Trial Outcomes & Findings for Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis (NCT NCT04292223)

NCT ID: NCT04292223

Last Updated: 2025-01-14

Results Overview

The mFSQ is a self-administered questionnaire. It comprises 34 core items that produce 6 summary scale scores (i.e. basic activities of daily living (ADL); intermediate ADL; psychological function and mental health; work performance, social activity, and quality of interaction) and 6 single-item scores (work situation; days/month in bed due to illness/injury; days/month when illness/injury reduced activities normally performed for half a day; satisfaction with sexual relationship; satisfaction with health; frequency of social interaction). The mFSQ is calculated as the unweighted mean of predefined subscale scores. The maximum mFSQ total score is 100, with higher scores indicating better functional status. The minimum score is 0 and the maximum score is 100.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 29 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2025-01-14

Participant Flow

Participant milestones

Measure	Pimavanserin 34 mg Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Overall Study STARTED	29
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Pimavanserin 34 mg Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1
Overall Study Noncompliance with study drug	2
Overall Study Patient moved out of the state	1

Baseline Characteristics

Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease Psychosis

Baseline characteristics by cohort

Measure	Pimavanserin 34 mg n=29 Participants Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Age, Continuous	70.2 years STANDARD_DEVIATION 8.51 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: All patients enrolled and with baseline mFSQ value

The mFSQ is a self-administered questionnaire. It comprises 34 core items that produce 6 summary scale scores (i.e. basic activities of daily living (ADL); intermediate ADL; psychological function and mental health; work performance, social activity, and quality of interaction) and 6 single-item scores (work situation; days/month in bed due to illness/injury; days/month when illness/injury reduced activities normally performed for half a day; satisfaction with sexual relationship; satisfaction with health; frequency of social interaction).

The mFSQ is calculated as the unweighted mean of predefined subscale scores. The maximum mFSQ total score is 100, with higher scores indicating better functional status. The minimum score is 0 and the maximum score is 100.

Outcome measures

Measure	Pimavanserin 34 mg n=28 Participants Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Change From Baseline to Week 16 in Modified Functional Status Questionnaire (mFSQ) Total Score	14.0 score on a scale Standard Error 2.50

SECONDARY outcome

Timeframe: 16 Weeks

Population: All patients enrolled and with baseline mFSQ value

The Schwab & England ADL Scale is a scale ranging from 0% to 100% scale with 10% intervals, where 100% is "Completely independent. Unaware of difficulty" and 0% is "Vegetative functions such as swallowing, bladder and bowel functions are not functioning. Bedridden"

Outcome measures

Measure	Pimavanserin 34 mg n=28 Participants Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Change From Baseline to Week 16 on the Schwab and England Activity of Daily Living (ADL) Scale, Caregiver and Patient Versions Caregiver version	2.6 score on a scale Standard Error 2.75
Change From Baseline to Week 16 on the Schwab and England Activity of Daily Living (ADL) Scale, Caregiver and Patient Versions Patient version	3.4 score on a scale Standard Error 2.97

SECONDARY outcome

Timeframe: 16 Weeks

Population: All patients enrolled and with baseline mFSQ value

The MDS-UPDRS is a battery of motor and behavioral indices. MDS-UPDRS Part I assesses non-motor aspects of experiences of daily living (EDL) and consists of 13 items (6 investigator assessed; 7 patient assessed, each scored on a 5-point Likert scale). The total score is the sum of the 13 individual items. The highest score is 52, higher scores mean more severe impact of the disease on non-motor aspects of ADL and the lowest score is 0. In Part 1, a lower score is better while a higher score is worse.

Part II assesses motor aspects of EDL and consists of 13 items (all patient assessed, each on a 5-point Likert scale). The highest score is 52, higher scores mean more severe impact of the disease on motor aspects of ADL and the lowest score is 0. In Part 2, a lower score is better while a higher score is worse.

