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    Clinical Trial Results:
    A multi-center, open-label extension study to examine the safety and tolerability of ACP-103 in the treatment of psychosis in Parkinson’s Disease

    Summary
    EudraCT number
    2007-003035-22
    Trial protocol
    GB   FR   SE   BE   AT   PT   IT  
    Global end of trial date
    30 May 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Jun 2019
    First version publication date
    14 Jun 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACP-103-015
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00550238
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    ACADIA Pharmaceuticals Inc.
    Sponsor organisation address
    3611 Valley Centre Drive, Ste. 300, San Diego, CA, United States, 92130
    Public contact
    Sr. Dir. Medical Information and Medical Communications, ACADIA Pharmaceuticals Inc., +1 858-261-2897, medicalinformation@acadia-pharm.com
    Scientific contact
    Sr. Dir. Medical Information and Medical Communications, ACADIA Pharmaceuticals Inc., +1 858-261-2897, medicalinformation@acadia-pharm.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 May 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and tolerability of ACP-103 in patients with Parkinson’s Disease Psychosis (PDP) This study did not have a fixed duration, and the duration of individual patient participation was determined based on investigator assessment of patient tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no patients, therefore, were considered to have “completed” the study.
    Protection of trial subjects
    Not applicable
    Background therapy
    Patients were allowed to continue protocol-permitted medications
    Evidence for comparator
    Not applicable; this was a single-arm, uncontrolled study.
    Actual start date of recruitment
    26 Jul 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Portugal: 10
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 1
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    India: 18
    Country: Number of subjects enrolled
    Russian Federation: 38
    Country: Number of subjects enrolled
    Serbia: 12
    Country: Number of subjects enrolled
    Ukraine: 22
    Country: Number of subjects enrolled
    United States: 317
    Worldwide total number of subjects
    459
    EEA total number of subjects
    48
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    90
    From 65 to 84 years
    355
    85 years and over
    14

    Subject disposition

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    Recruitment
    Recruitment details
    Eligible patients were adult males or females with Parkinson's Disease Psychosis who had completed a prior double blind study with pimavanserin and were determined by the treating physician (Investigator) to benefit from continued treatment. This study did not have a fixed duration. Thus, no patients were considered to have “completed” the study.

    Pre-assignment
    Screening details
    Patients could be enrolled in this study as early as the final visit of the previous double-blind study, or up to 28 days following completion of the treatment period of the previous double-blind study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Pimavanserin
    Arm description
    Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
    Arm type
    Experimental

    Investigational medicinal product name
    Pimavanserin
    Investigational medicinal product code
    ACP-103
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pimavanserin 40 mg (2 x 20 mg tablets, given as pimavanserin Tartrate) administered once daily by mouth.

    Number of subjects in period 1
    Pimavanserin
    Started
    459
    Completed
    0
    Not completed
    459
         Physician decision
    31
         Adverse event, serious fatal
    34
         Adverse event, non-fatal
    88
         Consent withdrawn by subject
    167
         Patient noncompliance
    25
         Disease progression
    46
         Lost to follow-up
    13
         Sponsor decision
    55

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pimavanserin
    Reporting group description
    Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients

    Reporting group values
    Pimavanserin Total
    Number of subjects
    459 459
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    90 90
        From 65-84 years
    355 355
        85 years and over
    14 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    71.2 ± 8.19 -
    Gender categorical
    Units: Subjects
        Female
    176 176
        Male
    283 283

    End points

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    End points reporting groups
    Reporting group title
    Pimavanserin
    Reporting group description
    Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients

    Primary: Number (%) of patients with drug-related treatment-emergent adverse events (AEs)

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    End point title
    Number (%) of patients with drug-related treatment-emergent adverse events (AEs) [1]
    End point description
    Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
    End point type
    Primary
    End point timeframe
    From first to last study drug dose plus 30 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This was a single-arm, uncontrolled trial. The primary endpoint was analysed using descriptive statistics only. No inferential testing was applied. A p-value was not defined.
    End point values
    Pimavanserin
    Number of subjects analysed
    459 [2]
    Units: Patients
    180
    Notes
    [2] - Enrolled patients who received at least 1 dose of study drug
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first to last study drug dose plus 30 days
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Pimavanserin
    Reporting group description
    Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients

