An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients

• Sponsor: ACADIA Pharmaceuticals Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01518309
• Collaborator: (none)
• Enrollment: 39
• Location: 1
• Arm: 1
• Actual Duration (Months): 101.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease Psychosis	Drug: pimavanserin tartrate (ACP-103)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients
• Actual Study Start Date: Nov 17, 2004
• Actual Primary Completion Date: May 2, 2013
• Actual Study Completion Date: May 2, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pimavanserin tartrate (ACP-103) Tablets taken once daily by mouth at 20, 40, or 60 mg doses	Drug: pimavanserin tartrate (ACP-103); Tablets taken once daily by mouth at 20, 40, or 60 mg doses

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Danbury	Connecticut	United States	06810

Sponsors and Collaborators

• ACADIA Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ACADIA Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT01518309
• Other Study ID Numbers: ACP-103-010
• First Posted: Jan 26, 2012
• Last Update Posted: Nov 23, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease; Pimavanserin

Study Results

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.

Arm/Group Title	Pimavanserin
Arm/Group Description	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.
Period Title: Overall Study
STARTED	39
COMPLETED	0
NOT COMPLETED	39

Baseline Characteristics

Arm/Group Title	Pimavanserin
Arm/Group Description	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 Participants	39
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.9 (8.28)
Sex: Female, Male (Count of Participants)
Female	10 25.6%
Male	29 74.4%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	38 97.4%
Hispanic/Latino	1 2.6%
Region of Enrollment (participants) [Number]
United States	39 100%
Clinical Global Impression of Severity (Score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score on a scale]	3.6 (0.22)
UPDRS tremor (Score on a scale) [Median (Full Range) ]
Median (Full Range) [Score on a scale]	1.0
UPDRS duration of dyskinesias (Score on a scale) [Median (Full Range) ]
Median (Full Range) [Score on a scale]	0.0
UPDRS disability of dyskinesias (Score on a scale) [Median (Full Range) ]
Median (Full Range) [Score on a scale]	0.0

Outcome Measures

1. Primary Outcome

Title	Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Description	Number (%) of patients with drug-related treatment-emergent AEs
Time Frame	From first to last study drug dose plus 30 days

Outcome Measure Data

Analysis Population Description

Patients treated with at least one dose of study medication

Arm/Group Title	Pimavanserin
Arm/Group Description	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.
Measure Participants	39
Count of Participants [Participants]	17 43.6%

