Trial Outcomes & Findings for An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients (NCT NCT01518309)
NCT ID: NCT01518309
Last Updated: 2020-11-23
Results Overview
Number (%) of patients with drug-related treatment-emergent AEs
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
From first to last study drug dose plus 30 days
Results posted on
2020-11-23
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Death
|
6
|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Sponsor Decision
|
2
|
|
Overall Study
Not in Predefined Categories
|
9
|
Baseline Characteristics
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients
Baseline characteristics by cohort
| Measure |
Pimavanserin
n=39 Participants
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.
|
|---|---|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
|
Clinical Global Impression of Severity
|
3.6 Score on a scale
STANDARD_DEVIATION 0.22 • n=5 Participants
|
|
UPDRS tremor
|
1.0 Score on a scale
n=5 Participants
|
|
UPDRS duration of dyskinesias
|
0.0 Score on a scale
n=5 Participants
|
|
UPDRS disability of dyskinesias
|
0.0 Score on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: From first to last study drug dose plus 30 daysPopulation: Patients treated with at least one dose of study medication
Number (%) of patients with drug-related treatment-emergent AEs
Outcome measures
| Measure |
Pimavanserin
n=39 Participants
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.
|
|---|---|
|
Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
|
17 Participants
|
Adverse Events
Pimavanserin
Serious events: 18 serious events
Other events: 34 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Pimavanserin
n=39 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Cardiac disorders
Myocardial infarction
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Gastrointestinal disorders
Inguinal hernia
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
General disorders
Pyrexia
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Infections and infestations
Bronchitis
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Infections and infestations
Cellulitis
|
2.6%
1/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
7.7%
3/39 • Number of events 4 • Study treatment (median treatment duration: 475 days)
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
2.6%
1/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Cerebrovascular accident
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Depressed level of consciousness
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Parkinson's disease
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Agitation
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Delusion
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Mental status change
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.6%
1/39 • Number of events 1 • Study treatment (median treatment duration: 475 days)
|
Other adverse events
| Measure |
Pimavanserin
n=39 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.5%
8/39 • Number of events 10 • Study treatment (median treatment duration: 475 days)
|
|
Gastrointestinal disorders
Constipation
|
23.1%
9/39 • Number of events 13 • Study treatment (median treatment duration: 475 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
4/39 • Number of events 4 • Study treatment (median treatment duration: 475 days)
|
|
Gastrointestinal disorders
Dysphagia
|
10.3%
4/39 • Number of events 5 • Study treatment (median treatment duration: 475 days)
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • Number of events 4 • Study treatment (median treatment duration: 475 days)
|
|
General disorders
Asthenia
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
General disorders
Oedema peripheral
|
12.8%
5/39 • Number of events 7 • Study treatment (median treatment duration: 475 days)
|
|
General disorders
Pain
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Infections and infestations
Cellulitis
|
7.7%
3/39 • Number of events 4 • Study treatment (median treatment duration: 475 days)
|
|
Infections and infestations
Urinary tract infection
|
20.5%
8/39 • Number of events 14 • Study treatment (median treatment duration: 475 days)
|
|
Injury, poisoning and procedural complications
Contusion
|
10.3%
4/39 • Number of events 7 • Study treatment (median treatment duration: 475 days)
|
|
Injury, poisoning and procedural complications
Fall
|
17.9%
7/39 • Number of events 12 • Study treatment (median treatment duration: 475 days)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
7.7%
3/39 • Number of events 5 • Study treatment (median treatment duration: 475 days)
|
|
Investigations
Prothrombin time prolonged
|
12.8%
5/39 • Number of events 5 • Study treatment (median treatment duration: 475 days)
|
|
Investigations
Weight decreased
|
17.9%
7/39 • Number of events 7 • Study treatment (median treatment duration: 475 days)
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.3%
4/39 • Number of events 6 • Study treatment (median treatment duration: 475 days)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.3%
4/39 • Number of events 4 • Study treatment (median treatment duration: 475 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
6/39 • Number of events 6 • Study treatment (median treatment duration: 475 days)
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Confusional state
|
15.4%
6/39 • Number of events 6 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Dyskinesia
|
10.3%
4/39 • Number of events 4 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Somnolence
|
12.8%
5/39 • Number of events 7 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Agitation
|
10.3%
4/39 • Number of events 5 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Depression
|
12.8%
5/39 • Number of events 6 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Hallucination
|
23.1%
9/39 • Number of events 10 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Hallucination, visual
|
10.3%
4/39 • Number of events 4 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Insomnia
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Renal and urinary disorders
Urinary retention
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Vascular disorders
Hypertension
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Vascular disorders
Orthostatic hypertension
|
12.8%
5/39 • Number of events 9 • Study treatment (median treatment duration: 475 days)
|
|
Gastrointestinal disorders
Faecaloma
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
General disorders
Fatigue
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.1%
2/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Investigations
Blood bilirubin increased
|
5.1%
2/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Investigations
Haematocrit decreased
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Investigations
Haemoglobin decreased
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Investigations
Low density lipoprotein increased
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Investigations
Lymphocyte count decreased
|
5.1%
2/39 • Number of events 4 • Study treatment (median treatment duration: 475 days)
|
|
Investigations
Pyuria
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Investigations
Retyculocyte count decreased
|
5.1%
2/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.7%
3/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Metabolism and nutrition disorders
Anorexia
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Metabolism and nutrition disorders
Facial wasting
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Amnesia
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Balance disorder
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Dementia
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • Number of events 4 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Dystonia
|
5.1%
2/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Nervous system disorders
Gait disturbance
|
5.1%
2/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Anxiety
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Delusion
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Paranoia
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Psychiatric disorders
Sleep disorder
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Renal and urinary disorders
Haematuria
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Reproductive system and breast disorders
Benign prostatic hypertrophy
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
5.1%
2/39 • Number of events 2 • Study treatment (median treatment duration: 475 days)
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
5.1%
2/39 • Number of events 3 • Study treatment (median treatment duration: 475 days)
|
Additional Information
Sr. Dir. Medical Information and Medical Communications
ACADIA Pharmaceuticals Inc.
Phone: 858-261-2897
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator may publish the study results, relative to his/her 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