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    Clinical Trial Results:
    Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain.

    Summary
    EudraCT number
    		 2020-001175-32
    Trial protocol
    		 GB   PT   IT   CZ   PL  
    Global end of trial date
    16 Feb 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 May 2025
    First version publication date
    30 May 2025
    Other versions
    Summary report(s)
    		 BIA-91067-404_CTR Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    BIA-91067-404
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04986982
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bial - Portela & Ca, S.A.
    Sponsor organisation address
    À Av. da Siderurgia Nacional, Trofa, Portugal, 4745-457
    Public contact
    Ruben Arnelas, Bial - Portela & Ca, S.A., +351 229866100, clinical.trials@bial.com
    Scientific contact
    Responsible of Clinical Development, Bial - Portela & Ca, S.A., +351 229866100, clinical.trials@bial.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
    21 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to investigate the efficacy of opicapone 50 mg when administered with the existing treatment of L-DOPA plus a DDCI, in PD patients with end-of-dose motor fluctuations and associated pain.
    Protection of trial subjects
    This study was performed in neurological centres and conducted in compliance with the study protocol, by the study personnel, who were qualified by education, training, and experienced in their roles. The patients were closely monitored during the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 2021
    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
    Poland: 28
    Country: Number of subjects enrolled
    Czechia: 26
    Country: Number of subjects enrolled
    Portugal: 20
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Italy: 10
    Worldwide total number of subjects
    127
    EEA total number of subjects
    108
    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)
    52
    From 65 to 84 years
    74
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment was terminated before reaching the estimated number of randomised patients. However, this had no impact on the analysis of data since the drop-out rate was less than 15% and thus the planned number of evaluable patients was reached. A total of 19 patients prematurely terminated the study.

    Pre-assignment
    Screening details
    		 A total of 144 patients were enrolled at 44 active sites in Europe. Of these, 127 patients were randomised and received at least 1 dose of IP. A total of 122 patients met the criteria for the Full Analysis Set including 59 opicapone 50 mg patients and 63 placebo patients.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A - Opicapone
    Arm description
    		 Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
    Arm type
    		 Experimental

    Investigational medicinal product name
    Opicapone
    Investigational medicinal product code
    BIA 9-1067
    Other name
    Ongentys
    Pharmaceutical forms
    Oral suspension, Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI.

    Arm title
    		 Group B - Placebo
    Arm description
    		 Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Placebo
    Pharmaceutical forms
    Capsule, hard, Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

    Number of subjects in period 1
    		Group A - Opicapone Group B - Placebo
    Started
    64
    63
    Completed
    53
    55
    Not completed
    11
    8
         Consent withdrawn by subject
    3
    1
         Adverse event, non-fatal
    4
    4
         Ineligibility
    3
    -
         Sponsor's discretion
    1
    -
         Lost to follow-up
    -
    1
         Lack of efficacy
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A - Opicapone
    Reporting group description
    		 Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

    Reporting group title
    Group B - Placebo
    Reporting group description
    		 Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

    Reporting group values
    		 Group A - Opicapone Group B - Placebo Total
    Number of subjects
    		 64 63 127
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 23 29 52
        From 65-84 years
    		 40 34 74
        85 years and over
    		 1 0 1
    Age continuous
    Units: years
        median (standard deviation)
    		 67.0 ( 9.14 ) 65 ( 9.39 ) -
    Gender categorical
    Units: Subjects
        Female
    		 31 31 62
        Male
    		 33 32 65
    Race
    Units: Subjects
        White
    		 64 62 126
        Black or African American
    		 0 0 0
        Asian
    		 0 0 0
        American Indian or Alaska Native
    		 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Unknown
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Group A - Opicapone
    Reporting group description
    		 Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

    Reporting group title
    Group B - Placebo
    Reporting group description
    		 Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

    Primary: Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)

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    End point title
    		 Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
    End point description
    The KING's PARKINSON's DISEASE PAIN SCALE (KPPS) evaluates the burden (global and bedside) and characterises various phenotypes of pain in Parkinson's disease. The investigator will complete the questionnaire by interviewing the patient about seven domains and answering to 14 items. The questionnaire will be fill out on Visit 1, Visit 2b/Baseline, Visit 4, Visit 5 and Visit 6/EDV Domain 3 assesses fluctuation-related pain (score range: 0 - 36). Higher score values indicate higher levels of pain.
    End point type
    Primary
    End point timeframe
    The questionnaire will be fill out on Visit 1 (Day -7 ±2), Visit 2b/Baseline (Day 1), Visit 4 (Day 29 (±2)), Visit 5 (Day 85 (±4)) and Visit 6/Early Discontinuation Visit (EDV) (Day 169 (±4)) - Up to 24 weeks
    End point values
    		 Group A - Opicapone Group B - Placebo
    Number of subjects analysed
    59
    63
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Visit 1 (Day -7 ±2)
    17.2 ( 5.72 )
    16.7 ( 5.18 )
        Visit 2b (Day 1)
    17.1 ( 5.58 )
    16.9 ( 5.20 )
        Baseline (Day 1)
    17.1 ( 5.58 )
    16.9 ( 5.20 )
        Visit 4 (Day 29 (±2)) - Observed Value
    10.5 ( 7.92 )
    11.0 ( 7.51 )
        Visit 4 (Day 29 (±2)) - Change from Baseline
    -6.6 ( 7.28 )
    -5.9 ( 6.02 )
        Visit 5 (Day 85 (±4)) - Observed Value
    8.3 ( 7.27 )
    9.3 ( 5.73 )
        Visit 5 (Day 85 (±4)) - Change from Baseline
    -8.7 ( 6.68 )
    -7.6 ( 6.13 )
        Visit 6 (Day 169 (±4)) - Observed Value
    8.4 ( 6.93 )
    7.5 ( 6.48 )
        Visit 6 (Day 169 (±4)) - Change from Baseline
    -8.8 ( 6.85 )
    -9.3 ( 6.24 )
    Statistical analysis title
    		 Change from baseline in Domain 3 of KPPS
    Statistical analysis description
    The King’s Parkinson’s Disease Pain Scale (KPPS) evaluates the burden (global and bedside) and characterises various phenotypes of pain in PD. Its seven domains include 14 items, each item scored by severity (0-3) multiplied by frequency (0-4), resulting in subscores of 0 to 12. The total possible KPPS score (0 to 168) represents the symptomatic burden by pain. The questionnaire will be fill out on Visit 1, Visit 2b, Visit 4, Visit 5 and Visit 6/EDV.
    Comparison groups
    Group B - Placebo v Group A - Opicapone
    Number of subjects included in analysis
    122
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.794
    Method
    		 Mixed models analysis
    Confidence interval
         sides
    2-sided
         lower limit
    		 -1.96
         upper limit
    		 2.55
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Opicapone 50 mg
    Reporting group description
    		 Opicapone 50 mg: Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo: Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI

    Serious adverse events
    		 Opicapone 50 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 64 (6.25%)
    2 / 63 (3.17%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Faecaloma
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    		 Opicapone 50 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 64 (62.50%)
    36 / 63 (57.14%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 63 (1.59%)
         occurrences all number
    2
    1
    Deep vein thrombosis
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Hypotension
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Varicose vein
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    5 / 64 (7.81%)
    3 / 63 (4.76%)
         occurrences all number
    6
    3
    Fatigue
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 63 (3.17%)
         occurrences all number
    2
    2
    Oedema peripheral
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Application site irritation
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Erectile dysfunction
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Pruritus genital
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Atelectasis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Cough
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Dysphonia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    6 / 64 (9.38%)
    2 / 63 (3.17%)
         occurrences all number
    6
    3
    Insomnia
         subjects affected / exposed
    3 / 64 (4.69%)
    3 / 63 (4.76%)
         occurrences all number
    3
    3
    Depression
         subjects affected / exposed
    3 / 64 (4.69%)
    1 / 63 (1.59%)
         occurrences all number
    3
    1
    Hallucination, visual
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Abnormal dreams
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Bruxism
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Delirium
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Delusion
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Depressed mood
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Hallucinations, mixed
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Illusion
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Impulse-control disorder
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Irritability
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Mood altered
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Nightmare
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Obsessive-compulsive disorder
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Terminal insomnia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Investigations
    Blood pressure decreased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Body temperature increased
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 63 (4.76%)
         occurrences all number
    7
    3
    Skin abrasion
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Skin laceration
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Arthropod sting
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Chest injury
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Wrist fracture
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Atrial fibrillation
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Cardiomegaly
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dyskinesia
         subjects affected / exposed
    3 / 64 (4.69%)
    4 / 63 (6.35%)
         occurrences all number
    3
    4
    Headache
         subjects affected / exposed
    3 / 64 (4.69%)
    3 / 63 (4.76%)
         occurrences all number
    4
    3
    Parkinson's disease
         subjects affected / exposed
    3 / 64 (4.69%)
    3 / 63 (4.76%)
         occurrences all number
    3
    3
    Dizziness
         subjects affected / exposed
    1 / 64 (1.56%)
    3 / 63 (4.76%)
         occurrences all number
    1
    4
    On and off phenomenon
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 63 (3.17%)
         occurrences all number
    2
    2
    Sciatica
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Altered state of consciousness
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Balance disorder
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Bradykinesia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Dystonia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Freezing phenomenon
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Hemiparesis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Memory impairment
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Poor quality sleep
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Somnolence
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Taste disorder
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Tension headache
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Tremor
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 63 (1.59%)
         occurrences all number
    2
    2
    Eye disorders
    Diplopia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Visual acuity reduced
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 64 (10.94%)
    5 / 63 (7.94%)
         occurrences all number
    8
    5
    Constipation
         subjects affected / exposed
    5 / 64 (7.81%)
    1 / 63 (1.59%)
         occurrences all number
    5
    1
    Dyspepsia
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 63 (1.59%)
         occurrences all number
    2
    1
    Dry mouth
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    Vomiting
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    2
    Abdominal pain
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Crohn's disease
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Gastritis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Oral discomfort
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Salivary hypersecretion
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Toothache
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    3
    0
    Umbilical hernia
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Skin lesion
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Nocturia
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Renal cyst
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Ureterolithiasis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Urinary incontinence
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 64 (3.13%)
    2 / 63 (3.17%)
         occurrences all number
    2
    2
    Arthralgia
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 63 (3.17%)
         occurrences all number
    1
    2
    Back pain
         subjects affected / exposed
    0 / 64 (0.00%)
    3 / 63 (4.76%)
         occurrences all number
    0
    3
    Pain in extremity
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Limb discomfort
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Mobility decreased
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    COVID-19
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Influenza
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis bacterial
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Tooth abscess
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 63 (1.59%)
         occurrences all number
    2
    1
    Folate deficiency
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0

    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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    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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