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    Clinical Trial Results:
    A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder

    Summary
    EudraCT number
    		 2010-020493-42
    Trial protocol
    		 BG   PL   LV   ES  
    Global end of trial date
    28 Apr 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Jan 2023
    First version publication date
    04 Oct 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    13546A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05014919
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000455-PIP02-10
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Apr 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Apr 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the trail was to evaluate the efficacy of vortioxetine in the prevention of relapse of major depressive episodes in paediatric participants with Major Depressive Disorder (MDD).
    Protection of trial subjects
    This study was conducted in compliance with Good Clinical Practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Aug 2021
    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
    Colombia: 6
    Country: Number of subjects enrolled
    Mexico: 14
    Country: Number of subjects enrolled
    United States: 5
    Country: Number of subjects enrolled
    Latvia: 1
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Russian Federation: 4
    Country: Number of subjects enrolled
    Ukraine: 1
    Worldwide total number of subjects
    35
    EEA total number of subjects
    5
    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)
    29
    Adolescents (12-17 years)
    6
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study population included de novo participants as well as rollover participants from other paediatric vortioxetine studies (Studies 12709A [NCT02709655] and 12712A [NCT02871297]) who, in the investigator’s opinion, would benefit from continued treatment with vortioxetine.

    Pre-assignment
    Screening details
    		 Rollover participants from Study 12709A enrolled to the open-label period and rollover participants from Study 12712A randomized to double-blind period. Overall 35 participants treated in this study: 33 in open-label period (24 de novo and 9 rollover participants from Study 12709A) and 4 in double-blind period (2 rolled-over from Study 12712A).

    Period 1
    Period 1 title
    Open-Label (12 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Open-Label Treatment: Vortioxetine
    Arm description
    		 Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vortioxetine was administered per dose and schedule specified in the arm description.

    Number of subjects in period 1 [1]
    		Open-Label Treatment: Vortioxetine
    Started
    33
    Received at least 1 dose of study drug
    33
    Completed
    5
    Not completed
    28
         Consent withdrawn by subject
    2
         Based on Results From Vortioxetine Study
    15
         Adverse event, non-fatal
    1
         Sponsor Decision
    4
         Study Terminated by Sponsor
    5
         Lack of efficacy
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 35 participants enrolled in this study: 33 in the open-label period and 2 in the double-blind period.
    Period 2
    Period 2 title
    Double-Blind (26 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Double-Blind Relapse Prevention: Vortioxetine
    Arm description
    		 Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vortioxetine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vortioxetine was administered per dose and schedule specified in the arm description.

    Arm title
    		 Double-Blind Relapse Prevention: Placebo
    Arm description
    		 Participants received placebo for 26 weeks in the double-blind relapse prevention period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to vortioxetine was administered per schedule specified in the arm description.

    Number of subjects in period 2 [2]
    		Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Started
    2
    2
    Received at least 1 dose of study drug
    2
    2
    Completed
    1
    0
    Not completed
    1
    2
         Based on Results From Vortioxetine Study
    1
    1
         Study Terminated by Sponsor
    -
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Of 5 participants who completed open-label period, only 2 participants entered in the double-blind period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-Label Treatment: Vortioxetine
    Reporting group description
    		 Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed.

    Reporting group values
    		 Open-Label Treatment: Vortioxetine Total
    Number of subjects
    		 33 33
    Age Categorical
    Units: Subjects
        Children (2-11 years)
    		 27 27
        Adolescents (12-17 years)
    		 6 6
    Gender Categorical
    Units: Subjects
        Female
    		 18 18
        Male
    		 15 15
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 18 18
        Not Hispanic or Latino
    		 15 15
        Unknown or Not Reported
    		 0 0
    Race
    Units: Subjects
        White
    		 13 13
        Black or African American
    		 3 3
        Asian
    		 1 1
        Other
    		 16 16
    Subject analysis sets

    Subject analysis set title
    Double-Blind Relapse Prevention: Vortioxetine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.

    Subject analysis set title
    Double-Blind Relapse Prevention: Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received placebo for 26 weeks in the double-blind relapse prevention period.

    Subject analysis sets values
    		 Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Number of subjects
    2
    2
    Age Categorical
    Units: Subjects
        Children (2-11 years)
    2
    2
        Adolescents (12-17 years)
    0
    0
    Age Continuous
    Units:
        
    ±
    ±
    Gender Categorical
    Units: Subjects
        Female
    1
    1
        Male
    1
    1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    2
    1
        Not Hispanic or Latino
    0
    0
        Unknown or Not Reported
    0
    1
    Race
    Units: Subjects
        White
    0
    2
        Black or African American
    0
    0
        Asian
    0
    0
        Other
    2
    0

    End points

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    End points reporting groups
    Reporting group title
    Open-Label Treatment: Vortioxetine
    Reporting group description
    		 Participants initiated treatment with vortioxetine tablets 5 milligrams (mg)/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting adverse events (AEs), vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed.
    Reporting group title
    Double-Blind Relapse Prevention: Vortioxetine
    Reporting group description
    		 Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.

    Reporting group title
    Double-Blind Relapse Prevention: Placebo
    Reporting group description
    		 Participants received placebo for 26 weeks in the double-blind relapse prevention period.

    Subject analysis set title
    Double-Blind Relapse Prevention: Vortioxetine
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.

