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    Clinical Trial Results:
    A Phase 2b, double-blind, randomized, placebo-controlled study of RVT-101 in subjects with dementia with Lewy bodies (DLB).

    Summary
    EudraCT number
    		 2015-005495-19
    Trial protocol
    		 ES   NL   IT  
    Global end of trial date
    04 Dec 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Jan 2019
    First version publication date
    16 Jan 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RVT-101-2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02669433
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Axovant Sciences Ltd.
    Sponsor organisation address
    2 Church Street, Hamilton, Bermuda,
    Public contact
    Clinical Trial Information Dept., Axovant Sciences, Inc, +34 900834223, Registroespanoldeestudiosclinicos@druginfo.com
    Scientific contact
    Clinical Trial Information Dept., Axovant Sciences, Inc, +34 900834223, Registroespanoldeestudiosclinicos@druginfo.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Dec 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the effects of 35-mg and 70-mg doses of RVT- 101 compared with placebo on the primary endpoint of motor function as measured by the Unified Parkinson’s Disease Rating Scale – Part III (UPDRS-III). The UPDRS-III is a gold standard measurement for capturing pharmacologic effects on parkinsonian motor symptoms. The secondary objectives are to assess the effects of RVT-101 compared to placebo on cognition as measured by the ADAS-Cog 11 and global function as measured by the CIBIC+.
    Protection of trial subjects
    Subjects were required to provide full written informed consent prior to the performance of any protocol specified procedure; or if unable to provide informed consent due to cognitive status, subject has provided assent and a legally acceptable representative has provided full written informed consent on behalf of the subject. Collection of AEs and SAEs were collected at the time of informed consent and continued until the follow-up contact. SAEs that were spontaneously reported by the subject or subject representative or discovered by the investigator or designee after the follow-up visit and up to 30 days after the last dose of investigational product were collected and reported. Subjects were withdrawn from the study based on consultation between the principal investigator and Medical Monitor, with the ultimate decision by the principal investigator or subject. Study safety data was periodically reviewed by an independent data monitoring committee.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    United Kingdom: 29
    Country: Number of subjects enrolled
    France: 38
    Country: Number of subjects enrolled
    Italy: 28
    Country: Number of subjects enrolled
    United States: 144
    Country: Number of subjects enrolled
    Canada: 6
    Worldwide total number of subjects
    269
    EEA total number of subjects
    119
    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)
    34
    From 65 to 84 years
    229
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects were screened for eligibility during the Screening Period. An ICF was signed by each subject or by the caregiver with subject assent. Consent forms were also signed by the caregiver before any study specific procedures were performed. Subjects were screened according to study inclusion/exclusion criteria.

    Period 1
    Period 1 title
    Double-Blind (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This study included a 24-week Double-Blind Treatment Period when neither subjects nor investigators knew which of the three treatments the subject was receiving. Subjects were informed that they would receive placebo at some point during the study but they did not know when this would be. Subjects were not informed of the transition from the Single-Blind Run-In Period to the Double-Blind Treatment Period. RVT 101 and placebo were provided as tablets that are indistinguishable.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects dosed with two Placebo tablets
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo was administered as pink film-coated round tablets.Subjects were instructed to take 2 tablets orally daily at bedtime without regard to food for 24 weeks.

    Arm title
    		 RVT-101 35 mg
    Arm description
    		 Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101
    Arm type
    		 Experimental

    Investigational medicinal product name
    RVT-101
    Investigational medicinal product code
    Other name
    Intepirdine
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RVT-101 was administered as pink film-coated round 35-mg tablets. Subjects were instructed to take tablets orally each morning without regard to food for 24 weeks.

    Arm title
    		 RVT-101 70 mg
    Arm description
    		 Subjects dosed with two RVT-101 35 mg tablets
    Arm type
    		 Experimental

    Investigational medicinal product name
    RVT-101
    Investigational medicinal product code
    Other name
    Intepirdine
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RVT-101 was administered as pink film-coated round 35-mg tablets. Subjects were instructed to take tablets orally each morning without regard to food for 24 weeks.

