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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin for the Treatment of Schizophrenia

    Summary
    EudraCT number
    		 2016-003434-24
    Trial protocol
    		 HU   BG   CZ   LT   PL  
    Global end of trial date
    25 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Nov 2020
    First version publication date
    18 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACP-103-034
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02970292
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Acadia Pharmaceuticals Inc.
    Sponsor organisation address
    3611 Valley Centre Drive, Ste. 300, San Diego, United States, 92130
    Public contact
    Sr. Dir. Medical Information and Medical Communications, Acadia Pharmaceuticals Inc., 1 8582612897, medicalinformation@acadia-pharm.com
    Scientific contact
    Sr. Dir. Medical Information and Medical Communications, Acadia Pharmaceuticals Inc., 1 8582612897, 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
    28 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to evaluate the efficacy of adjunctive pimavanserin compared with adjunctive placebo in the treatment of schizophrenia
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Patients were to continue intake of their antipsychotic treatment
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Oct 2016
    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
    Canada: 2
    Country: Number of subjects enrolled
    Russian Federation: 90
    Country: Number of subjects enrolled
    Serbia: 77
    Country: Number of subjects enrolled
    Ukraine: 40
    Country: Number of subjects enrolled
    United States: 71
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Bulgaria: 93
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Lithuania: 9
    Worldwide total number of subjects
    396
    EEA total number of subjects
    116
    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)
    396
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed between 26 Oct 2016 (first patient consented) and 25 Jun 2019 (last patient last visit).

    Pre-assignment
    Screening details
    		 Eligible patients had to be taking an adequate dose of an antipsychotic, in the dose range recommended by the local product information, for >=8 weeks before screening. For patients taking 2 antipsychotics, the main antipsychotic was determined and continued, while the second antipsychotic was discontinued (if clinically appropriate).

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pimavanserin
    Arm description
    		 Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator’s discretion. Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background, main antipsychotic treatment.
    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
    Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator’s discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Each daily dose consisted of 2 individual tablets that were to be taken together at approximately the same time each day as the patient's main antipsychotic.

    Arm title
    		 Placebo
    Arm description
    		 Pimavanserin-matching Placebo. Patients were to continue their background main antipsychotic Treatment.
    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
    Pimavanserin-matching Placebo. Each daily dose consisted of 2 individual tablets that were to be taken together at approximately the same time each day as the patient's main antipsychotic.

    Number of subjects in period 1
    		Pimavanserin Placebo
    Started
    198
    198
    Completed
    174
    190
    Not completed
    24
    8
         Consent withdrawn by subject
    11
    5
         Physician decision
    1
    1
         Adverse event, non-fatal
    5
    -
         Not specified
    1
    -
         Noncompliance with study drug
    2
    2
         Lost to follow-up
    1
    -
         Lack of efficacy
    1
    -
         Protocol deviation
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pimavanserin
    Reporting group description
    		 Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator’s discretion. Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background, main antipsychotic treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Pimavanserin-matching Placebo. Patients were to continue their background main antipsychotic Treatment.

    Reporting group values
    		 Pimavanserin Placebo Total
    Number of subjects
    		 198 198 396
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 198 198 396
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.8 ( 9.42 ) 37.4 ( 9.45 ) -
    Gender categorical
    Units: Subjects
        Female
    		 72 78 150
        Male
    		 126 120 246

    End points

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    End points reporting groups
    Reporting group title
    Pimavanserin
    Reporting group description
    		 Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator’s discretion. Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background, main antipsychotic treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Pimavanserin-matching Placebo. Patients were to continue their background main antipsychotic Treatment.

    Primary: Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score

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    End point title
    		 Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score
    End point description
    The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS total score can range from a minimum of 30 to a maximum of 210, where a higher score signifies greater severity of schizophrenia symptoms.
    End point type
    Primary
    End point timeframe
    From baseline to Week 6
    End point values
    		 Pimavanserin Placebo
    Number of subjects analysed
    193 [1]
    196 [2]
    Units: Score points
    arithmetic mean (standard error)
        Baseline
    88.3 ( 0.68 )
    88.1 ( 0.61 )
        Change from baseline to Week 6
    -15.3 ( 0.93 )
    -13.4 ( 0.83 )
    Notes
    [1] - 193 at baseline; 173 at Week 6
    [2] - 196 at baseline; 189 at Week 6
    Statistical analysis title
    		 Primary analysis
    Comparison groups
    Pimavanserin v Placebo
    Number of subjects included in analysis
    389
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.094
    Method
    		 Mixed-effects model for repeated measure
    Parameter type
    		 Difference in MMRM LSMs
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.5
         upper limit
    		 0.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.24

