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    Clinical Trial Results:
    A Randomized, Open-Label, Cross-over Study to Assess the Relative Bioavailability of LY03004 and EU Risperdal® Consta® at 50 mg Following Multiple Intramuscular Injections in Stable Patients with Schizophrenia

    Summary
    EudraCT number
    		 2016-005010-22
    Trial protocol
    		 HR  
    Global end of trial date
    24 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Oct 2021
    First version publication date
    22 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LY03004/CT-EUR-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Project number (CRO): CLY16001
    Sponsors
    Sponsor organisation name
    Nanjing Luye Pharmaceutical Co., Ltd.
    Sponsor organisation address
    No.28, Gaoxin Road; Nanjing Hightech Industrial Development Zone, Nanjing, China, 210061
    Public contact
    Sponsor´s Vice President Project Management / Clinical Operations, Luye Pharma Group, Ltd., +1 609-212-0609, joe.tai@luye.com
    Scientific contact
    Sponsor´s Vice President Project Management / Clinical Operations, Luye Pharma Group, Ltd., +1 609-212-0609, joe.tai@luye.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
    13 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the relative bioavailability of a test preparation containing 50 mg risperidone [Test IMP: LY03004, manufactured by Nanjing Luye Pharmaceutical Co., Ltd., China] as compared to a market standard [Reference IMP: EU RISPERDAL® CONSTA® 50 mg (risperidone), Janssen] following multiple doses of deep intramuscular gluteal injection of 50 mg risperidone at stead-ystate under fasting conditions in two different periods.
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles of Good Clinical Practice, according to the ICH Harmonized Tripartite Guideline and the local laws and regulations of the countries of clinical sites.
    Background therapy
    		 Patients with schizophrenia stabilized on risperidone (given either orally or as a depot medication) at a dose equivalent (for intramuscular dosing) or proportional (for oral dosing) to 50 mg dose in the form of a depot medication for intramuscular administration for at least 4 weeks prior to screening. (FOR SERBIA) Patients with schizophrenia on a stable dose of oral antipsychotic medication(s) or on Risperidone depot 50 mg for at least 4 weeks prior to screening. (FOR ALL OTHER COUNTRIES)
    Evidence for comparator
    		 In the EU, Risperdal® Consta® has been approved for the maintenance treatment of schizophrenia in patients currently stabilized with oral antipsychotics at 25, 37.5 and 50 mg doses supplied with three dosage forms (25 mg, 37.5 mg and 50 mg vial kits). 50 mg was selected for both LY03004 and EU Risperdal® Consta® in this study, since it is the commonly used dose for Risperdal® Consta® in EU. Similar dose regimen (four biweekly injections) and PK sampling time points were applied in this study to allow relevant comparison of the two treatments within the same study and comparison of this study to published studies with EU Risperdal® Consta®. Further the BfArM had given the scientific advice to use 50 mg in this trial.
    Actual start date of recruitment
    31 May 2019
    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
    Moldova, Republic of: 34
    Country: Number of subjects enrolled
    Serbia: 40
    Country: Number of subjects enrolled
    Russian Federation: 96
    Country: Number of subjects enrolled
    Poland: 12
    Country: Number of subjects enrolled
    Croatia: 20
    Country: Number of subjects enrolled
    Bulgaria: 65
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Hungary: 12
    Worldwide total number of subjects
    280
    EEA total number of subjects
    110
    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)
    280
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study population consisted of male or non-pregnant female patients, 18 to 65 years old, BMI 18.0 to 38.0 kg/m2, with schizophrenia who were on a stable dose of oral risperidone (FOR SERBIA) / antipsychotic medication(s) (FOR ALL OTHER COUNTRIES) or on Risperidone depot 50 mg for at least 4 weeks prior to screening.

    Pre-assignment
    Screening details
    		 The screening period lasted up to 28 days before treatment period 1. A total number of 280 patients were screened. Two hundred fifty-five patients were randomized; thereof 246 patients were treated with study medication.

