Parkinson's Disease Psychosis
Conditions
Keywords
Parkinson's Disease Psychosis
Brief summary
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
Detailed description
This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have completed the study.
Interventions
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Sponsors
ACADIA Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has completed the treatment period of a previous blinded study of pimavanserin * The subject is willing and able to provide consent * Caregiver is willing and able to accompany the subject to all visits
Exclusion criteria
* Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder * Subject is judged by the Investigator to be inappropriate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | From first to last study drug dose plus 30 days | Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug) |
Countries
Austria, Belgium, Canada, France, India, Italy, Poland, Portugal, Russia, Serbia, Sweden, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Eligible patients were adult males or females with Parkinson's Disease Psychosis who had completed a prior double blind study with pimavanserin and were determined by the treating physician (Investigator) to benefit from continued treatment. This study did not have a fixed duration. Thus, no patients were considered to have completed the study.
Pre-assignment details
Patients could be enrolled in this study as early as the final visit of the previous double-blind study, or up to 28 days following completion of the treatment period of the previous double-blind study.
Participants by arm
| Arm | Count |
|---|---|
| Pimavanserin Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients | 459 |
| Total | 459 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 88 |
| Overall Study | Death | 34 |
| Overall Study | Disease progression | 46 |
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Patient noncompliance | 25 |
| Overall Study | Physician Decision | 31 |
| Overall Study | Sponsor decision | 55 |
| Overall Study | Withdrawal by Subject | 167 |
Baseline characteristics
| Characteristic | Pimavanserin |
|---|---|
| Age, Continuous | 71.2 years STANDARD_DEVIATION 8.19 |
| Race/Ethnicity, Customized Asian | 19 Participants |
| Race/Ethnicity, Customized Black/African American | 4 Participants |
| Race/Ethnicity, Customized Other | 13 Participants |
| Race/Ethnicity, Customized White | 423 Participants |
| Region of Enrollment Europe | 120 participants |
| Region of Enrollment India | 18 participants |
| Region of Enrollment North America | 321 participants |
| Sex: Female, Male Female | 176 Participants |
| Sex: Female, Male Male | 283 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 59 / 459 |
| other Total, other adverse events | 328 / 459 |
| serious Total, serious adverse events | 188 / 459 |
Outcome results
Primary
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
Time frame: From first to last study drug dose plus 30 days
Population: Enrolled patients who received at least 1 dose of study drug
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pimavanserin | Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | 180 Participants |