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    Clinical Trial Results:
    A Randomized, Placebo-Controlled Study of ABX-1431 in Adult Patients with Tourette Syndrome or Chronic Motor Tic Disorder

    Summary
    EudraCT number
    		 2018-000100-41
    Trial protocol
    		 ES  
    Global end of trial date
    14 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2020
    First version publication date
    13 Dec 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    18423A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03625453
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Abide Therapeutics, Inc. : PN018
    Sponsors
    Sponsor organisation name
    H. Lundbeck A/S
    Sponsor organisation address
    Ottiliavej 9, Valby, Denmark, 2500
    Public contact
    LundbeckClinicalTrials@Lundbeck.com, Email contact via, +45 36301311, LundbeckClinicalTrials@Lundbeck.com
    Scientific contact
    LundbeckClinicalTrials@Lundbeck.com, Email contact via, +45 36301311, LundbeckClinicalTrials@Lundbeck.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
    14 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of ABX-1431 in treating adult patients with Tourette Syndrome or Chronic Motor Tic Disorder as measured by the change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS-TTS) compared with placebo.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (2013) and ICH Good Clinical Practice (1996). The dose escalation could be adjusted for individual patients based on the occurrence of central nervous system (CNS) adverse events. Depending on the occurrence and severity of CNS adverse events, the protocol-specified dose-escalation guidelines allowed for dose increase, maintenance, and decrease, or the interruption of dosing.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Oct 2018
    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
    Poland: 10
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Germany: 34
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    49
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 53 patients were screened: 37 patients at 5 centers in Germany, 5 patients at 2 centers in Spain, and 11 patients at 1 center in Poland. 4 patients were screening failures (3 patients in Germany, 1 patient in Poland) and 49 patients were randomized to study treatment.

    Pre-assignment
    Screening details
    		 Subjects who met each of the inclusion and none of the exclusion criteria were eligible to participate in the study.

    Period 1
    Period 1 title
    Main treatment - Part 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    ABX-1431 and placebo capsules were identical in appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1: ABX-1431
    Arm description
    		 The dose was escalated from 10 mg/day to a maximum of 40 mg/day ABX-1431 between Day 1 and Day 56.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABX-1431
    Investigational medicinal product code
    ABX-1431
    Other name
    Lu AG06466
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules were swallowed once daily in the morning with food (within 30 minutes of eating). The dose was escalated from 10 mg/day (1 capsule) to 40 mg/day (4 capsules) ABX-1431 between Day 1 and Day 56. Daily dosing schedule: Days 1 to 3 - 10 mg (1 capsule); Days 4 to 28 - 20 mg (2 capsules); Days 29 to 35 - 30 mg (3 capsules); Days 36 to 56 - 40 mg (4 capsules).

    Arm title
    		 Part 1: Placebo
    Arm description
    		 The number of placebo capsules was increased from 1 (matching 10 mg/day) to a maximum of 4 (matching 40 mg/day) between Day 1 and Day 56.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Placebo
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules were swallowed once daily in the morning with food (within 30 minutes of eating). Placebo was escalated following the same scheme as ABX-1431 from 1 capsule (matching 10 mg/day) to 4 capsules (matching 40 mg/day) between Day 1 and Day 56. Daily dosing schedule: Days 1 to 3 - 1 capsule; Days 4 to 28 - 2 capsules; Days 29 to 35 - 3 capsules; Days 36 to 56 - 4 capsules.

    Number of subjects in period 1
    		Part 1: ABX-1431 Part 1: Placebo
    Started
    23
    26
    Completed
    19
    25
    Not completed
    4
    1
         Physician decision
    1
    -
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    3
    -
    Period 2
    Period 2 title
    Open-label - Part 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    All subjects received ABX-1431.

    Arms
    Arm title
    		 Part 2: ABX-1431
    Arm description
    		 Upon completion of Day 56 of Part 1, patients could proceed to Part 2. During Part 2, patients took 10 mg/day ABX-1431 and escalated to a maximum dose of 20 mg/day.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABX-1431
    Investigational medicinal product code
    ABX-1431
    Other name
    Lu AG06466
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules were swallowed once daily in the morning with food (within 30 minutes of eating). The dose was escalated from 10 mg/day (1 capsule) to 20 mg/day (2 capsules) ABX-1431 between Day 1 and Day 28. Daily dosing schedule: Days 1 to 3 - 10 mg (1 capsule); Days 4 to 28 - 20 mg (2 capsules).