    Serious adverse events
    Pimavanserin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    188 / 459 (40.96%)
         number of deaths (all causes)
    59
         number of deaths resulting from adverse events
    59
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    5 / 459 (1.09%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    4 / 459 (0.87%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Aortic dissection
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Circulatory collapse
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hypertensive crisis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Deep brain stimulation
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin neoplasm excision
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Bladder cancer
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Colon cancer stage III
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic neoplasm malignant
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Meningioma benign
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple myeloma
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraproteinaemia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Recurrent cancer
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    6 / 459 (1.31%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Death
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Asthenia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Axillary pain
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    7 / 459 (1.53%)
         occurrences causally related to treatment / all
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    7 / 459 (1.53%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    Hallucination
         subjects affected / exposed
    6 / 459 (1.31%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abnormal behaviour
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aggression
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Delusion
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Jealous delusion
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Panic attack
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    10 / 459 (2.18%)
         occurrences causally related to treatment / all
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    6 / 459 (1.31%)
         occurrences causally related to treatment / all
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    4 / 459 (0.87%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Contusion
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Humerus fracture
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Stress fracture
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Femur fracture
         subjects affected / exposed
    4 / 459 (0.87%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Nuclear magnetic resonance imaging
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    5 / 459 (1.09%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    Cardiac arrest
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    Cardiac failure congestive
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Angina pectoris
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Cardiopulmonary failure
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Coronary artery disease
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Atrial flutter
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Myocardial ischaemia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sick sinus syndrome
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    11 / 459 (2.40%)
         occurrences causally related to treatment / all
    1 / 13
         deaths causally related to treatment / all
    1 / 2
    Pulmonary embolism
         subjects affected / exposed
    8 / 459 (1.74%)
         occurrences causally related to treatment / all
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    5 / 459 (1.09%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    Respiratory failure
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    1 / 2
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Aspiration
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Atelectasis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Choking
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hydropneumothorax
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Respiratory distress
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Parkinson's disease
         subjects affected / exposed
    10 / 459 (2.18%)
         occurrences causally related to treatment / all
    1 / 10
         deaths causally related to treatment / all
    0 / 5
    Syncope
         subjects affected / exposed
    8 / 459 (1.74%)
         occurrences causally related to treatment / all
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    Dementia
         subjects affected / exposed
    7 / 459 (1.53%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    Cerebrovascular accident
         subjects affected / exposed
    5 / 459 (1.09%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    Transient ischaemic attack
         subjects affected / exposed
    4 / 459 (0.87%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Convulsion
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Presyncope
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Encephalopathy
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Autonomic nervous system imbalance
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Burning sensation
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Ischaemic stroke
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neuroleptic malignant syndrome
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    On and off phenomenon
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Visual acuity reduced
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Rectal haemorrhage
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyschezia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hiatus hernia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Presbyoesophagus
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Urinary retention
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bladder neck obstruction
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Calculus ureteric
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure chronic
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis
         subjects affected / exposed
    4 / 459 (0.87%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Exostosis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Scoliosis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Spondylolysis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    9 / 459 (1.96%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    21 / 459 (4.58%)
         occurrences causally related to treatment / all
    0 / 23
         deaths causally related to treatment / all
    0 / 5
    Urinary tract infection
         subjects affected / exposed
    17 / 459 (3.70%)
         occurrences causally related to treatment / all
    1 / 19
         deaths causally related to treatment / all
    0 / 1
    Sepsis
         subjects affected / exposed
    7 / 459 (1.53%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    Cellulitis
         subjects affected / exposed
    4 / 459 (0.87%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Diverticulitis
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 459 (0.65%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Candiduria
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Coccidioidomycosis
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Urosepsis
         subjects affected / exposed
    2 / 459 (0.44%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Abscess limb
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fungal infection
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 459 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Pimavanserin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    328 / 459 (71.46%)
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    40 / 459 (8.71%)
         occurrences all number
    48
    Hypertension
         subjects affected / exposed
    34 / 459 (7.41%)
         occurrences all number
    36
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    145 / 459 (31.59%)
         occurrences all number
    326
    Contusion
         subjects affected / exposed
    37 / 459 (8.06%)
         occurrences all number
    55
    Laceration
         subjects affected / exposed
    36 / 459 (7.84%)
         occurrences all number
    51
    Excoriation
         subjects affected / exposed
    23 / 459 (5.01%)
         occurrences all number
    41
    Investigations
    Weight decreased
         subjects affected / exposed
    57 / 459 (12.42%)
         occurrences all number
    65
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    35 / 459 (7.63%)
         occurrences all number
    37
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    43 / 459 (9.37%)
         occurrences all number
    50
    Dementia
         subjects affected / exposed
    30 / 459 (6.54%)
         occurrences all number
    33
    Somnolence
         subjects affected / exposed
    29 / 459 (6.32%)
         occurrences all number
    33
    Parkinson's disease
         subjects affected / exposed
    27 / 459 (5.88%)
         occurrences all number
    30
    Headache
         subjects affected / exposed
    23 / 459 (5.01%)
         occurrences all number
    30
    Tremor
         subjects affected / exposed
    23 / 459 (5.01%)
         occurrences all number
    26
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    43 / 459 (9.37%)
         occurrences all number
    52
    Psychiatric disorders
    Hallucination
         subjects affected / exposed
    62 / 459 (13.51%)
         occurrences all number
    89
    Confusional state
         subjects affected / exposed
    50 / 459 (10.89%)
         occurrences all number
    65
    Anxiety
         subjects affected / exposed
    41 / 459 (8.93%)
         occurrences all number
    47
    Depression
         subjects affected / exposed
    39 / 459 (8.50%)
         occurrences all number
    41
    Insomnia
         subjects affected / exposed
    34 / 459 (7.41%)
         occurrences all number
    36
    Psychotic disorder
         subjects affected / exposed
    33 / 459 (7.19%)
         occurrences all number
    39
    Agitation
         subjects affected / exposed
    32 / 459 (6.97%)
         occurrences all number
    37
    Cognitive disorder
         subjects affected / exposed
    28 / 459 (6.10%)
         occurrences all number
    33
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    46 / 459 (10.02%)
         occurrences all number
    54
    Dysphagia
         subjects affected / exposed
    43 / 459 (9.37%)
         occurrences all number
    46
    Nausea
         subjects affected / exposed
    39 / 459 (8.50%)
         occurrences all number
    49
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    31 / 459 (6.75%)
         occurrences all number
    42
    Back pain
         subjects affected / exposed
    28 / 459 (6.10%)
         occurrences all number
    38
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    25 / 459 (5.45%)
         occurrences all number
    34
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    79 / 459 (17.21%)
         occurrences all number
    160

