Parkinson's Disease Psychosis
Conditions
Brief summary
This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).
Interventions
Tablets taken once daily by mouth at 20, 40, or 60 mg doses
Sponsors
ACADIA Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
- * Patients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin * Patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin * Patient is willing and able to provide consent
Exclusion criteria
- * Female patient of childbearing potential * Patient has a clinically significant concurrent medical illness * Patient is judged by the treating physician to be inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
This was an open-label extension study, including patients with idiopathic Parkinson's Disease (PD) who had completed study ACP-103-006 (PD psychosis \[PDP\]) or study ACP-103-004 (PD with dyskinesias) and would benefit from continued pimavanserin treatment, as judged by the investigator.
Participants by arm
| Arm | Count |
|---|---|
| Pimavanserin All patients started treatment with pimavanserin 20 mg/day. Based on clinical benefit and Investigator judgment, dose escalation to 40 mg and 60 mg was allowed, after a minimum of 2 and 4 weeks treatment duration, respectively. Dose reductions to 40 and/or 20 mg/day were allowed for the management of AEs or intolerability. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Death | 6 |
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Not in Predefined Categories | 9 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Sponsor Decision | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Pimavanserin |
|---|---|
| Age, Continuous | 71.9 years STANDARD_DEVIATION 8.28 |
| Clinical Global Impression of Severity | 3.6 Score on a scale STANDARD_DEVIATION 0.22 |
| Race/Ethnicity, Customized Caucasian | 38 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 1 Participants |
| Region of Enrollment United States | 39 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 29 Participants |
| UPDRS disability of dyskinesias | 0.0 Score on a scale |
| UPDRS duration of dyskinesias | 0.0 Score on a scale |
| UPDRS tremor | 1.0 Score on a scale |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 39 |
| other Total, other adverse events | 34 / 39 |
| serious Total, serious adverse events | 18 / 39 |
Outcome results
Primary
Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Number (%) of patients with drug-related treatment-emergent AEs
Time frame: From first to last study drug dose plus 30 days
Population: Patients treated with at least one dose of study medication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pimavanserin | Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | 17 Participants |