Trial Outcomes & Findings for A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease (NCT NCT03575052)
NCT ID: NCT03575052
Last Updated: 2024-12-31
Results Overview
Number (%) of patients with treatment-emergent AEs
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
784 participants
Primary outcome timeframe
Treatment Period: 8 weeks
Results posted on
2024-12-31
Participant Flow
This was a multicenter study in adult and elderly patients with neuropsychiatric symptoms related to neurodegenerative disease.
Participant milestones
| Measure |
Placebo
Pimavanserin matching placebo (administered as 2 capsules) once daily
|
Pimavanserin 34 mg
Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily
|
|---|---|---|
|
Overall Study
STARTED
|
392
|
392
|
|
Overall Study
COMPLETED
|
367
|
363
|
|
Overall Study
NOT COMPLETED
|
25
|
29
|
Reasons for withdrawal
| Measure |
Placebo
Pimavanserin matching placebo (administered as 2 capsules) once daily
|
Pimavanserin 34 mg
Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
10
|
|
Overall Study
Not further specified
|
5
|
7
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Study drug noncompliance
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=392 Participants
Pimavanserin matching placebo (administered as 2 capsules) once daily
|
Pimavanserin 34 mg
n=392 Participants
Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily
|
Total
n=784 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.1 years
STANDARD_DEVIATION 7.13 • n=99 Participants
|
72.7 years
STANDARD_DEVIATION 6.91 • n=107 Participants
|
72.4 years
STANDARD_DEVIATION 7.02 • n=206 Participants
|
|
Sex: Female, Male
Female
|
213 Participants
n=99 Participants
|
240 Participants
n=107 Participants
|
453 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
179 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
331 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
00 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
367 Participants
n=99 Participants
|
368 Participants
n=107 Participants
|
735 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Region of Enrollment
Colombia
|
13 participants
n=99 Participants
|
11 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Region of Enrollment
Romania
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
117 participants
n=99 Participants
|
115 participants
n=107 Participants
|
232 participants
n=206 Participants
|
|
Region of Enrollment
Czechia
|
21 participants
n=99 Participants
|
17 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Region of Enrollment
Ukraine
|
62 participants
n=99 Participants
|
45 participants
n=107 Participants
|
107 participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
54 participants
n=99 Participants
|
55 participants
n=107 Participants
|
109 participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
6 participants
n=99 Participants
|
8 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
Region of Enrollment
Georgia
|
8 participants
n=99 Participants
|
19 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Region of Enrollment
Russia
|
55 participants
n=99 Participants
|
55 participants
n=107 Participants
|
110 participants
n=206 Participants
|
|
Region of Enrollment
Bulgaria
|
29 participants
n=99 Participants
|
29 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Region of Enrollment
Serbia
|
18 participants
n=99 Participants
|
27 participants
n=107 Participants
|
45 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Treatment Period: 8 weeksPopulation: All patients randomised and treated
Number (%) of patients with treatment-emergent AEs
Outcome measures
| Measure |
Placebo
n=392 Participants
Pimavanserin matching placebo (administered as 2 capsules) once daily
|
Pimavanserin 34 mg
n=392 Participants
Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily
|
|---|---|---|
|
Treatment-emergent Adverse Events (TEAEs)
|
115 Participants
|
119 Participants
|
SECONDARY outcome
Timeframe: Treatment Period: 8 weeksPopulation: All patients randomised and treated
The ESRS is a questionnaire to assess drug induced movement disorders, including parkinsonism; the ESRS-A is an accepted modified form of the original ESRS. The ESRS-A consists of 4 subscales and 4 clinical global impression movement severity scales of Parkinsonism, dyskinesia, dystonia, and akathisia. The Parkinsonism scale consists of 10 items, the dyskinesia subscale of 6 items, the dystonia subscale of 6 items, and the akathisia subscale of 2 items. Each item is scored on a 6-point scale from 0 (absent) to 5 (extreme). The ESRS-A total score is the sum of the 24 item scores with a possible range of 0 to 120. Higher scores denote more severe drug-induced movement disorders.
Outcome measures
| Measure |
Placebo
n=392 Participants
Pimavanserin matching placebo (administered as 2 capsules) once daily
|
Pimavanserin 34 mg
n=392 Participants
Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily
|
|---|---|---|
|
Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)
|
-0.6 score on a scale
Standard Error 0.19
|
-0.5 score on a scale
Standard Error 0.19
|
SECONDARY outcome
Timeframe: Treatment Period: 8 weeksPopulation: All patients randomised and treated
The MMSE is a 30-item questionnaire to quantitatively assess cognition, focusing on questions related to time and place of testing, repeating lists of words, arithmetic, language use and comprehension, and copying a drawing. Each of the 30 items has 2 possible values of 0 (incorrect) or 1 (correct). The MMSE total score is derived as the sum of the 30 item scores; thus, it can range from 0 to 30. Lower scores indicate more severe cognitive impairment.
Outcome measures
| Measure |
Placebo
n=392 Participants
Pimavanserin matching placebo (administered as 2 capsules) once daily
|
Pimavanserin 34 mg
n=392 Participants
Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily
|
|---|---|---|
|
Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE)
|
1.2 score on a scale
Standard Error 0.15
|
1.3 score on a scale
Standard Error 0.15
|
Adverse Events
Placebo
Serious events: 6 serious events
Other events: 16 other events
Deaths: 2 deaths
Pimavanserin 34 mg
Serious events: 8 serious events
Other events: 25 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=392 participants at risk
Pimavanserin matching placebo (administered as 2 capsules) once daily
|
Pimavanserin 34 mg
n=392 participants at risk
Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Infections and infestations
Erysipelas
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Infections and infestations
Pneumonia
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Infections and infestations
Urosepsis
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Injury, poisoning and procedural complications
Femure fracture
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Vascular disorders
Embolism
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/392 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
0.26%
1/392 • Number of events 1 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
Other adverse events
| Measure |
Placebo
n=392 participants at risk
Pimavanserin matching placebo (administered as 2 capsules) once daily
|
Pimavanserin 34 mg
n=392 participants at risk
Pimavanserin 34 mg (administered as 2 x 17 mg capsules) once daily
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
4.1%
16/392 • Number of events 16 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
6.4%
25/392 • Number of events 26 • Treatment period (8 weeks) and follow-up period (30 days): total of approximately 15 weeks
|
Additional Information
Sr. Dir. Medical Information and Medical Communications
Acadia Pharmaceuticals Inc.
Phone: 58-261
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