Outcome measures

Measure	Pimavanserin 34 mg n=28 Participants Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Change From Baseline to Week 16 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II MDS-UPDRS Part I	-0.63 score on a scale Standard Error 0.97
Change From Baseline to Week 16 on the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I and II MDS-UPDRS Part II	-2.6 score on a scale Standard Error 0.98

SECONDARY outcome

Timeframe: 16 Weeks

Population: All patients enrolled and with baseline mFSQ value

The CGI-I is a clinician-rated, 7-point scale to rate the improvement in patient symptoms at the time of assessment, relative to the symptoms at baseline. Severity ratings are based on the behavioral domains of hallucinations and delusions. The score ranges from 1=very much improved to 7=very much worse. Higher scores denote more severe symptoms of hallucinations and delusions

Outcome measures

Measure	Pimavanserin 34 mg n=28 Participants Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Week 16 Clinical Global Impression - Improvement (CGI-I) Score for Hallucinations and Delusions	1.9 score on a scale Standard Error 0.17

SECONDARY outcome

Timeframe: 16 Weeks

Population: All patients enrolled and with baseline mFSQ value

The CGI-S scale is a clinician-rated, 7-point scale to rate the severity of patient neuropsychiatric symptoms at the time of assessment using the Investigator's judgment and past experience with patients who have the same disorder. Severity ratings aree based on the behavioral domains of hallucinations and delusions.The score ranges from 1=normal, not at all ill to 7=among the most extremely ill patients. Higher scores denote more severe symptoms of hallucinations and delusions.

Outcome measures

Measure	Pimavanserin 34 mg n=28 Participants Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Change From Baseline to Week 16 on the Clinical Global Impression - Severity of Illness (CGI-S) Score for Hallucinations and Delusions	-1.5 score on a scale Standard Error 0.25

SECONDARY outcome

Timeframe: 16 Weeks

Population: All patients enrolled and with baseline mFSQ value

The PGI-I is a global index to rate the response of a condition to a therapy. Patients have to rate their current symptoms, compared with baseline. Responses range from 1=very much better to 7=very much worse. Severity ratings are based on the behavioral domains of hallucinations and delusions.

Outcome measures

Measure	Pimavanserin 34 mg n=28 Participants Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Patient Global Impression of Improvement (PGI-I) Score for Hallucinations and Delusions at Week 16	2.0 score on a scale Standard Error 0.22

Adverse Events

Pimavanserin 34 mg

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pimavanserin 34 mg n=29 participants at risk Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Metabolism and nutrition disorders Hyperuricaemia	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Nervous system disorders Syncope	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Vascular disorders Hypotension	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)

Other adverse events

Measure	Pimavanserin 34 mg n=29 participants at risk Pimavanserin 34 mg (one capsule of 34 mg dose strength) taken orally once daily
Gastrointestinal disorders Abdominal pain upper	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Gastrointestinal disorders Constipation	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Gastrointestinal disorders Nausea	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
General disorders Inflammation	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
General disorders Pain	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
General disorders Peripheral swelling	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Infections and infestations Urinary tract infection	6.9% 2/29 • Number of events 2 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Infections and infestations Cellulitis	3.4% 1/29 • Number of events 2 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Injury, poisoning and procedural complications Fall	6.9% 2/29 • Number of events 2 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Injury, poisoning and procedural complications Contusion	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Injury, poisoning and procedural complications Skin laceration	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Investigations Electrocardiogram QT prolonged	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	3.4% 1/29 • Number of events 3 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Nervous system disorders Sinus headache	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Psychiatric disorders Hallucination	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Psychiatric disorders Insomnia	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Renal and urinary disorders Dysuria	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)
Surgical and medical procedures Tooth extraction	3.4% 1/29 • Number of events 1 • From informed consent through the Safety Follow-up period, for a total of up to 181 day (i.e. Screening period of 3 to 35 days; Open-label Treatment period of 16 weeks; and Safety Follow-up period of 30 to 34 days)

Additional Information

Sr. Dir. Medical Information and Medical Communications

ACADIA Pharmaceuticals Inc.

Phone: +1-858-261

Email: medicalinformation@acadia-pharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator may publish the study results, relative to his/her 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