    Pre-assignment period milestones
    Number of subjects started
    		 280
    Number of subjects completed
    		 255 [1]

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 13
    Reason: Number of subjects
    		 Screening failure: 12
    Notes
    [1] - The number of subjects reported to be in the pre-assignment period is not consistent with the number starting period 1. It is expected that the number completing the pre-assignment period are also present in the arms in period 1.
    Justification: A total number of 255 subjects were randomized. Nine subjects were randomized, but dropped out before receiving any study medication. Therefore, 246 subjects were treated with study medication (patients starting period 1). But for 4 subjects all data were lost in a fire accidient. Due to this reason, the number of subjects starting period 1 was 242.
    Period 1
    Period 1 title
    Treatment (Period 1 / 2) (overall trial) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Test
    Arm description
    		 LY03004 (risperidone), 50 mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY03004
    Investigational medicinal product code
    Test IMP (T)
    Other name
    Pharmaceutical forms
    Powder and solvent for prolonged-release suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    - 50 mg risperidone (extended-release microspheres and diluent for prolonged-release suspension for intramuscular injection) - Multiple dose (4 doses in total) - For deep intramuscular gluteal injections every 2 weeks (14 days)

    Arm title
    		 Reference
    Arm description
    		 EU Risperdal® Consta®, 50 mg
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EU Risperdal® Consta®
    Investigational medicinal product code
    Reference IMP (R)
    Other name
    Pharmaceutical forms
    Powder and solvent for prolonged-release suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    - 50 mg risperidone (powder and solvent for prolonged-release suspension for intramuscular injection) - Multiple dose ( 4 doses in total) - For deep intramuscular gluteal injections every 2 weeks (14 days)

    Number of subjects in period 1
    		Test Reference
    Started
    228
    227
    Completed
    205
    203
    Not completed
    23
    24
         Consent withdrawn by subject
    17
    17
         Adverse event, non-fatal
    6
    4
         Lost to follow-up
    -
    1
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Treatment (Period 1 / 2) (overall trial)
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total number of 280 subjects signed informed consent, were screened, and therefore have to be regarded as enrolled into the trial (= worldwide number of subjects enrolled). 255 of the 280 screened subjects were randomized, 9 were randomized, but dropped out before receiving any IMP. Therefore, 246 subjects were treated with IMP (patients starting period 1). For 4 subjects all data were lost in a fire accidient. Due to this reason, the number of subjects in the baseline period is 242.
    Reporting group values
    		 Treatment (Period 1 / 2) (overall trial) Total
    Number of subjects
    		 242 242
    Age categorical
    Units: Subjects
        <18 years
    		 0 0
        Adults (18-39 years)
    		 102 102
        Adults (40-65 years)
    		 140 140
        >65 years
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.0 ± 10.9 -
    Gender categorical
    Units: Subjects
        Female
    		 86 86
        Male
    		 156 156
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Black or African American
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        White
    		 241 241
        Unknown
    		 1 1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 173.7 ± 8.8 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 82.1 ± 16.5 -
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 27.1 ± 4.6 -
    Subject analysis sets

    Subject analysis set title
    Per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Primary BE evaluation: 190 patients (per protocol set) were included in the statistical evaluation regarding the primary bioequivalence evaluation.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    255 patients were randomized; thereof 246 patients were treated with at least one dose of study medication. In a fire accidient at one Bulgarian study site the data of 4 patients got completely lost. Due to this reason the safety analysis set comprises data from only 242 patients.

    Subject analysis sets values
    		 Per protocol set Safety set
    Number of subjects
    190
    242
    Age categorical
    Units: Subjects
        <18 years
    0
    0
        Adults (18-39 years)
    81
    102
        Adults (40-65 years)
    109
    140
        >65 years
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.0 ± 11.3
    42.0 ± 10.9
    Gender categorical
    Units: Subjects
        Female
    62
    86
        Male
    128
    156
    Race
    Units: Subjects
        American Indian or Alaska Native
    0
    0
        Asian
    0
    0
        Black or African American
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
        White
    189
    241
        Unknown
    1
    1
    Height
    Units: cm
        arithmetic mean (standard deviation)
    174.1 ± 9.0
    173.7 ± 8.8
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    82.8 ± 17.1
    82.1 ± 16.5
    Body Mass Index
    Units: kg/m^2
        arithmetic mean (standard deviation)
    27.2 ± 4.7
    27.1 ± 4.6

    End points

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    End points reporting groups
    Reporting group title
    Test
    Reporting group description
    		 LY03004 (risperidone), 50 mg

    Reporting group title
    Reference
    Reporting group description
    		 EU Risperdal® Consta®, 50 mg

    Subject analysis set title
    Per protocol set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Primary BE evaluation: 190 patients (per protocol set) were included in the statistical evaluation regarding the primary bioequivalence evaluation.

    Subject analysis set title
    Safety set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    255 patients were randomized; thereof 246 patients were treated with at least one dose of study medication. In a fire accidient at one Bulgarian study site the data of 4 patients got completely lost. Due to this reason the safety analysis set comprises data from only 242 patients.