    Secondary: Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score

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    End point title
    		 Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score
    End point description
    The CGI-S is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients). A higher CGI-S score denotes greater severity of the disorder.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 6
    End point values
    		 Pimavanserin Placebo
    Number of subjects analysed
    193 [3]
    196 [4]
    Units: Score points
    arithmetic mean (standard error)
        Baseline
    4.6 ( 0.04 )
    4.6 ( 0.04 )
        Change from baseline to Week 6
    -0.8 ( 0.06 )
    -0.7 ( 0.05 )
    Notes
    [3] - 193 at baseline; 173 at Week 6
    [4] - 196 at baseline; 189 at Week 6
    No statistical analyses for this end point

    Secondary: Change From Baseline (CFBL) to Week 6 in PANSS Subscale Scores

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    End point title
    		 Change From Baseline (CFBL) to Week 6 in PANSS Subscale Scores
    End point description
    The Subscale Scores were: the PANSS Positive Subscale Score, PANSS Negative Subscale Score and PANSS General Psychopathological Scale Score. The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 General psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS positive subscale score can range from 7 to 49; the PANSS negative subscale score can range from 7 to 49; the PANSS general psychopathology scale score can range from 16 to 112. For each of the subscale scores, a higher score signifies greater severity of schizophrenia symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 Pimavanserin Placebo
    Number of subjects analysed
    193 [5]
    196 [6]
    Units: Score points
    arithmetic mean (standard error)
        PANSS positive scale BL
    23.0 ( 0.25 )
    22.8 ( 0.23 )
        PANSS positive scale CFBL to Week 6
    -5.4 ( 0.34 )
    -4.9 ( 0.30 )
        PANSS negative scale BL
    23.0 ( 0.29 )
    23.1 ( 0.29 )
        PANSS negative scale CFBL to Week 6
    -2.8 ( 0.28 )
    -2.1 ( 0.28 )
        PANSS general psychopathology scale BL
    42.4 ( 0.45 )
    42.2 ( 0.42 )
        PANSS general psychopathology scale CFBL to Week 6
    -7.2 ( 0.49 )
    -6.4 ( 0.47 )
    Notes
    [5] - 193 at baseline; 173 at Week 6
    [6] - 196 at baseline; 189 at Week 6
    No statistical analyses for this end point

    Secondary: PANSS Responders

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    End point title
    		 PANSS Responders
    End point description
    Porportion of patients showing a PANSS response of >=20% or >=30% reduction in PANSS total score. PANSS total score reduction signifies improvement.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 6
    End point values
    		 Pimavanserin Placebo
    Number of subjects analysed
    193
    196
    Units: Patients
        PANSS total score reduction >=20%
    109
    99
        PANSS total score reduction >=30%
    71
    67
    No statistical analyses for this end point

    Secondary: Clinical Global Impression-Improvement (CGI-I) Response

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    End point title
    		 Clinical Global Impression-Improvement (CGI-I) Response
    End point description
    The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement. A CGI-I score of 1 or 2 was counted as response. The Analysis was performed twice; once including missing values as non-responders (MN) and once including only observed cases (OC).
    End point type
    Secondary
    End point timeframe
    From baseline to Week 6
    End point values
    		 Pimavanserin Placebo
    Number of subjects analysed
    193 [7]
    196 [8]
    Units: Patients
        CGI-I response (MN)
    68
    65
        CGI-I response (OC)
    68
    65
    Notes
    [7] - 193 for CGI-I Response (MN); 173 for CGI-I Response (OC)
    [8] - 196 for CGI-I Response (MN); 189 for CGI-I Response (OC)
    No statistical analyses for this end point

    Secondary: Clinical Global Impression-Improvement (CGI-I) Score at Week 6

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    End point title
    		 Clinical Global Impression-Improvement (CGI-I) Score at Week 6
    End point description
    The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 6
    End point values
    		 Pimavanserin Placebo
    Number of subjects analysed
    173
    189
    Units: Score points
    arithmetic mean (standard error)
        CGI-I Score at Week 6
    2.8 ( 0.07 )
    3.0 ( 0.07 )
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score

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    End point title
    		 Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score
    End point description
    The PSP is a validated 100-point (1 to100) single-item rating scale to assess the psychosocial functioning of patients with schizophrenia. The maximum score is 100. Higher scores denote better psychosocial functioning.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 6
    End point values
    		 Pimavanserin Placebo
    Number of subjects analysed
    193 [9]
    196 [10]
    Units: Score points
    arithmetic mean (standard error)
        Baseline
    51.8 ( 0.79 )
    51.6 ( 0.78 )
        Change from baseline to Week 6
    6.8 ( 0.71 )
    5.7 ( 0.64 )
    Notes
    [9] - 193 at baseline; 173 at Week 6
    [10] - 196 at baseline; 188 at Week 6
    No statistical analyses for this end point

