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    Summary
    EudraCT Number:2016-002412-40
    Sponsor's Protocol Code Number:RVT-101-2002
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-002412-40
    A.3Full title of the trial
    A Long-Term Extension Study of the Safety and Tolerability of RVT-101 in Subjects with Dementia with Lewy Bodies (DLB)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Safety and Tolerability of RVT-101 in patients with Dementia with Lewy Bodies (DLB)
    A.4.1Sponsor's protocol code numberRVT-101-2002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAxovant Sciences Ltd.
    B.1.3.4CountryBermuda
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAxovant Sciences Ltd.
    B.4.2CountryBermuda
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAxovant Sciences, Inc.
    B.5.2Functional name of contact pointClinical Trial Information Dept.
    B.5.3 Address:
    B.5.3.1Street Address11 Times Square, 33rd Floor
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10036
    B.5.3.4CountryUnited States
    B.5.6E-mailheadwaylb@axovant.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRVT-101
    D.3.2Product code RVT-101
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIntepirdine
    D.3.9.1CAS number 607742-69-8
    D.3.9.2Current sponsor codeRVT-101
    D.3.9.3Other descriptive name3-Phenylsulfonyl-8-(piperazin-1-yl)quinoline
    D.3.9.4EV Substance CodeSUB30703
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dementia with Lewy bodies (DLB)
    E.1.1.1Medical condition in easily understood language
    Dementia with Lewy bodies (DLB) is a type of dementia that shares symptoms with both Alzheimer's disease and Parkinson's disease.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067889
    E.1.2Term Dementia with Lewy bodies
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety and tolerability of 35 mg and 70 mg RVT-101 in subjects with DLB
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects who have completed the last on-treatment visit (Visit 12) of the lead-in study (RVT-101-2001). Subjects who were prematurely discontinued from the lead-in study may be enrolled in this study only after discussion with the Medical Monitor. The number of subjects enrolled in this study who did not complete the lead-in study (RVT-101-2001) will be capped at 12.
    2. If the subject is currently receiving any of the following medications or non-medication therapies, the treatment regimen has been stable (i.e., no changes in the type of drug, dose or frequency of dosing) for at least 30 days prior to the Screening/Baseline Visit and there is no intent to change this treatment regimen up to Visit 4 of this study.
    • Acetylcholinesterase inhibitors (i.e., donepezil, galantamine, rivastigmine, tacrine)
    • Memantine
    • Axona® (caprylidene)
    • Antidepressants (other than MAO inhibitors)
    • Thyroid hormones
    • Atypical antipsychotics (e.g., quetiapine)
    • Benzodiazepines and other sedatives/hypnotics Note: Benzodiazepines or other sedatives/hypnotics (including antihistamines) with half-life less than 6 hours can be taken on an as needed basis.
    • Cognitive tasks for cognitive rehabilitation under medical supervision
    • Neurostimulation
    3. Female subjects must be:
    a) Of non-childbearing potential (i.e., any female who is post-menopausal [greater than 1 year without menstrual period in the absence of hormone replacement therapy]) or surgically sterile; or,
    b) If pre-menopausal or menopausal for 1 year or less, must have a negative pregnancy test and must not be lactating at the Screening/Baseline visit. Female subjects of childbearing potential and who are sexually active are required to use a highly effective method of birth control during the course of the study. Female subjects for whom menopausal status is in doubt, in the opinion of the investigator, will be required to use a highly effective form of birth control. Highly effective forms of birth control are defined as methods that have a failure rate of less than 1% per year when used correctly and consistently and include:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal, or transdermal
    • progestogen-only hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable
    • intrauterine device (IUD)
    • intrauterine hormone-releasing system (IUS)
    • bilateral tubal occlusion
    • vasectomised partner
    • sexual abstinence
    Subjects who have a positive pregnancy test during the study or become pregnant during the study will be discontinued.
    4. Male subjects who are sexually active and whose partner is of child-bearing potential are required to use an adequate form of birth control, including at least 1 barrier method.
    5. Subject continues to be able to ingest pills (in tablet form) whole.
    6. Subject has a caregiver who has signed an agreement to oversee the subject’s compliance with IP and protocol-specified procedures and report on subject’s health status.