    Number of subjects in period 2 [1]
    		Part 2: ABX-1431
    Started
    35
    Completed
    33
    Not completed
    2
         Consent withdrawn by subject
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: As Part 2 of the trial was optional, not all patients completing Part 1 continued in Part 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: ABX-1431
    Reporting group description
    		 The dose was escalated from 10 mg/day to a maximum of 40 mg/day ABX-1431 between Day 1 and Day 56.

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 The number of placebo capsules was increased from 1 (matching 10 mg/day) to a maximum of 4 (matching 40 mg/day) between Day 1 and Day 56.

    Reporting group values
    		 Part 1: ABX-1431 Part 1: Placebo Total
    Number of subjects
    		 23 26 49
    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)
    		 23 26 49
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 32.0 (19 to 55) 31.0 (20 to 58) -
    Gender categorical
    Units: Subjects
        Female
    		 3 5 8
        Male
    		 20 21 41
    Yale global tic severity scale total tic score (YGTSS-TTS)
    Units: Score
        median (full range (min-max))
    		 28.0 (14 to 48) 29.0 (22 to 44) -
    Adult tic questionnaire (ATQ)
    Units: score
        median (full range (min-max))
    		 7.0 (4 to 12) 7.0 (0 to 14) -
    Premonitory urge for tics (PUTS) scale
    Units: score
        median (full range (min-max))
    		 24.0 (12 to 33) 20.5 (9 to 33) -

    End points

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    End points reporting groups
    Reporting group title
    Part 1: ABX-1431
    Reporting group description
    		 The dose was escalated from 10 mg/day to a maximum of 40 mg/day ABX-1431 between Day 1 and Day 56.

    Reporting group title
    Part 1: Placebo
    Reporting group description
    		 The number of placebo capsules was increased from 1 (matching 10 mg/day) to a maximum of 4 (matching 40 mg/day) between Day 1 and Day 56.
    Reporting group title
    Part 2: ABX-1431
    Reporting group description
    		 Upon completion of Day 56 of Part 1, patients could proceed to Part 2. During Part 2, patients took 10 mg/day ABX-1431 and escalated to a maximum dose of 20 mg/day.

    Primary: Change from Baseline in YGTSS-TTS - Part 1

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    End point title
    		 Change from Baseline in YGTSS-TTS - Part 1
    End point description
    The YGTSS is a clinician-administered interview considering tics in the prior week based on a semi-structured interview. The YGTSS-TTS (0 to 50) consists of ratings for motor tics (0 to 25) and vocal tics (0 to 25) concerning dimensions of number, frequency, intensity, complexity, and interference, with each dimension graded 0 to 5. Higher scores represents greater severity.
    End point type
    Primary
    End point timeframe
    Change from Baseline to Day 28 and Day 56.
    End point values
    		 Part 1: ABX-1431 Part 1: Placebo
    Number of subjects analysed
    23
    26
    Units: Score
    least squares mean (standard error)
        Day 28
    -2.5 ( 0.9 )
    -2.9 ( 0.8 )
        Day 56
    -2.7 ( 1.1 )
    -5.7 ( 1.0 )
    Statistical analysis title
    		 Mean difference in YGTSS-TTS changes at Day 56
    Statistical analysis description
    The mean difference in change from Baseline (ABX-1431 vs placebo) at Day 56 was estimated based on the least squares means for the treatment-by-visit interaction. The changes from Baseline were analysed using a restricted maximum likelihood (REML)-based linear mixed model with repeated measures (MMRM). The model included treatment, visit (as a categorical variable), pooled site, YGTSS-TTS at Baseline, YGTSS-TTS at baseline-by-visit interaction, and a treatment-by-visit interaction term.
    Comparison groups
    Part 1: ABX-1431 v Part 1: Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.0428 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.1
         upper limit
    		 5.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.4
    Notes
    [1] - A positive point estimate indicates larger improvement in the placebo arm. An unstructured covariance matrix was used for within-patient correlation. The Kenward-Roger approximation was used to estimate denominator degrees of freedom. The model converged and no adaptations were used.
    [2] - A 1-sided alpha level of 0.025 was used to determine significance.
    Statistical analysis title
    		 Mean difference in YGTSS-TTS changes at Day 28
    Statistical analysis description
    The mean difference in change from Baseline (ABX-1431 vs placebo) at Day 28 was estimated based on the least squares means for the treatment-by-visit interaction. The changes from baselinewere analysed using a REML-based linear MMRM. The model included treatment, visit (as a categorical variable), pooled site, YGTSS-TTS at Baseline, YGTSS-TTS at baseline-by-visit interaction, and a treatment-by-visit interaction term.
    Comparison groups
    Part 1: ABX-1431 v Part 1: Placebo
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.7463 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 2.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [3] - A positive point estimate indicates larger improvement in the placebo arm. An unstructured covariance matrix was used for within-patient correlation. The Kenward-Roger approximation was used to estimate denominator degrees of freedom. The model converged and no adaptations were used.
    [4] - A 1-sided alpha level of 0.025 was used to determine significance.

