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    Clinical Trial Results:
    A Double-blind, Placebo-controlled, Relapse Prevention Study of Pimavanserin for the Treatment of Hallucinations and Delusions Associated With Dementia-related Psychosis

    Summary
    EudraCT number
    		 2017-002227-13
    Trial protocol
    		 GB   CZ   SK   BG   ES   PL   FR   IT  
    Global end of trial date
    30 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 May 2021
    First version publication date
    16 May 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACP-103-045
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03325556
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Acadia Pharmaceuticals Inc.
    Sponsor organisation address
    12830 El Camino Real, Suite 400, San Diego, United States, 92130
    Public contact
    Sr. Dir. Medical Information and Medical Communications, Acadia Pharmaceuticals Inc., +1 858 2612897, medicalinformation@acadia-pharm.com
    Scientific contact
    Sr. Dir. Medical Information and Medical Communications, Acadia Pharmaceuticals Inc., +1 858 2612897, 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
    31 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate relapse prevention in subjects with dementia-related psychosis treated with pimavanserin compared to placebo
    Protection of trial subjects
    Not applicable
    Background therapy
    		 No
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Aug 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 42
    Country: Number of subjects enrolled
    Slovakia: 35
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Czechia: 11
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    United States: 118
    Country: Number of subjects enrolled
    Ukraine: 74
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    Chile: 27
    Country: Number of subjects enrolled
    Serbia: 44
    Worldwide total number of subjects
    392
    EEA total number of subjects
    129
    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)
    54
    From 65 to 84 years
    299
    85 years and over
    39

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed in subjects with all-cause dementia according to NIA-AA guidelines, including dementia associated with Parkinson's disease, dementia with Lewy Bodies, possible/probable Alzheimer's disease, frontotemporal degeneration spectrum disorder, or vascular dementia, and were to have had >=2-month history of psychotic symptoms.

    Pre-assignment
    Screening details
    		 During the screening period, subjects were assessed for study eligibility and prohibited medications were discontinued when medically appropriate. Subjects and partner/caregivers also received a standardized psychosocial therapy training.

    Period 1
    Period 1 title
    Open-Label Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Arm title
    		 Pimavanserin OL period
    Arm description
    		 Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pimavanserin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pimavanserin 34 mg once daily with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily.

    Number of subjects in period 1
    		Pimavanserin OL period
    Started
    392
    Completed
    217
    Not completed
    175
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    17
         Lack of response in OL period
    70
         Adverse event, non-fatal
    27
         Not otherwise specified
    8
         Noncompliance with study drug
    5
         Administrative discont. at study termination
    41
         Use of prohibited medication
    1
         Lost to follow-up
    1
         Protocol deviation
    4
    Period 2
    Period 2 title
    Double-blind period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Data analyst, Carer, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pimavanserin DB Period
    Arm description
    		 Pimavanserin 34 mg once daily or pimavanserin 20 mg once daily (the dose at which patients completed the Open-Label Period) for 26 weeks or until relapse
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pimavanserin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pimavanserin 34 mg once daily or pimavanserin 20 mg once daily (the dose at which patients completed the Open-Label Period) for 26 weeks or until relapse

    Arm title
    		 Placebo DB Period
    Arm description
    		 Placebo once daily for 26 weeks or until relapse
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo once daily for 26 weeks or until relapse

    Number of subjects in period 2
    		Pimavanserin DB Period Placebo DB Period
    Started
    105
    112
    Completed
    44
    35
    Not completed
    61
    77
         Relapse
    15
    34
         Consent withdrawn by subject
    6
    4
         Physician decision
    -
    1
         Adverse event, non-fatal
    3
    1
         Not otherwise specified
    1
    5
         Noncompliance with study drug
    -
    1
         Administrative discont. at study termination
    35
    31
         Use of prohibited medication
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-Label Period
    Reporting group description
    		 Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily.