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jun 2007
    - Added EudraCT number - Deleted use of a medication diary for recording study drug dosing - Revised schedule of assessments - Added use of a centralized rating Service for conducting SAPS assessment at North American Centers - Replaced Non-Motor Symptoms Questionnaire with the NMSS
    30 Aug 2007
    - Added Exclusion Criterion 2 (failed a prior antipsychotic medication) - Modified Exclusion Criterion 5 (females of nonchildbearing potential) - Replaced centralised ECG reads with Investigator-read ECGs
    14 Nov 2007
    - Deleted Exclusion Criterion 2 (prior antipsychotic medication) - Updated/ corrected SAE reporting procedures - Updated pregnancy reporting procedures
    14 Apr 2008
    - Increased number of study centers from About 100 to 130 - Revised Exclusion Criterion 5 (sex-specific QTcB criteria; deleted QRS and PR requirements) - Added: test article description; drug packaging; dosage and administration - Updated sample collection and bioanalytical processing specifications - Replaced pCRFs with eCRFs - Added description of PK Analysis - Added caregiver information in regard to Subject Informed Consent - Specified use of antipsychotics, centrally acting anticholinergics, anticholinesterase inhibitors, amantadine, antidepressants, and anxiolytics - Removed Clinical Global Impression Efficacy Index
    04 Aug 2008
    - Added RUD-Lite, a health economics outcome questionnaire, as an exploratory endpoint
    30 Jun 2010
    - Replaced ACP-103 with pimavanserin - Allowed enrolement of patients with PDP from any double-blind study of pimavanserin - Eliminated Week 1 phone call - Replaced 3-monthly visits (beyond Month 12) by 6-monthy visits - Deleted Inclusion Criterion 2 (stimulator settings for patients that had received stereotaxic surgery for subthalamic nucleus deep brain Stimulation) - Deleted Exclusion Criterion 2 (previous ablative stereotaxic surgery) - Reduced planned patient number from 560 to 400 - Increased number of study centers from 130 to 150 - Removed NMSS scale

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None
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