    Secondary: Change from Baseline in ATQ scores - Part 1

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    End point title
    		 Change from Baseline in ATQ scores - Part 1
    End point description
    The ATQ is a patient self-assessment of frequency and intensity for several common motor and vocal tics. The ATQ was analysed by summing the intensity (1 to 4) and frequency (1 to 4) to determine the severity (2 to 8) across all endorsed tics. The clinical relevance of changes in the ATQ was presented by the change in the average intensity score (that is total intensity score divided by total number of tics) and average frequency score (that is total frequency score divided by total number of tics). Higher scores indicate greater tic burden.
    End point type
    Secondary
    End point timeframe
    Change from Baseline to Day 28 and Day 56
    End point values
    		 Part 1: ABX-1431 Part 1: Placebo
    Number of subjects analysed
    23 [5]
    26 [6]
    Units: Score
    median (full range (min-max))
        Day 28 - total number of motor+vocal tics
    -1.0 (-6 to 5)
    -0.5 (-7 to 6)
        Day 56 - total number of motor+vocal tics
    -1.0 (-6 to 4)
    -1.0 (-8 to 2)
        Day 28 - total frequency score of motor+vocal tics
    -6.0 (-21 to 8)
    0.0 (-35 to 10)
        Day 56 - total frequency score of motor+vocal tics
    -6.5 (-19 to 7)
    -2.0 (-41 to 11)
        Day 28 - total intensity score of motor+vocal tics
    -1.0 (-16 to 11)
    -2.5 (-25 to 8)
        Day 56 - total intensity score of motor+vocal tics
    -3.5 (-20 to 8)
    -3.0 (-31 to 8)
        Day 28 - average frequency score motor+vocal tics
    0.0 (-1 to 1)
    0.0 (-1 to 1)
        Day 56 - average frequency score motor+vocal tics
    0.0 (-1 to 1)
    0.0 (-2 to 1)
        Day 28 - average intensity score motor+vocal tics
    0.0 (-1 to 1)
    0.0 (-1 to 1)
        Day 56 - average intensity score motor+vocal tics
    0.0 (-2 to 1)
    0.0 (-1 to 1)
    Notes
    [5] - Day 28: N=21 with N=1 missing Day 56: N=20
    [6] - Day 56: N=25
    No statistical analyses for this end point

    Secondary: Change from Baseline in ATQ scores - Part 2

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    End point title
    		 Change from Baseline in ATQ scores - Part 2
    End point description
    The ATQ is a patient self-assessment of frequency and intensity for several common motor and vocal tics. The ATQ was analysed by summing the intensity (1 to 4) and frequency (1 to 4) to determine the severity (2 to 8) across all endorsed tics. The clinical relevance of changes in the ATQ was presented by the change in the average intensity score (that is total intensity score divided by total number of tics) and average frequency score (that is total frequency score divided by total number of tics). Higher scores indicate greater tic burden.
    End point type
    Secondary
    End point timeframe
    Change from Baseline to Day 28
    End point values
    		 Part 2: ABX-1431
    Number of subjects analysed
    35 [7]
    Units: Scores
    median (full range (min-max))
        Total number of motor+vocal tics
    -1.0 (-6 to 3)
        Total frequency score of motor+vocal tics
    0.0 (-46 to 18)
        Total intensity score of motor+vocal tics
    -1.0 (-31 to 13)
        Average frequency score motor+vocal tics
    0.0 (-2 to 2)
        Average intensity score motor+vocal tics
    0.0 (-1 to 1)
    Notes
    [7] - Day 28: N=33
    No statistical analyses for this end point

