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    Clinical Trial Results:
    Safety and efficacy of repeated low dose D-lysergic acid diethylamide (LSD) D-Tartrate (MM-120) as treatment for ADHD in adults: a multi-center, randomized, double- blind, placebo-controlled Phase 2a Proof of Concept Trial

    Summary
    EudraCT number
    		 2020-001098-55
    Trial protocol
    		 NL  
    Global end of trial date
    04 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Nov 2024
    First version publication date
    14 Nov 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MMED007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05200936
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mind Medicine, Inc.
    Sponsor organisation address
    One World Trade Center, Suite 8500, New York, United States, NY1007
    Public contact
    Dan Karlin, Mind Medicine, Inc., +1 917-699-6564, dkarlin@mindmed.co
    Scientific contact
    Dan Karlin, Mind Medicine, Inc., +1 917-699-6564, dkarlin@mindmed.co
    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
    04 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the treatment efficacy vs placebo of repeated low doses (20 μg) of MM120 for six weeks in adult subjects with attention-deficit/hyperactivity disorder (ADHD) measured by Adult Attention Deficit Investigator Symptom Rating Scale (AISRS).
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization (ICH) guideline E6: Good Clinical Practice (GCP). Before a subject participated in the study, written informed consent was obtained. The subject was asked to read a subject information section of the consent form prospectively approved by the Ethics Committee and to sign it to indicate consent to participate in the study. Informed consent was obtained before the initiation of any study procedures for each subject. If the subject was not capable of providing a signature, an oral statement of consent could be given in the presence of a witness.
    Background therapy
    		 -
    Evidence for comparator
    		 Placebo used as a comparator to assess the efficacy of the IMP.
    Actual start date of recruitment
    20 Dec 2021
    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
    Netherlands: 3
    Country: Number of subjects enrolled
    Switzerland: 50
    Worldwide total number of subjects
    53
    EEA total number of subjects
    3
    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)
    53
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 52 subjects were planned to be enrolled in this study, in the Netherlands and in Switzerland, of which 26 are expected to be recruited in Basel. Advertisement flyers that were hung around UHB and Maastricht University were used early in the study in May 2020 to June 2023.

    Pre-assignment
    Screening details
    		 A total of 74 subjects were screened, 21 out of 74 subjects failed screening. The reason for subjects failing screening was not meeting the inclusion/exclusion criteria. 53 subjects were randomized in the study. A total of 53 subjects were analysed in the Full Analysis Set (FAS) and Safety Set (SAF).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MM120
    Arm description
    		 Subjects receive 20 μg of MM120 administered orally twice weekly for 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    D-Lysergic Acid Diethylamide (LSD) D-Tartrate
    Investigational medicinal product code
    MM120
    Other name
    LSD D-tartrate
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    LSD-tartrate 0.029mg (corresp. 0.020 mg LSD), ethanol 0.16 g, aqua pur ad 1 mL Subjects to receive MM120 twice weekly for 6 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Subjects receive Placebo administered orally twice weekly for 6 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Ethanol 0.16 g aqua pur ad 1 mL Subjects to receive Placebo twice weekly for 6 weeks.

    Number of subjects in period 1
    		MM120 Placebo
    Started
    27
    26
    Completed
    23
    23
    Not completed
    4
    3
         Consent withdrawn by subject
    2
    2
         Pregnancy
    -
    1
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MM120
    Reporting group description
    		 Subjects receive 20 μg of MM120 administered orally twice weekly for 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects receive Placebo administered orally twice weekly for 6 weeks.

    Reporting group values
    		 MM120 Placebo Total
    Number of subjects
    		 27 26 53
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 27 26 53
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.3 ( 12.82 ) 33.1 ( 11.00 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 9 22
        Male
    		 14 17 31
    Country
    Units: Subjects
        Switzerland
    		 25 25 50
        Netherlands
    		 2 1 3
    AISRS Score
    AISRS - Adult ADHD investigator symptom rating scale
    Units: score on a scale
        arithmetic mean (standard deviation)
    		 37.3 ( 5.83 ) 36.9 ( 5.10 ) -
    CGI - Severity
    CGI - Clinical Global Impression
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 4.9 ( 0.72 ) 4.7 ( 0.62 ) -
    ASRS Score
    ASRS - Adult attention-deficit/hyperactivity disorder self-reporting rating scale N= 26 for MM120 group
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 47.3 ( 7.72 ) 43.9 ( 7.33 ) -
    CAARS-L-SR: ADHD Index
    ADHD = Attention-deficit/hyperactivity disorder; CAARS-L-SR = Connors’ adult ADHD rating scale self-report long form
    Units: Score on a scale
        arithmetic mean (standard deviation)
    		 27.1 ( 13.32 ) 22.3 ( 9.25 ) -