    Subject analysis set title
    Double-Blind Relapse Prevention: Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants received placebo for 26 weeks in the double-blind relapse prevention period.

    Primary: Time to Relapse in the Double-blind Period

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    End point title
    		 Time to Relapse in the Double-blind Period [1]
    End point description
    Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression). Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this endpoint.
    End point type
    Primary
    End point timeframe
    From randomisation to Week 26 in the double-blind treatment period
    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: This endpoint is for double-blind period only.
    End point values
    		 Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: weeks
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [2] - The efficacy analyses were not performed and data were not collected for this endpoint.
    [3] - The efficacy analyses were not performed and data were not collected for this endpoint.
    No statistical analyses for this end point

    Secondary: Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse

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    End point title
    		 Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse
    End point description
    Relapse was defined as either a total score ≥40 on the CDRS-R with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression). Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this endpoint.
    End point type
    Secondary
    End point timeframe
    From randomisation to Week 26 in the double-blind treatment period
    End point values
    		 Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: percentage of participants
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [4] - The efficacy analyses were not performed and data were not collected for this endpoint.
    [5] - The efficacy analyses were not performed and data were not collected for this endpoint.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26

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    End point title
    		 Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26
    End point description
    The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression). Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [6] - The efficacy analyses were not performed and data were not collected for this endpoint.
    [7] - The efficacy analyses were not performed and data were not collected for this endpoint.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26

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    End point title
    		 Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26
    End point description
    The CGI-S provides the clinician’s impression of the participant’s current state of mental illness. The clinician uses his or her clinical experience of this participant population to rate the severity of the participant’s current mental illness on a 7-point scale ranging from 1 (normal – not at all ill) to 7 (among the most extremely ill participants). Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [8] - The efficacy analyses were not performed and data were not collected for this endpoint.
    [9] - The efficacy analyses were not performed and data were not collected for this endpoint.
    No statistical analyses for this end point

    Secondary: Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26

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    End point title
    		 Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26
    End point description
    The CGI-I provides the clinician’s impression of the participant’s improvement (or worsening). The clinician assesses the participant’s condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 26
    End point values
    		 Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [10] - The efficacy analyses were not performed and data were not collected for this endpoint.
    [11] - The efficacy analyses were not performed and data were not collected for this endpoint.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26

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    End point title
    		 Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26
    End point description
    The PQ-LES-Q is a participant-rated scale designed to assess satisfaction with life. It is an adaptation of the Quality of Life Enjoyment and Satisfaction Questionnaire, which is used to measure quality of life in adults. The PQ-LES-Q consist of 15 items, item 1 to 14 assess the degree of satisfaction experienced by participants in various areas of daily functioning, and item 15 allows participants to summarise their experience in a global rating. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total score range of item 1 to 14 is 14 to 70, with higher scores indicating greater satisfaction. Due to the early termination of study and limited number of participants who completed the double-blind period, the efficacy analyses were not performed and data were not collected for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26
    End point values
    		 Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [12] - The efficacy analyses were not performed and data were not collected for this endpoint.
    [13] - The efficacy analyses were not performed and data were not collected for this endpoint.
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Vortioxetine

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    End point title
    		 Plasma Concentration of Vortioxetine
    End point description
    Due to early termination of the study, the pharmacokinetic analyses were not performed and the data were not collected.
    End point type
    Secondary
    End point timeframe
    From randomisation to Week 26 in the double-blind treatment period
    End point values
    		 Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: nanograms (ng)/milliliter (mL)
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [14] - Pharmacokinetic analyses were not performed and the data were not collected.
    [15] - Pharmacokinetic analyses were not performed and the data were not collected.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline (Week 0) up to Week 42
    Adverse event reporting additional description
    All-patients-enrolled (APES) included all participants enrolled to the 12-week open-label, flexible-dose treatment period who took at least 1 dose of study drug. All-patients-randomized set (APRS) included all participants randomized to the 26-week double-blind treatment period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Open-Label Treatment: Vortioxetine
    Reporting group description
    		 Participants initiated treatment with vortioxetine tablets 5 mg/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting AEs, vortioxetine dose could be up- or down-titrated with 5 mg/day to a maximum of 20 mg/day during the first 8 weeks. From Week 8 to Week 12, the dose remained fixed.

    Reporting group title
    Double-Blind Relapse Prevention: Vortioxetine
    Reporting group description
    		 Participants continued on the same fixed dose of vortioxetine as during the end of the open-label period for 26 weeks in the double-blind relapse prevention period.

    Reporting group title
    Double-Blind Relapse Prevention: Placebo
    Reporting group description
    		 Participants received placebo for 26 weeks in the double-blind relapse prevention period.

    Serious adverse events
    		 Open-Label Treatment: Vortioxetine Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Open-Label Treatment: Vortioxetine Double-Blind Relapse Prevention: Vortioxetine Double-Blind Relapse Prevention: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 33 (24.24%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Headache
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Nausea
         subjects affected / exposed
    6 / 33 (18.18%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    7
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 33 (6.06%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Coronavirus infection
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 33 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1

    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.
    The study was terminated based on new efficacy data from another study. The main primary and secondary efficacy objectives were not assessed due to termination of the study and the limited number of participants who completed the double-blind period.
    For support, Contact us.
    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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