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    Summary
    EudraCT Number:2017-002189-39
    Sponsor's Protocol Code Number:161802
    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:2017-12-11
    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 number2017-002189-39
    A.3Full title of the trial
    A randomised placebo-controlled trial to assess the effect of melatonin on circadian sleep-wake disturbances in ocular disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Melatonin treatment for sleep disturbance in eye disorders: Sandman Trial
    A.3.2Name or abbreviated title of the trial where available
    Melatonin treatment for sleep disturbance in ocular disorders:Sandman
    A.4.1Sponsor's protocol code number161802
    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 supportWellcome Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportFight for Sight
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOxford University Hospitals NHS Foundation Trust
    B.5.2Functional name of contact pointColm Andrews
    B.5.3 Address:
    B.5.3.1Street AddressWest Wing, Level LG1 John Radcliffe Hospital
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 9DU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865223042
    B.5.6E-mailcolm.andrews@ouh.nhs.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 Yes
    D.2.1.1.1Trade name Bio-melatonin
    D.2.1.1.2Name of the Marketing Authorisation holderDanish Medicines Agency
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameBio-melatonin
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Film-coated 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 INNBio-Melatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.4EV Substance CodeAS2
    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 placeboCoated tablet
    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
    circadian sleep-wake disturbances associated with ocular disease.
    E.1.1.1Medical condition in easily understood language
    Disturbance in sleep pattern associated with an eye condition
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10009191
    E.1.2Term Circadian rhythm sleep disorder
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10009191
    E.1.2Term Circadian rhythm sleep disorder
    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
    The primary objective of the study is to assess the capability of melatonin to improve sleep-wake patterns in participants with various ocular diseases as compared to a placebo.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to assess the effect of melatonin administration on mood as compared to a placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants will be Male or Female aged 18 to 75.

    Participants identified as having a sleep problem as determined from their participation in the “Effect of Ocular Diseases on Sleep and ‘Body-Clocks’ (Circadian Rhythms)” study (REC Reference: B 11/SC/0093). These participants must have had abnormally elevated PSQI , and consented to be contacted for potential involvement in future research.

    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 (oral, patch, injected or implanted hormonal contraception, vaginal contraceptive ring, intra-uterine device or surgical sterilization, in addition to condom plus spermicide; or total sexual abstinence) during the trial and for 3 months thereafter.

    Participants are willing and able to give informed consent for participation in the trial.
    E.4Principal exclusion criteria
    The participants may not enter the trial if ANY of the following apply:
    Non English speakers

    Currently taking medications which may affect sleep (i.e. sedatives, anti-histamines, antidepressants and hypnotics) unless anophthalmic.

    Previously taken medications which may affect sleep (i.e. sedatives, anti-histamines, antidepressants and hypnotics) within the last 2 months unless anophthalmic.

    Substance abuser

    Expecting to undergo a procedure involving anaesthetics during the study period

    Actively involved in night work during the study period

    IQ<70 as evidenced by medical notes and/or the opinion of the investigator.

    Pregnant or breast-feeding women

    Unlikely to cooperate in the study

    Unable to complete the protocol due to absences e.g. holiday or participants who may have potential jet lag.

    Significant urinary incontinence requiring regular use of pads

    History of liver or kidney disease

    History of sleep apnoea

    Hypersensitivity to bio-melatonin active substance or excipients
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of sleep-wake patterns between groups using:
    1. Pittsburgh Sleep Quality Index (PSQI)
    2. Jupiter Sleep Questionnaire
    3. General Health Questionnaire
    4. SF-36 Questionnaire
    5.Morningness-Eveningness (LARK/OWL) Questionnaire
    6.Pictoral Epworth Sleepiness Scale
    48 hour urine collection
    Sleep diary and actigraphy data
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of treatment phase
    E.5.2Secondary end point(s)
    Comparison of mood between groups as evidenced by Hospital Anxiety and Depression Scale (HADS) questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of treatment phase
    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 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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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.8.5The trial involves multiple Member States No
    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 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
    The last phone call of the last patient.
    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 months3
    E.8.9.1In the Member State concerned days9
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Visually impaired
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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)
    Participants will not be able to be prescribed their intervention after the study has finished.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-01
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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