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    Clinical Trial Results:
    A Double-Blind, Randomized, Dose Selection Vehicle–Controlled Multicenter Clinical Study for Evaluation of the Safety, Tolerability, Efficacy, and Pharmacokinetics of topical Neramexane in Subjects with Moderate to Severe Acne

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
    Summary
    EudraCT number
    		 2011-004998-83
    Trial protocol
    		 DE  
    Global end of trial date
    19 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2016
    First version publication date
    29 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MUS92579_2057_1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merz Pharmaceuticals GmbH
    Sponsor organisation address
    Eckenheimer Landstr. 100, Frankfurt, Germany, 60318
    Public contact
    Public Disclosure Manager, Merz Pharmaceuticals GmbH, +49 69 1503 0, clinicaltrials@merz.de
    Scientific contact
    Public Disclosure Manager, Merz Pharmaceuticals GmbH, +49 69 1503 0, clinicaltrials@merz.de
    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
    09 Jul 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the safety, tolerability, efficacy and pharmacokinetics of three concentrations [0.5 percent (%), 1.5 % and 3 %] of topical anti-Acne product Neramexane mesylate gel, quaque die (qd) when compared to vehicle in subjects with Moderate to Severe Acne.
    Protection of trial subjects
    High medical and ethical standards were followed in accordance with Good Clinical Practice and other applicable regulations. In addition, an independent data monitoring committee was in charge of monitoring subject safety while the study was ongoing.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Apr 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 237
    Worldwide total number of subjects
    237
    EEA total number of subjects
    237
    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)
    84
    Adults (18-64 years)
    153
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 292 subjects were screened for eligibility. 55 of these subjects were screening failures, the remaining 237 subjects were eligible to be randomized and applied investigational product.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vehicle
    Arm description
    		 Vehicle 0.5 g topical gel
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received vehicle 0.5 gram (g) topical gel on every morning during Stage 1 and on every evening after removal of makeup before going to sleep during Stage 2. The total duration of treatment was 12 Weeks.

    Arm title
    		 Neramexane mesylate 0.5 Percent (%)
    Arm description
    		 0.5% Neramexane mesylate 0.5 g topical gel
    Arm type
    		 Experimental

    Investigational medicinal product name
    Neramexane mesylate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received 0.5% Neramexane mesylate 0.5 g topical gel on every morning during Stage 1 and on every evening after removal of makeup before going to sleep during Stage 2. The total duration of treatment was 12 Weeks.

    Arm title
    		 Neramexane mesylate 1.5%
    Arm description
    		 1.5% Neramexane mesylate 0.5 g topical gel
    Arm type
    		 Experimental

    Investigational medicinal product name
    Neramexane mesylate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received 1.5% Neramexane mesylate 0.5 g topical gel on every morning during Stage 1 and on every evening after removal of makeup before going to sleep during Stage 2. The total duration of treatment was 12 Weeks.

    Arm title
    		 Neramexane mesylate 3%
    Arm description
    		 3% Neramexane mesylate 0.5 g topical gel
    Arm type
    		 Experimental

    Investigational medicinal product name
    Neramexane mesylate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Topical use
    Dosage and administration details
    Subjects received 3% Neramexane mesylate 0.5 g topical gel on every morning during Stage 1 and on every evening after removal of makeup before going to sleep during Stage 2. The total duration of treatment was 12 Weeks.

    Number of subjects in period 1
    		Vehicle Neramexane mesylate 0.5 Percent (%) Neramexane mesylate 1.5% Neramexane mesylate 3%
    Started
    59
    59
    59
    60
    Completed
    51
    49
    45
    49
    Not completed
    8
    10
    14
    11
         Consent withdrawn by subject
    -
    2
    3
    2
         Adverse event, non-fatal
    2
    -
    -
    1
         Administrative reasons
    6
    8
    11
    7
         Protocol deviation
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vehicle
    Reporting group description
    		 Vehicle 0.5 g topical gel

    Reporting group title
    Neramexane mesylate 0.5 Percent (%)
    Reporting group description
    		 0.5% Neramexane mesylate 0.5 g topical gel

    Reporting group title
    Neramexane mesylate 1.5%
    Reporting group description
    		 1.5% Neramexane mesylate 0.5 g topical gel

    Reporting group title
    Neramexane mesylate 3%
    Reporting group description
    		 3% Neramexane mesylate 0.5 g topical gel