    Number of subjects in period 1
    		Placebo RVT-101 35 mg RVT-101 70 mg
    Started
    91
    89
    89
    Safety Population
    91
    89
    88
    Intent-To-Treat Population
    89
    89
    87
    Per-Protocol Population
    78
    79
    82
    Completed
    76
    75
    74
    Not completed
    15
    14
    15
         Adverse event, serious fatal
    1
    1
    2
         Consent withdrawn by subject
    5
    1
    -
         Physician decision
    1
    1
    -
         Adverse event, non-fatal
    5
    6
    8
         Death
    -
    1
    1
         Sponsor Termination
    1
    -
    1
         Caregiver Withdrew Consent
    1
    -
    2
         Disease Progression
    1
    -
    -
         Protocol deviation
    -
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects dosed with two Placebo tablets

    Reporting group title
    RVT-101 35 mg
    Reporting group description
    		 Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101

    Reporting group title
    RVT-101 70 mg
    Reporting group description
    		 Subjects dosed with two RVT-101 35 mg tablets

    Reporting group values
    		 Placebo RVT-101 35 mg RVT-101 70 mg Total
    Number of subjects
    		 91 89 89 269
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 12 9 13 34
        From 65-84 years
    		 76 79 74 229
        85 years and over
    		 3 1 2 6
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 73.6 (59 to 86) 73.0 (55 to 85) 73.0 (55 to 86) -
    Gender categorical
    Units: Subjects
        Female
    		 20 22 15 57
        Male
    		 71 67 74 212

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects dosed with two Placebo tablets

    Reporting group title
    RVT-101 35 mg
    Reporting group description
    		 Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101

    Reporting group title
    RVT-101 70 mg
    Reporting group description
    		 Subjects dosed with two RVT-101 35 mg tablets

    Primary: Unified Parkinson’s Disease Rating Scale – Part III (UPDRS Part III) Score Change from Baseline to Week 24

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    End point title
    		 Unified Parkinson’s Disease Rating Scale – Part III (UPDRS Part III) Score Change from Baseline to Week 24
    End point description
    The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.
    End point type
    Primary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 Placebo RVT-101 35 mg RVT-101 70 mg
    Number of subjects analysed
    72
    72
    69
    Units: NA
    72
    72
    69
    Statistical analysis title
    		 Repeated Measures Analysis
    Statistical analysis description
    Placebo - active
    Comparison groups
    Placebo v RVT-101 35 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.158 [1]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 0.79
    Notes
    [1] - The threshold for statistical significance was p=0.05
    Statistical analysis title
    		 Repeated Measures Analysis
    Statistical analysis description
    Placebo - active
    Comparison groups
    RVT-101 70 mg v Placebo
    Number of subjects included in analysis
    141
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6069 [2]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.08
         upper limit
    		 3.55
    Notes
    [2] - The threshold for statistical significance was p=0.05

    Secondary: Alzheimer’s Disease Assessment Scale – Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24

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    End point title
    		 Alzheimer’s Disease Assessment Scale – Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24
    End point description
    The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 Placebo RVT-101 35 mg RVT-101 70 mg
    Number of subjects analysed
    73
    73
    71
    Units: NA
    73
    73
    71
    Statistical analysis title
    		 Repeated Measures Analysis
    Statistical analysis description
    Placebo - active
    Comparison groups
    Placebo v RVT-101 35 mg
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6531 [3]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.55
         upper limit
    		 1.6
    Notes
    [3] - The threshold for statistical significance was p=0.05
    Statistical analysis title
    		 Repeated Measures Analysis
    Statistical analysis description
    Placebo - active
    Comparison groups
    Placebo v RVT-101 70 mg
    Number of subjects included in analysis
    144
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5274 [4]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.41
         upper limit
    		 2.75
    Notes
    [4] - The threshold for statistical significance was p=0.05 Primary:

