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    Clinical Trial Results:
    A Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (“Off” Episodes)

    Summary
    EudraCT number
    		 2012-000181-37
    Trial protocol
    		 GB  
    Global end of trial date
    29 Nov 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Aug 2016
    First version publication date
    17 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CVT-301-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01617135
    WHO universal trial number (UTN)
    		 -
    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,, Civitas Therapeutics, Inc., a wholly owned subsidiary of Acorda Therapeutics, Inc., +1 914-347-4300,
    Scientific contact
    Acorda Medical Lead/Scientific Lead, Clinical Development, , Civitas Therapeutics, Inc., a wholly owned subsidiary of Acorda Therapeutics, Inc., +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
    28 Jun 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the safety and tolerability of inhaled CVT 301 in Parkinson’s disease patients experiencing “off” episodes
    Protection of trial subjects
    The use of rescue therapy for patients experiencing a prolonged OFF (development of motor fluctuations) period was permitted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Apr 2012
    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
    United Kingdom: 15
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    Israel: 4
    Worldwide total number of subjects
    24
    EEA total number of subjects
    15
    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)
    12
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The screening period, which took place within 35 days prior to the dosing period, had 2 separate visits. At Screening Visit 1, patients provided written informed consent and were assessed for eligibility in an ON state. At Visit 2, the patient took his/her standard levodopa-containing morning dose along with other prescribed PD medication.

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Oral CD/LD
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Oral Carbidopa/Levadopa oCD/LD
    Investigational medicinal product code
    Other name
    SINEMET® Plus
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg/100 mg Tablets

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    2 placebo capsules for 25 mg levadopa fine particle dose (FPD)

    Arm title
    		 CVT-301 25mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVT-301 (25 mg FPD)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    2 active drug capsules for 25 mg levadopa fine particle dose (FPD)

    Arm title
    		 CVT-301 50mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CVT-301 (50 mg FPD)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder, hard capsule
    Routes of administration
    Inhalation use
    Dosage and administration details
    4 active drug capsules for 50 mg levadopa fine particle dose (FPD)

    Number of subjects in period 1
    		Oral CD/LD Placebo CVT-301 25mg CVT-301 50mg
    Started
    24
    23
    23
    24
    Dosing Period (Visit 3 - Visit 6)
    24
    23
    23
    24
    Completed
    24
    23
    23
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dosing Period
    Reporting group description
    		 -

    Reporting group values
    		 Dosing Period Total
    Number of subjects
    		 24 24
    Age categorical
    Age categories not defined in Clinical Study Report. See age contnuous characteristics.
    Units: Subjects
        Not Recorded
    		 24 24
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.3 ( 7.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5
        Male
    		 19 19

    End points

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    End points reporting groups
    Reporting group title
    Oral CD/LD
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    CVT-301 25mg
    Reporting group description
    		 -

    Reporting group title
    CVT-301 50mg
    Reporting group description
    		 -

    Primary: Pharmacokinetics Cmax

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    End point title
    		 Pharmacokinetics Cmax [1]
    End point description
    Variable baseline-adjusted plasma concentration-time profiles for the following; - maximum plasma concentration (Cmax)
    End point type
    Primary
    End point timeframe
    0-30 minutes post-dosing
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results of the trial are considered valid.
    End point values
    		 Oral CD/LD Placebo CVT-301 25mg CVT-301 50mg
    Number of subjects analysed
    24
    23
    23
    24
    Units: ng/mL
    arithmetic mean (standard deviation)
        Cmax 0-10
    242 ( 379 )
    45 ( 85 )
    273 ( 183 )
    578 ( 315 )
        Cmax 0-30
    620 ( 810 )
    49 ( 87 )
    322 ( 201 )
    690 ( 351 )
    No statistical analyses for this end point

    Primary: Pharmacokinetics AUC

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    End point title
    		 Pharmacokinetics AUC [2]
    End point description
    Variable baseline adjusted plasma concentration-time profiles for the below: - area under the concentration time curve (AUC)
    End point type
    Primary
    End point timeframe
    0-30 minutes post-dose
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results of the trial are considered valid.
    End point values
    		 Oral CD/LD Placebo CVT-301 25mg CVT-301 50mg
    Number of subjects analysed
    24
    23
    23
    24
    Units: ng-min/mL
    arithmetic mean (standard deviation)
        AUC 0-10
    758 ( 1166 )
    285 ( 580 )
    1957 ( 1522 )
    3833 ( 2202 )
        AUC 0-30
    9813 ( 14701 )
    1015 ( 2202 )
    7188 ( 4739 )
    15711 ( 8296 )
    No statistical analyses for this end point

