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    Clinical Trial Results:
    ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia

    Summary
    EudraCT number
    		 2014-003738-24
    Trial protocol
    		 DE   ES   AT  
    Global end of trial date
    10 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Mar 2017
    First version publication date
    25 Mar 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ADS-AMT-PD304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02136914
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Adamas Pharmaceuticals, Inc
    Sponsor organisation address
    1900 Powell Street, Suite 750, Emeryville, United States, CA94608
    Public contact
    Clinical Trials Information, Adamas Pharmaceuticals, Inc., +1 5104503500, RegistroEspanolDeEstudiosClinicos@druginfo.com
    Scientific contact
    Clinical Trials Information, Adamas Pharmaceuticals, Inc., +1 5104503500, RegistroEspanolDeEstudiosClinicos@druginfo.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
    12 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of ADS-5102 oral capsules, an extended release formulation of amantadine, at a dose level of 340 mg, dosed once nightly at bedtime for 13 weeks, for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles of Good Clinical Practice, according to International Council for Harmonisation Guidelines.
    Background therapy
    		 For at least 30 days prior to Screening and throughout participation in the study, subjects were to receive stable doses and regimens of antiparkinson medications, including any levodopa preparation administered at least 3 times daily.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Oct 2014
    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
    Spain: 9
    Country: Number of subjects enrolled
    United States: 25
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Germany: 24
    Worldwide total number of subjects
    77
    EEA total number of subjects
    52
    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)
    31
    From 65 to 84 years
    46
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who provided written informed consent and met all eligibility criteria were randomly assigned in a 1:1 ratio to receive either placebo or ADS-5102 (340mg).

    Pre-assignment
    Screening details
    		 Male and female subjects between 30 and 85 years of age, inclusive; had PD per the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria; were ambulatory or ambulatory aided (walker or cane) while ON (the time during which PD symptoms were adequately controlled) and could complete study assignments were selected per protocol.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    Study drug was administered in a double blind fashion. Placebo capsules were indistinguishable in size and appearance from ADS-5102 capsules. A subject's treatment assignment was only to be unblinded when knowledge of the treatment was essential to the safety of the patient. The investigator was responsible for ensuring that instructions for unblinding were stored safely, the location known and readily available to the relevant staff if required. No emergency unblinding was performed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ADS-5102
    Arm description
    		 Active treatment group
    Arm type
    		 Experimental

    Investigational medicinal product name
    ADS-5102
    Investigational medicinal product code
    ADS-5102
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    ADS-5102 was taken once daily at bedtime (if possible, no earlier than 9pm). The ADS-5102 dose was 170 mg during week 1 (1 ADS-5102 capsule and 1 placebo capsule), 340 mg during Weeks 2 through 12 (2 ADS-5102 capsules) and 170 mg during Week 13 (1 ADS-5102 capsule and 1 placebo capsule). Capsules were to be swallowed intact with any non-alcoholic beverage with or without food.

    Arm title
    		 Placebo
    Arm description
    		 Placebo group
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was taken once daily at bedtime (if possible, no earlier than 9pm) and consisted of 2 placebo capsules Weeks 1 through 13. Capsules were to be swallowed intact with any non-alcoholic beverage with or without food.

    Number of subjects in period 1 [1]
    		ADS-5102 Placebo
    Started
    37
    38
    Completed
    29
    35
    Not completed
    8
    3
         Unwilling to proceed
    1
    -
         Consent withdrawn by subject
    6
    3
         Adverse event, non-fatal
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 77 Subjects were enrolled worldwide but 2 Subjects were randomized in error and did not receive study medication. One Subject was randomized to placebo and one was randomized to active. Results are reported for the 75 Subjects who received at least one dose of study medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial (overall period) Total
    Number of subjects
    		 75 75
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 31 31
        From 65-84 years
    		 44 44
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.8 ( 9.31 ) -
    Gender categorical
    Units: Subjects
        Female
    		 36 36
        Male
    		 39 39
    Subject analysis sets

    Subject analysis set title
    Modified Intent to Treat (MITT) ADS-5102
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The MITT population included all randomized subjects who were dosed and provided at least 1 post-baseline assessment of UDysRS (Unified Dyskinesia Rating Scale). The MITT population was used for the primary analysis, as well as for all secondary efficacy analyses. In all analyses and summaries based on the MITT population, subjects were included in the treatment group to which they were randomized.

    Subject analysis set title
    Modified Intent to Treat (MITT) Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The MITT population included all randomized subjects who were dosed and provided at least 1 post-baseline assessment of UDysRS (Unified Dyskinesia Rating Scale). The MITT population was used for the primary analysis, as well as for all secondary efficacy analyses. In all analyses and summaries based on the MITT population, subjects were included in the treatment group to which they were randomized.

    Subject analysis set title
    Safety Population ADS-5102
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all randomized subjects who received at least 1 dose of study drug. The safety population was used for safety analyses. In these analyses, subjects were analysed according to the treatment received most often.

    Subject analysis set title
    Safety population - placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all randomized subjects who received at least 1 dose of study drug. The safety population was used for safety analyses. In these analyses, subjects were analysed according to the treatment received most often.

