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    Clinical Trial Results:
    A Long-Term, Open-Label Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Alzheimer’s Disease

    Summary
    EudraCT number
    2016-000587-42
    Trial protocol
    CZ   SK   ES   BG   DE   GB   HR   IT  
    Global end of trial date
    12 Mar 2018

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

    Trial information

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    Trial identification
    Sponsor protocol code
    RVT-101-3002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02586909
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Axovant Sciences
    Sponsor organisation address
    Viaduktstrasse 8, Basel, Switzerland, 4051
    Public contact
    Project Management, Worldwide Clinical Trials , +44 207121 6161,
    Scientific contact
    Project Management, Worldwide Clinical Trials , +44 207121 6161,
    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
    12 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 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 RVT-101
    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
    26 Apr 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
    Argentina: 103
    Country: Number of subjects enrolled
    Australia: 31
    Country: Number of subjects enrolled
    Canada: 37
    Country: Number of subjects enrolled
    Chile: 48
    Country: Number of subjects enrolled
    Korea, Republic of: 9
    Country: Number of subjects enrolled
    Singapore: 16
    Country: Number of subjects enrolled
    Serbia: 21
    Country: Number of subjects enrolled
    Taiwan: 16
    Country: Number of subjects enrolled
    United States: 281
    Country: Number of subjects enrolled
    Poland: 47
    Country: Number of subjects enrolled
    Slovakia: 42
    Country: Number of subjects enrolled
    Spain: 65
    Country: Number of subjects enrolled
    United Kingdom: 164
    Country: Number of subjects enrolled
    Croatia: 30
    Country: Number of subjects enrolled
    Bulgaria: 7
    Country: Number of subjects enrolled
    Czech Republic: 53
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 55
    Country: Number of subjects enrolled
    Italy: 61
    Worldwide total number of subjects
    1099
    EEA total number of subjects
    537
    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)
    158
    From 65 to 84 years
    907
    85 years and over
    34

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This is a multi-center, open-label, extension study in subjects with AD who have completed the 24-week, double-blind, placebo-controlled, lead-in study (RVT-101-3001). Subjects who have completed the double-blind lead-in study will be enrolled in this study.

    Period 1
    Period 1 title
    Open Label Treatment (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo to Intepirdine
    Arm description
    -
    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
    Take 1 tablet orally each morning without regard to food

    Arm title
    Intepirdine to Intepirdine
    Arm description
    -
    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
    Take 1 tablet orally each morning without regard to food

    Number of subjects in period 1
    Placebo to Intepirdine Intepirdine to Intepirdine
    Started
    538
    561
    Completed
    80
    71
    Not completed
    458
    490
         Protocol deviation
    1
    5
         Advice From Hrec
    7
    5
         Physician decision
    14
    11
         Lack of efficacy
    19
    20
         Adverse event, serious fatal
    3
    4
         Sponsor Termination
    338
    369
         Adverse event, non-fatal
    22
    22
         Consent withdrawn by subject
    36
    39
         Caregiver Withdrew Consent
    13
    8
         Sponsor Decision
    2
    3
         Ae On V8/V1 Recorded Under 3001 Protocol
    -
    1
         Lost to follow-up
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo to Intepirdine
    Reporting group description
    -

    Reporting group title
    Intepirdine to Intepirdine
    Reporting group description
    -

    Reporting group values
    Placebo to Intepirdine Intepirdine to Intepirdine Total
    Number of subjects
    538 561 1099
    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)
    73.0 ± 7.51 73.2 ± 7.60 -
    Gender categorical
    Units: Subjects
        Female
    336 340 676
        Male
    202 221 423
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    84 109 193
        Not Hispanic or Latino
    448 449 897
        Missing
    6 3 9

    End points

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    End points reporting groups
    Reporting group title
    Placebo to Intepirdine
    Reporting group description
    -

    Reporting group title
    Intepirdine to Intepirdine
    Reporting group description
    -

    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
    52 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 AD, and the study was terminated early on 11 January 2018 because intepirdine did not meet its primary endpoint for Study RVT-101-3001 (the lead-in study). Thus, no formal statistical analyses were performed for the primary endpoint.
    End point values
    Placebo to Intepirdine Intepirdine to Intepirdine
    Number of subjects analysed
    538
    561
    Units: Subjects
    263
    286
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    52 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo to Intepirdine
    Reporting group description
    -

    Reporting group title
    Intepirdine to Intepirdine
    Reporting group description
    -

    Serious adverse events
    Placebo to Intepirdine Intepirdine to Intepirdine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 538 (7.06%)
    49 / 561 (8.73%)
         number of deaths (all causes)
    4
    6
         number of deaths resulting from adverse events
    4
    6
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 538 (0.19%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastatic neoplasm
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    2 / 538 (0.37%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer female
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage I
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycosis fungoides
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden death
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 538 (0.00%)
    2 / 561 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    2 / 538 (0.37%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    3 / 10
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delusion
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervix disorder
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix haemorrhage uterine
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 538 (0.56%)
    2 / 561 (0.36%)
         occurrences causally related to treatment / all
    1 / 26
    1 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative delirium
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Full blood count decreased
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 538 (0.00%)
    3 / 561 (0.53%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Atrial fibrillation
         subjects affected / exposed
    2 / 538 (0.37%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 538 (0.19%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 538 (0.19%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve stenosis
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    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 / 538 (0.19%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 538 (0.37%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dementia of the Alzheimer's type, with delirium
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 538 (0.37%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    2 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 538 (0.19%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 538 (0.19%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    3 / 10
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    3 / 538 (0.56%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (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
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 538 (0.37%)
    3 / 561 (0.53%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 538 (0.19%)
    3 / 561 (0.53%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastroenteritis
         subjects affected / exposed
    1 / 538 (0.19%)
    2 / 561 (0.36%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 538 (0.00%)
    2 / 561 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 538 (0.19%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    1 / 24
    3 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 538 (0.00%)
    2 / 561 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 538 (0.00%)
    1 / 561 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 538 (0.19%)
    0 / 561 (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: 2%
    Non-serious adverse events
    Placebo to Intepirdine Intepirdine to Intepirdine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 538 (15.99%)
    88 / 561 (15.69%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    23 / 538 (4.28%)
    26 / 561 (4.63%)
         occurrences all number
    26
    28
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 538 (1.86%)
    7 / 561 (1.25%)
         occurrences all number
    12
    7
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    8 / 538 (1.49%)
    14 / 561 (2.50%)
         occurrences all number
    8
    14
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    23 / 538 (4.28%)
    22 / 561 (3.92%)
         occurrences all number
    24
    23
    Nasopharyngitis
         subjects affected / exposed
    11 / 538 (2.04%)
    12 / 561 (2.14%)
         occurrences all number
    11
    12
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 538 (2.04%)
    7 / 561 (1.25%)
         occurrences all number
    11
    7

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 May 2016
    Protocol RVT-101-3002 version 2.0 includes the following changes to protocol version 1.0 dated 18 February 2016: the Dependence Scale (DS) and EuroQOL 5 dimensions questionnaire (EQ-5D) have been added as efficacy assessments at Visits 1, 5, and 7; caregiver requirements have been added; and administrative changes were made for clarification.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    11 Jan 2018
    This study was terminated early on 9 January 2018 because RVT-101 (intepirdine) did not meet its primary endpoint for Study RVT-101-3001 (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
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