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    Clinical Trial Results:
    A multicentre, double-blind, randomised, placebo-controlled phase II trial with a 3-week treatment period to assess the efficacy, safety and tolerability of add-on treatment with Ketamine hydrochloride prolonged release tablets (KET01, 120 mg or 240 mg once daily) in outpatients with treatment resistant depression

    Summary
    EudraCT number
    		 2021-004927-34
    Trial protocol
    		 DE   CZ   PL  
    Global end of trial date
    10 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 May 2024
    First version publication date
    24 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    KET01-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ketabon GmbH
    Sponsor organisation address
    Wilhelm-Wagenfeld-Straße 20, München, Germany, 80807
    Public contact
    Hans Eriksson, MD, PhD, MBA, Sponsor’s Medical Expert, 0049 15172515268, hans.eriksson@hmnc-brainhealth.com
    Scientific contact
    Hans Eriksson, MD, PhD, MBA, Sponsor’s Medical Expert, 0049 15172515268, hans.eriksson@hmnc-brainhealth.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
    26 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Apr 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore the efficacy of KET01 (120 mg or 240 mg) administered once daily (OD) as add-on therapy to standard treatment compared to placebo with respect to improvement of depressive symptoms assessed by change in Montgomery–Åsberg Depression Rating Scale (MADRS) total score in subjects with major depressive disorder (MDD), fulfilling criteria for treatment-resistant depression (TRD).
    Protection of trial subjects
    This trial was performed in compliance with Good Clinical Practices (GCP) and applicable regulatory requirements, including the archiving of essential documents.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 May 2022
    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
    Germany: 53
    Country: Number of subjects enrolled
    Czechia: 52
    Country: Number of subjects enrolled
    Poland: 62
    Worldwide total number of subjects
    167
    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)
    166
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This exploratory trial was performed from May 2022 to May 2023 at 29 sites in Czech Republic, Germany and Poland. 167 subjects enrolled in the trial

    Pre-assignment
    Screening details
    		 Subjects who met all the inclusion criteria and none of the exclusion criteria. Of the 167 subjects enrolled in the trial, 45 were screening failures and 122 were kept to be randomised to receive either KET01 240 mg, KET01 120 mg or placebo at Treatment Period - Visit 2b.

    Pre-assignment period milestones
    Number of subjects started
    		 167
    Number of subjects completed
    		 122

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 1
    Reason: Number of subjects
    		 Ineligibility/development of 1/mult. excl. crit.: 42
    Reason: Number of subjects
    		 Lost to follow-up: 1
    Period 1
    Period 1 title
    Baseline - Visit 2a
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    At this visit, where baseline values are evaluated, there was still no allocation to treatment done. This period and it arms are defined due to technical issues since validator expects a postassignment period marked for baseline and expects definition of arms for a postassignment period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Baseline - KET01-240
    Arm description
    		 Defined due to technical issues: Subjects that were randomised to KET01-240 at Visit 2b. Visit 2a is part of preassignment screening period
    Arm type
    		 Active comparator

    Investigational medicinal product name
    None
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    Defined due to technical issues: Subjects that were randomised to KET01-240 at Visit 2b. Visit 2a is part of preassignment screening period

    Arm title
    		 Baseline - KET01-120
    Arm description
    		 Defined due to technical issues: Subjects that were randomised to KET01-120 at Visit 2b. Visit 2a is part of preassignment screening period
    Arm type
    		 Active comparator

    Investigational medicinal product name
    None
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    Defined due to technical issues: Subjects that were randomised to KET01-120 at Visit 2b. Visit 2a is part of preassignment screening period

    Arm title
    		 Baseline - Placebo
    Arm description
    		 Defined due to technical issues: Subjects that were randomised to Placebo at Visit 2b. Visit 2a is part of preassignment screening period
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Not mentioned
    Dosage and administration details
    Defined due to technical issues: Subjects that were randomised to Placebo at Visit 2b. Visit 2a is part of preassignment screening period

    Number of subjects in period 1 [1]
    		Baseline - KET01-240 Baseline - KET01-120 Baseline - Placebo
    Started
    40
    42
    40
    Completed
    40
    42
    40
    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: Number of subjects in the baseline period are defined as subjects who met all the inclusion criteria and none of the exclusion criteria. Of the 167 subjects enrolled in the trial, 45 were screening failures and 122 were kept to be randomised to receive either KET01 240 mg, KET01 120 mg or placebo at Treatment Period.
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment - KET01-240
    Arm description
    		 KET01 240 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ketamine hydrochloride (HCl)
    Investigational medicinal product code
    KET01
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration. Subjects took a total daily dose of 240 mg ketamine hydrochloride by 2 KET01 tablets 40 mg (pink) and 2 KET01 tablets 80 mg (white). Dose was taken once daily in the morning. Duration of treatment: Subjects received 240 mg KET01 as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b. Subjects had to take 4 tablets, once daily in the morning together with a glass of water.