    Reporting group values
    		 Vehicle Neramexane mesylate 0.5 Percent (%) Neramexane mesylate 1.5% Neramexane mesylate 3% Total
    Number of subjects
    		 59 59 59 60 237
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 16 27 24 18 85
        Adults (18-64 years)
    		 43 32 35 42 152
    Gender categorical
    Units: Subjects
        Female
    		 31 24 21 30 106
        Male
    		 28 35 38 30 131

    End points

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    End points reporting groups
    Reporting group title
    Vehicle
    Reporting group description
    		 Vehicle 0.5 g topical gel

    Reporting group title
    Neramexane mesylate 0.5 Percent (%)
    Reporting group description
    		 0.5% Neramexane mesylate 0.5 g topical gel

    Reporting group title
    Neramexane mesylate 1.5%
    Reporting group description
    		 1.5% Neramexane mesylate 0.5 g topical gel

    Reporting group title
    Neramexane mesylate 3%
    Reporting group description
    		 3% Neramexane mesylate 0.5 g topical gel

    Primary: Change From Baseline in Inflammatory Acne Lesion Counts at Week 12

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    End point title
    		 Change From Baseline in Inflammatory Acne Lesion Counts at Week 12
    End point description
    The inflammatory acne lesions were counted. In the counting procedure, primary acne lesions were evaluated and accounted independently for papules and pustules, and nodules greater than or equal to 5 millimeters (mm) in diameter. The nose region was included in the counting only for inflammatory lesions. The full analysis set (FAS) was the subset of subjects in the safety evaluation set (SES), all subjects who had the baseline and at least one post-baseline value of the primary efficacy variable. The Multiple Imputation (MI) missing value imputation method was used.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Vehicle Neramexane mesylate 0.5 Percent (%) Neramexane mesylate 1.5% Neramexane mesylate 3%
    Number of subjects analysed
    53
    52
    52
    52
    Units: lesion
    arithmetic mean (standard deviation)
        Baseline
    29.5 ( 9 )
    32.4 ( 10.1 )
    31 ( 8.4 )
    30.5 ( 8.6 )
        Change at Week 12
    -10.5 ( 11.7 )
    -10.9 ( 10.9 )
    -9.7 ( 9.4 )
    -10.9 ( 12.8 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Vehicle v Neramexane mesylate 0.5 Percent (%)
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7972
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.7
         upper limit
    		 4.8
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Vehicle v Neramexane mesylate 1.5%
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5228
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Difference
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 5.5
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Vehicle v Neramexane mesylate 3%
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9677
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Mean Differences
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 4.2

    Secondary: Change From Baseline in Non-Inflammatory Acne Lesion Counts at Week 12

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    End point title
    		 Change From Baseline in Non-Inflammatory Acne Lesion Counts at Week 12
    End point description
    The non-inflammatory acne lesions were counted. In the counting procedure, primary acne lesions were evaluated and accounted independently for open and closed comedones. The nose region was excluded in the counting for non-inflammatory lesions. The FAS was the subset of subjects in the SES, all subjects who had the baseline and at least one post-baseline value of the primary efficacy variable. The MI missing value imputation method was used.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Vehicle Neramexane mesylate 0.5 Percent (%) Neramexane mesylate 1.5% Neramexane mesylate 3%
    Number of subjects analysed
    53
    52
    52
    52
    Units: lesion
    arithmetic mean (standard deviation)
        Baseline
    43.4 ( 19.1 )
    45.6 ( 20.5 )
    45.3 ( 22.5 )
    49.4 ( 22 )
        Change at Week 12
    -6.7 ( 23.3 )
    -9.2 ( 19.3 )
    -8.4 ( 21.1 )
    -9.5 ( 19.8 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With Two Grade Improvement in Evaluator Global Severity Score (EGSS) at Week 12

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    End point title
    		 Number of Subjects With Two Grade Improvement in Evaluator Global Severity Score (EGSS) at Week 12
    End point description
    The EGSS was performed to assess the grade of the acne. The grading ranges from 0 to 5. Clear (0): Normal, clear skin with no evidence of acne vulgaris; Almost Clear (1): Rare non-inflammatory lesions present, with rare non-inflamed papules; Mild (2): Some non-inflammatory lesions are present, with few inflammatory lesions; Moderate (3): Non-inflammatory lesions predominating, with multiple inflammatory lesions evident and several to many comedones and papules/pustules, there may be one small nodulocystic lesion; Severe (4): Inflammatory lesions more apparent, with many comedones and papules/pustules, there may be a few nodulocystic lesions; Very Severe (5): Highly inflammatory lesions predominating, with variable numbers of comedones, many papules/pustules, and many nodulocystic lesions. The FAS was the subset of subjects in the SES, all subjects who had the baseline and at least one post-baseline.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Vehicle Neramexane mesylate 0.5 Percent (%) Neramexane mesylate 1.5% Neramexane mesylate 3%
    Number of subjects analysed
    53
    52
    52
    52
    Units: subject
    4
    6
    4
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Screening (Week -2) until Safety Follow-up (Up to Week 14)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Vehicle
    Reporting group description
    		 Subjects received vehicle 0.5 gram (g) topical gel on every morning during Stage 1 and on every evening after removal of makeup before going to sleep during Stage 2. The total duration of treatment was 12 Weeks.

