
Locations
3
Arms
11.1
Actual Duration (Months)
0.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 23, 2019
Actual Primary Completion Date :
Sep 25, 2020
Actual Study Completion Date :
Sep 25, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: Drug - pimavanserin

Pimavanserin 34 mg provided as 2 x 17 mg encapsulated tablets

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

Placebo Comparator: Placebo

Placebo encapsulated tablet

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

Active Comparator: Quetiapine

Immediate release Quetiapine encapsulated tablets

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

Outcome Measures

Primary Outcome Measures

  1. Treatment-emergent Adverse Events (TEAEs) [4-week treatment duration, plus 30 days treatment-free safety follow-up]

    Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Movement Disorders Center of ArizonaScottsdaleArizonaUnited States85258
2Tucson Neuroscience ResearchTucsonArizonaUnited States85710
3Sutter Institute for Medical ResearchSacramentoCaliforniaUnited States95816
4Galiz ResearchHialeahFloridaUnited States30016
5Charter Research, LLCLady LakeFloridaUnited States32159
6Premier Clinical Research Institute, Inc.MiamiFloridaUnited States33122
7Infinity Clinical Research, LLCSunriseFloridaUnited States33351
8Charter Research, LLCWinter ParkFloridaUnited States32792
9Meridian Clinical ResearchSavannahGeorgiaUnited States31406
10Hawaii Pacific Neuroscience, LLC.HonoluluHawaiiUnited States96817
11University of lowa Hospital and ClinicsIowa CityIowaUnited States52242
12SRI InternationalPlymouthMichiganUnited States48170
13Bio Behavioral HealthToms RiverNew JerseyUnited States08755
14M3 Wake Research, Inc.RaleighNorth CarolinaUnited States27612
15Dayton Center for Neurological DisordersCentervilleOhioUnited States45459
16Prisma Health-UpstateGreenvilleSouth CarolinaUnited States29615

Sponsors and Collaborators

  • ACADIA Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT04164758
Other Study ID Numbers:
  • ACP-103-056
First Posted:
Nov 15, 2019
Last Update Posted:
Oct 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsThe study was performed in patients aged 50-85 years with a diagnosis of idiopathic Parkinson's disease (PD) with a minimum duration of >1 year at screening and with no other known or suspected cause of parkinsonism.
Pre-assignment DetailDuring the screening period, patients were assessed for study eligibility, and prohibited medications were discontinued when medically appropriate.
Arm/Group TitlePlaceboQuetiapinePimavanserin 34 mg
Arm/Group DescriptionTwo encapsulated placebo tablets, taken once dailyQuetiapine starting dose 25 mg once daily (provided as 1 × 25 mg quetiapine immediate release encapsulated tablet plus 1 placebo encapsulated tablet), with the possibility to increase the dose to 50 mg (2 × 25 mg quetiapine immediate release encapsulated tablets) or 100 mg (2 × 50 mg quetiapine immediate release encapsulated tablets) taken once daily, based on clinical response.Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
Period Title: Overall Study
STARTED443
COMPLETED333
NOT COMPLETED110

Baseline Characteristics

Arm/Group TitlePlaceboQuetiapinePimavanserin 34 mgTotal
Arm/Group DescriptionTwo encapsulated placebo tablets, taken once dailyQuetiapine starting dose 25 mg once daily (provided as 1 × 25 mg quetiapine immediate release encapsulated tablet plus 1 placebo encapsulated tablet), with the possibility to increase the dose to 50 mg (2 × 25 mg quetiapine immediate release encapsulated tablets) or 100 mg (2 × 50 mg quetiapine immediate release encapsulated tablets) taken once daily, based on clinical response.Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once dailyTotal of all reporting groups
Overall Participants44311
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
69.8
(5.74)
68.0
(8.49)
62.0
(3.00)
67.0
(6.65)
Sex: Female, Male (Count of Participants)
Female
3
75%
0
0%
1
33.3%
4
36.4%
Male
1
25%
4
100%
2
66.7%
7
63.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
1
25%
0
0%
0
0%
1
9.1%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
0
0%
White
3
75%
4
100%
3
100%
10
90.9%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
4
100%
4
100%
3
100%
11
100%