    Reporting group values
    		 Open-Label Period Total
    Number of subjects
    		 392 392
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 54 54
        From 65-84 years
    		 299 299
        85 years and over
    		 39 39
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 74.5 ( 8.28 ) -
    Gender categorical
    Units: Subjects
        Female
    		 229 229
        Male
    		 163 163
    Dementia severity
    Units: Subjects
        Mild
    		 65 65
        Moderate
    		 275 275
        Severe
    		 52 52
    SAPS-H+D total score
    SAPS-H+D (Scale for the Assessment of Positive Symptoms–Hallucinations and Delusions) is a 20-item scale; the total score is the sum of the 20 item scores (range 0-100); higher scores denote more severe Symptoms.
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 24.4 ( 9.22 ) -
    Clinical Global Impression Severity (CGI-S)
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 4.7 ( 0.69 ) -

    End points

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    End points reporting groups
    Reporting group title
    Pimavanserin OL period
    Reporting group description
    		 Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily.
    Reporting group title
    Pimavanserin DB Period
    Reporting group description
    		 Pimavanserin 34 mg once daily or pimavanserin 20 mg once daily (the dose at which patients completed the Open-Label Period) for 26 weeks or until relapse

    Reporting group title
    Placebo DB Period
    Reporting group description
    		 Placebo once daily for 26 weeks or until relapse

    Primary: Time From Randomization to Relapse in the Double-blind (DB) Period

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    End point title
    		 Time From Randomization to Relapse in the Double-blind (DB) Period
    End point description
    Time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by the hazard ratio (HR). Relapse was defined as (1) ≥30% increase in SAPS-H+D total score from DB baseline (BL) and CGI-I score ≥6 relative to DB BL, (2) treatment with antipsychotic for dementia-related delusions/hallucinations, (3) treatment/study discontinuation due to lack of efficacy, and/or (4) hospitalisation for worsening dementia-related psychosis. CGI-I is a clinician-rated 7-point scale to rate improvement in hallucinations/delusions relative to BL (range 1-7); higher scores denote less improvement or worsening. A pre-specified IA was conducted after 40 adjudicated relapse events had accrued during the study. The prespecified stopping criterion was met; the study was stopped for efficacy. The median time to relapse could not be estimated as the KM estimate of relapse over the 26-week DB period did not exceed 50%.
    End point type
    Primary
    End point timeframe
    From randomization in the DB period through 26 weeks
    End point values
    		 Pimavanserin DB Period Placebo DB Period
    Number of subjects analysed
    95 [1]
    99 [2]
    Units: Patients
        Patients relapsing
    12
    28
    Notes
    [1] - All patients randomized on or before the database cutoff date for the IA.
    [2] - All patients randomized on or before the database cutoff date for the IA.
    Statistical analysis title
    		 Primary analysis
    Statistical analysis description
    Time from randomization to relapse in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by HR. The median time to relapse could not be estimated as the Kaplan-Meier probability estimate of relapse over the 26-week DB period did not exceed 50%.
    Comparison groups
    Pimavanserin DB Period v Placebo DB Period
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.0023 [4]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.353
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.172
         upper limit
    		 0.727
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3676
    Notes
    [3] - Cox regression model included covariates for Treatment group, designated Dementia subtype, and region, and robust sandwich-type variance estimator.
    [4] - 1-sided p-value reported. The protocol-defined O'Brien Flemming stopping boundary for the planned IA was a 1-sided p-value equal to 0.0033.

    Secondary: Time From Randomization to Discontinuation From the DB Period for Any Reason

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    End point title
    		 Time From Randomization to Discontinuation From the DB Period for Any Reason
    End point description
    The endpoint of time from randomization to discontinuation from the DB period for any reason (other than termination of the study by the sponsor) was compared between treatment groups using a Cox regression model. The treatment effect was measured by the HR. The median time to discontinuation could not be estimated as the Kaplan-Meier probability estimate of discontinuation over the 26-week DB period did not exceed 50%.
    End point type
    Secondary
    End point timeframe
    From randomization in the DB period through 26 weeks
    End point values
    		 Pimavanserin DB Period Placebo DB Period
    Number of subjects analysed
    95 [5]
    99 [6]
    Units: Patients
        Patients who discontinued
    21
    38
    Notes
    [5] - All patients randomized on or before the database cutoff date for the IA.
    [6] - All patients randomized on or before the database cutoff date for the IA.
    Statistical analysis title
    		 Secondary analysis
    Statistical analysis description
    Time from randomization to discontinuation in the DB period was compared between treatment groups using a Cox regression model. The treatment effect was measured by HR. The median time to discontinuation could not be estimated as the Kaplan-Meier probability estimate of discontinuation over the 26-week DB period did not exceed 50%.
    Comparison groups
    Pimavanserin DB Period v Placebo DB Period
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.0024 [8]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.452
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.261
         upper limit
    		 0.785
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.2812
    Notes
    [7] - Cox regression model included covariates for Treatment group, designated Dementia subtype, and region, and robust sandwich-type variance estimator.
    [8] - 1-sided p-value reported