    End points

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    End points reporting groups
    Reporting group title
    MM120
    Reporting group description
    		 Subjects receive 20 μg of MM120 administered orally twice weekly for 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects receive Placebo administered orally twice weekly for 6 weeks.

    Primary: Change from Baseline to Week 6 in AISRS score

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    End point title
    		 Change from Baseline to Week 6 in AISRS score
    End point description
    AISRS = Adult ADHD investigator symptom rating scale The AISRS total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS), which were derived based on DSM-5 criteria for ADHD. The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
    End point type
    Primary
    End point timeframe
    Baseline to Week 6
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    27
    26
    Units: score on a scale
        least squares mean (standard error)
    -7.68 ( 1.59 )
    -8.96 ( 1.60 )
    Statistical analysis title
    		 Change from Baseline to Week 6 in AISRS score
    Comparison groups
    MM120 v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7145 [1]
    Method
    		 Mixed model for repeated measures
    Parameter type
    		 Least Squares Mean
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.14
         upper limit
    		 5.69
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.25
    Notes
    [1] - p-value is one-sided

    Secondary: Summary of Change from Baseline to Week 2 (predose) in AISRS score

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    End point title
    		 Summary of Change from Baseline to Week 2 (predose) in AISRS score
    End point description
    AISRS = Adult ADHD investigator symptom rating scale The AISRS total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS), which were derived based on DSM-5 criteria for ADHD. The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    26
    26
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -3.3 ( 3.62 )
    -4.8 ( 3.24 )
    No statistical analyses for this end point

    Secondary: Occurrence of subjects who experienced at least a 1-point decrease in the CGI-S

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    End point title
    		 Occurrence of subjects who experienced at least a 1-point decrease in the CGI-S
    End point description
    CGI-S = Clinical global impression-severity scale The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. Possible ratings are: 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    27
    26
    Units: Subjects
    18
    15
    No statistical analyses for this end point

    Secondary: Summary of Change from Baseline to Week 2 (predose) of CGI-S

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    End point title
    		 Summary of Change from Baseline to Week 2 (predose) of CGI-S
    End point description
    CGI-S = Clinical global impression-severity scale The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. Possible ratings are: 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients
    End point type
    Secondary
    End point timeframe
    Baseline to Week 2
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    26
    26
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.3 ( 0.47 )
    -0.4 ( 0.50 )
    No statistical analyses for this end point

    Secondary: Summary of Change from Baseline to Week 6 of CGI-S

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    End point title
    		 Summary of Change from Baseline to Week 6 of CGI-S
    End point description
    CGI-S = Clinical global impression-severity scale The Clinical Global Impression – Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. Possible ratings are: 1. Normal, not at all ill 2. Borderline mentally ill 3. Mildly ill 4. Moderately ill 5. Markedly ill 6. Severely ill 7. Among the most extremely ill patients
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    23
    23
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.9 ( 0.69 )
    -1.0 ( 0.95 )
    No statistical analyses for this end point

    Secondary: Summary of Change from Baseline to Week 6 (Day 40) of ASRS Score

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    End point title
    		 Summary of Change from Baseline to Week 6 (Day 40) of ASRS Score
    End point description
    ASRS = Adult attention-deficit/hyperactivity disorder self-reporting rating scale The Adult Attention-Deficit/Hyperactivity Disorder Self-Reporting Rating Scale (ASRS) is composed of 18 questions, and uses a scale that ranges from 0-4 based on the individuals mark in either the "never, rarely, sometimes, often, very often" column for a possible total score of 72.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    17
    22
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -18.6 ( 10.66 )
    -12.3 ( 10.93 )
    No statistical analyses for this end point

    Secondary: Summary of Change from Baseline to Week 6 (Day 40) of CAARS

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    End point title
    		 Summary of Change from Baseline to Week 6 (Day 40) of CAARS
    End point description
    ADHD = Attention-deficit/hyperactivity disorder; CAARS = Connors’ adult ADHD rating scale; DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Ed The CAARS Self-Report Long Form is a 66-item measure of ADHD symptoms that was designed as a self-report assessment for adult ADHD. Responses are scored on a 4-point scale, where 0 = not at all, 1 = just a little, 2 = pretty much, and 3 = very much.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 6
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    18 [2]
    21
    Units: Score on a scale
    arithmetic mean (full range (min-max))
        DSM-IV Inattentive Symptoms Week 6
    -6.3 (-15 to 5)
    -4.3 (-16 to 6)
        DSM-IV Hyperactive/ Impulsive symptoms Week 6
    -5.3 (-15 to 3)
    -2.4 (-15 to 5)
        DSM-IV ADHD Symptoms Total Week 6
    -11.6 (-30 to 7)
    -6.8 (-30 to 6)
        ADHD Index Week 6
    -7.8 (-18 to 2)
    -4.8 (-16 to 1)
        Inattention/ Memory problems Week 6
    -7.8 (-16 to 1)
    -6.0 (-22 to 3)
        Hyperactivity/ Restlessness Week 6
    -8.0 (-17 to 1)
    -4.4 (-21 to 7)
        Impulsivity/ Emotional lability Week 6
    -7.9 (-20 to 6)
    -5.0 (-21 to 6)
        Problems with self-concept Week 6
    -3.6 (-10 to 1)
    -1.9 (-9 to 4)
    Notes
    [2] - N=17 Inattention problem, Hyperactivity Restlessness,Impulsivity/ Emotional ability and problems wSC
    No statistical analyses for this end point

    Secondary: Summary of 5D-ASC Total Score at Week 1 Day 1 and Week 6

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    End point title
    		 Summary of 5D-ASC Total Score at Week 1 Day 1 and Week 6
    End point description
    5D-ASC = 5 dimensions of altered states of consciousness scale The 5 dimensions of altered states of consciousness (5D-ASC) scale is a visual analog scale consisting of 94 items (Dittrich, 1998; Studerus et al., 2010). The instrument is constructed of five scales, and allows assessing mood, anxiety, derealization, depersonalization, changes in perception, auditory alterations, and reduced vigilance.
    End point type
    Secondary
    End point timeframe
    From Week 1 Day 1 to Week 6
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    27 [3]
    26 [4]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Oceanic boundlessness Week 1 Day 1
    479.6 ( 511.47 )
    161.3 ( 334.52 )
        Anxious ego dissolution Week 1 Day 1
    103.6 ( 171.94 )
    19.0 ( 32.53 )
        Visionary destructuralization Week 1 Day 1
    233.4 ( 247.17 )
    94.8 ( 188.58 )
        Auditory alterations Week 1 Day 1
    71.0 ( 148.54 )
    32.7 ( 77.09 )
        Vigilance reduction Week 1 Day 1
    288.5 ( 228.77 )
    155.2 ( 187.82 )
        Total score Week 1 Day 1
    1176.0 ( 997.40 )
    463.0 ( 733.11 )
        Oceanic boundlessness Week 6
    403.3 ( 483.36 )
    70.2 ( 125.32 )
        Anxious ego dissolution Week 6
    41.0 ( 96.29 )
    4.2 ( 10.53 )
        Visionary destructuralization Week 6
    199.7 ( 260.91 )
    32.9 ( 61.36 )
        Auditory alterations Week 6
    18.4 ( 42.26 )
    4.2 ( 9.75 )
        Vigilance reduction Week 6
    90.3 ( 88.27 )
    20.0 ( 30.40 )
        Total Score Week 6
    752.9 ( 845.69 )
    131.4 ( 188.21 )
    Notes
    [3] - N = 23 for Week 6
    [4] - N = 23 for Week 6
    No statistical analyses for this end point

    Secondary: Summary of MEQ30 at Week 1 Day 1 and Week 6

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    End point title
    		 Summary of MEQ30 at Week 1 Day 1 and Week 6
    End point description
    MEQ30 = Mystical experience questionnaire 30 items This 30-item questionnaire is rated on a six-point scale.
    End point type
    Secondary
    End point timeframe
    From Week 1 Day 1 to Week 6
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    27 [5]
    26 [6]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 1 Day 1
    22.37 ( 19.720 )
    10.40 ( 15.929 )
        Week 6
    20.50 ( 19.791 )
    5.20 ( 8.585 )
    Notes
    [5] - N= 23 for Week 6
    [6] - N= 22 for Week 6
    No statistical analyses for this end point

    Secondary: Summary of VAS Scores Before and After the First Dose

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    End point title
    		 Summary of VAS Scores Before and After the First Dose
    End point description
    VAS = Visual analog scale The boundaries blur = The boundaries between myself and my surroundings seem to blur
    End point type
    Secondary
    End point timeframe
    Time between 0 to 6 hours post first dose
    End point values
    		 MM120 Placebo
    Number of subjects analysed
    27
    26
    Units: Score on a scale
    arithmetic mean (full range (min-max))
        Time 0 (predose) - Any drug effect
    0.0 (0 to 0)
    0.0 (0 to 0)
        Time 0 (predose) - Drug liking
    37.1 (0 to 55)
    44.9 (0 to 52)
        Time 0 (predose) - Fear
    2.7 (0 to 36)
    1.4 (0 to 23)
        Time 0 (predose) - Nausea
    1.1 (0 to 30)
    0.0 (0 to 0)
        Time 0 (predose) - Alteration of vision
    0.0 (0 to 0)
    0.0 (0 to 0)
        Time 0 (predose) - Alteration of sense of time
    0.0 (0 to 0)
    0.0 (0 to 0)
        Time 0 (predose) - The boundaries blur
    0.0 (0 to 0)
    0.0 (0 to 0)
        0.5 hours post dose - Any drug effect
    8.9 (0 to 78)
    11.3 (0 to 75)
        0.5 hours post dose - Drug liking
    44.4 (0 to 78)
    48.1 (0 to 83)
        0.5 hours post dose - Fear
    2.0 (0 to 54)
    2.2 (0 to 48)
        0.5 hours post dose - Nausea
    2.0 (0 to 53)
    0.2 (0 to 3)
        0.5 hours post dose - Alteration of vision
    3.5 (0 to 54)
    7.4 (0 to 81)
        0.5 hours post dose - Alteration of sense of time
    2.5 (0 to 41)
    3.2 (0 to 35)
        0.5 hours post dose - The boundaries blur
    3.0 (0 to 71)
    0.8 (0 to 12)
        1 hour post dose - Any drug effect
    24.1 (0 to 100)
    12.7 (0 to 64)
        1 hour post dose - Drug liking
    49.7 (0 to 97)
    51.8 (2 to 97)
        1 hour post dose - Fear
    1.4 (0 to 32)
    0.1 (0 to 2)
        1 hour post dose - Nausea
    2.7 (0 to 37)
    1.0 (0 to 23)
        1 hour post dose - Alteration of vision
    4.0 (0 to 56)
    6.9 (0 to 72)
        1 hour post dose - Alteration of sense of time
    8.1 (0 to 73)
    6.3 (0 to 68)
        1 hour post dose - The boundaries blur
    6.0 (0 to 87)
    1.5 (0 to 24)
        2 hours post dose - Any drug effect
    38.1 (0 to 97)
    12.8 (0 to 72)
        2 hours post dose - Drug liking
    57.3 (0 to 100)
    53.3 (3 to 100)
        2 hours post dose - Fear
    4.1 (0 to 68)
    0.1 (0 to 2)
        2 hours post dose - Nausea
    8.2 (0 to 60)
    0.1 (0 to 2)
        2 hours post dose - Alteration of vision
    13.0 (0 to 84)
    6.2 (0 to 88)
        2 hours post dose - Alteration of sense of time
    13.5 (0 to 78)
    4.4 (0 to 53)
        2 hours post dose - The boundaries blur
    12.3 (0 to 83)
    1.3 (0 to 14)
        3 hours post dose - Any drug effect
    44.3 (0 to 97)
    11.1 (0 to 65)
        3 hours post dose - Drug liking
    61.6 (0 to 100)
    53.1 (3 to 96)
        3 hours post dose - Fear
    2.9 (0 to 54)
    0.2 (0 to 2)
        3 hours post dose - Nausea
    8.0 (0 to 56)
    0.2 (0 to 3)
        3 hours post dose - Alteration of vision
    13.9 (0 to 84)
    6.5 (0 to 76)
        3 hours post dose - Alteration of sense of time
    12.3 (0 to 89)
    4.9 (0 to 74)
        3 hours post dose - The boundaries blur
    12.7 (0 to 88)
    1.4 (0 to 31)
        4 hours post dose - Any drug effect
    38.5 (0 to 97)
    15.1 (0 to 100)
        4 hours post dose - Drug liking
    60.7 (0 to 100)
    48.0 (2 to 100)
        4 hours post dose - Fear
    2.7 (0 to 50)
    0.1 (0 to 2)
        4 hours post dose - Nausea
    6.9 (0 to 65)
    0.1 (0 to 2)
        4 hours post dose - Alteration of vision
    12.4 (0 to 86)
    3.2 (0 to 37)
        4 hours post dose - Alteration of sense of time
    12.1 (0 to 92)
    7.0 (0 to 57)
        4 hours post dose - The boundaries blur
    6.9 (0 to 69)
    0.2 (0 to 2)
        6 hours post dose - Any drug effect
    16.7 (0 to 75)
    9.6 (0 to 72)
        6 hours post dose - Drug liking
    54.8 (0 to 100)
    49.6 (0 to 100)
        6 hours post dose - Fear
    2.3 (0 to 52)
    2.1 (0 to 48)
        6 hours post dose - Nausea
    3.6 (0 to 52)
    0.2 (0 to 4)
        6 hours post dose - Alteration of vision
    4.1 (0 to 59)
    5.8 (0 to 59)
        6 hours post dose - Alteration of sense of time
    6.3 (0 to 69)
    3.0 (0 to 55)
        6 hours post dose - The boundaries blur
    4.1 (0 to 61)
    0.1 (0 to 2)
    No statistical analyses for this end point

    Secondary: Maximum Plasma Concentration (Cmax) of MM120

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    End point title
    		 Maximum Plasma Concentration (Cmax) of MM120 [7]
    End point description
    Cmax = maximum plasma concentration
    End point type
    Secondary
    End point timeframe
    Between 0 -6 hours after first dose
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic parameters were only studied for MM120 administered subjects.
    End point values
    		 MM120
    Number of subjects analysed
    24
    Units: ng/mL
        arithmetic mean (standard deviation)
    0.4811 ( 0.14279 )
    No statistical analyses for this end point

    Secondary: Time to maximum plasma concentration (tmax) of MM120

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    End point title
    		 Time to maximum plasma concentration (tmax) of MM120 [8]
    End point description
    Tmax = time to peak plasma concentration
    End point type
    Secondary
    End point timeframe
    Between 0 -6 hours after first dose
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic parameters were only studied for MM120 administered subjects.
    End point values
    		 MM120
    Number of subjects analysed
    24
    Units: hour
        median (full range (min-max))
    1.00 (0.5 to 3.0)
    No statistical analyses for this end point

    Secondary: The half- life (t½) of MM120 Plasma concentration

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    End point title
    		 The half- life (t½) of MM120 Plasma concentration [9]
    End point description
    t1/2 = half-life, The PK parameters AUC0-inf and t½ are not reported for the individual PK profiles where lambda was not measured (e.g., fewer than 3 non-zero concentrations in the terminal elimination phase or adjusted Rsq <0.8).
    End point type
    Secondary
    End point timeframe
    Between 0 -6 hours after first dose
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic parameters were only studied for MM120 administered subjects.
    End point values
    		 MM120
    Number of subjects analysed
    21
    Units: hour
        arithmetic mean (standard deviation)
    3.8187 ( 1.27269 )
    No statistical analyses for this end point

    Secondary: Area under the Plasma Concentration time curve from time 0 to Infinity (AUC 0-inf) of MM120

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    End point title
    		 Area under the Plasma Concentration time curve from time 0 to Infinity (AUC 0-inf) of MM120 [10]
    End point description
    AUC = area under the plasma concentration curve The PK parameters AUC0-inf and t½ are not reported for the individual PK profiles where lambda was not measured (e.g., fewer than 3 non-zero concentrations in the terminal elimination phase or adjusted Rsq <0.8).
    End point type
    Secondary
    End point timeframe
    Between 0 -6 hours after first dose
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic parameters were only studied for MM120 administered subjects.
    End point values
    		 MM120
    Number of subjects analysed
    21
    Units: ng∙hr/mL
        arithmetic mean (standard deviation)
    3.2450 ( 1.58494 )
    No statistical analyses for this end point

    Secondary: Area under the Plasma Concentration-time Curve from Time 0 to 6 hours (AUC 0-6h) of MM120

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    End point title
    		 Area under the Plasma Concentration-time Curve from Time 0 to 6 hours (AUC 0-6h) of MM120 [11]
    End point description
    AUC = area under the plasma concentration curve
    End point type
    Secondary
    End point timeframe
    Between 0 -6 hours after first dose
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Pharmacokinetic parameters were only studied for MM120 administered subjects.
    End point values
    		 MM120
    Number of subjects analysed
    24
    Units: ng∙hr/mL
        arithmetic mean (standard deviation)
    1.9411 ( 0.63490 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    MM120
    Reporting group description
    		 MM120 - LSD D-tartrate A total of 26 subjects were planned to receive 20 μg of MM120 twice weekly for 6 weeks.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly for 6 weeks

    Serious adverse events
    		 MM120 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
    0 / 26 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 MM120 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 27 (77.78%)
    23 / 26 (88.46%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Hypertension
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 26 (3.85%)
         occurrences all number
    4
    1
    Feeling abnormal
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Swelling
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Social circumstances
    High risk sexual behaviour
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Substance use
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Premenstrual pain
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 27 (0.00%)
    2 / 26 (7.69%)
         occurrences all number
    0
    2
    Epistaxis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Nasal congestion
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Throat tightness
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Illusion
         subjects affected / exposed
    4 / 27 (14.81%)
    0 / 26 (0.00%)
         occurrences all number
    4
    0
    Insomnia
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 26 (3.85%)
         occurrences all number
    3
    1
    Apathy
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 26 (7.69%)
         occurrences all number
    1
    2
    Euphoric mood
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Flashback
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Hypersomnia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Sleep disorder
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Full blood count normal
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Heart rate increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Pregnancy test positive
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Urine cannabinoids increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Ankle fracture
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Palate injury
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Wound
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Syncope
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 27 (48.15%)
    9 / 26 (34.62%)
         occurrences all number
    13
    9
    Disturbance in attention
         subjects affected / exposed
    2 / 27 (7.41%)
    2 / 26 (7.69%)
         occurrences all number
    2
    2
    Akathisia
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Dizziness postural
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 27 (18.52%)
    1 / 26 (3.85%)
         occurrences all number
    5
    1
    Abdominal pain
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 26 (7.69%)
         occurrences all number
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 26 (7.69%)
         occurrences all number
    1
    2
    Diarrhoea
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 26 (3.85%)
         occurrences all number
    1
    1
    Flatulence
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 26 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urethritis noninfective
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Back pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Muscle tightness
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 27 (18.52%)
    5 / 26 (19.23%)
         occurrences all number
    5
    5
    Urinary tract infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 26 (3.85%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypophosphataemia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 26 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2022
    There was one substantial amendment filed both in Netherlands (submitted 18MAY2022/approved 07JUL2022) and Switzerland (16MAY2022/Approved 03JUN2022). The main reason for the update of the protocol was due to health authorities feedback during the review. A brief summary of the changes are noted below. Study population number decreased from approximately 87 to 52 Add Inclusion criteria 1, 4, 7, 8, 12, 8, 9, 10, 11, 19 and 20. Updated exclusion criteria 16: Women of childbearing potential (WOCBP) (i.e., physiologically capable of becoming pregnant) who are unwilling or unable to use a highly effective method of contraception, as defined in Appendix 2, for the duration of the study, OR Men physiologically capable of fathering a child who are sexually active with WOCBP but are unwilling or unable to use barrier contraception (e.g., condom with or without spermicidal cream or jelly) for the duration of the study NOTE: See Appendix 2 for definitions of WOCBP and highly effective methods of contraception and for information about unacceptable methods of contraception

    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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