    Primary: Pharmacokinetics Tmax

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    End point title
    		 Pharmacokinetics Tmax [3]
    End point description
    Variable baseline-adjusted plasma concentration-time profiles for the following; - time to reach Cmax (T Cmax) - time to maximum concentration (Tmax)
    End point type
    Primary
    End point timeframe
    up to 80 minutes post-dose
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results of the trial are considered valid.
    End point values
    		 Oral CD/LD Placebo CVT-301 25mg CVT-301 50mg
    Number of subjects analysed
    24
    23
    23
    24
    Units: min
    arithmetic mean (standard deviation)
        T Cmax 50
    51.6 ( 33.2 )
    13.4 ( 26.5 )
    4.5 ( 2.34 )
    4.96 ( 2.43 )
        Tmax
    78 ( 40 )
    55 ( 57 )
    16 ( 10 )
    23 ( 24 )
    No statistical analyses for this end point

    Primary: UPDRS III motor score

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    End point title
    		 UPDRS III motor score [4]
    End point description
    The Unified Parkinson’s Disease Rating Scale, Part III motor section (UPDRS III) is the motor section of the UPDRS examination, given by interview with actions performed by the patient. Some questions required multiple ratings to be assigned to each extremity. The areas addressed by this exam included speech, facial expression, tremor at rest, postural tremor, rigidity, finger taps, hand movements, rapid alternating movement (hands), leg agility, arising from a chair, posture, gait, postural stability, and body bradykinesia/hypokinesia. Early effect, defined as average response of assessments at 0-30 minutes after the dose of study medication.
    End point type
    Primary
    End point timeframe
    pre-dose and up to 180 minutes post-dose.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results of the trial are considered valid.
    End point values
    		 Oral CD/LD Placebo CVT-301 25mg CVT-301 50mg
    Number of subjects analysed
    24 [5]
    22 [6]
    23
    24
    Units: number/score on a scale
    arithmetic mean (standard deviation)
        Average response
    -13.3 ( 5.42 )
    -3.2 ( 5.71 )
    -5.2 ( 5.89 )
    -7.5 ( 6.64 )
        Best response
    -23.3 ( 6.46 )
    -10.8 ( 7.91 )
    -12.3 ( 8.55 )
    -16.2 ( 7.85 )
        Early effect AUC 0-30
    1854.04 ( 743.56 )
    1905.33 ( 946.66 )
    1908.8 ( 634.37 )
    1795.42 ( 750.83 )
    Notes
    [5] - Early effect AUC 0-30: Number of subjects 23
    [6] - Early effect AUC 0-30: Number of subjects 23
    No statistical analyses for this end point

    Primary: Tapping Test

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    End point title
    		 Tapping Test [7]
    End point description
    The finger tapping test requires a patient to alternately tap 2 manual counters that are separated by 20 cm for 30 seconds using one hand, and the number of taps per time interval is recorded.
    End point type
    Primary
    End point timeframe
    up to 180 minutes post-dose.
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Results of the trial are considered valid.
    End point values
    		 Oral CD/LD Placebo CVT-301 25mg CVT-301 50mg
    Number of subjects analysed
    24
    23
    23
    24
    Units: number of taps
    arithmetic mean (standard deviation)
        Average response
    7.9 ( 7.92 )
    1.5 ( 7.36 )
    4.4 ( 9.74 )
    6.5 ( 8.51 )
        Best response
    19.2 ( 11.76 )
    8.3 ( 9.81 )
    13.5 ( 12.12 )
    16 ( 12 )
        Early effect AUC 0-30
    1778.6 ( 651.31 )
    1827.7 ( 529.55 )
    1983.9 ( 667.5 )
    1954.6 ( 637.69 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 12 weeks
    Adverse event reporting additional description
    Events were classified as treatment-emergent if they started on or after the first dose of study drug administration at Visit 3 (start of 2-6 week dosing period) and up to and including the completion/termination date.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Oral CD/LD
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    CVT-301 25mg
    Reporting group description
    		 -

    Reporting group title
    CVT-301 50mg
    Reporting group description
    		 -

    Serious adverse events
    		 Oral CD/LD Placebo CVT-301 25mg CVT-301 50mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Oral CD/LD Placebo CVT-301 25mg CVT-301 50mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    5 / 23 (21.74%)
    8 / 24 (33.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    0
    0
    1
    Parkinson's disease
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 23 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    5 / 23 (21.74%)
    5 / 24 (20.83%)
         occurrences all number
    0
    0
    10
    10
    Rhinorrhoea
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    1
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 23 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    1

    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
    For support, Contact us.
    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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