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were to be documented through 30 days after the last dose in the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Pimavanserin OL period
    Reporting group description
    		 Pimavanserin 34 mg once daily, with the possibility to adjust to pimavanserin 20 mg once daily between Weeks 1 and 4 based on tolerability. After Week 4, the dose of study drug remained fixed at either 34 or 20 mg once daily.

    Reporting group title
    Pimavanserin DB period
    Reporting group description
    		 Pimavanserin 34 mg once daily or pimavanserin 20 mg once daily (the dose at which patients completed the Open-Label Period) for 26 weeks or until relapse.

    Reporting group title
    Placebo DB period
    Reporting group description
    		 Placebo once daily for 26 weeks or until relapse

    Serious adverse events
    		 Pimavanserin OL period Pimavanserin DB period Placebo DB period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 392 (5.10%)
    5 / 105 (4.76%)
    4 / 112 (3.57%)
         number of deaths (all causes)
    1
    1
    0
         number of deaths resulting from adverse events
    1
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 392 (0.00%)
    1 / 105 (0.95%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Bone fissure
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    2 / 392 (0.51%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure congestive
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Nervous system disorders
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 392 (0.00%)
    1 / 105 (0.95%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 392 (0.00%)
    0 / 105 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 392 (0.00%)
    1 / 105 (0.95%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain lower
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agression
         subjects affected / exposed
    1 / 392 (0.26%)
    1 / 105 (0.95%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropsychiatric symptoms
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess jaw
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 392 (0.00%)
    0 / 105 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 392 (0.00%)
    1 / 105 (0.95%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic encephalopathy
         subjects affected / exposed
    0 / 392 (0.00%)
    1 / 105 (0.95%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 392 (0.51%)
    1 / 105 (0.95%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 392 (0.00%)
    0 / 105 (0.00%)
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 392 (0.51%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 392 (0.26%)
    0 / 105 (0.00%)
    0 / 112 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pimavanserin OL period Pimavanserin DB period Placebo DB period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 392 (6.12%)
    16 / 105 (15.24%)
    9 / 112 (8.04%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 392 (1.53%)
    10 / 105 (9.52%)
    5 / 112 (4.46%)
         occurrences all number
    6
    13
    8
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    18 / 392 (4.59%)
    6 / 105 (5.71%)
    4 / 112 (3.57%)
         occurrences all number
    19
    8
    5

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Aug 2018
    Clarifications of the following items were introduced: - IN criteria (clarified definition of stable use of Cholinesterase inhibitors/memantine; acceptable methods of birth control) - EX criteria (provision of NYHA Grading Scale; ECG parameters for pts on certain antidepressants; Parameters required to allow repeat HR; exclusion of pts with severe renal or hepatic impairment; criteria for repeat laboratory testing; clarifications on intracranial aneurysm exclusions; urine drug screening process) - Clarifying study discontinuation and completion definitions - Extension of Screening period to allow for confirmatory testing - Sample size calculation; methodology for determining statistical significance at interim and final analyses - Subject discontinuation procedures - Allowance of a brain MRI with contrast or a head CT with contrast if clinically warranted - Laboratory Evaluations - Included a maximum number of randomized pts in the study (n=400) - Procedures clarified for prohibited medication - Laboratory testing at screening (magnesium; TSH and free T4) - Added temperature as a vital sign measurement

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    31 Jul 2019
    A protocol-specified interim analysis (IA) was performed after 40 relapse events had been adjudicated by an independent adjudication committee (IAC). The study was terminated following positive IA results, which met the prespecified stopping criteria for efficacy.
    -

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