Trial Outcomes & Findings for Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease (NCT NCT03623321)
NCT ID: NCT03623321
Last Updated: 2024-12-20
Results Overview
Number (%) of patients experiencing at least one TEAE
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
595 participants
Primary outcome timeframe
Treatment period and Follow-up period: 56 weeks
Results posted on
2024-12-20
Participant Flow
This was an open-label extension study to evaluate the long-term safety and tolerability of pimavanserin in patients with neuropsychiatric symptoms related to neurodegenerative disease, who had completed an antecedent study (ACP-103-046) or had participated in a pimavanserin study that the sponsor terminated early.
Participant milestones
| Measure |
Pimavanserin
Pimavanserin 34 mg once daily (QD). Dose reductions to pimavanserin 20 mg and subsequent dose increases to 34 mg were allowed at any time, based on investigator assessment of clinical response of the patient.
|
|---|---|
|
Overall Study
STARTED
|
595
|
|
Overall Study
COMPLETED
|
452
|
|
Overall Study
NOT COMPLETED
|
143
|
Reasons for withdrawal
| Measure |
Pimavanserin
Pimavanserin 34 mg once daily (QD). Dose reductions to pimavanserin 20 mg and subsequent dose increases to 34 mg were allowed at any time, based on investigator assessment of clinical response of the patient.
|
|---|---|
|
Overall Study
Adverse Event
|
32
|
|
Overall Study
Death
|
9
|
|
Overall Study
Lack of Efficacy
|
9
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Noncompliance with study drug
|
6
|
|
Overall Study
Use of prohibited medication
|
3
|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Consent withdrawn by patient or legally accepted representative
|
29
|
|
Overall Study
Not further specified
|
43
|
Baseline Characteristics
Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Baseline characteristics by cohort
| Measure |
Pimavanserin
n=595 Participants
Pimavanserin 34 mg once daily (QD). Dose reductions to pimavanserin 20 mg and subsequent dose increases to 34 mg were allowed at any time, based on investigator assessment of clinical response of the patient.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
508 Participants
n=5 Participants
|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 6.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
348 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
247 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
561 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
197 participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
81 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
90 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
9 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
29 participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
68 participants
n=5 Participants
|
|
Mini Mental State Examination total score
|
20.0 units on a scale
STANDARD_DEVIATION 5.16 • n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment period and Follow-up period: 56 weeksNumber (%) of patients experiencing at least one TEAE
Outcome measures
| Measure |
Pimavanserin
n=595 Participants
Pimavanserin 34 mg once daily (QD). Dose reductions to pimavanserin 20 mg and subsequent dose increases to 34 mg were allowed at any time, based on investigator assessment of clinical response of the patient.
|
|---|---|
|
Treatment-emergent Adverse Events (TEAEs)
|
238 Participants
|
Adverse Events
Pimavanserin
Serious events: 37 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Pimavanserin
n=595 participants at risk
Pimavanserin 34 mg once daily (QD). Dose reductions to pimavanserin 20 mg and subsequent dose increases to 34 mg were allowed at any time, based on investigator assessment of clinical response of the patient.
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
0.34%
2/595 • Number of events 2 • Treatment period and Follow-up period: 56 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.34%
2/595 • Number of events 2 • Treatment period and Follow-up period: 56 weeks
|
|
Cardiac disorders
Bradycardia
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Cardiac disorders
Left ventricular failure
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Infections and infestations
Pneumonia
|
0.34%
2/595 • Number of events 2 • Treatment period and Follow-up period: 56 weeks
|
|
Infections and infestations
COVID-19 pneumonia
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Infections and infestations
Perirectal abscess
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Infections and infestations
Pneumonia necrotising
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Infections and infestations
Sepsis
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.34%
2/595 • Number of events 2 • Treatment period and Follow-up period: 56 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.50%
3/595 • Number of events 3 • Treatment period and Follow-up period: 56 weeks
|
|
Nervous system disorders
Brain oedema
|
0.34%
2/595 • Number of events 2 • Treatment period and Follow-up period: 56 weeks
|
|
Nervous system disorders
Coma
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Nervous system disorders
Parkinson's disease
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Nervous system disorders
Seizure
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Nervous system disorders
Syncope
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Nervous system disorders
Transient ischaemic attack
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Psychiatric disorders
Agitation
|
0.34%
2/595 • Number of events 2 • Treatment period and Follow-up period: 56 weeks
|
|
Psychiatric disorders
Aggression
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Psychiatric disorders
Anxiety disorder
|
0.17%
1/595 • Number of events 2 • Treatment period and Follow-up period: 56 weeks
|
|
Psychiatric disorders
Disorientation
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
|
Vascular disorders
Hypotension
|
0.17%
1/595 • Number of events 1 • Treatment period and Follow-up period: 56 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Sr. Dir. Medical Information and Medical Communications
Acadia Pharmaceuticals Inc.
Phone: 858-261
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