Trial Outcomes & Findings for Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia (NCT NCT03121586)
NCT ID: NCT03121586
Last Updated: 2025-08-24
Results Overview
Number of patients with treatment emergent adverse events
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
995 participants
Primary outcome timeframe
Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
Results posted on
2025-08-24
Participant Flow
This was an open-label extension study for patients from studies ACP-103-034, 038, and 064. Patients who had completed any of those studies and had not shown significant worsening of symptoms, or who may have benefited, or were expected to benefit from continued pimavanserin treatment based on the investigator's judgment were eligible.
Participant milestones
| Measure |
Rollover From ACP-103-034
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-038
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-064
Pimavanserin dose of 34 mg throughout the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
323
|
325
|
347
|
|
Overall Study
COMPLETED
|
248
|
280
|
217
|
|
Overall Study
NOT COMPLETED
|
75
|
45
|
130
|
Reasons for withdrawal
| Measure |
Rollover From ACP-103-034
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-038
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-064
Pimavanserin dose of 34 mg throughout the study.
|
|---|---|---|---|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
99
|
|
Overall Study
Withdrawal by Subject
|
37
|
14
|
9
|
|
Overall Study
Not further specified
|
6
|
11
|
10
|
|
Overall Study
Adverse Event
|
16
|
5
|
6
|
|
Overall Study
Protocol Violation
|
0
|
5
|
0
|
|
Overall Study
Lack of Efficacy
|
3
|
3
|
1
|
|
Overall Study
Physician Decision
|
2
|
2
|
0
|
|
Overall Study
Noncompliance with study drug
|
5
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
0
|
|
Overall Study
Death
|
2
|
0
|
0
|
Baseline Characteristics
Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Baseline characteristics by cohort
| Measure |
Rollover From ACP-103-034
n=323 Participants
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-038
n=325 Participants
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-064
n=347 Participants
Pimavanserin dose of 34 mg throughout the study.
|
Total
n=995 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.2 years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
37.8 years
STANDARD_DEVIATION 9.32 • n=7 Participants
|
38.0 years
STANDARD_DEVIATION 9.47 • n=5 Participants
|
37.7 years
STANDARD_DEVIATION 9.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
202 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
625 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
370 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 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
|
25 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
295 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
346 Participants
n=5 Participants
|
950 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
North America
|
45 participants
n=5 Participants
|
29 participants
n=7 Participants
|
0 participants
n=5 Participants
|
74 participants
n=4 Participants
|
|
Region of Enrollment
Europe
|
278 participants
n=5 Participants
|
296 participants
n=7 Participants
|
284 participants
n=5 Participants
|
858 participants
n=4 Participants
|
|
Region of Enrollment
South America
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
63 participants
n=5 Participants
|
63 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).Population: Safety Analysis Set
Number of patients with treatment emergent adverse events
Outcome measures
| Measure |
Rollover From ACP-103-034
n=323 Participants
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-038
n=325 Participants
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-064
n=347 Participants
Pimavanserin dose of 34 mg throughout the study (Week 26)
|
|---|---|---|---|
|
Treatment Emergent Adverse Events
|
128 Participants
|
111 Participants
|
110 Participants
|
Adverse Events
Rollover From ACP-103-034
Serious events: 13 serious events
Other events: 21 other events
Deaths: 2 deaths
Rollover From ACP-103-038
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Rollover From ACP-103-064
Serious events: 4 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rollover From ACP-103-034
n=323 participants at risk
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-038
n=325 participants at risk
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-064
n=347 participants at risk
Pimavanserin dose of 34 mg throughout the study
|
|---|---|---|---|
|
Gastrointestinal disorders
Dental cyst
|
0.00%
0/323 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.31%
1/325 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
General disorders
Chest pain
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
General disorders
Drowning
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Infections and infestations
Cellulitis
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Infections and infestations
Pneumonia
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Infections and infestations
Sepsis
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/323 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.31%
1/325 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/323 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.31%
1/325 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm benign
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Nervous system disorders
Epilepsy
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Psychiatric disorders
Schizophrenia
|
0.93%
3/323 • Number of events 3 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.31%
1/325 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.86%
3/347 • Number of events 3 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Psychiatric disorders
Completed suicide
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.00%
0/323 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.31%
1/325 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Psychiatric disorders
Substance-induced psychotic disorder
|
0.00%
0/323 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.29%
1/347 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.31%
1/323 • Number of events 1 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/325 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
0.00%
0/347 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
Other adverse events
| Measure |
Rollover From ACP-103-034
n=323 participants at risk
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-038
n=325 participants at risk
Starting dose of 20 mg at week 1. The dose could be continued, decreased to 10 mg, or increased to 34 mg at investigator discretion through Week 52.
|
Rollover From ACP-103-064
n=347 participants at risk
Pimavanserin dose of 34 mg throughout the study
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
6.5%
21/323 • Number of events 23 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
9.2%
30/325 • Number of events 36 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
5.5%
19/347 • Number of events 24 • Treatment period (52 weeks) and follow-up period (30 days): planned total of 56 weeks. Since the study was prematurely terminated, the reporting period was shortened; AEs were assessed to the end of treatment, at a mean duration of 319 days (or 46 weeks).
This was an open-label extension study with assessment of safety/tolerability as primary objective. Inferential statistics was not planned. The study was terminated prematurely due to business reasons; mean follow-up duration of patients was shorter than specified in the protocol. Therefore, it was considered adequate to analyse pooled data, i.e. regardless of the trial from which patients originated or dose and dosing regimen patients used in this study.
|
Additional Information
Sr. Dir. Medical Information and Medical Communications
Acadia Pharmaceuticals Inc.
Phone: 844-422-2342
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