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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena).

    Summary
    EudraCT number
    		 2012-005822-31
    Trial protocol
    		 GB   IT  
    Global end of trial date
    21 Jan 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jun 2016
    First version publication date
    14 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CVT-301-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01777555
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sample data: Sample data
    Sponsors
    Sponsor organisation name
    Civitas Therapeutics, Inc., a wholly owned subsidiary of Acorda Therapeutics, Inc.
    Sponsor organisation address
    420 Saw Mill River Road, Ardsley, United States, 10502
    Public contact
    Acorda Medical Lead/Scientific Lead, Clinical Development & Medical Affairs (CDMA), +1 914-347-4300,
    Scientific contact
    Acorda Medical Lead/Scientific Lead, CDMA, +1 914-347-4300,
    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
    18 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial is to compare the effects of CVT-301 Dose Level 2 (DL2; high dose) and placebo on the mean change from pre-dose in average UPDRS Part 3 motor score at 10 to 60 minutes following treatment of patients experiencing an OFF episode at the end-of-treatment (EOT) visit (Visit 6).
    Protection of trial subjects
    n/a
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Apr 2013
    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
    Italy: 10
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 64
    Country: Number of subjects enrolled
    Serbia: 8
    Worldwide total number of subjects
    86
    EEA total number of subjects
    14
    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
    37
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 89 [1]
    Number of subjects completed
    		 86

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Withdrawn from study before receiving study drug: 3
    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 patients (89) were randomized. (3) patients were withdrawn from study before receiving any study drug. (86) patients continued to Treatment Period 1.
    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    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
    Capsule, hard
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo powder was intended to provide a sensation of dose administration, but was not intended to provide a respirable dose.

    Arm title
    		 CVT-301
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVT-301
    Investigational medicinal product code
    Other name
    Levodopa
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    CVT-301 capsule designed to deliver an approximate respirable dose.

    Number of subjects in period 1
    		Placebo CVT-301
    Started
    43
    43
    Completed
    43
    43
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    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
    Capsule, hard
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo consists of inhalation grade lactose monohydrate 120MS, United States Pharmacopeia (USP).

    Arm title
    		 CVT-301
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVT-301
    Investigational medicinal product code
    Other name
    Levodopa
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    CVT-301 capsule designed to deliver an approximate respirable dose.

    Number of subjects in period 2
    		Placebo CVT-301
    Started
    43
    43
    Completed
    36
    39
    Not completed
    7
    4
         Consent withdrawn by subject
    3
    3
         Adverse event, non-fatal
    3
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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

    Reporting group title
    CVT-301
    Reporting group description
    		 -

    Reporting group values
    		 Placebo CVT-301 Total
    Number of subjects
    		 43 43 86
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.7 ± 9.08 62 ± 8.36 -
    Gender categorical
    Units: Subjects
        Female
    		 11 18 29
        Male
    		 32 25 57

    End points

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

    Reporting group title
    CVT-301
    Reporting group description
    		 -
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    CVT-301
    Reporting group description
    		 -

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The Intent-to-Treat (ITT) population will include all patients who received at least one dose of inhaled CVT-301 or placebo. Patients will be analyzed according to randomized treatment. The ITT Population will be used for all analyses of efficacy endpoints and summaries of patient demographic and baseline characteristics.

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Population will include all patients who received at least one dose of inhaled CVT-301 or placebo. Patients will be analyzed according to treatment received. The Safety Population will be used for all analyses of safety endpoints.