    Secondary: Drug Attitude Inventory (DAI-10)

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    End point title
    		 Drug Attitude Inventory (DAI-10)
    End point description
    The DAI-10 contains 6 items (1, 3, 4, 7, 9, and 10) that a patient who is fully adherent to study medication would answer as "True" and 4 items (2, 5, 6, and 8) that a patient who is fully adherent to study medication would answer as "False." A correct answer is scored +1 and an incorrect answer is scored -1; the total score is derived as overall sum. The score can range from -10 to 10. Positive total scores indicate adherence and negative total scores indicate non-adherence. Higher scores denote better adherence.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 6
    End point values
    		 Pimavanserin Placebo
    Number of subjects analysed
    193 [11]
    196 [12]
    Units: Score points
    arithmetic mean (standard error)
        Baseline
    5.6 ( 0.24 )
    5.8 ( 0.23 )
        Change from baseline to Week 6
    0.4 ( 0.20 )
    0.4 ( 0.20 )
    Notes
    [11] - 193 at baseline; 173 at Week 6
    [12] - 196 at baseline; 188 at Week 6
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score

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    End point title
    		 Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score
    End point description
    The KSS is a self-reported measure of a patient’s level of drowsiness. In this study, drowsiness was to be rated during the last week (7 days). Scoring is based on a 9-point verbally anchored scale ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep). The maximum score is 9. Higher scores denote more drowsiness.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 6
    End point values
    		 Pimavanserin Placebo
    Number of subjects analysed
    193 [13]
    196 [14]
    Units: Score points
    arithmetic mean (standard error)
        Baseline
    4.6 ( 0.11 )
    4.7 ( 0.12 )
        Change from baseline to Week 6
    -0.5 ( 0.12 )
    -0.2 ( 0.12 )
    Notes
    [13] - 193 at baseline; 173 at Week 6
    [14] - 196 at baseline; 189 at Week 6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline to Week 6
    Adverse event reporting additional description
    The analysis population were those patients who received at least one dose of the study drug. Patients were classified according to the actual treatment received.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Pimavanserin
    Reporting group description
    		 Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator’s discretion. Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment.

    Reporting group title
    Placebo
    Reporting group description
    		 Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic Treatment.

    Serious adverse events
    		 Pimavanserin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 198 (1.01%)
    2 / 198 (1.01%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Hallucination, auditory
         subjects affected / exposed
    1 / 198 (0.51%)
    0 / 198 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic symptom
         subjects affected / exposed
    0 / 198 (0.00%)
    1 / 198 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 198 (0.51%)
    1 / 198 (0.51%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Self-injurious ideation
         subjects affected / exposed
    0 / 198 (0.00%)
    1 / 198 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 198 (0.51%)
    0 / 198 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pimavanserin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 198 (15.66%)
    31 / 198 (15.66%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 198 (6.57%)
    18 / 198 (9.09%)
         occurrences all number
    16
    24
    Somnolence
         subjects affected / exposed
    13 / 198 (6.57%)
    7 / 198 (3.54%)
         occurrences all number
    19
    8
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    10 / 198 (5.05%)
    7 / 198 (3.54%)
         occurrences all number
    10
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Nov 2016
    The following main changes were introduced: - Increase in the number of participating study sites to 70 - Addition of the US Package Insert for NUPLAZID® (pimavanserin) - Requirement to complete baseline PK sampling before the first dose of study drug; requirement to maintain PK data blinded until the unblinding of the database at the end of the study - Updates to the timing of study drug administration (at approximately the same time as the main antipsychotic medication; guidance in case of missed doses) - Prohibition of strong cytochrome CYP3A4 Inhibitors; introduction of stopping rules for CYP3A4 Inhibitors/inducers - Updates to compliance assessments; introduced possibility to discontinue patients with <80% or >120% compliance from the study - Requirement to measure vital signs before study drug administration - Requirement for a screening blood sample to confirm the presence or absence of the main antipsychotic - Requirement to collect written agreement of the patient's caregiver prior to screening procedures to participate in the study in the caregiver role. - Update of the PANSS to include the caregiver-reported IQ-PANSS
    30 Mar 2017
    The following main changes were introduced: - Update of the eligibility criteria for age to be ≥18 and ≤55 years - Addition of PK endpoints - Update of the independent variables in the statistical model to include baseline CGI-S score and baseline-by-visit interaction for CGI-S and PANSS - Update of statistical methods to hierarchical testing procedure to control the type 1 error rate across the primary and key secondary endpoint - Update of the PK statistical method to include the main antipsychotic - Update to the AE collection period for patients rolling over into study ACP-103-035

    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 reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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