    Secondary: Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24

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    End point title
    		 Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24
    End point description
    To assess the effects of RVT-101 versus placebo on global function as measured by the CIBIC+ after 24 weeks of treatment
    End point type
    Secondary
    End point timeframe
    Baseline, 24 weeks
    End point values
    		 Placebo RVT-101 35 mg RVT-101 70 mg
    Number of subjects analysed
    75
    74
    72
    Units: NA
    75
    74
    72
    Statistical analysis title
    		 Repeated Measures Analysis
    Statistical analysis description
    Placebo - active
    Comparison groups
    Placebo v RVT-101 35 mg
    Number of subjects included in analysis
    149
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3953 [5]
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 0.5
    Notes
    [5] - The threshold for statistical significance was p=0.05
    Statistical analysis title
    		 Repeated Measures Analysis
    Statistical analysis description
    Placebo - active
    Comparison groups
    Placebo v RVT-101 70 mg
    Number of subjects included in analysis
    147
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7008
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.28
         upper limit
    		 0.42

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Collection of AEs and SAEs will begin at the time a subject signs informed consent and continues until the follow-up contact.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    RVT-101 35 mg
    Reporting group description
    		 -

    Reporting group title
    RVT 70 mg
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo RVT-101 35 mg RVT 70 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 91 (12.09%)
    11 / 89 (12.36%)
    13 / 88 (14.77%)
         number of deaths (all causes)
    1
    1
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial flutter
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Rectal haemorrhage
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Enteritis
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Volvulus
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropsychiatric syndrome
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 91 (2.20%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    2 / 88 (2.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 91 (1.10%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 91 (0.00%)
    0 / 89 (0.00%)
    1 / 88 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 91 (0.00%)
    1 / 89 (1.12%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 91 (1.10%)
    0 / 89 (0.00%)
    0 / 88 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo RVT-101 35 mg RVT 70 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 91 (72.53%)
    69 / 89 (77.53%)
    59 / 88 (67.05%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    19 / 91 (20.88%)
    17 / 89 (19.10%)
    18 / 88 (20.45%)
         occurrences all number
    19
    17
    18
    Vascular disorders
    Hypertension
         subjects affected / exposed
    5 / 91 (5.49%)
    1 / 89 (1.12%)
    2 / 88 (2.27%)
         occurrences all number
    5
    1
    2
    Orthostatic hypotension
         subjects affected / exposed
    12 / 91 (13.19%)
    3 / 89 (3.37%)
    5 / 88 (5.68%)
         occurrences all number
    12
    3
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 91 (4.40%)
    3 / 89 (3.37%)
    5 / 88 (5.68%)
         occurrences all number
    4
    3
    5
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    5 / 91 (5.49%)
    9 / 89 (10.11%)
    6 / 88 (6.82%)
         occurrences all number
    5
    9
    6
    Diarrhoea
         subjects affected / exposed
    3 / 91 (3.30%)
    7 / 89 (7.87%)
    5 / 88 (5.68%)
         occurrences all number
    3
    7
    5
    Nausea
         subjects affected / exposed
    2 / 91 (2.20%)
    4 / 89 (4.49%)
    5 / 88 (5.68%)
         occurrences all number
    2
    4
    5
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    7 / 91 (7.69%)
    8 / 89 (8.99%)
    1 / 88 (1.14%)
         occurrences all number
    7
    8
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 91 (3.30%)
    5 / 89 (5.62%)
    2 / 88 (2.27%)
         occurrences all number
    3
    5
    2
    Confusional state
         subjects affected / exposed
    3 / 91 (3.30%)
    5 / 89 (5.62%)
    5 / 88 (5.68%)
         occurrences all number
    3
    5
    5
    Hallucination, visual
         subjects affected / exposed
    4 / 91 (4.40%)
    6 / 89 (6.74%)
    3 / 88 (3.41%)
         occurrences all number
    4
    6
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 91 (0.00%)
    7 / 89 (7.87%)
    5 / 88 (5.68%)
         occurrences all number
    0
    7
    5
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 91 (4.40%)
    7 / 89 (7.87%)
    7 / 88 (7.95%)
         occurrences all number
    4
    7
    7
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 91 (6.59%)
    3 / 89 (3.37%)
    2 / 88 (2.27%)
         occurrences all number
    6
    3
    2

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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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