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    Clinical Trial Results:
    Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off.

    Summary
    EudraCT number
    		 2015-004507-23
    Trial protocol
    		 LV   DE   HU   FI  
    Global end of trial date
    27 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2019
    First version publication date
    03 Apr 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    3112004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02764125
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Orion Corporation Orion Pharma
    Sponsor organisation address
    Orionintie 1, Espoo, Finland, 02200
    Public contact
    clinicaltrials@orionpharma.com, Orion Corporation Orion Pharma, 358 0104261, clinicaltrials@orionpharma.com
    Scientific contact
    clinicaltrials@orionpharma.com, Orion Corporation Orion Pharma, 358 0104261, clinicaltrials@orionpharma.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
    27 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the efficacy and safety of ODM-104 in combination with modified release (MR) levodopa and 65 mg of carbidopa in the treatment of Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations) compared to active control (Stalevo).
    Protection of trial subjects
    ECG and safety laboratory parameters were measured at screening, at each visit and at the end-of-study visit. Adverse events were followed from the time that a study subject signed the IC form until the end-of-study visit (7-21 days after the last study treatment administration).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2016
    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
    Finland: 7
    Country: Number of subjects enrolled
    Germany: 43
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    Latvia: 18
    Worldwide total number of subjects
    84
    EEA total number of subjects
    84
    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)
    40
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Male and female patients with Parkinson's disease were recruited in four countries during the years 2016-2018.

    Pre-assignment
    Screening details
    		 Male or female patients with idiopathic PD, with end-of-dose wearingoff (motor fluctuations). Hoehn and Yahr stage 2-4 performed during the ON-state. At least 2 h of OFF-time on each day. Treatment with 4-8 daily doses of levodopa/AADC inhibitor, either combined or without entacapone. Age of 30 years or above.

    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
    Blinding implementation details
    Double dummy technique was used.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ODM-104
    Arm description
    		 ODM-104 100 mg, carbidopa 65 mg and levodopa according to subject's own individual levodopa dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-104 100 mg capsule
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg of ODM-104 with 65 mg of carbidopa and levodopa (the dose depended on subject’s own individual levodopa dose) and placebo for Stalevo. The daily dose of ODM-104 was 400 - 800 mg, levodopa 300 - 1200 mg and carbidopa 75 - 520 mg.

    Arm title
    		 Stalevo
    Arm description
    		 Stalevo combination tablets containing levodopa/carbidopa/entacapone.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Stalevo tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Levodopa/carbidopa/entacapone combination (Stalevo) and placebo for ODM-104. The daily dose of levodopa was 300 - 1200 mg, carbidopa 75 - 520 mg and entacapone 800 - 1600 mg.

    Number of subjects in period 1
    		ODM-104 Stalevo
    Started
    84
    84
    Completed
    70
    70
    Not completed
    14
    14
         Adverse event, non-fatal
    8
    8
         Other
    4
    4
         Personal reason
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 84 84
    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)
    		 40 40
        From 65-84 years
    		 44 44
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Females
    		 31 31
        Males
    		 53 53

    End points

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    End points reporting groups
    Reporting group title
    ODM-104
    Reporting group description
    		 ODM-104 100 mg, carbidopa 65 mg and levodopa according to subject's own individual levodopa dose.

    Reporting group title
    Stalevo
    Reporting group description
    		 Stalevo combination tablets containing levodopa/carbidopa/entacapone.

    Primary: Mean change in OFF-time

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    End point title
    		 Mean change in OFF-time
    End point description
    End point type
    Primary
    End point timeframe
    The subjects recorded their PD status using the ON/OFF diary on 3 consecutive days before baseline and weeks 4 and 8 visits, after 4 weeks of each treatments.
    End point values
    		 ODM-104 Stalevo
    Number of subjects analysed
    72 [1]
    73 [2]
    Units: hour
        least squares mean (confidence interval 95%)
    -1.0687 (-1.73 to -0.41)
    -0.9644 (-1.62 to -0.31)
    Notes
    [1] - miTT population
    [2] - miTT population
    Statistical analysis title
    		 Change from baseline in duration of daily OFF-time
    Statistical analysis description
    Analysed using an analysis of covariance (ANCOVA) model for crossover design.
    Comparison groups
    ODM-104 v Stalevo
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7718
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.104
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.819
         upper limit
    		 0.61

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of the study treatment until the end-of-study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    ODM-104
    Reporting group description
    		 ODM-104 100 mg, carbidopa 65 mg and levodopa according to subject's own individual levodopa dose.

