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    Summary
    EudraCT Number:2015-000323-86
    Sponsor's Protocol Code Number:N/A
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-03-09
    Trial 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 number2015-000323-86
    A.3Full title of the trial
    A randomised, parallel group, double blind, placebo controlled, add on clinical trial to investigate whether the lithium mimetic, ebselen, can reduce symptoms of hypomania and mania in bipolar patients experiencing an acute episode of mania or hypomania
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ebselen as an add-on treatment in hypo/mania
    A.3.2Name or abbreviated title of the trial where available
    Ebselen as an add-on treatment in hypo/mania V1.0
    A.4.1Sponsor's protocol code numberN/A
    A.5.4Other Identifiers
    Name:ClinicalTrials.GovNumber:NCT03013400
    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 SponsorUniversity of Oxford
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Stanley Medical Research Institute
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointPhilip Cowen
    B.5.3 Address:
    B.5.3.1Street AddressNeurosciences Building, Warneford Hospital
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX37JX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865-618311
    B.5.5Fax number01865251076
    B.5.6E-mailphil.cowen@psych.ox.ac.uk
    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 nameSPI-1005, Ebselen
    D.3.2Product code NA
    D.3.4Pharmaceutical form Capsule
    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 INNSPI-1005, ebselen
    D.3.9.1CAS number 60940-34-3
    D.3.9.3Other descriptive namePZ-51 , Ebselene, Ebselenum, Ebseleno , Harmokisane,Ebselene, Ebseleno
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 placeboCapsule
    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
    Patients with bipolar disorder meeting DSM-5 criteria for hypomania or mania
    E.1.1.1Medical condition in easily understood language
    Bipolar disorder is characterised by periods of elevated mood and periods of depression. The elevated mood is known as hypomania or mania: an individual feels abnormally happy, energetic or irritable.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10000852
    E.1.2Term Acute mania
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10021030
    E.1.2Term Hypomania
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principle research objective is to compare the effect of ebselen versus placebo as an 'add on' treatment to help stabilise hypo/manic symptoms in bipolar disorder. The primary outcome measure will be the difference in the clinician-rated Young Mania Rating Scale (YMRS) between the two groups and this will be measured at the screening interview and weekly throughout the trial, which lasts a total of four weeks.
    E.2.2Secondary objectives of the trial
    To investigate whether ebselen, compared to placebo, is able to improve clinician and self-rated mania, depression and sleep symptoms. Also to see if ebselen is able to improve day to day activity (circadian) rhythms and reduce over activity measured using a wrist worn monitor, similar to a wrist watch.


    To observe any adverse events and whether those taking ebselen have reduced overall use of concomitant medication compared to placebo. Also to determine
    how successful the study is in keeping secret whether or not individuals were taking the active or placebo treatments throughout the trial using questionnaires.

    Also to check compliance using capsule count and record checking and to determine whether the participants and researchers could guess whether participants had been given ebselen or placebo using a Visual Analogue Scales and to look at the success of PPI engagement.

    Finally to investigate ebselen levels and markers of inflammationin in plasma.








    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant is willing and able to give informed consent for participation in the trial.
    • Male or Female aged 18-70 years
    • Diagnosed with bipolar disorder, screened using the SCID to meet DSM-5 criteria for Manic or Hypomanic Episode.
    • Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial
    • In the Investigator’s opinion, is able and willing to comply with all trial requirements.
    • The Clinical/GP team treating the patient are in agreement with the patient's participation
    E.4Principal exclusion criteria
    • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
    • Known significant renal or hepatic impairment.
    • Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
    • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
    • Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
    • Clinically significant illicit substance or alcohol misuse where dependence criteria are satisfied.
    • Taking lithium.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in the Young Mania Rating Scale (YMRS) between placebo and ebselen groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and weekly for 4 weeks. The main time point is at the end of week three before ebselen is stopped.
    E.5.2Secondary end point(s)
    Clinician-rated CGI-BP mania scale
    Self-rated ASRM
    Clinician-rated HAM-D
    Self-rated QIDS
    Actigraphy
    Self-rated LSEQ
    Self-rated Adverse effects
    Concomitant medication recorded
    Researcher and participant blinding questionnaire
    Compliance: capsule count and records checked
    Randomisation Guess VAS
    PPI questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints measured up to 3 x weekly throughout the trial. Actigraphy will be continuous.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    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 No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    The end of trial is the date of database lock. This ensures all data is valid and participants numbers are correct.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Ebselen will not be available once the research has finished. This will be made clear on the participant information leaflet and before consent is taken. All participants will continue their usual care with their clinical team.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation University of Oxford, Dept. Psychiatry
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-29
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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