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    Clinical Trial Results:
    Interventional, open-label, flexible-dose, long-term safety study of Lu AF35700 in adult patients with schizophrenia

    Summary
    EudraCT number
    		 2015-003284-11
    Trial protocol
    		 ES   CZ   SK   EE   FI   BG   PL  
    Global end of trial date
    10 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2020
    First version publication date
    16 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16159B Debut
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02892422
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, 45 36301311, LundbeckClinicalTrials@lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@lundbeck.com, H. Lundbeck A/S, 45 36301311, LundbeckClinicalTrials@lundbeck.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
    10 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Oct 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of the long-term treatment with Lu AF35700
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2016
    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
    United States: 98
    Country: Number of subjects enrolled
    Ukraine: 48
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Mexico: 57
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Slovakia: 8
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Bulgaria: 107
    Country: Number of subjects enrolled
    Czech Republic: 11
    Country: Number of subjects enrolled
    Estonia: 16
    Country: Number of subjects enrolled
    Russian Federation: 112
    Country: Number of subjects enrolled
    Serbia: 43
    Country: Number of subjects enrolled
    Romania: 3
    Worldwide total number of subjects
    528
    EEA total number of subjects
    167
    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)
    513
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the 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
    		 Lu AF35700 Flexible dose
    Arm description
    		 Lu AF35700: flexible dose of Lu AF35700, 10 or 20 mg/day, tablets, orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lu AF35700
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lu AF35700 - 10, 20 or 70 mg/day, tablets, orally, once daily

    Number of subjects in period 1
    		Lu AF35700 Flexible dose
    Started
    528
    Completed
    318
    Not completed
    210
         Physician decision
    1
         Withdrawal of consent
    13
         Patient legally incapable
    1
         Consent withdrawn by subject
    56
         Patient decision
    7
         Adverse event, non-fatal
    38
         Sponsor information 16159A results
    21
         Moving elsewhere
    4
         Exclusion crietria met
    3
         Non-compliance
    10
         Non-compliance with study drug
    11
         Lost to follow-up
    5
         Enrolled but not treated
    4
         Lack of efficacy
    32
         Protocol deviation
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 528 528
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 513 513
        From 65-84 years
    		 15 15
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 41.3 ( 11.67 ) -
    Gender categorical
    Units: Subjects
        Female
    		 220 220
        Male
    		 308 308

    End points

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    End points reporting groups
    Reporting group title
    Lu AF35700 Flexible dose
    Reporting group description
    		 Lu AF35700: flexible dose of Lu AF35700, 10 or 20 mg/day, tablets, orally

    Primary: Number of participants with Treatment-Emergent Adverse Events

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    End point title
    		 Number of participants with Treatment-Emergent Adverse Events [1]
    End point description
    Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight, waist circumference and ECG)
    End point type
    Primary
    End point timeframe
    From dosing to end of study (57 weeks)
    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: Only descriptive statistics
    End point values
    		 Lu AF35700 Flexible dose
    Number of subjects analysed
    524
    Units: participants
    289
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    58 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    AF35700 flex-dose
    Reporting group description
    		 -

    Serious adverse events
    		 AF35700 flex-dose
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 524 (5.34%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Intentional overdose
         subjects affected / exposed
    2 / 524 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Coma
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Disinhibition
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hallucination, auditory
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 524 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    3 / 524 (0.57%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Schizophrenia
         subjects affected / exposed
    16 / 524 (3.05%)
         occurrences causally related to treatment / all
    10 / 19
         deaths causally related to treatment / all
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 524 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AF35700 flex-dose
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 524 (8.21%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    43 / 524 (8.21%)
         occurrences all number
    49

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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