    Secondary: Change from Baseline in PUTS scores - Part 1

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    End point title
    		 Change from Baseline in PUTS scores - Part 1
    End point description
    The PUTS is a patient self-assessment of the intensity of agreement of several statements about premonitory feelings preceding tics, each scored on a Likert scale (1 to 4). The scale asks about current feelings. The PUTS (item 1-9) total score ranges from 9 to 36, that is the sum of single items.
    End point type
    Secondary
    End point timeframe
    Change from Baseline to Day 28 and Day 56
    End point values
    		 Part 1: ABX-1431 Part 1: Placebo
    Number of subjects analysed
    23 [8]
    26 [9]
    Units: Score
    median (full range (min-max))
        Day 28 - PUTS total score
    2.0 (-14 to 7)
    0.0 (-10 to 5)
        Day 56 - PUTS total score
    -1.0 (-12 to 8)
    0.0 (-10 to 7)
    Notes
    [8] - Day 28: N=22 Day 56: N=20
    [9] - Day 56: N=25
    No statistical analyses for this end point

    Secondary: Change from Baseline in PUTS scores - Part 2

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    End point title
    		 Change from Baseline in PUTS scores - Part 2
    End point description
    The PUTS is a patient self-assessment of the intensity of agreement of several statements about premonitory feelings preceding tics, each scored on a Likert scale (1 to 4). The scale asks about current feelings. The PUTS (item 1-9) total score ranges from 9 to 36, that is the sum of single items.
    End point type
    Secondary
    End point timeframe
    Change from Baseline to Day 28
    End point values
    		 Part 2: ABX-1431
    Number of subjects analysed
    35 [10]
    Units: Score
    median (full range (min-max))
        PUTS total score
    0.0 (-7 to 12)
    Notes
    [10] - Day 28: N=33
    No statistical analyses for this end point

    Secondary: Clinical global impressions scale for improvement (CGI-I) - Part 1

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    End point title
    		 Clinical global impressions scale for improvement (CGI-I) - Part 1
    End point description
    The CGI-I is a 7-point ordinal, clinician-rated scale used to assess the patient’s overall improvement or worsening in disease status relative to their condition at baseline. Rating is: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
    End point type
    Secondary
    End point timeframe
    Improvement at Day 28 and Day 56
    End point values
    		 Part 1: ABX-1431 Part 1: Placebo
    Number of subjects analysed
    23 [11]
    26 [12]
    Units: Score
    median (full range (min-max))
        Day 28 - CGI-I score
    4.0 (2 to 5)
    4.0 (1 to 6)
        Day 56 - CGI-I score
    3.5 (1 to 5)
    4.0 (1 to 6)
    Notes
    [11] - Day 28: N=22 Day 56: N=20
    [12] - Day 56: N=25
    No statistical analyses for this end point

    Secondary: CGI-I - Part 2

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    End point title
    		 CGI-I - Part 2
    End point description
    The CGI-I is a 7-point ordinal, clinician-rated scale used to assess the patient’s overall improvement or worsening in disease status relative to their condition at baseline. Rating is: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
    End point type
    Secondary
    End point timeframe
    Score at Day 28
    End point values
    		 Part 2: ABX-1431
    Number of subjects analysed
    35 [13]
    Units: Score
    median (full range (min-max))
        CGI-I
    3.0 (1 to 4)
    Notes
    [13] - Day 28: N=33
    No statistical analyses for this end point

    Secondary: Change from Baseline in YGTSS-TTS - Part 2

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    End point title
    		 Change from Baseline in YGTSS-TTS - Part 2
    End point description
    The YGTSS is a clinician-administered interview considering tics in the prior week based on a semi-structured interview. The YGTSS-TTS (0 to 50) consists of ratings for motor tics (0 to 25) and vocal tics (0 to 25) concerning dimensions of number, frequency, intensity, complexity, and interference, with each dimension graded 0 to 5. Higher scores represents greater severity.
    End point type
    Secondary
    End point timeframe
    Change from Baseline to Day 28
    End point values
    		 Part 2: ABX-1431
    Number of subjects analysed
    35 [14]
    Units: Score
    median (full range (min-max))
        YGTSS-TTS
    -1.0 (-20 to 7)
    Notes
    [14] - Day 28: N=33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of ABX-1431 or placebo until the end of the study.
    Adverse event reporting additional description
    Adverse events with start date after the first dose of ABX-1431 or placebo in the first period but before the first dose of ABX-1431 in the second period were allocated to Part 1. Adverse events with start date, stop date, or ongoing during the second period were allocated to Part 2.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    ABX-1431 Part 1
    Reporting group description
    		 During Part 1, the dose was escalated from 10 mg/day (1 capsule) to 40 mg/day (4 capsules) ABX-1431 between Day 1 and Day 56. Daily dosing schedule: Days 1 to 3 - 10 mg (1 capsule); Days 4 to 28 - 20 mg (2 capsules); Days 29 to 35 - 30 mg (3 capsules); Days 36 to 56 - 40 mg (4 capsules).