    Reporting group title
    Neramexane mesylate 0.5 Percent (%)
    Reporting group description
    		 Subjects received 0.5% Neramexane mesylate 0.5 g topical gel on every morning during Stage 1 and on every evening after removal of makeup before going to sleep during Stage 2. The total duration of treatment was 12 Weeks.

    Reporting group title
    Neramexane mesylate 1.5%
    Reporting group description
    		 Subjects received 1.5% Neramexane mesylate 0.5 g topical gel on every morning during Stage 1 and on every evening after removal of makeup before going to sleep during Stage 2. The total duration of treatment was 12 Weeks.

    Reporting group title
    Neramexane mesylate 3%
    Reporting group description
    		 Subjects received 3% Neramexane mesylate 0.5 g topical gel on every morning during Stage 1 and on every evening after removal of makeup before going to sleep during Stage 2. The total duration of treatment was 12 Weeks.

    Serious adverse events
    		 Vehicle Neramexane mesylate 0.5 Percent (%) Neramexane mesylate 1.5% Neramexane mesylate 3%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    1 / 59 (1.69%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    0 / 59 (0.00%)
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Intestinal adhesion lysis
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 59 (0.00%)
    1 / 59 (1.69%)
    0 / 59 (0.00%)
    0 / 60 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Vehicle Neramexane mesylate 0.5 Percent (%) Neramexane mesylate 1.5% Neramexane mesylate 3%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 59 (49.15%)
    29 / 59 (49.15%)
    40 / 59 (67.80%)
    37 / 60 (61.67%)
    Surgical and medical procedures
    Wisdom teeth removal
         subjects affected / exposed
    3 / 59 (5.08%)
    0 / 59 (0.00%)
    2 / 59 (3.39%)
    2 / 60 (3.33%)
         occurrences all number
    3
    0
    3
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 59 (6.78%)
    6 / 59 (10.17%)
    6 / 59 (10.17%)
    3 / 60 (5.00%)
         occurrences all number
    7
    6
    10
    3
    General disorders and administration site conditions
    Application site pain
         subjects affected / exposed
    3 / 59 (5.08%)
    9 / 59 (15.25%)
    20 / 59 (33.90%)
    23 / 60 (38.33%)
         occurrences all number
    3
    18
    32
    28
    Application site pruritus
         subjects affected / exposed
    6 / 59 (10.17%)
    4 / 59 (6.78%)
    16 / 59 (27.12%)
    12 / 60 (20.00%)
         occurrences all number
    6
    6
    31
    19
    Application site dryness
         subjects affected / exposed
    5 / 59 (8.47%)
    10 / 59 (16.95%)
    8 / 59 (13.56%)
    5 / 60 (8.33%)
         occurrences all number
    9
    15
    13
    6
    Application site exfoliation
         subjects affected / exposed
    3 / 59 (5.08%)
    7 / 59 (11.86%)
    4 / 59 (6.78%)
    3 / 60 (5.00%)
         occurrences all number
    3
    7
    4
    4
    Application site erythema
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 59 (1.69%)
    2 / 59 (3.39%)
    3 / 60 (5.00%)
         occurrences all number
    3
    1
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 59 (3.39%)
    3 / 59 (5.08%)
    2 / 59 (3.39%)
    0 / 60 (0.00%)
         occurrences all number
    2
    3
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 59 (22.03%)
    11 / 59 (18.64%)
    21 / 59 (35.59%)
    21 / 60 (35.00%)
         occurrences all number
    13
    15
    22
    22
    Oral herpes
         subjects affected / exposed
    3 / 59 (5.08%)
    1 / 59 (1.69%)
    1 / 59 (1.69%)
    4 / 60 (6.67%)
         occurrences all number
    3
    1
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Mar 2012
    Amendment prior to study start to address comments by BfArM and Ethics Committee.
    11 May 2012
    Main reason for the amendment was to address practical issues observed during treatment of the first study subjects, including a dose reduction to 0.5 gram (g) of gel daily.

    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
    For support, Contact us.
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