    Primary: UPDRS Part 3 Score Mean Change From Predose to 10 to 60 Minutes Postdose at Visit 6

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    End point title
    		 UPDRS Part 3 Score Mean Change From Predose to 10 to 60 Minutes Postdose at Visit 6
    End point description
    End point type
    Primary
    End point timeframe
    Predose to 10 to 60 Minutes Postdose
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    40
    42
    Units: Units on a scale
        least squares mean (standard error)
    -3.07 ± 1.54
    -10.02 ± 1.5
    Statistical analysis title
    		 UPDRS Part 3 Score Mean Change at Visit 6
    Statistical analysis description
    MMRM model uses UPDRS Part III total score at 10 to 60 minutes at visits 4, 5, and 6 as the dependent variable, and includes baseline PD severity, country, treatment, visit, and treatment-by-visit interaction as factors and baseline UPDRS Part III score, screening score in OFF state, as a covariate.
    Comparison groups
    Placebo v CVT-301
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 < 0.001 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -6.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.31
         upper limit
    		 -3.6
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.5
    Notes
    [1] - Mixed effect Model Repeat Measurement
    [2] - CVT-301 p-value at Visit 6 Dispersion value SE of the mean shown below is for CVT-301. Placebo (SE) dispersion value is 1.544

    Secondary: Change from pre-dose in the average UPDRS Part 3 motor score at the end of 1 week of treatment (Visit 4)

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    End point title
    		 Change from pre-dose in the average UPDRS Part 3 motor score at the end of 1 week of treatment (Visit 4)
    End point description
    ITT Population
    End point type
    Secondary
    End point timeframe
    10 to 60 minutes post-dose
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    40
    42
    Units: Units on a scale
        least squares mean (standard error)
    -5.3 ± 1.53
    -9.9 ± 1.49
    No statistical analyses for this end point

    Secondary: Number of patients achieving objective UPDRS 3 motor response (≥30%)

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    End point title
    		 Number of patients achieving objective UPDRS 3 motor response (≥30%)
    End point description
    ITT Population Objective motor response is defined as a patient having ≥30% reduction in the UPDRS Part 3 total score from pre-dose to post-dose at any time point post-dose.
    End point type
    Secondary
    End point timeframe
    From 10 to 60 minutes post-dose visits 4, 5 and 6.
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Number
        Visit 4 (N=40/42) ≥30% reduction
    15
    27
        Visit 5 (N=39/40) ≥30% reduction
    11
    28
        Visit 6 (N=36/38) ≥30% reduction
    10
    27
    No statistical analyses for this end point

    Secondary: Change and percent change in UPDRS Part 3 Total Score at specified time points from Pre-dose to Post-dose

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    End point title
    		 Change and percent change in UPDRS Part 3 Total Score at specified time points from Pre-dose to Post-dose
    End point description
    End point type
    Secondary
    End point timeframe
    10 to 60 minutes following treatment.
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Percent change/Score
    arithmetic mean (standard deviation)
        Visit 4 Change 10 min post-dose (N=40/42)
    -3.2 ± 6.59
    -6.1 ± 7.96
        Visit 4 Percent Change 10 min post-dose (N=40/42)
    -9.74 ± 17.86
    -15.18 ± 30.27
        Visit 4 Change 20 min post-dose (N=40/42)
    -5.9 ± 7.83
    -10 ± 9.32
        Visit 4 Percent Change 20 min post-dose (N=40/42)
    -18.25 ± 22
    -27.79 ± 33.95
        Visit 4 Change 30 min post-dose (N=40/42)
    -6.1 ± 7.71
    -11 ± 9.2
        Visit 4 Percent Change 30 min post-dose (N=40/42)
    -19.25 ± 25.14
    -31.83 ± 28.45
        Visit 4 Change 60 min post-dose (N=40/42)
    -4.2 ± 6.51
    -9.3 ± 11.12
        Visit 4 Percent Change 60 min post-dose (N=40/42)
    -13.73 ± 23.49
    -24.22 ± 40.68
        Visit 5 Change 10 min Post-dose (N=38/40)
    -2.5 ± 7.81
    -4.6 ± 7.11
        Visit 5 Percent Change 10 min Post-dose (N=38/40)
    -3.72 ± 25.02
    -13.96 ± 20.87
        Visit 5 Change 20 min Post-dose (N=39/40)
    -4.5 ± 7.53
    -9.8 ± 9.06
        Visit 5 Percent Change 20 min Post-dose (N=39/40)
    -9.71 ± 27.56
    -28.66 ± 25.7
        Visit 5 Change 30 min Post-dose (N=39/40)
    -3.4 ± 8.27
    -11.7 ± 10.8
        Visit 5 Percent Change 30 min Post-dose (N=39/40)
    -5.66 ± 30.63
    -33.55 ± 26.47
        Visit 5 Change 60 min Post-dose (N=39/40)
    -1.9 ± 6.07
    -11.4 ± 11.98
        Visit 5 Percent Change 60 min Post-dose (N=39/40)
    -0.91 ± 31.86
    -33.02 ± 30.53
        Visit 6 Change 10 min Post-dose (N=36/38)
    -2 ± 7.48
    -4.9 ± 7.82
        Visit 6 Percent Change 10 min Post-dose (N=36/38)
    -3.46 ± 27.49
    -14.45 ± 20
        Visit 6 Change 20 min Post-dose (N=36/38)
    -3.8 ± 8.96
    -8.9 ± 9.78
        Visit 6 Percent Change 20 min Post-dose (N=36/38)
    -8.81 ± 28.54
    -27.73 ± 27.42
        Visit 6 Change 30 min Post-dose (N=36/38)
    -3.3 ± 7.56
    -11.6 ± 9.67
        Visit 6 Percent Change 30 min Post-dose (N=36/38)
    -7.66 ± 27.35
    -35.27 ± 27.56
        Visit 6 Change 60 min Post-dose (N=36/38)
    -1.6 ± 6.53
    -11.2 ± 9.83
        Visit 6 Percent Change 60 min Post-dose (N=36/38)
    -2.47 ± 25.88
    -33.82 ± 28.22
    No statistical analyses for this end point