    Reporting group title
    Placebo Part 1
    Reporting group description
    		 During Part 1, placebo was escalated following the same scheme as ABX-1431 from 1 capsule (matching 10 mg/day) to 4 capsules (matching 40 mg/day) between Day 1 and Day 56. Daily dosing schedule: Days 1 to 3 - 1 capsule; Days 4 to 28 - 2 capsules; Days 29 to 35 - 3 capsules; Days 36 to 56 - 4 capsules.

    Reporting group title
    ABX-1431 Part 2
    Reporting group description
    		 During Part 2, the dose was escalated from 10 mg/day (1 capsule) to 20 mg/day (2 capsules) ABX-1431 between Day 1 and Day 28. Daily dosing schedule: Days 1 to 3 - 10 mg (1 capsule); Days 4 to 28 - 20 mg (2 capsules).

    Serious adverse events
    		 ABX-1431 Part 1 Placebo Part 1 ABX-1431 Part 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 26 (0.00%)
    1 / 35 (2.86%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 26 (0.00%)
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABX-1431 Part 1 Placebo Part 1 ABX-1431 Part 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 23 (100.00%)
    24 / 26 (92.31%)
    29 / 35 (82.86%)
    Congenital, familial and genetic disorders
    Tourette's disorder
         subjects affected / exposed
    2 / 23 (8.70%)
    3 / 26 (11.54%)
    3 / 35 (8.57%)
         occurrences all number
    3
    3
    4
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    6 / 23 (26.09%)
    3 / 26 (11.54%)
    5 / 35 (14.29%)
         occurrences all number
    7
    3
    5
    Dizziness
         subjects affected / exposed
    4 / 23 (17.39%)
    2 / 26 (7.69%)
    6 / 35 (17.14%)
         occurrences all number
    6
    2
    7
    Headache
         subjects affected / exposed
    3 / 23 (13.04%)
    8 / 26 (30.77%)
    4 / 35 (11.43%)
         occurrences all number
    4
    10
    6
    Memory impairment
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 26 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    2
    0
    2
    Migraine
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 26 (7.69%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    1
    Paraesthesia
         subjects affected / exposed
    5 / 23 (21.74%)
    0 / 26 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    6
    0
    2
    Somnolence
         subjects affected / exposed
    2 / 23 (8.70%)
    4 / 26 (15.38%)
    6 / 35 (17.14%)
         occurrences all number
    2
    6
    10
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 23 (34.78%)
    4 / 26 (15.38%)
    5 / 35 (14.29%)
         occurrences all number
    9
    4
    5
    Feeling abnormal
         subjects affected / exposed
    4 / 23 (17.39%)
    5 / 26 (19.23%)
    3 / 35 (8.57%)
         occurrences all number
    7
    5
    4
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    4 / 23 (17.39%)
    4 / 26 (15.38%)
    3 / 35 (8.57%)
         occurrences all number
    4
    5
    3
    Eye disorders
    Ocular discomfort
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 26 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 23 (8.70%)
    3 / 26 (11.54%)
    0 / 35 (0.00%)
         occurrences all number
    3
    4
    0
    Dry mouth
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 26 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    4
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 26 (7.69%)
    1 / 35 (2.86%)
         occurrences all number
    1
    2
    1
    Nausea
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 26 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Toothache
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 26 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 26 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 26 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 23 (4.35%)
    4 / 26 (15.38%)
    2 / 35 (5.71%)
         occurrences all number
    1
    5
    2
    Depressive symptom
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 26 (3.85%)
    2 / 35 (5.71%)
         occurrences all number
    0
    1
    2
    Disorientation
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 26 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    0
    2
    Renal and urinary disorders
    Leukocyturia
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 26 (7.69%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Micturition urgency
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 26 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    1
    0
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 26 (7.69%)
    1 / 35 (2.86%)
         occurrences all number
    0
    2
    1
    Myalgia
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 26 (7.69%)
    0 / 35 (0.00%)
         occurrences all number
    0
    2
    0
    Pain in extremity
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 26 (11.54%)
    0 / 35 (0.00%)
         occurrences all number
    0
    3
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 23 (26.09%)
    4 / 26 (15.38%)
    5 / 35 (14.29%)
         occurrences all number
    6
    4
    5
    Oral herpes
         subjects affected / exposed
    1 / 23 (4.35%)
    2 / 26 (7.69%)
    0 / 35 (0.00%)
         occurrences all number
    1
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jul 2018
    Study title, protocol flexibility criteria, primary and secondary objectives, study design, dose escalation, and inclusion and exclusion criteria

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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