    Primary: AUCss-tau [h*pg/mL] per protocol set

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    End point title
    		 AUCss-tau [h*pg/mL] per protocol set
    End point description
    End point type
    Primary
    End point timeframe
    Treatment (Period 1 / 2) (overall trial)
    End point values
    		 Test Reference
    Number of subjects analysed
    190
    190
    Units: h*pg/mL
        geometric mean (standard deviation)
    2872487.90 ± 4287077.22
    3144335.92 ± 5027028.61
    Statistical analysis title
    		 T vs. R per protocol set
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    		 ANOVA
    Parameter type
    		 Geometric mean ratio
    Point estimate
    91.35
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 85.87
         upper limit
    		 97.18

    Primary: Css-max [pg/mL] per protocol set

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    End point title
    		 Css-max [pg/mL] per protocol set
    End point description
    End point type
    Primary
    End point timeframe
    Treatment (Period 1 / 2 ) (overall trial)
    End point values
    		 Test Reference
    Number of subjects analysed
    190
    190
    Units: pg/mL
        geometric mean (standard deviation)
    13626.50 ± 17732.14
    15846.44 ± 26066.72
    Statistical analysis title
    		 T vs. R per protocol set
    Comparison groups
    Reference v Test
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    85.99
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 80.02
         upper limit
    		 92.41

    Primary: Ctrough [pg/mL] per protocol set

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    End point title
    		 Ctrough [pg/mL] per protocol set
    End point description
    End point type
    Primary
    End point timeframe
    Treatment (Period 1 / 2) (overall trial)
    End point values
    		 Test Reference
    Number of subjects analysed
    190
    190
    Units: pg/mL
        geometric mean (standard deviation)
    5767.44 ± 10322.81
    7433.14 ± 11537.38
    Statistical analysis title
    		 T vs. R per protocol set
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    		 ANOVA
    Parameter type
    		 Geometric mean ratio
    Point estimate
    77.59
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 69.43
         upper limit
    		 86.72

    Other pre-specified: Css-min [pg/mL] per protocol set

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    End point title
    		 Css-min [pg/mL] per protocol set
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Treatment (Period 1 / 2) (overall trial)
    End point values
    		 Test Reference
    Number of subjects analysed
    190
    190
    Units: pg/mL
        geometric mean (standard deviation)
    4193.53 ± 9394.36
    4081.80 ± 7573.00
    Statistical analysis title
    		 T vs. R per protocol set
    Comparison groups
    Test v Reference
    Number of subjects included in analysis
    380
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    		 ANOVA
    Parameter type
    		 Geometric mean ratio
    Point estimate
    102.74
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 93.06
         upper limit
    		 113.42

    Other pre-specified: Css-avg [pg/mL] per protocol set

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    End point title
    		 Css-avg [pg/mL] per protocol set
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Treatment (Period 1 / 2) (overall trial)
    End point values
    		 Test Reference
    Number of subjects analysed
    190
    190
    Units: pg/mL
        geometric mean (standard deviation)
    8549.07 ± 12759.16
    9358.14 ± 14961.39
    No statistical analyses for this end point

    Other pre-specified: Fluctuation [%] per protocol set

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    End point title
    		 Fluctuation [%] per protocol set
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Treatment (Period 1 / 2) (overall trial)
    End point values
    		 Test Reference
    Number of subjects analysed
    190
    190
    Units: per cent
        geometric mean (standard deviation)
    95.84 ± 106.51
    115.65 ± 77.40
    No statistical analyses for this end point

    Other pre-specified: Tss-max [h] per protocol set

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    End point title
    		 Tss-max [h] per protocol set
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Treatment (Period 1 / 2) (overall trial)
    End point values
    		 Test Reference
    Number of subjects analysed
    190
    190
    Units: hour
        arithmetic mean (standard deviation)
    121.13 ± 76.294
    101.19 ± 95.968
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Collection of adverse events started after signing informed consent form during the pre-assignment period [non treatment emergent adverse events (AEs)] and during the treatment period of the trial [treatment emergent adverse events (TEAEs).
    Adverse event reporting additional description
    Non treatment emergent AEs and TEAEs
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Test
    Reporting group description
    		 LY03004 (risperidone), 50 mg

    Reporting group title
    Reference
    Reporting group description
    		 EU Risperdal® Consta®, 50 mg

