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    Clinical Trial Results:
    A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Dementia with Lewy Bodies (DLB)

    Summary
    EudraCT number
    		 2016-002412-40
    Trial protocol
    		 GB   ES   NL   IT  
    Global end of trial date
    09 Feb 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    RVT-101-2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02928445
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Axovant Sciences
    Sponsor organisation address
    Viaduktstrasse 8, Basel, Switzerland, 4051
    Public contact
    Clinical Trial Information Dept., Axovant Sciences, +41 43 215 59 99,
    Scientific contact
    Clinical Trial Information Dept., Axovant Sciences, +41 43 215 59 99,
    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
    09 Feb 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and tolerability of 35 mg and 70 mg RVT-101 in subjects with DLB
    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
    03 Oct 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: 4
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    France: 34
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    United States: 114
    Worldwide total number of subjects
    213
    EEA total number of subjects
    95
    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)
    29
    From 65 to 84 years
    181
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects who were randomized to the treatment arms RVT-101 35 mg and RVT-101 70 mg in the lead-in study (RVT-101-2001) will remain in those same treatment groups for this study, while subjects who were randomized to placebo in Study RVT-101-2001 will be assigned to the RVT-101 70 mg treatment group.

    Period 1
    Period 1 title
    Double-Blind Treatment (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
    Treatment assignments for this study were double-blind, meaning neither subjects nor investigators knew which of the two treatments the subject was receiving. If this study was ongoing when the database for the lead-in study (RVT-101-2001) was locked and unblinded, this study became double-blind, Sponsor-open, meaning the subject and investigator did not know what treatment assignment he/she had been given but the Sponsor and its representatives did.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RVT-101 35 mg
    Arm description
    		 RVT-101 35 mg once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    RVT-101 35 mg
    Investigational medicinal product code
    Other name
    Intepirdine 35 mg
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RVT-101 35 mg once daily

    Arm title
    		 RVT-101 70 mg
    Arm description
    		 RVT-101 70 mg once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    RVT-101 70 mg
    Investigational medicinal product code
    Other name
    Intepirdine 70 mg
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RVT-101 70 mg once daily

    Number of subjects in period 1
    		RVT-101 35 mg RVT-101 70 mg
    Started
    71
    142
    Completed
    16
    26
    Not completed
    55
    116
         Adverse event, serious fatal
    -
    2
         Consent withdrawn by subject
    1
    5
         Physician decision
    1
    -
         Adverse event, non-fatal
    3
    11
         Lost to follow-up
    -
    6
         Sponsor termination
    49
    87
         Caregiver Withdrew Consent
    -
    4
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RVT-101 35 mg
    Reporting group description
    		 RVT-101 35 mg once daily

    Reporting group title
    RVT-101 70 mg
    Reporting group description
    		 RVT-101 70 mg once daily

    Reporting group values
    		 RVT-101 35 mg RVT-101 70 mg Total
    Number of subjects
    		 71 142 213
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72.4 ( 5.98 ) 72.6 ( 6.58 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 28 46
        Male
    		 53 114 167
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 5 3 8
        Not Hispanic or Latino
    		 66 137 203
        Unknown or Not Reported
    		 0 2 2

    End points

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    End points reporting groups
    Reporting group title
    RVT-101 35 mg
    Reporting group description
    		 RVT-101 35 mg once daily

    Reporting group title
    RVT-101 70 mg
    Reporting group description
    		 RVT-101 70 mg once daily

    Primary: At Least one On-Treatment Adverse Event (OTAE)

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    End point title
    		 At Least one On-Treatment Adverse Event (OTAE) [1]
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The objective of this study was to assess the long-term safety and tolerability of RVT-101 (intepirdine) in subjects with DLB, and the study was terminated early on 9 January 2018 because intepirdine did not meet its primary endpoint for Study RVT-101-2001 (the lead-in study). Thus, no formal statistical analyses were performed for the primary endpoint.
    End point values
    		 RVT-101 35 mg RVT-101 70 mg
    Number of subjects analysed
    71
    142
    Units: Participants
        At Least one On-Treatment Adverse Event (OTAE)
    54
    103
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    RVT-101 35 mg
    Reporting group description
    		 -

    Reporting group title
    RVT-101 70 mg
    Reporting group description
    		 -

    Serious adverse events
    		 RVT-101 35 mg RVT-101 70 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 71 (12.68%)
    17 / 142 (11.97%)
         number of deaths (all causes)
    0
    3
         number of deaths resulting from adverse events
    0
    3
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Gait disturbance
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 3
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric decompensation
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    2 / 14
    3 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dementia with Lewy bodies
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Encephalopathy
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radial nerve palsy
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 71 (0.00%)
    2 / 142 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Syncope
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenal ulcer
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 71 (1.41%)
    0 / 142 (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
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 71 (2.82%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 RVT-101 35 mg RVT-101 70 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 71 (63.38%)
    86 / 142 (60.56%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    14 / 71 (19.72%)
    35 / 142 (24.65%)
         occurrences all number
    14
    36
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 71 (5.63%)
    10 / 142 (7.04%)
         occurrences all number
    4
    10
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    4 / 71 (5.63%)
    4 / 142 (2.82%)
         occurrences all number
    4
    4
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 71 (1.41%)
    8 / 142 (5.63%)
         occurrences all number
    1
    8
    Diarrhoea
         subjects affected / exposed
    3 / 71 (4.23%)
    10 / 142 (7.04%)
         occurrences all number
    3
    10
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    6 / 71 (8.45%)
    3 / 142 (2.11%)
         occurrences all number
    6
    3
    Insomnia
         subjects affected / exposed
    4 / 71 (5.63%)
    3 / 142 (2.11%)
         occurrences all number
    4
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 71 (5.63%)
    3 / 142 (2.11%)
         occurrences all number
    4
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 71 (9.86%)
    1 / 142 (0.70%)
         occurrences all number
    7
    1
    Urinary tract infection
         subjects affected / exposed
    6 / 71 (8.45%)
    7 / 142 (4.93%)
         occurrences all number
    6
    7

    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? Yes
    Date
    Interruption
    Restart date
    09 Jan 2018
    This study was terminated early on 9 January 2018 because RVT-101 (intepirdine) did not meet its primary endpoint for Study RVT-101-2001 (the lead-in study).
    -

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

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