    Arm title
    		 Treatment - KET01-120
    Arm description
    		 KET01 120 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ketamine hydrochloride (HCl)
    Investigational medicinal product code
    KET01
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration. Subjects took a total daily dose of 120 mg ketamine hydrochloride by 1 KET01 tablet 40 mg (pink), 1 KET01 tablet 80 mg (white), 1 Placebo tablet1 40 mg (pink) and 1 Placebo tablet 80 mg (white). Dose was taken once daily in the morning. Duration of treatment: Subjects received 120 mg KET01 as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b. Subjects had to take 4 tablets, once daily in the morning together with a glass of water.

    Arm title
    		 Treatment - Placebo
    Arm description
    		 Placebo once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration. Subjects took a total daily dose of 0 mg ketamine hydrochloride by 2 Placebo tablets 40 mg (pink) and 2 Placebo tablets 80 mg (white). Dose was taken once daily in the morning. Duration of treatment: Subjects received placebo as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b. Subjects had to take 4 tablets, once daily in the morning together with a glass of water.

    Number of subjects in period 2
    		Treatment - KET01-240 Treatment - KET01-120 Treatment - Placebo
    Started
    40
    42
    40
    Completed
    36
    38
    39
    Not completed
    4
    4
    1
         Ineligibility/development of 1/mult. excl. crit.
    1
    1
    -
         Consent withdrawn by subject
    1
    -
    -
         Adverse event, non-fatal
    1
    2
    -
         Other
    1
    -
    1
         Lack of efficacy
    -
    1
    -
    Period 3
    Period 3 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Follow-up - KET01-240
    Arm description
    		 KET01 240 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ketamine hydrochloride (HCl)
    Investigational medicinal product code
    KET01
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration. Subjects took a total daily dose of 240 mg ketamine hydrochloride by 2 KET01 tablets 40 mg (pink) and 2 KET01 tablets 80 mg (white). Dose was taken once daily in the morning. Duration of treatment: Subjects received 240 mg KET01 as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b. Subjects had to take 4 tablets, once daily in the morning together with a glass of water.

    Arm title
    		 Follow-up - KET01-120
    Arm description
    		 KET01 120 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ketamine hydrochloride (HCl)
    Investigational medicinal product code
    KET01
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration. Subjects took a total daily dose of 120 mg ketamine hydrochloride by 1 KET01 tablet 40 mg (pink), 1 KET01 tablet 80 mg (white), 1 Placebo tablet 40 mg (pink) and 1 Placebo tablet 80 mg (white). Dose was taken once daily in the morning. Duration of treatment: Subjects received 120 mg KET01 as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b. Subjects had to take 4 tablets, once daily in the morning together with a glass of water.

    Arm title
    		 Follow-up - Placebo
    Arm description
    		 Placebo once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Prolonged-release tablet
    Routes of administration
    Oral use
    Dosage and administration details
    KET01 tablets 40 mg (pink), KET01 tablets 80 mg (white) and Placebo tablets matching KET01 tablets 40 mg (pink) and 80 mg (white) for oral administration. Subjects took a total daily dose of 0 mg ketamine hydrochloride by 2 Placebo tablets 40 mg (pink) and 2 Placebo tablets 80 mg (white). Dose was taken once daily in the morning. Duration of treatment: Subjects received placebo as add-on treatment for a duration of 21 (±2) days, starting at Visit 2b. Subjects had to take 4 tablets, once daily in the morning together with a glass of water.

