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    Clinical Trial Results:
    Prospective naturalistic clinical trail with loxapine in agitated patients with personality disorder

    Summary
    EudraCT number
    		 2016-004884-38
    Trial protocol
    		 ES  
    Global end of trial date
    18 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Nov 2021
    First version publication date
    07 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FER-LOX-2016-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, Vall d'Hebron University Hospital, 34 934894295, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Psychiatry service, Vall d'Hebron University Hospital, 34 934894295,
    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
    18 Jun 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the clinical trial is to assess the effectiveness, defined as time respone of loxapine 9.1mg in acute pre/agitated patients with personality disorder. This respones is define as 1 (very much improvement) or 2 (much improvement) score in the Clinical Global Impression – Improvement scale (CGI-I)
    Protection of trial subjects
    It was ensured that the recruitment procedures did not imply any modification in the medical treatment that the participants could receive in case they did not wish to participate
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Oct 2017
    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
    Spain: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Thirty adult patients were consecutively recruited for the study from December 2017 to June 2019 when they attended the Psychiatry Emergency Departments for agitation as the highest priority goal treatment

    Pre-assignment
    Screening details
    		 Inclusion criteria for this study included being aged between 18 and 65 years, presenting moderate-severe agitation according to Clinical Global Impression-Severity (CGI-S) scoring (GCI-S ≥ 3 and ≤ 5), being diagnosed with PD according to the Diagnostic and Statistical Manual of Mental Disorder 5th edition (DSM-5), and signing informed consent.

    Period 1
    Period 1 title
    Overall trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Inhaled Loxapine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loxapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    A single dose of 9.1 mg inhaled loxapine

    Number of subjects in period 1
    		Inhaled Loxapine
    Started
    30
    Completed
    30
    Period 2
    Period 2 title
    10 minutes treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 IL 10 minutes
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loxapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    A single dose of 9.1 mg inhaled loxapine

    Number of subjects in period 2
    		IL 10 minutes
    Started
    30
    Completed
    30
    Period 3
    Period 3 title
    30 minutes treatment
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 IL 30 minutes
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Loxapine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pressurised inhalation, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    A single dose of 9.1 mg inhaled loxapine

    Number of subjects in period 3
    		IL 30 minutes
    Started
    30
    Completed
    30

    Baseline characteristics

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

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 30 30
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.0 ± 9.7 -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Inhaled Loxapine
    Reporting group description
    		 -
    Reporting group title
    IL 10 minutes
    Reporting group description
    		 -
    Reporting group title
    IL 30 minutes
    Reporting group description
    		 -

    Primary: ACES

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    End point title
    		 ACES
    End point description
    Agitation-Calmness Evaluation scale. A single item that evaluates general agitation and sedation at the moment of the assessment. It ranges from 1 (severe agitation) to 9 (unarousable)
    End point type
    Primary
    End point timeframe
    30 minutes after treatment
    End point values
    		 Inhaled Loxapine IL 10 minutes IL 30 minutes
    Number of subjects analysed
    30
    30
    30
    Units: units
        number (confidence interval 95%)
    2 (2 to 2)
    4 (4 to 4.25)
    4 (4 to 6)
    Statistical analysis title
    		 ACES score
    Comparison groups
    Inhaled Loxapine v IL 10 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 ACES score 30 min
    Comparison groups
    Inhaled Loxapine v IL 30 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: PANSS-EC

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    End point title
    		 PANSS-EC
    End point description
    Excited Component of the Positive and Negative Syndrome scale (PANSS-EC) [29]: a 5-item scale (low impulse control, tension, hostility, lack of cooperation and excitement), with a rating from 1 to 7 per item. Scores higher than 20 indicate severe agitation.
    End point type
    Primary
    End point timeframe
    30 minutes after treatment
    End point values
    		 Inhaled Loxapine IL 10 minutes IL 30 minutes
    Number of subjects analysed
    30
    30
    30
    Units: units
        number (confidence interval 95%)
    21.5 (19.5 to 24.25)
    8 (6 to 14.25)
    5 (5 to 7)
    Statistical analysis title
    		 PANSS-EC 10 minutes
    Comparison groups
    Inhaled Loxapine v IL 10 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 PANSS-EC 30 minutes
    Comparison groups
    Inhaled Loxapine v IL 30 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: PANSS-EC T

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    End point title
    		 PANSS-EC T
    End point description
    PANSS-EC Tension item
    End point type
    Secondary
    End point timeframe
    30 minutes after treatment
    End point values
    		 Inhaled Loxapine IL 10 minutes IL 30 minutes
    Number of subjects analysed
    30
    30
    30
    Units: units
        number (confidence interval 95%)
    4 (4 to 6)
    2 (1 to 3)
    1 (1 to 1.25)
    Statistical analysis title
    		 PANSS-EC T 10 minutes
    Comparison groups
    Inhaled Loxapine v IL 10 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 PANSS-EC T 30 minutes
    Comparison groups
    Inhaled Loxapine v IL 30 minutes
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    30 minutes after tretament
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Total adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Total adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No significant adverse effects were registered. Given the low time considered and safety of the treatment, no adverse effects were expected in such a short time (30 minutes).

    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.
    Loxapine efficacy could not be directly compared with other treatments. Results of the mixed effect logistic regression models must be interpreted with caution, not allowing to obtain robust estimates. A small sample size was used.
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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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