    Secondary: Examiner-rated Time to Resolution of OFF Episodes to ON State

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    End point title
    		 Examiner-rated Time to Resolution of OFF Episodes to ON State
    End point description
    Time to Resolution of OFF Episodes to ON State is calculated as (Time patient turns “ON” – Time of study drug administration). Measure type number = 25% Quantile 999 number = NE (not equatable)
    End point type
    Secondary
    End point timeframe
    Following observed treatment of patients experiencing an Off episode at each visit
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Minutes
    number (confidence interval 95%)
        Visit 4 (N=40/42)
    22.5 (13 to 30)
    16 (9 to 20)
        Visit 5 (N=39/39)
    17 (8 to 38)
    15 (9 to 20)
        Visit 6 (N=36/37)
    13.5 (10 to 999)
    10 (8 to 18)
    No statistical analyses for this end point

    Secondary: Time from Dosing to Dyskinesia Onset

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    End point title
    		 Time from Dosing to Dyskinesia Onset
    End point description
    ITT Population
    End point type
    Secondary
    End point timeframe
    Following study medication administration at each visit.
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Minutes
    arithmetic mean (standard deviation)
        Visit 4 (N=4/5)
    21 ± 9.9
    44.8 ± 16.98
        Visit 5 (N=2/12)
    14 ± 12.73
    43 ± 27.76
        Visit 6 (N=2/10)
    29 ± 33.94
    29.3 ± 11.17
    No statistical analyses for this end point

    Secondary: Occurrence and Severity of Dyskinesia Visit 4

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    End point title
    		 Occurrence and Severity of Dyskinesia Visit 4
    End point description
    Dyskinesia in Parkinson's Disease (DPD)
    End point type
    Secondary
    End point timeframe
    Following study medication at visit 4 (Week 2).
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Number
        DPD Turned ON Post Inhaled Treatment
    18
    28
        DPD Among Patients Turned ON Post Treatment- Yes
    4
    5
        DPD Among Patients Turned ON Post Treatment- No
    14
    23
        Dyskinesia Among All Patients - Yes
    4
    5
        Dyskinesia Among All Patients - No
    36
    37
        Severity of Dyskinesia - Mild
    1
    4
        Severity of Dyskinesia - Moderate
    2
    1
        Severity of Dyskinesia - Severe
    0
    0
        Severity of Dyskinesia - Unknown
    1
    0
    No statistical analyses for this end point