    Number of subjects in period 3 [2]
    		Follow-up - KET01-240 Follow-up - KET01-120 Follow-up - Placebo
    Started
    36
    38
    38
    Completed
    36
    38
    38
    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: In total not only the subjects that completed the previous period but all 122 subjects started in the treatment period should be followed up and should complete a Follow-Up visit to document the development of score . In total 121 of 122 subjects did the Follow-Up visit. Due to technical issues only the 112 of 113 subjects, that completed the previous period and had a follow-up visit, could be stated here instead the 121 participating subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Baseline - KET01-240
    Reporting group description
    		 Defined due to technical issues: Subjects that were randomised to KET01-240 at Visit 2b. Visit 2a is part of preassignment screening period

    Reporting group title
    Baseline - KET01-120
    Reporting group description
    		 Defined due to technical issues: Subjects that were randomised to KET01-120 at Visit 2b. Visit 2a is part of preassignment screening period

    Reporting group title
    Baseline - Placebo
    Reporting group description
    		 Defined due to technical issues: Subjects that were randomised to Placebo at Visit 2b. Visit 2a is part of preassignment screening period

    Reporting group values
    		 Baseline - KET01-240 Baseline - KET01-120 Baseline - Placebo Total
    Number of subjects
    		 40 42 40 122
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    		 0 0 0 0
        Preterm newborn- gestational age < 37 wk
    		 0 0 0 0
        Newborns (0-27days)
    		 0 0 0 0
        Infants and toddlers (28days – 23months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 year)
    		 0 0 0 0
        From 18 - 64 years
    		 40 41 40 121
        From 65 – 84 years
    		 0 1 0 1
        Over 85 years
    		 0 0 0 0
    Age Continuous
    Age Continuous Characteristic
    Units: years
        arithmetic mean (standard deviation)
    		 40.6 ( 12.52 ) 41.3 ( 12.43 ) 38.9 ( 9.16 ) -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    		 24 27 21 72
        Male
    		 16 15 19 50

    End points

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    End points reporting groups
    Reporting group title
    Baseline - KET01-240
    Reporting group description
    		 Defined due to technical issues: Subjects that were randomised to KET01-240 at Visit 2b. Visit 2a is part of preassignment screening period

    Reporting group title
    Baseline - KET01-120
    Reporting group description
    		 Defined due to technical issues: Subjects that were randomised to KET01-120 at Visit 2b. Visit 2a is part of preassignment screening period

    Reporting group title
    Baseline - Placebo
    Reporting group description
    		 Defined due to technical issues: Subjects that were randomised to Placebo at Visit 2b. Visit 2a is part of preassignment screening period
    Reporting group title
    Treatment - KET01-240
    Reporting group description
    		 KET01 240 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial

    Reporting group title
    Treatment - KET01-120
    Reporting group description
    		 KET01 120 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial

    Reporting group title
    Treatment - Placebo
    Reporting group description
    		 Placebo once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial
    Reporting group title
    Follow-up - KET01-240
    Reporting group description
    		 KET01 240 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial

    Reporting group title
    Follow-up - KET01-120
    Reporting group description
    		 KET01 120 mg once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial

    Reporting group title
    Follow-up - Placebo
    Reporting group description
    		 Placebo once daily in addition to subject's current antidepressant treatment. Treatment with agreed ongoing antidepressant medication(s) had to be continued and to be kept at a stable dose throughout the trial

    Subject analysis set title
    Treatment - KET01-240 x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set (SAF) was defined as all subjects who received at least one dose of IP.

    Subject analysis set title
    Treatment - KET01-120 x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set (SAF) was defined as all subjects who received at least one dose of IP.

    Subject analysis set title
    Treatment - Placebo x Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety set (SAF) was defined as all subjects who received at least one dose of IP.

    Subject analysis set title
    Treatment - KET01-240 x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set was defined as all subjects who received at least one dose of IP and who had at least one post-baseline assessment of primary efficacy measurement.

    Subject analysis set title
    Treatment - KET01-120 x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set was defined as all subjects who received at least one dose of IP and who had at least one post-baseline assessment of primary efficacy measurement.

    Subject analysis set title
    Treatment - Placebo x Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set was defined as all subjects who received at least one dose of IP and who had at least one post-baseline assessment of primary efficacy measurement.

    Subject analysis set title
    Treatment - KET01-240 x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol set (PPS) was defined as all subjects who were included into the FAS and had no major protocol deviations that could have an influence on the primary efficacy endpoint.

    Subject analysis set title
    Treatment - KET01-120 x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol set (PPS) was defined as all subjects who were included into the FAS and had no major protocol deviations that could have an influence on the primary efficacy endpoint.