    Serious adverse events
    		 Test Reference
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 228 (1.32%)
    1 / 227 (0.44%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 227 (0.44%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Breast abscess
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Test Reference
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 228 (17.11%)
    54 / 227 (23.79%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Polycythaemia vera
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 227 (0.88%)
         occurrences all number
    0
    2
    Hypotension
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Thrombophlebitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Hyperthermia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Injection site pain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 227 (0.44%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Affect lability
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    3 / 228 (1.32%)
    5 / 227 (2.20%)
         occurrences all number
    3
    5
    Delusion
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Hallucination
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    5 / 228 (2.19%)
    9 / 227 (3.96%)
         occurrences all number
    5
    9
    Libido decreased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Nightmare
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Psychotic disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 227 (0.44%)
         occurrences all number
    1
    1
    Schizophrenia
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 227 (0.88%)
         occurrences all number
    0
    2
    Sleep disorder
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 228 (1.75%)
    2 / 227 (0.88%)
         occurrences all number
    4
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Blood prolactin increased
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 227 (0.44%)
         occurrences all number
    1
    1
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Transaminases increased
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Sinus tachycradia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Akathisia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 227 (0.44%)
         occurrences all number
    1
    1
    Dizziness
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Dyskinesia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Extrapyramidal disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 227 (0.44%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    2 / 228 (0.88%)
    3 / 227 (1.32%)
         occurrences all number
    2
    4
    Parkinsonism
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 227 (0.88%)
         occurrences all number
    0
    2
    Reduced facial expression
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    2 / 228 (0.88%)
    1 / 227 (0.44%)
         occurrences all number
    2
    1
    Tremor
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 227 (0.44%)
         occurrences all number
    1
    1
    Leukopenia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Accommodation disorder
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Blepharitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 228 (0.88%)
    0 / 227 (0.00%)
         occurrences all number
    2
    0
    Dental caries
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 227 (0.44%)
         occurrences all number
    1
    2
    Dyspepsia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Pancreatitis chronic
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Hepatic steatosis
         subjects affected / exposed
    1 / 228 (0.44%)
    1 / 227 (0.44%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Leukocyturia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Renal pain
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hyperprolactinaemia
         subjects affected / exposed
    5 / 228 (2.19%)
    6 / 227 (2.64%)
         occurrences all number
    5
    6
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 228 (0.00%)
    3 / 227 (1.32%)
         occurrences all number
    0
    3
    Bronchitis bacterial
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 227 (1.32%)
         occurrences all number
    1
    3
    Fungal infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 228 (0.00%)
    2 / 227 (0.88%)
         occurrences all number
    0
    2
    Otitis media
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Periodontitis
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    2
    0
    Pharyngitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 228 (0.44%)
    3 / 227 (1.32%)
         occurrences all number
    1
    3
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Tooth abscess
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 228 (0.44%)
    0 / 227 (0.00%)
         occurrences all number
    1
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 228 (0.00%)
    1 / 227 (0.44%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jan 2018
    This study was initially planned to be performed with 25 mg risperidone (Study protocol Version 1.6, dated 11-Aug-2017). Due to a deficiency letter from the German authority BfArM Amendment 1.0 and new study protocol (Version 2.0, dated 29-Jan-2018) was prepared, modifying some inclusion and exclusion criteria, adding Moldova to the participating countries and changing the project manager of the sponsor.
    25 Jul 2018
    The main reason for preparing Amendment 2.0 was the change of dose strength from 25 mg to 50 mg according to a scientific advice from the German authority BfArM. For implementing the changes updated version of study protocol (Version 3.6, dated 25-Jul-2018) and related documents were prepared.
    21 Dec 2018
    Local Amendment 3.0 became necessary due to deficiency letter from the Serbian Medicines and Medical Devices Agency. In Serbia only patients who were stabilized on risperidone (given either orally or as a depot medication) at a dose equivalent (for intramuscular dosing) or proportional (for oral dosing) to 50 mg dose in the form of a depot medication for intramuscular administration could be included into the present trial. Due to this reason, country-specific study protocol, version 4.0 (dated 21-Dec-2018) was prepared.
    20 Jan 2020
    Due to the shelf life of the batch of the reference product (June 2020) it was possible that for the last subjects randomized in the trial a new batch of the same reference product might be needed. Amendment 3.0 introduced no changes to the study protocol; only new labels had to be prepared.
    08 Apr 2020
    This Amendment described urgent measures in connection with the COVID-19 (Coronavirus) pandemic. It is based on the recommendations of the EMA Guidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic. Also new version of study protocol (Version 5.0, dated 16-Apr-2020) was prepared, as this is mandatory in some countries.

    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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