    Secondary: Occurrence and Severity of Dyskinesia Visit 5

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    End point title
    		 Occurrence and Severity of Dyskinesia Visit 5
    End point description
    Dyskinesia in Parkinson's Disease (DPD)
    End point type
    Secondary
    End point timeframe
    Following study medication at visit 5 (Week 3).
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Number
        Turned ON Post Inhaled Treatment
    16
    30
        DPD Among Patients Turned ON Post Treatment- Yes
    1
    12
        DPD Among Patients Turned ON Post Treatment- No
    15
    18
        Dyskinesia Among All Patients - Yes
    2
    12
        Dyskinesia Among All Patients - No
    37
    28
        Severity of Dyskinesia - Mild
    1
    12
        Severity of Dyskinesia - Moderate
    1
    0
        Severity of Dyskinesia - Severe
    0
    0
        Severity of Dyskinesia - Unknown
    0
    0
    No statistical analyses for this end point

    Secondary: Occurrence and Severity of Dyskinesia Visit 6

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    End point title
    		 Occurrence and Severity of Dyskinesia Visit 6
    End point description
    Dyskinesia in Parkinson's Disease (DPD)
    End point type
    Secondary
    End point timeframe
    Following study medication at visit 6 (Week 5).
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Number
        Turned ON Post Inhaled Treatment
    13
    30
        DPD Among Patients Turned ON Post Treatment- Yes
    2
    12
        DPD Among Patients Turned ON Post Treatment- No
    11
    18
        Dyskinesia Among All Patients - Yes
    2
    12
        Dyskinesia Among All Patients - No
    34
    26
        Severity of Dyskinesia - Mild
    2
    9
        Severity of Dyskinesia - Moderate
    0
    2
        Severity of Dyskinesia - Severe
    0
    0
        Severity of Dyskinesia - Unknown
    0
    1
    No statistical analyses for this end point

    Secondary: Number of patients achieving objective UPDRS III motor response ( ≥20% reduction, ≥6 point and ≥11 point reduction)

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    End point title
    		 Number of patients achieving objective UPDRS III motor response ( ≥20% reduction, ≥6 point and ≥11 point reduction)
    End point description
    ITT Population Objective motor response is defined as a patient having ≥20% reduction, ≥6 point and ≥11 point reduction in the UPDRS Part III total score from pre-dose to post-dose at any time point post-dose.
    End point type
    Secondary
    End point timeframe
    From 10 to 60 minutes post-dose visits 4, 5 and 6.
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Number
        Visit 4 (N=40/42) ≥20% reduction
    21
    31
        Visit 5 (N=39/40) ≥20% reduction
    14
    31
        Visit 6 (N=36/38) ≥20% reduction
    13
    31
        Visit 4 (N=40/42) ≥6 point reduction
    22
    32
        Visit 5 (N=39/40) ≥6 point reduction
    17
    32
        Visit 6 (N=36/38) ≥6 point reduction
    13
    31
        Visit 4 (N=40/42) ≥11 point reduction
    11
    24
        Visit 5 (N=39/40) ≥11 point reduction
    11
    26
        Visit 6 (N=36/38) ≥11 point reduction
    10
    25
    No statistical analyses for this end point

    Secondary: Mean time from study treatment to resolution of an OFF episode to an ON state during 2 week at-home period

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    End point title
    		 Mean time from study treatment to resolution of an OFF episode to an ON state during 2 week at-home period
    End point description
    End point type
    Secondary
    End point timeframe
    At-home treatment weeks 1-2.
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Minutes
        least squares mean (standard error)
    59.3 ± 6.92
    48.9 ± 6.78
    No statistical analyses for this end point

    Secondary: Mean daily ON time without dyskinesia, ON time with dyskinesia (troublesome and non-troublesome), and OFF time from PD diaries