    7. Subject has provided 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 (LAR) has provided full written informed consent on behalf of the subject.
    8. Subject is able to comply with the study procedures in the opinion of the investigator.
    9. The subject’s general health status is acceptable for participation in this study.
    E.4Principal exclusion criteria
    1. Subject who, at Visit 1, is experiencing an ongoing, uncontrolled AE(s) from the lead-in study (RVT-101-2001) or did experience an uncontrolled AE in the lead-in study (RVT-101-2001) that might prevent the subject from safely participating in the study in the opinion of the investigator. Subjects who experienced an SAE that was deemed related, possibly related or probably related to IP during the lead-in study may be considered for participation in this study only after discussion with the Medical Monitor.
    2. Subject who, in the opinion of the investigator, had a clinically significant vital sign or ECG abnormality at Visit 12 of the lead-in study, or at the Screening/Baseline visit for this study, that would prevent the subject from safely participating in this study.
    3. Subject who, in the opinion of the investigator, had a clinically significant laboratory abnormality at Visit 11 or Visit 12 of the lead-in study, or at the Screening/Baseline visit for this study, that would prevent the subject from safely participating in this study. Investigators need not wait for laboratory results at Visit 12 of the lead-in study or the Screening/Baseline Visit of this study before enrolling the subject in this study. However, any clinically significant abnormality subsequently identified from Visit 12 of the lead-in study and/or at the Screening/Baseline visit for this study will be evaluated by the investigator and the subject assessed for continued participation.
    4. Subject who, in the opinion of the investigator, has any confounding medical or psychiatric condition that would prevent the subject from safely participating in this study.
    5. Significant suicide risk as defined by (a) suicidal ideation as endorsed on items 4 or 5 of the suicidal ideation section of the Since Last Visit version C-SSRS at the Screening/Baseline visit of this study or (b) any suicidal behaviour endorsed on the Since Last Visit version of the C-SSRS at the Screening/Baseline visit of this study, or (c) clinical assessment of significant suicidal risk.
    6. Treatment with any concomitant medication detailed in Table 1. Prohibited medications as outlined in Table 1 unless otherwise specified, need to have been discontinued for 5 half-lives prior to the Screening/Baseline Visit and assessed as no longer clinically necessary for the subject.
    7. Confirmed corrected QT interval (QTc) value ≥ 450 msec for males or ≥ 470 msec for females at the Screening/Baseline visit for this study. Subjects with a QRS value greater than 120 msec and subjects with a QTc value less than 500 msec may be eligible following discussion with the Medical Monitor.
    8. Subject who, in the investigator’s opinion, is unable to take the IP product as directed throughout the study (with assistance is acceptable) or who has demonstrated significant non-compliance with IP in the lead-in study (RVT-101-2001).
    9. Subject or caregiver is an immediate family member or employee of the participating investigator, any of the participating site staff, or of the sponsor study staff.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of AEs and changes in physical examinations, vital signs measurements (including measurements of orthostatic changes in BP and HR), ECGs, clinical laboratory assessments, QSO, and C-SSRS results
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 1 (Screening/Baseline)

    Treatment Period (V2 through V7): Visits 2 through 7 should be scheduled relative to Visit 1 with a visit window of ±3 days for Visits 2 and 3 and a visit window of ±7 days for Visits 4 to 7. If the visit window is used, the subsequent visit should remain according to the planned visit schedule (i.e., the subsequent visit date should not be re-calculated from the date of the previous visit but should remain relative to the Screening/Baseline visit).

    Follow-Up Visit (Visit 8): All subjects who complete Visit 7 or the ET Visit will be required to attend a Safety Follow-up Visit (Visit 8) 14 to 19 days after Visit 7 or the ET Visit.
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different dosage of same product
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days21
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subject unable to provide informed consent due to cognitive status.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 240
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Axovant commit to provide continued access of RVT-101 (intepiridine) in the UK to subjects who have completed the study, until:
    intepiridine is commercially available in the UK, or
    the rejection of the marketing application by the European or UK Competent Authority, or
    the efficacy results of the parent study are received and are negative.
    Axovant will provide details of program for extended access if above conditions do not apply by the time the study extension to 48 weeks is completed.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-01-08
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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
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