    Subject analysis sets values
    		 Modified Intent to Treat (MITT) ADS-5102 Modified Intent to Treat (MITT) Placebo Safety Population ADS-5102 Safety population - placebo
    Number of subjects
    37
    38
    37
    38
    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)
    16
    15
    16
    15
        From 65-84 years
    21
    23
    21
    23
        85 years and over
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.7 ( 9.66 )
    64.9 ( 9.08 )
    64.7 ( 9.66 )
    64.9 ( 9.08 )
    Gender categorical
    Units: Subjects
        Female
    18
    18
    18
    18
        Male
    19
    20
    19
    20

    End points

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    End points reporting groups
    Reporting group title
    ADS-5102
    Reporting group description
    		 Active treatment group

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo group

    Subject analysis set title
    Modified Intent to Treat (MITT) ADS-5102
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The MITT population included all randomized subjects who were dosed and provided at least 1 post-baseline assessment of UDysRS (Unified Dyskinesia Rating Scale). The MITT population was used for the primary analysis, as well as for all secondary efficacy analyses. In all analyses and summaries based on the MITT population, subjects were included in the treatment group to which they were randomized.

    Subject analysis set title
    Modified Intent to Treat (MITT) Placebo
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The MITT population included all randomized subjects who were dosed and provided at least 1 post-baseline assessment of UDysRS (Unified Dyskinesia Rating Scale). The MITT population was used for the primary analysis, as well as for all secondary efficacy analyses. In all analyses and summaries based on the MITT population, subjects were included in the treatment group to which they were randomized.

    Subject analysis set title
    Safety Population ADS-5102
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all randomized subjects who received at least 1 dose of study drug. The safety population was used for safety analyses. In these analyses, subjects were analysed according to the treatment received most often.

    Subject analysis set title
    Safety population - placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety population included all randomized subjects who received at least 1 dose of study drug. The safety population was used for safety analyses. In these analyses, subjects were analysed according to the treatment received most often.

    Primary: Change from Baseline in UDysRS Total Score at Week 12 (MITT population)

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    End point title
    		 Change from Baseline in UDysRS Total Score at Week 12 (MITT population)
    End point description
    The UDysRS is a 26-item rating scale which evaluates involuntary movements often associated with treated Parkinson's Disease. The scale has four parts with a total possible score of 104.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 Modified Intent to Treat (MITT) ADS-5102 Modified Intent to Treat (MITT) Placebo
    Number of subjects analysed
    37
    38
    Units: Total Score
    arithmetic mean (standard deviation)
        Baseline
    41.7 ( 12.57 )
    40.4 ( 10.09 )
        Week 12
    20.8 ( 11.83 )
    33.3 ( 14.35 )
        Change from Baseline
    -21 ( 16.6 )
    -7.1 ( 12.14 )
    Statistical analysis title
    		 MMRM Treatment Difference (Active-Placebo)
    Statistical analysis description
    The mixed model with repeat measures (MMRM) included all categorical effects for treatment group, visit (Weeks 2, 4, 8, and 12), and the interaction between treatment group and visit; the baseline value was included as a continuous covariate. The dependent variable was the change from baseline. MMRM Least squares (standard error) mean change from baseline at Week 12 were calculated. Summary statistics were computed using data for subjects who had values at both baseline and Week 12.
    Comparison groups
    Modified Intent to Treat (MITT) ADS-5102 v Modified Intent to Treat (MITT) Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 MMRM
    Parameter type
    		 LS mean treatment difference
    Point estimate
    -14.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -20.4
         upper limit
    		 -8.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.03

    Secondary: Change from Baseline in PD Diary ON Time Without Troublesome Dyskinesia at Week 12 (MITT Population)

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    End point title
    		 Change from Baseline in PD Diary ON Time Without Troublesome Dyskinesia at Week 12 (MITT Population)
    End point description
    Patient reported diary state where ON time without troublesome dyskinesia is the duration of time that a patient is free from troublesome dyskinesia.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Modified Intent to Treat (MITT) ADS-5102 Modified Intent to Treat (MITT) Placebo
    Number of subjects analysed
    37
    38
    Units: Hours
        arithmetic mean (standard deviation)
    9.14 ( 2.388 )
    7.64 ( 3.234 )
    Statistical analysis title
    		 MMRM Treatment Difference (Active - Placebo)
    Statistical analysis description
    The MMRM results were from a model that used all available data at each time point. In this model, the dependent variable was the change from baseline. The model included categorical effects for treatment group, visit (weeks 2, 4, 8, and 12), and the interaction between treatment group and visit; the baseline value was included as a continuous covariate. Summary statistics were computed using data from subjects who had values at both baseline and Week 12.
    Comparison groups
    Modified Intent to Treat (MITT) ADS-5102 v Modified Intent to Treat (MITT) Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0168
    Method
    		 MMRM
    Parameter type
    		 LS mean treatment difference
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 3.45
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.775

