Relapse Prevention Study of Pimavanserin in Dementia-related Psychosis
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03325556 |
|
Recruitment Status :
Completed
First Posted : October 30, 2017
Results First Posted : June 21, 2021
Last Update Posted : June 21, 2021
|
Sponsor:
ACADIA Pharmaceuticals Inc.
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Dementia-related Psychosis |
| Interventions |
Drug: Placebo Drug: Pimavanserin 34 mg Drug: Pimavanserin 20 mg |
| Enrollment | 392 |
Participant Flow
| Recruitment Details | The study was performed in subjects with all-cause dementia according to NIA-AA guidelines, including dementia associated with Parkinson's disease, dementia with Lewy Bodies, possible or probable Alzheimer's disease, frontotemporal degeneration spectrum disorder, and/or vascular dementia, and were to have had at least a 2-month history of psychotic symptoms. |
| Pre-assignment Details | During the screening period, subjects were assessed for study eligibility and prohibited medications were discontinued when medically appropriate. Subjects and partner/caregivers also received a standardized psychosocial therapy training. |
| Arm/Group Title | Pimavanserin Open-Label Period | Pimavanserin Double-Blind Period | Placebo Double-Blind Period |
|---|---|---|---|
 Arm/Group Description |
Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily. | Pimavanserin 34 mg once daily or pimavanserin 20 mg once daily (the dose at which patients completed the Open-Label Period) for 26 weeks or until relapse | Placebo once daily for 26 weeks or until relapse |
| Period Title: Open-label Period | |||
| Started | 392 | 0 | 0 |
| Completed | 217 | 0 | 0 |
| Not Completed | 175 | 0 | 0 |
| Reason Not Completed | |||
| Lack of Response in OL period | 70 | 0 | 0 |
| Adverse Event | 27 | 0 | 0 |
| Death | 1 | 0 | 0 |
| Lost to Follow-up | 1 | 0 | 0 |
| Non-compliance with study drug | 5 | 0 | 0 |
| Use of prohibited medication | 1 | 0 | 0 |
| Protocol Violation | 4 | 0 | 0 |
| Withdrawal by Subject | 17 | 0 | 0 |
| Not otherwise specified | 8 | 0 | 0 |
| Administrative discont. at study termination | 41 | 0 | 0 |
| Period Title: Double-blind Period | |||
| Started | 0 | 105 | 112 |
| Completed | 0 | 44 | 35 |
| Not Completed | 0 | 61 | 77 |
| Reason Not Completed | |||
| Relapse | 0 | 15 | 34 |
| Adverse Event | 0 | 3 | 1 |
| Noncompliance with study drug | 0 | 0 | 1 |
| Use of prohibited medication | 0 | 1 | 0 |
| Physician Decision | 0 | 0 | 1 |
| Withdrawal by Subject | 0 | 6 | 4 |
| Not otherwise specified | 0 | 1 | 5 |
| Administrative discont. at study termination | 0 | 35 | 31 |
Baseline Characteristics
| Arm/Group Title | Pimavanserin Open-Label Period | |
|---|---|---|
|
Arm/Group Description |
Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily. | |
| Overall Number of Baseline Participants | 392 | |
|
Baseline Analysis Population Description |
Patients who entered the respective study period and received at least one dose of study medication
|
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||
| Number Analyzed | 392 participants | |
| 74.5 (8.28) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||
| Number Analyzed | 392 participants | |
| Female |
229 58.4%
|
|
| Male |
163 41.6%
|
|
|
Race (NIH/OMB)
[1] Measure Type: Count of Participants Unit of measure: Participants |
||
| Number Analyzed | 384 participants | |
| American Indian or Alaska Native |
0 0.0%
|
|
| Asian |
0 0.0%
|
|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
|
|
| Black or African American |
10 2.6%
|
|
| White |
371 96.6%
|
|
| More than one race |
0 0.0%
|
|
| Unknown or Not Reported |
3 0.8%
|
|
|
[1]
Measure Analysis Population Description: For 8 patients, Information on race was not available.
|
||
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||
| United States | Number Analyzed | 392 participants |
| 118 | ||
| Czechia | Number Analyzed | 392 participants |
| 11 | ||
| Ukraine | Number Analyzed | 392 participants |
| 74 | ||
| United Kingdom | Number Analyzed | 392 participants |
| 8 | ||
| Spain | Number Analyzed | 392 participants |
| 9 | ||
| Poland | Number Analyzed | 392 participants |
| 42 | ||
| Italy | Number Analyzed | 392 participants |
| 13 | ||
| Slovakia | Number Analyzed | 392 participants |
| 35 | ||
| Bulgaria | Number Analyzed | 392 participants |
| 3 | ||
| Chile | Number Analyzed | 392 participants |
| 27 | ||
| France | Number Analyzed | 392 participants |
| 7 | ||
| Serbia | Number Analyzed | 392 participants |
| 44 | ||
| Germany | Number Analyzed | 392 participants |
| 1 | ||
|
Dementia severity
Measure Type: Count of Participants Unit of measure: Participants |
||
| Number Analyzed | 392 participants | |
| Mild |
65 16.6%
|
|
| Moderate |
275 70.2%
|
|
| Severe |
52 13.3%
|
|
|
Scale for the Assessment of Positive Symptoms-Hallucinations+Delusions (SAPS-H+D) total score
[1] Mean (Standard Deviation) Unit of measure: Score on a scale |
||
| Number Analyzed | 392 participants | |
| 24.4 (9.22) | ||
|
[1]
Measure Description: The Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions (SAPS-H+D) is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe symptoms.
|
||
|
Clinical Global Impression-Severity (CGI-S)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
||
| Number Analyzed | 392 participants | |
| 4.7 (0.69) | ||
|
[1]
Measure Description: The Clinical Global Impression-Severity (CGI-S) is a clinician-rated, 7-point scale to rate the severity of the patient's hallucinations and delusions at the time of assessment. Scores range from 1 to 7, with a higher score marking a more severe state.
|
||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
| Name/Title: | Sr. Dir. Medical Information and Medical Communications |
| Organization: | Acadia Pharmaceuticals Inc. |
| Phone: | 858-261- ext 2897 |
| EMail: | medicalinformation@acadia-pharm.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ACADIA Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT03325556 |
| Other Study ID Numbers: |
ACP-103-045 2017-002227-13 ( EudraCT Number ) |
| First Submitted: | October 18, 2017 |
| First Posted: | October 30, 2017 |
| Results First Submitted: | April 30, 2021 |
| Results First Posted: | June 21, 2021 |
| Last Update Posted: | June 21, 2021 |