    Reporting group title
    Stalevo
    Reporting group description
    		 Stalevo combination tablets containing levodopa/carbidopa/entacapone.

    Serious adverse events
    		 ODM-104 Stalevo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 81 (7.41%)
    0 / 78 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Blood pressure increased
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (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
    Parkinson's disease
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign gastric neoplasm
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (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
    Acute kidney injury
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Localised infection
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (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: 0%
    Non-serious adverse events
    		 ODM-104 Stalevo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 81 (60.49%)
    47 / 78 (60.26%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    0
    2
    Hypotension
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Orthostatic hypotension
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    0
    2
    Chest discomfort
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Drug effect decreased
         subjects affected / exposed
    2 / 81 (2.47%)
    2 / 78 (2.56%)
         occurrences all number
    2
    2
    Face oedema
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    2 / 81 (2.47%)
    2 / 78 (2.56%)
         occurrences all number
    2
    2
    Feeling abnormal
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Gait disturbance
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Malaise
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Medical device site irritation
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    8 / 81 (9.88%)
    2 / 78 (2.56%)
         occurrences all number
    8
    2
    Therapeutic response delayed
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Therapeutic response shortened
         subjects affected / exposed
    8 / 81 (9.88%)
    3 / 78 (3.85%)
         occurrences all number
    9
    4
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    Pulmonary oedema
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Delusion
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Hallucination, visual
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 81 (1.23%)
    3 / 78 (3.85%)
         occurrences all number
    2
    3
    Nightmare
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Sleep attacks
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Sleep disorder
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Blood potassium increased
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Road traffic accident
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Skin injury
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Cardiac failure chronic
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Coronary artery disease
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Akinesia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Cognitive disorder
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    1 / 81 (1.23%)
    4 / 78 (5.13%)
         occurrences all number
    1
    5
    Dysarthria
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Dyskinesia
         subjects affected / exposed
    4 / 81 (4.94%)
    4 / 78 (5.13%)
         occurrences all number
    4
    4
    Dystonia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 78 (2.56%)
         occurrences all number
    1
    3
    Hypersomnia
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Hypokinesia
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    Paraesthesia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Parkinson's disease
         subjects affected / exposed
    7 / 81 (8.64%)
    8 / 78 (10.26%)
         occurrences all number
    8
    8
    Restless legs syndrome
         subjects affected / exposed
    0 / 81 (0.00%)
    3 / 78 (3.85%)
         occurrences all number
    0
    3
    Somnolence
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Spinal cord disorder
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    4 / 81 (4.94%)
    1 / 78 (1.28%)
         occurrences all number
    4
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Colon adenoma
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 78 (2.56%)
         occurrences all number
    1
    2
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    2
    Ocular hyperaemia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    0
    2
    Constipation
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    2 / 81 (2.47%)
    1 / 78 (1.28%)
         occurrences all number
    2
    1
    Dry mouth
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    2 / 81 (2.47%)
    1 / 78 (1.28%)
         occurrences all number
    2
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Hiatus hernia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Lip swelling
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    4 / 81 (4.94%)
    3 / 78 (3.85%)
         occurrences all number
    4
    9
    Reactive gastropathy
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Erythema
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 78 (2.56%)
         occurrences all number
    1
    2
    Pigmentation disorder
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Skin fissures
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Skin irritation
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    Haematuria
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 78 (2.56%)
         occurrences all number
    1
    3
    Leukocyturia
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Urinary tract disorder
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Urine odour abnormal
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Back pain
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    1 / 81 (1.23%)
    3 / 78 (3.85%)
         occurrences all number
    1
    3
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 81 (1.23%)
    2 / 78 (2.56%)
         occurrences all number
    1
    2
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 81 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    0
    2
    Nasopharyngitis
         subjects affected / exposed
    5 / 81 (6.17%)
    4 / 78 (5.13%)
         occurrences all number
    5
    4
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 81 (1.23%)
    1 / 78 (1.28%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 81 (1.23%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 81 (2.47%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 81 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Dec 2016
    Interim analyses included.
    08 Jun 2017
    Opicapone added as a prohibited treatment and option for another interim analysis added.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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