Adverse Events

Time Frame	Study treatment (median treatment duration: 475 days)
Arm/Group Title	Pimavanserin
Arm/Group Description	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.
All Cause Mortality
	Pimavanserin
	Affected / at Risk (%)	# Events
Total	8/39 (20.5%)
Serious Adverse Events
	Pimavanserin
	Affected / at Risk (%)	# Events
Total	18/39 (46.2%)
Cardiac disorders
Cardiac failure	1/39 (2.6%)	1
Myocardial infarction	3/39 (7.7%)	3
Gastrointestinal disorders
Diarrhoea	1/39 (2.6%)	1
Inguinal hernia	1/39 (2.6%)	1
General disorders
Pyrexia	1/39 (2.6%)	1
Infections and infestations
Bronchitis	1/39 (2.6%)	1
Cellulitis	1/39 (2.6%)	2
Injury, poisoning and procedural complications
Hip fracture	3/39 (7.7%)	4
Joint dislocation	1/39 (2.6%)	2
Subdural haematoma	2/39 (5.1%)	2
Metabolism and nutrition disorders
Dehydration	1/39 (2.6%)	1
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	1/39 (2.6%)	1
Rhabdomyolysis	1/39 (2.6%)	1
Nervous system disorders
Cerebrovascular accident	1/39 (2.6%)	1
Depressed level of consciousness	1/39 (2.6%)	1
Parkinson's disease	2/39 (5.1%)	2
Psychiatric disorders
Agitation	1/39 (2.6%)	1
Delusion	1/39 (2.6%)	1
Mental status change	1/39 (2.6%)	1
Respiratory, thoracic and mediastinal disorders
Aspiration	1/39 (2.6%)	1
Pneumonia aspiration	1/39 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Pimavanserin
	Affected / at Risk (%)	# Events
Total	34/39 (87.2%)
Blood and lymphatic system disorders
Anaemia	8/39 (20.5%)	10
Gastrointestinal disorders
Constipation	9/39 (23.1%)	13
Diarrhoea	4/39 (10.3%)	4
Dysphagia	4/39 (10.3%)	5
Nausea	3/39 (7.7%)	4
Faecaloma	2/39 (5.1%)	2
Gastrooesophageal reflux disease	2/39 (5.1%)	2
General disorders
Asthenia	3/39 (7.7%)	3
Oedema peripheral	5/39 (12.8%)	7
Pain	3/39 (7.7%)	3
Fatigue	2/39 (5.1%)	2
Infections and infestations
Cellulitis	3/39 (7.7%)	4
Urinary tract infection	8/39 (20.5%)	14
Injury, poisoning and procedural complications
Contusion	4/39 (10.3%)	7
Fall	7/39 (17.9%)	12
Skin laceration	3/39 (7.7%)	5
Excoriation	2/39 (5.1%)	3
Investigations
Prothrombin time prolonged	5/39 (12.8%)	5
Weight decreased	7/39 (17.9%)	7
Blood bilirubin increased	2/39 (5.1%)	3
Haematocrit decreased	2/39 (5.1%)	2
Haemoglobin decreased	2/39 (5.1%)	2
Low density lipoprotein increased	2/39 (5.1%)	2
Lymphocyte count decreased	2/39 (5.1%)	4
Pyuria	2/39 (5.1%)	2
Retyculocyte count decreased	2/39 (5.1%)	3
Metabolism and nutrition disorders
Dehydration	3/39 (7.7%)	3
Hyponatraemia	3/39 (7.7%)	3
Anorexia	2/39 (5.1%)	2
Facial wasting	2/39 (5.1%)	2
Hypercholesterolaemia	2/39 (5.1%)	2
Hypokalaemia	2/39 (5.1%)	2
Musculoskeletal and connective tissue disorders
Arthralgia	4/39 (10.3%)	6
Groin pain	3/39 (7.7%)	3
Muscle spasms	4/39 (10.3%)	4
Pain in extremity	6/39 (15.4%)	6
Shoulder pain	3/39 (7.7%)	3
Back pain	2/39 (5.1%)	2
Buttock pain	2/39 (5.1%)	2
Nervous system disorders
Confusional state	6/39 (15.4%)	6
Dyskinesia	4/39 (10.3%)	4
Somnolence	5/39 (12.8%)	7
Amnesia	2/39 (5.1%)	2
Balance disorder	2/39 (5.1%)	2
Dementia	2/39 (5.1%)	2
Dizziness	2/39 (5.1%)	4
Dystonia	2/39 (5.1%)	3
Gait disturbance	2/39 (5.1%)	3
Psychiatric disorders
Agitation	4/39 (10.3%)	5
Depression	5/39 (12.8%)	6
Hallucination	9/39 (23.1%)	10
Hallucination, visual	4/39 (10.3%)	4
Insomnia	3/39 (7.7%)	3
Anxiety	2/39 (5.1%)	2
Delusion	2/39 (5.1%)	2
Paranoia	2/39 (5.1%)	2
Sleep disorder	2/39 (5.1%)	2
Renal and urinary disorders
Urinary retention	3/39 (7.7%)	3
Haematuria	2/39 (5.1%)	2
Reproductive system and breast disorders
Benign prostatic hypertrophy	2/39 (5.1%)	2
Respiratory, thoracic and mediastinal disorders
Cough	3/39 (7.7%)	3
Skin and subcutaneous tissue disorders
Decubitus ulcer	2/39 (5.1%)	2
Seborrhoeic dermatitis	2/39 (5.1%)	3
Vascular disorders
Hypertension	3/39 (7.7%)	3
Orthostatic hypertension	5/39 (12.8%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.