    Secondary: Change from Baseline to Week 12 in PD Diary OFF time

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    End point title
    		 Change from Baseline to Week 12 in PD Diary OFF time
    End point description
    OFF time refers to the duration of time when a patient is not benefiting from medication.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Modified Intent to Treat (MITT) ADS-5102 Modified Intent to Treat (MITT) Placebo
    Number of subjects analysed
    37
    38
    Units: Hours
        arithmetic mean (standard deviation)
    2.76 ( 2.104 )
    1.95 ( 1.687 )
    Statistical analysis title
    		 MMRM Treatment Difference (Active - Placebo)
    Statistical analysis description
    The MMRM results were from a model that used all available data at each time point. In this model, the dependent variable was the change from baseline. The model included categorical effects for treatment group, visit (weeks 2, 4, 8, and 12), and the interaction between treatment group and visit; the baseline value was included as a continuous covariate. Summary statistics were computed using data from subjects who had values at both baseline and Week 12.
    Comparison groups
    Modified Intent to Treat (MITT) ADS-5102 v Modified Intent to Treat (MITT) Placebo
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0199
    Method
    		 MMRM
    Parameter type
    		 LS mean treatment difference
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.02
         upper limit
    		 -0.18
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.461

    Secondary: Overview of Adverse Events

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    End point title
    		 Overview of Adverse Events
    End point description
    Overview of Adverse Events (Safety Population)
    End point type
    Secondary
    End point timeframe
    From start of study medication (all AEs collected were treatment-emergent) to final follow-up assessment.
    End point values
    		 Safety Population ADS-5102 Safety population - placebo
    Number of subjects analysed
    37
    38
    Units: Subjects
        Subjects with any AEs
    31
    19
        Subjects with study drug related AEs
    21
    10
        Subjects with Serious AEs
    4
    0
        Subjects with study drug related SAEs
    1
    0
        Subjects who discontinued due to AE
    7
    3
        Discontinued due to study drug related AEs
    6
    2
        Subjects with any AEs highest intensity MILD
    8
    12
        Subjects with any AEs highest intensity MODERATE
    18
    5
        Subjects with any AEs highest intensity SEVERE
    5
    2
        Subjects with related AEs highest intensity MILD
    5
    7
        Subjects with related AEs highest intensity MOD.
    12
    2
        Subjects with related AEs highest intensity SEVERE
    4
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Any adverse event with an onset date after study drug administration up to and including the designated Safety Follow-up Visit.
    Adverse event reporting additional description
    Adverse events are reported as one occurrence for each event reported. Non-serious adverse events: Most common AEs (at least 5% of subjects in the active treatment group) are reported. Total subjects affected by non-serious AEs refers to the number of subjects with any AEs experienced by >=5% of subjects in the active treatment group.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Safety Population ADS-5102
    Reporting group description
    		 -

    Reporting group title
    Safety Population Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Population ADS-5102 Safety Population Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 38 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiorespiratory arrest
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dysesthesia
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    1 / 37 (2.70%)
    0 / 38 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Population ADS-5102 Safety Population Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 37 (83.78%)
    19 / 38 (50.00%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 38 (5.26%)
         occurrences all number
    3
    2
    Vascular disorders
    Orthostatic hypotension
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 38 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Dystonia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    2 / 37 (5.41%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Somnolence
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    5 / 37 (13.51%)
    1 / 38 (2.63%)
         occurrences all number
    5
    1
    Nausea
         subjects affected / exposed
    5 / 37 (13.51%)
    1 / 38 (2.63%)
         occurrences all number
    5
    1
    Constipation
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 38 (0.00%)
         occurrences all number
    4
    0
    Hallucination (Pooled)
    Additional description: The "Hallucinations (Pooled)" term combines all PTs that contain the term "Hallucination" and in this case combines "Hallucination, visual" and "Hallucination, auditory".
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 38 (5.26%)
         occurrences all number
    3
    2
    Apathy
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Depressed Mood
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Hallucination, visual
         subjects affected / exposed
    3 / 37 (8.11%)
    2 / 38 (5.26%)
         occurrences all number
    3
    2
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    2 / 37 (5.41%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 37 (5.41%)
    3 / 38 (7.89%)
         occurrences all number
    2
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 37 (10.81%)
    0 / 38 (0.00%)
         occurrences all number
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Dec 2014
    Amendment 1. To the exclusion criterion regarding sexually active females, simplified the wording regarding acceptable contraception and specified that a hormonal method was to used in combination with a barrier method. Added that subjects with untreated angle closure glaucoma would be excluded from the study. Added that subjects with suicidal ideation and subjects with a history of suicidal ideation or suicide attempt during amantadine treatment would be excluded from the study. Added that use of medications that prolonged the QT interval and had a known risk of torsades de pointes would exclude a subject from the study unless the medication was discontinued at least 60 days prior to Screening. Added (to the appendix of prohibited medications) a list of agents that prolong the QT interval and had a known risk of torsades de pointes. Added urine pregnancy testing for female subjects of childbearing potential at the end of Weeks 4, 8, 12 and 18; modified the schedule of assessments accordingly.

    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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