Trial Outcomes & Findings for Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine (NCT NCT04164758)
NCT ID: NCT04164758
Last Updated: 2021-10-14
Results Overview
Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
4-week treatment duration, plus 30 days treatment-free safety follow-up
Results posted on
2021-10-14
Participant Flow
The 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.
During the screening period, patients were assessed for study eligibility, and prohibited medications were discontinued when medically appropriate.
Participant milestones
| Measure |
Placebo
Two encapsulated placebo tablets, taken once daily
|
Quetiapine
Quetiapine 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 34 mg
Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Two encapsulated placebo tablets, taken once daily
|
Quetiapine
Quetiapine 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 34 mg
Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
|
|---|---|---|---|
|
Overall Study
COVID-19 withdrawal of consent
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Two encapsulated placebo tablets, taken once daily
|
Quetiapine
n=4 Participants
Quetiapine 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 34 mg
n=3 Participants
Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
69.8 years
STANDARD_DEVIATION 5.74 • n=5 Participants
|
68.0 years
STANDARD_DEVIATION 8.49 • n=7 Participants
|
62.0 years
STANDARD_DEVIATION 3.00 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 6.65 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4-week treatment duration, plus 30 days treatment-free safety follow-upPopulation: Safety Analysis set, i.e. all patients who had received at least one dose of study medication
Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.
Outcome measures
| Measure |
Placebo
n=4 Participants
Two encapsulated placebo tablets, taken once daily
|
Quetiapine
n=4 Participants
Quetiapine 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 34 mg
n=3 Participants
Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
|
|---|---|---|---|
|
Treatment-emergent Adverse Events (TEAEs)
|
1 Participants
|
3 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Quetiapine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Pimavanserin 34 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=4 participants at risk
Two encapsulated placebo tablets, taken once daily
|
Quetiapine
n=4 participants at risk
Quetiapine 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 34 mg
n=3 participants at risk
Pimavanserin provided as 2 × 17 mg encapsulated tablets, taken once daily
|
|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
0.00%
0/4 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
33.3%
1/3 • Number of events 1 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
25.0%
1/4 • Number of events 1 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
0.00%
0/3 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/4 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
25.0%
1/4 • Number of events 1 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
0.00%
0/3 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
50.0%
2/4 • Number of events 2 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
0.00%
0/3 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
25.0%
1/4 • Number of events 1 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
0.00%
0/3 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
0.00%
0/4 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
33.3%
1/3 • Number of events 1 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
|
Psychiatric disorders
Hallucination
|
25.0%
1/4 • Number of events 1 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
0.00%
0/4 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
0.00%
0/3 • 4-week treatment duration, plus 30 days treatment-free safety follow-up
|
Additional Information
Sr. Dir. Medical Information and Medical Communications
Acadia Pharmaceuticals Inc.
Phone: 858-261
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER