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    Clinical Trial Results:
    A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of MIN-101 in Patients With Negative Symptoms of Schizophrenia, Followed by a 24-Week, Open-Label Extension.

    Summary
    EudraCT number
    2014-004878-42
    Trial protocol
    LV   EE   RO   BG  
    Global end of trial date
    02 Sep 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Sep 2018
    First version publication date
    27 Sep 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MIN-101C03
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Minerva Neurosciences, Inc.
    Sponsor organisation address
    1601 Trapelo Road, Suite 286, Waltham, United States, 02451
    Public contact
    Joseph Reilly, Minerva Neurosciences, Inc., 1 6176007380, jreilly@minervaneurosciences.com
    Scientific contact
    Jay Saoud, Minerva Neurosciences, Inc., 1 6176007375, jsaoud@minervaneurosciences.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
    20 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of MIN-101 compared to placebo in improving the negative symptoms of schizophrenia as measured by the change from Baseline in the Positive and Negative Syndrome Scale (PANSS) negative subscale score of the pentagonal model over 12 weeks of treatment.
    Protection of trial subjects
    Prior to initiation of the study, the study protocol and associated documentation were reviewed and approved by an Independent Ethics Committee (IEC). This study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practices (GCP) and applicable regulatory requirements. Subjects or their legally acceptable representatives provided their written consent to participate in the study after having been informed about the nature and purpose of the study, participation/termination conditions, and risks and benefits of treatment. Personal data from subjects enrolled in this study was limited to those data necessary to investigate the efficacy, safety, quality, and utility of the investigational study agent(s) used in this study, and were collected and processed with adequate precautions to ensure confidentiality and compliance with applicable data privacy protection laws and regulations. Moreover, safety evaluations were performed during the study to ensure patient safety.
    Background therapy
    The most commonly taken concomitant medications (by >4% of subjects) were the benzodiazepines lorazepam (11 subjects, 4.5%) and phenazepam (10 subjects, 4.1%); both were used as rescue medications allowed by the study protocol.
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Mar 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 56
    Country: Number of subjects enrolled
    Bulgaria: 37
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    Latvia: 11
    Country: Number of subjects enrolled
    Russian Federation: 36
    Country: Number of subjects enrolled
    Ukraine: 103
    Worldwide total number of subjects
    244
    EEA total number of subjects
    105
    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)
    244
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Enrolled subjects were recruited for this study at 44 study centers in 6 countries (Bulgaria, Estonia, Latvia, Romania, Russia, and Ukraine).

    Pre-assignment
    Screening details
    Subjects were screened for eligibility to participate in the study within 28 days before dosing.

    Pre-assignment period milestones
    Number of subjects started
    342 [1]
    Number of subjects completed
    244

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Adverse event, non-fatal: 1
    Reason: Number of subjects
    Consent withdrawn by subject: 6
    Reason: Number of subjects
    Physician decision: 2
    Reason: Number of subjects
    Lost to follow-up: 1
    Reason: Number of subjects
    Screening failure: 82
    Reason: Number of subjects
    Subject moved out of area: 1
    Reason: Number of subjects
    Other: 5
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to have started the pre-assignment period include screened subjects (N=342); however, the worldwide number only includes the number of subjects enrolled (i.e., randomized) (N=244).
    Period 1
    Period 1 title
    12-Week Double-Blind Study Phase
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Study drug was packaged using a double-dummy, double-blind design.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Arm title
    MIN-101 32 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    MIN-101
    Investigational medicinal product code
    MIN-101
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose consisted of 2 tablets identically matched in appearance (one MIN-101 32 mg tablet and one Placebo tablet). The study drug was to be administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Arm title
    MIN-101 64 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    MIN-101
    Investigational medicinal product code
    MIN-101
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose consisted of 2 tablets (two MIN-101 32 mg tablets). The study drug was to be administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Number of subjects in period 1
    Placebo MIN-101 32 mg MIN-101 64 mg
    Started
    83
    78
    83
    Completed
    44
    45
    53
    Not completed
    39
    33
    30
         Consent withdrawn by subject
    13
    12
    5
         Other
    1
    1
    1
         Subject moved out of area
    -
    2
    -
         Unsatisfactory treatment response
    17
    11
    11
         Adverse event
    3
    3
    8
         Non-compliance with study medication
    1
    -
    -
         Lost to follow-up
    1
    2
    1
         Protocol deviation
    3
    2
    4
    Period 2
    Period 2 title
    Whole Study Period
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Whole study period includes 12 week randomized double-blind phase and 24-week open-label phase.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    MIN-101 32 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    MIN-101
    Investigational medicinal product code
    MIN-101
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose consisted of 2 tablets identically matched in appearance (one MIN-101 32 mg tablet and one Placebo tablet). The study drug was to be administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Investigational medicinal product name
    MIN-101
    Investigational medicinal product code
    MIN-101
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose consisted of 2 tablets identically matched in appearance (one MIN-101 32 mg tablet and one Placebo tablet). The study drug was to be administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Arm title
    MIN-101 64 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    MIN-101
    Investigational medicinal product code
    MIN-101
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose consisted of 2 tablets (two MIN-101 32 mg tablets). The study drug was to be administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Investigational medicinal product name
    MIN-101
    Investigational medicinal product code
    MIN-101
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose consisted of 2 tablets (two MIN-101 32 mg tablets). The study drug was to be administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Arm title
    Placebo to MIN-101
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    MIN-101
    Investigational medicinal product code
    MIN-101
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose consisted of 2 tablets identically matched in appearance (one MIN-101 32 mg tablet and one Placebo tablet). The study drug was to be administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Investigational medicinal product name
    MIN-101
    Investigational medicinal product code
    MIN-101
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The daily dose consisted of 2 tablets (two MIN-101 32 mg tablets). The study drug was to be administered in a single dose in the morning at approximately the same time each day, in fasting condition, and 2 hours before a light breakfast. Tablets were to be swallowed whole with water and not divided, crushed, chewed, or placed in water.

    Number of subjects in period 2
    MIN-101 32 mg MIN-101 64 mg Placebo to MIN-101
    Started
    45
    53
    44
    Completed
    28
    32
    28
    Not completed
    17
    21
    16
         Consent withdrawn by subject
    9
    9
    6
         Adverse event, non-fatal
    2
    2
    2
         Unsatisfactory treatment response
    4
    5
    5
         Noncompliance with study drug
    -
    -
    1
         Lost to follow-up
    1
    4
    2
         Protocol deviation
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    MIN-101 32 mg
    Reporting group description
    -

    Reporting group title
    MIN-101 64 mg
    Reporting group description
    -

    Reporting group values
    Placebo MIN-101 32 mg MIN-101 64 mg Total
    Number of subjects
    83 78 83 244
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    83 78 83 244
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    40 ( 10.2 ) 39.8 ( 10.2 ) 40.6 ( 10.6 ) -
    Gender categorical
    Units: Subjects
        Female
    35 37 35 107
        Male
    48 41 48 137
    Race
    Units: Subjects
        Caucasian
    83 78 83 244
    Height
    Height measured only at Screening Visit.
    Units: cm
        arithmetic mean (standard deviation)
    172.5 ( 8.6 ) 170.9 ( 9.7 ) 171.5 ( 8.2 ) -
    Weight
    Subjects were weighed clothed (lightly) and without shoes.
    Units: kg
        arithmetic mean (standard deviation)
    77.42 ( 14.21 ) 74.16 ( 16.60 ) 75.25 ( 13.70 ) -
    BMI
    The BMI was calculated and presented using the following formula: BMI = (weight in kg/height in m2).
    Units: kg/m2
        arithmetic mean (standard deviation)
    26.0389 ( 4.4749 ) 25.2967 ( 4.4992 ) 25.5814 ( 4.3349 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group title
    MIN-101 32 mg
    Reporting group description
    -

    Reporting group title
    MIN-101 64 mg
    Reporting group description
    -
    Reporting group title
    MIN-101 32 mg
    Reporting group description
    -

    Reporting group title
    MIN-101 64 mg
    Reporting group description
    -

    Reporting group title
    Placebo to MIN-101
    Reporting group description
    -

    Primary: Change from Baseline to Week 12 in PANSS Negative Symptoms Subscale (Pentagonal Structure Model)

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    End point title
    Change from Baseline to Week 12 in PANSS Negative Symptoms Subscale (Pentagonal Structure Model)
    End point description
    Change from Baseline to Week 12 in PANSS negative subscale score of the pentagonal structure model using mixed model repeated measures (MMRM) analysis, intent-to-treat population.
    End point type
    Primary
    End point timeframe
    Positive and Negative Syndrome Scale (PANSS) negative subscale score of the pentagonal structure model assessment data were collected at Screening, Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    -1.53 ( 0.47 )
    -3.07 ( 0.49 )
    -3.50 ( 0.48 )
    Statistical analysis title
    Change from Baseline to Week 12 in PANSS
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    MIN-101 32 mg v MIN-101 64 mg v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.024 [1]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [1] - MIN-101 32 mg vs Placebo: p ≤ 0.0240 MIN-101 64 mg vs Placebo p ≤ 0.0036

    Secondary: Change from Baseline to Week 12 in CGI-S

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    End point title
    Change from Baseline to Week 12 in CGI-S
    End point description
    Change from Baseline to Week 12 in Clinical Global Impression - Severity Scale Score (CGI-S), intent-to-treat (ITT) population. Least-squares mean are from an analysis of covariance (ANCOVA) of ranked data with treatment (Placebo, MIN-101 32 mg, MIN-101 64 mg) as a factor, and Baseline value as covariate.
    End point type
    Secondary
    End point timeframe
    Clinical Global Impression - Severity (CGI-S) assessment data were collected at Screening, Baseline, Weeks 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    152.38 ( 8.81 )
    131.32 ( 9.08 )
    123.87 ( 8.81 )
    Statistical analysis title
    Change from Baseline to Week 12 in CGI-S
    Statistical analysis description
    Change from Baseline to Week 12 in Clinical Global Impression - Severity (CGI-S) Score using analysis of covariance (ANCOVA) of ranked data, with treatment (Placebo, MIN-101 32 mg, MIN-101 64 mg), as a factor and Baseline value as covariate.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.0982 [2]
    Method
    ANCOVA
    Confidence interval
    Notes
    [2] - MIN-101 32 mg vs Placebo: p ≤ 0.0982 MIN-101 64 mg vs Placebo: p ≤ 0.0234

    Secondary: Clinical Global Impression - Global Improvement Scale Scores

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    End point title
    Clinical Global Impression - Global Improvement Scale Scores
    End point description
    Change in Clinical Global Impression - Improvement Scale Score (CGI-I) with CGI-S as Baseline value, intent-to-treat (ITT) population. Least-squares mean are from an analysis of covariance (ANCOVA) of ranked data with treatment (Placebo, MIN-101 32 mg, MIN-101 64 mg) as a factor, and Baseline value as covariate.
    End point type
    Secondary
    End point timeframe
    Clinical Global Impression - Global Improvement assessment data were collected at Weeks 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    155.19 ( 9.50 )
    139.02 ( 9.79 )
    115.02 ( 9.50 )
    Statistical analysis title
    Clinical Global Impression - Improvement Scores
    Statistical analysis description
    Clinical Global Impression - Improvement Scores using analysis of covariance (ANCOVA) of ranked data, with treatment (Placebo, MIN-101 32 mg, MIN-101 64 mg), as a factor and Baseline value as covariate.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.2378 [3]
    Method
    ANCOVA
    Confidence interval
    Notes
    [3] - MIN-101 32 mg vs Placebo: p ≤ 0.2378 MIN-101 64 mg vs Placebo: p ≤ 0.0032

    Secondary: Change from Baseline to Week 12 in BACS Total Verbal Fluency Score

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    End point title
    Change from Baseline to Week 12 in BACS Total Verbal Fluency Score
    End point description
    Change from Baseline to Week 12 BACS using mixed model repeated measures (MMRM) analysis, intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Brief Assessment of Cognition in Schizophrenia (BACS) assessment data were collected at Baseline, Week 4, and Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    78
    83
    Units: NA
        least squares mean (standard error)
    0.98 ( 1.27 )
    5.76 ( 1.29 )
    4.37 ( 1.29 )
    Statistical analysis title
    Change from Baseline to Week 12 in BACS Total
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.292 [4]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [4] - MIN-101 32 mg vs Placebo: p ≤ 0.292 MIN-101 64 mg vs Placebo: p ≤ 0.5446

    Secondary: Change from Baseline to Week 12 in PANSS Total Score

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    End point title
    Change from Baseline to Week 12 in PANSS Total Score
    End point description
    Change from Baseline to Week 12 in PANSS total score analysis using model from mixed-model repeated measures (MMRM) analysis, ITT population.
    End point type
    Secondary
    End point timeframe
    Positive and Negative Syndrome Scale (PANSS) total score assessment data were collected at Screening, Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    -0.56 ( 1.25 )
    -3.66 ( 1.28 )
    -5.83 ( 1.26 )
    Statistical analysis title
    Change from Baseline to Week 12 in PANSS Total
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.0819 [5]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [5] - MIN-101 32 mg vs Placebo: p ≤ 0.0819 MIN-101 64 mg vs Placebo: p ≤ 0.0031

    Secondary: Change from Baseline to Week 12 in PANSS General Psychopathology Subscore

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    End point title
    Change from Baseline to Week 12 in PANSS General Psychopathology Subscore
    End point description
    Change from Baseline in Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Total Score of the 3 factors analysis using mixed model repeated measures (MMRM), intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Total Score assessment data were collected at Screening, Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    -0.05 ( 0.61 )
    -1.07 ( 0.62 )
    -2.58 ( 0.62 )
    Statistical analysis title
    Change from Baseline to Week 12 in PANSS GP Score
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.2359 [6]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [6] - MIN-101 32 mg vs Placebo: p ≤ 0.2359 MIN-101 64 mg vs Placebo: p ≤ 0.0034

    Secondary: Change from Baseline to Week 12 in PANSS Negative Scale Total Score

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    End point title
    Change from Baseline to Week 12 in PANSS Negative Scale Total Score
    End point description
    Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale Total Score of the 3 factor analysis using mixed model repeated measures (MMRM), intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Positive and Negative Syndrome Scale (PANSS) Negative Scale Total Score assessment data were collected at Screening, Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    -1.71 ( 0.41 )
    -3.35 ( 0.43 )
    -3.82 ( 0.42 )
    Statistical analysis title
    Change from Baseline to Week 12 in PANSS NS Score
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.0064 [7]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [7] - MIN-101 32 mg vs Placebo: p ≤ 0.0064 MIN-101 64 mg vs Placebo: p ≤ 0.0004

    Secondary: Change from Baseline to Week 12 in PANSS Positive Scale Total Score

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    End point title
    Change from Baseline to Week 12 in PANSS Positive Scale Total Score
    End point description
    Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Scale Total Score of the 3 factors analysis using mixed model repeated measures (MMRM), intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Positive and Negative Syndrome Scale (PANSS) Positive Scale Total Score assessment data were collected at Screening, Baseline, Weeks 2, 4, 8 and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    0.99 ( 0.44 )
    0.46 ( 0.45 )
    0.36 ( 0.44 )
    Statistical analysis title
    Change from Baseline to Week 12 in PANSS PS Score
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.4018 [8]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [8] - MIN-101 32 mg vs Placebo: p ≤ 0.4018 MIN-101 64 mg vs Placebo: p ≤ 0.3067

    Secondary: Change from Baseline to Week 12 in PANSS Positive Factor

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    End point title
    Change from Baseline to Week 12 in PANSS Positive Factor
    End point description
    Change from Baseline in PANSS Positive Factor of the pentagonal model using mixed model repeated measures (MMRM) analysis, intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Positive and Negative Syndrome Scale (PANSS) Positive Factor assessment data were collected at Screening, Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    0.29 ( 0.31 )
    0.58 ( 0.32 )
    -0.25 ( 0.31 )
    Statistical analysis title
    Change from Baseline to Week 12 in PANSS PF Score
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    MIN-101 32 mg v MIN-101 64 mg v Placebo
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.5045 [9]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [9] - MIN-101 32 mg vs Placebo: p ≤ 0.5045 MIN-101 64 mg vs Placebo: p ≤ 0.2146

    Secondary: Change from Baseline to Week 12 in PANSS Activation Factor

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    End point title
    Change from Baseline to Week 12 in PANSS Activation Factor
    End point description
    Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Activation Score of the pentagonal model using mixed model repeated measures (MMRM), intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Positive and Negative Syndrome Scale (PANSS) Activation Factor assesment data were collected at Screening, Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    1.09 ( 0.35 )
    -0.05 ( 0.36 )
    -0.17 ( 0.36 )
    Statistical analysis title
    Change from Baseline to Week 12 in PANSS AF Score
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.024 [10]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [10] - MIN-101 32 mg vs Placebo: p ≤ 0.0240 MIN-101 64 mg vs Placebo: p ≤ 0.0118

    Secondary: Change from Baseline in PANSS Dysphoric Mood Factor

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    End point title
    Change from Baseline in PANSS Dysphoric Mood Factor
    End point description
    Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Dysphoric Mood Factor of the pentagonal model using mixed model repeated measures (MMRM), intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Positive and Negative Syndrome Scale (PANSS) Dysphoric Mood Factor assessment data were collected at Screening, Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    -0.07 ( 0.31 )
    -0.32 ( 0.32 )
    -1.04 ( 0.32 )
    Statistical analysis title
    Change from Baseline to Week 12 in PANSS DM Score
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.5644 [11]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [11] - MIN-101 32 mg vs Placebo: p ≤ 0.5644 MIN-101 64 mg vs Placebo: p ≤ 0.0266

    Secondary: Change from Baseline to Week 12 in PANSS Autistic Preoccupation Factor

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    End point title
    Change from Baseline to Week 12 in PANSS Autistic Preoccupation Factor
    End point description
    Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Autistic Preoccupation Factor of the pentagonal model using mixed model repeated measures (MMRM), intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Positive and Negative Syndrome Scale (PANSS) Autistic Preoccupation Factor assessment data were collected at Screening, Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    -0.65 ( 0.34 )
    -0.85 ( 0.35 )
    -1.21 ( 0.34 )
    Statistical analysis title
    Change from Baseline to Week 12 in PANSS AP Score
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.67 [12]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [12] - MIN-101 32 mg vs Placebo: p ≤ 0.6700 MIN-101 64 mg vs Placebo: p ≤ 0.2408

    Secondary: Change from Baseline to Week 12 in BNSS Total Score

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    End point title
    Change from Baseline to Week 12 in BNSS Total Score
    End point description
    Change from Baseline in Brief Negative Symptom Scale (BNSS) Total Score using mixed model repeated measures (MMRM) analysis, intent-to-treat population.
    End point type
    Secondary
    End point timeframe
    Brief Negative Symptom Scale (BNSS) Total Score assessment data were collected at Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    -3.23 ( 0.90 )
    -5.44 ( 0.93 )
    -6.94 ( 0.92 )
    Statistical analysis title
    Change from Baseline to Week 12 in BNSS Total
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.0869 [13]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [13] - MIN-101 32 mg vs Placebo: p ≤ 0.0869 MIN-101 64 mg vs Placebo: p ≤ 0.0040

    Other pre-specified: Change from Baseline to Week 12 in PSP Total Score

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    End point title
    Change from Baseline to Week 12 in PSP Total Score
    End point description
    Change from Baseline in Personal and Social Performance (PSP) Total Score using mixed model repeated measures (MMRM), intent-to-treat population.
    End point type
    Other pre-specified
    End point timeframe
    Personal and Social Performance (PSP) Total Score assessment data were collected at Baseline, and Weeks 4 and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    -0.67 ( 0.27 )
    -1.16 ( 0.28 )
    -1.89 ( 0.28 )
    Statistical analysis title
    Change from Baseline to Week 12 in PSP Total Score
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    > 0.201 [14]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [14] - MIN-101 32 mg vs Placebo: p ≤ 0.2010 MIN-101 64 mg vs Placebo: p ≤ 0.0016

    Other pre-specified: Change from Baseline to Week 12 in Sheehan-STS Total Score

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    End point title
    Change from Baseline to Week 12 in Sheehan-STS Total Score
    End point description
    The SSTS was adapted from the Suicidality Module of the MINI Structured Diagnostic Interview for DMS-IV. SSTS is an 8-item scale that can be administered by the clinician or the subject through self-report. Each item was scored on a 5-point Likert scale (0=not at all, 1=a little, 2=moderately, 3=very, and 4=extremely). Data from SSTS was analyzed as individual item scores, suicidal ideation subscale score (sum of scores from items 2, 3, and 4, plus score from item 5 if ≤1), suicidal behavior subscale score (sum of scores from items 6, 7a, and 8, plus score from item 5 if >1), and total score. On the basis of data collected using SSTS, potential suicide-related events were categorized by the investigator.
    End point type
    Other pre-specified
    End point timeframe
    Sheehan Suicidality Tracking Scale (SSTS) scores were collected at Screening, Baseline, Day 2, and Weeks 2, 4, 8, 12, 12 ± 1-2 days, 14, 18, 24, 30, 36, and 37. SSTS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    -0.1 ( 0.1 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Upper Extremities

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Upper Extremities
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    0.1 ( 0.0 )
    -0.1 ( 0.0 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Lower Extremities

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Lower Extremities
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Muscles of Facial Expression

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Muscles of Facial Expression
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    0.0 ( 0.0 )
    -0.1 ( 0.0 )
    -0.1 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Lips and Perioral Area

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Lips and Perioral Area
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    0.0 ( 0.0 )
    -0.1 ( 0.1 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Jaw

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Jaw
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Tongue

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Tongue
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Severity of Abnormal Movements

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Severity of Abnormal Movements
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    0.1 ( 0.0 )
    -0.1 ( 0.0 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Incapacitation due to Abnormal Movements

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Incapacitation due to Abnormal Movements
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Patient Awareness of Abnormal Movements

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Patient Awareness of Abnormal Movements
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard error)
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in AIMS Score - Neck, Shoulders, Hips

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    End point title
    Change from Baseline to Week 12 in AIMS Score - Neck, Shoulders, Hips
    End point description
    The AIMS was used as a safety assessment in this study to detect involuntary movements as potential adverse effects. Items were scored on a 5-point scale (0=none, 1=minimal, may be extreme normal, 2=mild, 3=moderate, 4=severe).
    End point type
    Other pre-specified
    End point timeframe
    Abnormal Involuntary Movement Scale (AIMS) scores were collected at Screening, Baseline, and Weeks 4, 8, 12, 18, 24, 30, 36, and 37. AIMS scores are presented here for Week 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    54
    51
    54
    Units: NA
        arithmetic mean (standard deviation)
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    -0.1 ( 0.0 )
    No statistical analyses for this end point

    Other pre-specified: Change from Baseline to Week 12 in CDSS Total Score

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    End point title
    Change from Baseline to Week 12 in CDSS Total Score
    End point description
    Change from Baseline to Week 12 in Calgary Depression Scale for Schizophrenia (CDSS) scores, intent-to-treat population. Least-squares mean are from a mixed model repeated measures (MMRM) with treatment (Placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subjects nested in treatment as a random effect with Baseline value as covariates. An unstructured covariance matrix was used.
    End point type
    Other pre-specified
    End point timeframe
    Calgary Depression Scale for Schizophrenia scores for exploratory endpoint were collected at Screening, Baseline, Weeks 2, 4, 8, and 12.
    End point values
    Placebo MIN-101 32 mg MIN-101 64 mg
    Number of subjects analysed
    79
    76
    79
    Units: NA
        least squares mean (standard error)
    0.04 ( 0.22 )
    -0.37 ( 0.22 )
    -0.75 ( 0.21 )
    Statistical analysis title
    Change from Baseline to Week 12 in CDSS Total
    Statistical analysis description
    MMRM with treatment (placebo, MIN-101 32 mg, MIN-101 64 mg), visit, pooled study center, and treatment-by-visit interaction terms as fixed effects, subject nested in treatment as a random effect with Baseline value as covariate. An unstructured covariance matrix was used.
    Comparison groups
    Placebo v MIN-101 32 mg v MIN-101 64 mg
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    ≤ 0.1756 [15]
    Method
    Mixed models analysis
    Confidence interval
    Notes
    [15] - MIN-101 32 mg vs Placebo: p ≤ 0.1756 MIN-101 64 mg vs Placebo p ≤ 0.0091

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from time of signed informed consent until completion of last study-related procedure.
    Adverse event reporting additional description
    Adverse events (AEs) were classified as treatment-emergent AEs (TEAEs) if the AEs were not present before the first dose or were present before first dose by increased in severity on or after first dose.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Placebo - Whole Study Period
    Reporting group description
    -

    Reporting group title
    MIN-101 32 mg - Whole Study Period
    Reporting group description
    -

    Reporting group title
    MIN-101 64 mg Whole Study Period
    Reporting group description
    -

    Serious adverse events
    Placebo - Whole Study Period MIN-101 32 mg - Whole Study Period MIN-101 64 mg Whole Study Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 83 (4.82%)
    6 / 103 (5.83%)
    2 / 102 (1.96%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 103 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 103 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 103 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    1 / 83 (1.20%)
    3 / 103 (2.91%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric decompensation
         subjects affected / exposed
    1 / 83 (1.20%)
    0 / 103 (0.00%)
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute psychosis
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 103 (0.97%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    0 / 83 (0.00%)
    1 / 103 (0.97%)
    0 / 102 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3.5%
    Non-serious adverse events
    Placebo - Whole Study Period MIN-101 32 mg - Whole Study Period MIN-101 64 mg Whole Study Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 83 (31.33%)
    36 / 103 (34.95%)
    45 / 102 (44.12%)
    Cardiac disorders
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 83 (0.00%)
    0 / 103 (0.00%)
    5 / 102 (4.90%)
         occurrences all number
    0
    0
    5
    Psychiatric disorders
    Headache
         subjects affected / exposed
    2 / 83 (2.41%)
    6 / 103 (5.83%)
    6 / 102 (5.88%)
         occurrences all number
    2
    6
    6
    Anxiety
         subjects affected / exposed
    3 / 83 (3.61%)
    5 / 103 (4.85%)
    5 / 102 (4.90%)
         occurrences all number
    3
    5
    5
    Insomnia
         subjects affected / exposed
    4 / 83 (4.82%)
    4 / 103 (3.88%)
    6 / 102 (5.88%)
         occurrences all number
    4
    4
    6
    Somnolence
         subjects affected / exposed
    0 / 83 (0.00%)
    3 / 103 (2.91%)
    4 / 102 (3.92%)
         occurrences all number
    0
    3
    4
    Schizophrenia
         subjects affected / exposed
    7 / 83 (8.43%)
    1 / 103 (0.97%)
    1 / 102 (0.98%)
         occurrences all number
    7
    1
    1
    Agitation
         subjects affected / exposed
    3 / 83 (3.61%)
    0 / 103 (0.00%)
    1 / 102 (0.98%)
         occurrences all number
    3
    0
    1

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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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