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    The EU Clinical Trials Register currently displays   35504   clinical trials with a EudraCT protocol, of which   5838   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-000914-37
    Sponsor's Protocol Code Number:NEU 1X
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-14
    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 number2004-000914-37
    A.3Full title of the trial
    A DOUBLE-BLIND, PARALLEL GROUP, RANDOMISED, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF CIRCADIN® 2MG IN THE IMPROVEMENT OF SLEEP QUALITY IN PATIENTS WITH INSOMNIA AGED 55-80 YEARS.
    A.4.1Sponsor's protocol code numberNEU 1X
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNeurim Pharmaceuticals (1991) Ltd
    B.1.3.4CountryIsrael
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameCIRCADIN ®
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeSynthetic chemical product endogenous hormone
    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
    Primary Insomnia in adults over 55 years
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare, by the end of the 3 weeks treatment period, the rate of patients in the Circadin® (2 mg) and placebo-treated groups improving by 10 mm or more on the QOS and BFW variables of the LSEQ, in patients with primary insomnia aged 55-80.
    E.2.2Secondary objectives of the trial
    To compare by the end of the 3 weeks treatment period, vs. placebo the effects of Circadin® 2 mg:
    1. on all parameters derived from the Leeds SEQ: on the global score of the PSQI: on QON and QOD derived from the Diary and on Clinical Global Impression Scale score derived from the Clinical General Impression Score (CGIS).
    2. in patients with low endogenous melatonin (defined as urinary excretion of the major melatonin metabolite 6 sulphatoxymelatonin (6 SMT) of < 7 mg 6-SMT per night), on the rate of patients improving by 10 mm on both the QOS and BFW variables of the Leeds SEQ and all other parameters identified under point 1.
    3. in patients who excrete <7 mg 6-SMT versus patients who excrete > 7 mg 6-SMT on the global score of the PSQI and all other parameters identified under point 1.
    4. To assess safety parameters
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    · male or female and aged 55-80 years
    · suffering from primary insomnia according to DSM-IV criteria (307.42 primary
    insomnia, Appendix 24.3) characterized by poor quality of sleep with or without
    difficulty in initiating sleep or difficulty in maintaining sleep (Based on a Sleep
    History Questionnaire that is given to the patient before Visit 1, Appendix 24.11)
    · have not been using BZD and non-BZD hypnotics for the past 2 weeks or more
    · have not been using psychotropic treatments for the past 3 months or more
    · are stabilized on non-psychotropic treatments for more than 3 months
    · are willing to take a 6-SMT level evaluation test on the night of the visit
    · are willing to sign a written informed consent to participate in the study

    Patients completing the two week placebo run-in and who fulfil the following criteria will be eligible to be randomised:
    · Negative drug screen (BZD and opiates)
    · No reported use of BZD and non-BZD hypnotics, antihistamines or psychotropic
    treatments during the two-week placebo run-in period
    · A good compliance during the two-week placebo run-in period defined as 70% to
    130% of prescribed tablets
    · Correct use of the LSEQ and Sleep Diary
    E.4Principal exclusion criteria
    · Incorrect use of the Sleep Diary or of the Leeds questionnaire.
    · Use of benzodiazepines or other hypnotics (including psychotropic treatments) during the study and preceding two weeks.
    · Alcohol intake more than 30 g of pure alcohol per day and any intake after lunch-time.
    · Pharmacological immunosuppression
    · Participation in a clinical trial with any investigational agent within two months prior
    to study enrollment
    · According to DSM IV, subjects belonging to the following groups are excluded:
    780.59 (breathing related sleep disorder);
    307.45 (circadian rhythm sleep disorder);
    307.47 (dyssomnia not otherwise specified);
    780.xx (sleep disorder due to general medical condition)
    · Severe neurological, psychiatric disorders and alcoholism
    · Other serious diseases that could interfere with patient assessment
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint in this study for the EMEA, is responder rate (defined by improvement of at least 10 mm from baseline to end of the three-week treatment period in both the QOS and BFW variables, as derived as the means of Questions 4, 5 and of Questions 8, 9, 10 of the LSEQ respectively).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Last visit of Last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state520
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 520
    F.4.2.2In the whole clinical trial 520
    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)
    Normal treatment
    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 Decision2004-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-03-29
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