Outcome Measures

1. Primary Outcome
TitleTreatment-emergent Adverse Events (TEAEs)
DescriptionAssess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.
Time Frame4-week treatment duration, plus 30 days treatment-free safety follow-up

Outcome Measure Data

Analysis Population Description
Safety Analysis set, i.e. all patients who had received at least one dose of study medication
Arm/Group TitlePlaceboQuetiapinePimavanserin 34 mg
Arm/Group DescriptionTwo encapsulated placebo tablets, taken once dailyQuetiapine starting dose 25 mg once daily (provided as 1 × 25 mg quetiapine immediate release encapsulated tablet plus 1 placebo encapsulated tablet), with the possibility to increase the dose to 50 mg (2 × 25 mg quetiapine immediate release encapsulated tablets) or 100 mg (2 × 50 mg quetiapine immediate release encapsulated tablets) taken once daily, based on clinical response.Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
Measure Participants443
Count of Participants [Participants]
1
25%
3
75%
1
33.3%

Adverse Events

Time Frame4-week treatment duration, plus 30 days treatment-free safety follow-up
Adverse Event Reporting Description
Arm/Group TitlePlaceboQuetiapinePimavanserin 34 mg
Arm/Group DescriptionTwo encapsulated placebo tablets, taken once dailyQuetiapine starting dose 25 mg once daily (provided as 1 × 25 mg quetiapine immediate release encapsulated tablet plus 1 placebo encapsulated tablet), with the possibility to increase the dose to 50 mg (2 × 25 mg quetiapine immediate release encapsulated tablets) or 100 mg (2 × 50 mg quetiapine immediate release encapsulated tablets) taken once daily, based on clinical response.Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
All Cause Mortality
PlaceboQuetiapinePimavanserin 34 mg
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/4 (0%) 0/4 (0%) 0/3 (0%)
Serious Adverse Events
PlaceboQuetiapinePimavanserin 34 mg
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/4 (0%) 0/4 (0%) 0/3 (0%)
Other (Not Including Serious) Adverse Events
PlaceboQuetiapinePimavanserin 34 mg
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/4 (25%) 3/4 (75%) 1/3 (33.3%)
Cardiac disorders
Palpitations0/4 (0%) 00/4 (0%) 01/3 (33.3%) 1
Injury, poisoning and procedural complications
Fall0/4 (0%) 01/4 (25%) 10/3 (0%) 0
Metabolism and nutrition disorders
Increased appetite0/4 (0%) 01/4 (25%) 10/3 (0%) 0
Nervous system disorders
Somnolence0/4 (0%) 02/4 (50%) 20/3 (0%) 0
Ataxia0/4 (0%) 01/4 (25%) 10/3 (0%) 0
Dizziness0/4 (0%) 00/4 (0%) 01/3 (33.3%) 1
Psychiatric disorders
Hallucination1/4 (25%) 10/4 (0%) 00/3 (0%) 0

Limitations/Caveats

In March 2020, recruitment of new patients was paused due to the emerging coronavirus disease 2019 (COVID-19) pandemic. It was restarted in Jun 2020 and paused again in Aug 2020. Subsequently, no further patients were enrolled. On 24 Sep 2020, the sponsor decided to permanently stop the study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Investigator may publish the study results, relative to their own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the Sponsor for review and comment. The sponsor has 60 days to review and comment.

Results Point of Contact

Name/TitleSr. Dir. Medical Information and Medical Communications
OrganizationAcadia Pharmaceuticals Inc.
Phone858-261 ext 2897
Emailmedicalinformation@acadia-pharm.com
Responsible Party:
ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT04164758
Other Study ID Numbers:
  • ACP-103-056
First Posted:
Nov 15, 2019
Last Update Posted:
Oct 14, 2021
Last Verified:
Sep 1, 2021