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    End point title
    		 Mean daily ON time without dyskinesia, ON time with dyskinesia (troublesome and non-troublesome), and OFF time from PD diaries
    End point description
    ITT Population ON time with dyskinesia (troublesome and non-troublesome)
    End point type
    Secondary
    End point timeframe
    At Screening period and Treatment Weeks 1, 2 and 4.
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Hours
    least squares mean (standard error)
        Week 1 ON time without dyskinesia
    0.05 ± 0.42
    0.43 ± 0.42
        Week 2 ON time without dyskinesia
    0.38 ± 0.46
    0.7 ± 0.46
        Week 4 ON time without dyskinesia
    0.19 ± 0.48
    0.59 ± 0.47
        Week 1 ON time with dyskinesia
    0.54 ± 0.26
    0.3 ± 0.25
        Week 2 ON time with dyskinesia
    0.35 ± 0.22
    0.17 ± 0.22
        Week 4 ON time with dyskinesia
    0.4 ± 0.27
    0.7 ± 0.27
        Week 1 OFF time
    -0.72 ± 0.35
    -0.99 ± 0.35
        Week 2 OFF time
    -0.77 ± 0.37
    -1.06 ± 0.37
        Week 4 OFF time
    -0.77 ± 0.38
    -1.64 ± 0.37
    No statistical analyses for this end point

    Secondary: Number of treated OFF episodes that resolve to an ON state at pre-specified time intervals (minutes) after study treatment

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    End point title
    		 Number of treated OFF episodes that resolve to an ON state at pre-specified time intervals (minutes) after study treatment
    End point description
    Cumulative number indicates the total number of resolved episodes during the week in question.
    End point type
    Secondary
    End point timeframe
    At Treatment Weeks 1, 2, 3 and 4
    End point values
    		 Placebo CVT-301
    Number of subjects analysed
    43
    43
    Units: Cumulative Number
        Week 1 (≤ 5 min)
    10
    41
        Week 1 (≤ 10 min)
    53
    75
        Week 1 (≤ 20 min)
    176
    195
        Week 1 (≤ 30 min)
    258
    271
        Week 1 (≤ 45 min)
    323
    338
        Week 1 (≤ 180 min)
    495
    497
        Week 2 (≤ 5 min)
    20
    23
        Week 2 (≤ 10 min)
    35
    72
        Week 2 (≤ 20 min)
    145
    170
        Week 2 (≤ 30 min)
    215
    238
        Week 2 (≤ 45 min)
    274
    307
        Week 2 (≤ 180 min)
    474
    444
        Week 3 (≤ 5 min)
    23
    15
        Week 3 (≤ 10 min)
    70
    52
        Week 3 (≤ 20 min)
    168
    170
        Week 3 (≤ 30 min)
    240
    232
        Week 3 (≤ 45 min)
    354
    302
        Week 3 (≤ 180 min)
    499
    428
        Week 4 (≤ 5 min)
    29
    21
        Week 4 (≤ 10 min)
    78
    62
        Week 4 (≤ 20 min)
    129
    170
        Week 4 (≤ 30 min)
    188
    253
        Week 4 (≤ 45 min)
    256
    316
        Week 4 (≤ 180 min)
    456
    440
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 10 weeks.
    Adverse event reporting additional description
    Treatment Emergent Adverse Events (TEAEs)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    CVT-301
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo CVT-301
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Drop attacks
         subjects affected / exposed
    1 / 43 (2.33%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Placebo CVT-301
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 43 (13.95%)
    17 / 43 (39.53%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 43 (4.65%)
    3 / 43 (6.98%)
         occurrences all number
    4
    3
    Headache
         subjects affected / exposed
    2 / 43 (4.65%)
    2 / 43 (4.65%)
         occurrences all number
    3
    2
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 43 (2.33%)
    2 / 43 (4.65%)
         occurrences all number
    1
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 43 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 43 (2.33%)
    3 / 43 (6.98%)
         occurrences all number
    1
    4
    Sputum discoloured
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    0
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 43 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2

    More information

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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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