    Subject analysis set title
    Treatment - Placebo x Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per-protocol set (PPS) was defined as all subjects who were included into the FAS and had no major protocol deviations that could have an influence on the primary efficacy endpoint.

    Primary: Change in MADRS total score

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    End point title
    		 Change in MADRS total score
    End point description
    Change from baseline at Visit 2a to Visit 6 / early discontinuation visit (EDV) in MADRS total score.
    End point type
    Primary
    End point timeframe
    3 weeks
    End point values
    		 Treatment - KET01-240 x Full Analysis Set Treatment - KET01-120 x Full Analysis Set Treatment - Placebo x Full Analysis Set
    Number of subjects analysed
    40
    42
    40
    Units: [Score]
    number (standard deviation)
        Change
    -13.4
    -11.9
    -11
    Statistical analysis title
    		 MMRM, Full analysis set.
    Statistical analysis description
    mixed model for repeated measures (MMRM) with fixed effects of treatment, visit, visit and treatment interaction and baseline MADRS total score as a covariate as well as random effects of subject and country
    Comparison groups
    Treatment - KET01-240 x Full Analysis Set v Treatment - Placebo x Full Analysis Set
    Number of subjects included in analysis
    80
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4125
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.21
         upper limit
    		 2.57
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.215
    Statistical analysis title
    		 MMRM, Full analysis set.
    Statistical analysis description
    mixed model for repeated measures (MMRM) with fixed effects of treatment, visit, visit and treatment interaction and baseline MADRS total score as a covariate as well as random effects of subject and country
    Comparison groups
    Treatment - KET01-120 x Full Analysis Set v Treatment - Placebo x Full Analysis Set
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8516
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.75
         upper limit
    		 3.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.19

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs with the first onset or worsening after the first IP intake and not more than 14 days after the last IP intake were defined as TEAEs in this trial, the period of observation for the collection of AEs extends from informed consent given til final visit
    Adverse event reporting additional description
    Only numbers of TEAEs are reported. Frequency threshold for reporting non-serious adverse event was set to 4%.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Treatment - KET01-240 x Safety Set
    Reporting group description
    		 Subjects in the Safety Set treated with KET01 240 mg

    Reporting group title
    Treatment - Placebo x Safety Set
    Reporting group description
    		 Subjects in the Safety Set treated with Placebo

    Reporting group title
    Treatment - KET01-120 x Safety Set
    Reporting group description
    		 Subjects in the Safety Set treated with KET01 120 mg

    Serious adverse events
    		 Treatment - KET01-240 x Safety Set Treatment - Placebo x Safety Set Treatment - KET01-120 x Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Psychiatric disorders
    Depression suicidal
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Treatment - KET01-240 x Safety Set Treatment - Placebo x Safety Set Treatment - KET01-120 x Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 40 (50.00%)
    13 / 40 (32.50%)
    15 / 42 (35.71%)
    Investigations
    Blood pressure diastolic increased
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    0 / 42 (0.00%)
         occurrences all number
    0
    2
    0
    Inflammatory marker increased
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    4 / 40 (10.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    4
    0
    1
    Heart rate increased
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    0
    0
    2
    C-reactive protein increased
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 42 (4.76%)
         occurrences all number
    0
    1
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    2
    0
    1
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
         occurrences all number
    2
    1
    0
    Headache
         subjects affected / exposed
    4 / 40 (10.00%)
    7 / 40 (17.50%)
    5 / 42 (11.90%)
         occurrences all number
    4
    10
    6
    Dizziness
         subjects affected / exposed
    7 / 40 (17.50%)
    1 / 40 (2.50%)
    2 / 42 (4.76%)
         occurrences all number
    7
    1
    2
    Somnolence
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    2 / 42 (4.76%)
         occurrences all number
    1
    1
    2
    Paraesthesia
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    2
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    0 / 42 (0.00%)
         occurrences all number
    2
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    2
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 42 (4.76%)
         occurrences all number
    0
    0
    2
    Depression
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    2
    0
    1
    Dissociation
         subjects affected / exposed
    4 / 40 (10.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    4
    0
    0
    Anxiety
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 42 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Cystitis
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    1 / 42 (2.38%)
         occurrences all number
    3
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    0 / 42 (0.00%)
         occurrences all number
    1
    2
    0

    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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    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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