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    The EU Clinical Trials Register currently displays   36601   clinical trials with a EudraCT protocol, of which   6044   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
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    Summary
    EudraCT Number:2008-000281-23
    Sponsor's Protocol Code Number:Oxford University(None)
    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:2010-10-18
    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 number2008-000281-23
    A.3Full title of the trial
    Melatonin in Acute Mania Investigation (MIAMI-UK)
    A.3.2Name or abbreviated title of the trial where available
    Melatonin in Acute Mania Investigation Version 3.0
    A.4.1Sponsor's protocol code numberOxford University(None)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number28988273
    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 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 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 Yes
    D.2.1.1.1Trade name Circadin
    D.2.1.1.2Name of the Marketing Authorisation holderNeurim
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Prolonged-release 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 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) 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 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 Information not present in EudraCT
    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 placeboProlonged-release 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
    Bipolar Disorder (mania and hypomania)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10000852
    E.1.2Term Acute Mania
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12
    E.1.2Level LLT
    E.1.2Classification code 10021030
    E.1.2Term Hypomania
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether Circadin is able to contribute to a reduction of hypomanic or manic symptoms in acute bipolar disorder. The primary outcome measure is a 3 point reduction of the score on the Young Mania Rating Scale (YMRS).
    E.2.2Secondary objectives of the trial
    1. Activity, sleep architecture and environmental light intensity using the Actiwatch – L. 2. Quick Inventory of Depressive Symptoms – clinician report version (QIDS-C16) (Rush et al. 2003) to provide a measure of the severity of depressive symptoms. 3. Quick Inventory of Depressive Symptoms – self report version (QIDS-SR16 ) (Rush et al. 2003). 4. Altman Self-rating Scale for Manic Symptoms (Altman et al. 1997) to provide more frequent self-assessment of manic symptoms. 5. Leeds Sleep Evaluation Questionnaire (Zisapel and Laudon, 2003) 5. Adverse events. 6. Sex hormone levels on three occasions – testosterone, progesterone and oestrogen. 7. Melatonin levels at base-line and at two weeks measured by 24 hour urinary melatonin. 8. Genetic analysis may allow investigation of a genetic contribution to the possible effect of circadin on the other indices being measured.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria: • In or outpatients meeting DSM-IV criteria for bipolar disorder type 1 or 2 • Currently experiencing manic or hypomanic symptoms. • Minimum score on Young Mania Rating Scale (YMRS) (>/=20) • Informed consent possible or previously obtained. • Willing to allow his or her General Practitioner and consultant to be notified of participation in the study. • Aged 18-65
    E.4Principal exclusion criteria
    Exclusion Criteria: The participant may not enter the study if ANY of the following apply: • Clinically significant illicit substance or alcohol misuse where dependence criteria are satisfied – craving on abstinence, withdrawal symptoms develop and are relieved by the substance, an effect on the behavioural activity of the individual to procure the substance on a predictable basis and an effect on the socio-occupational or relational functioning of the individual. • Comorbid Axis 1 disorders (according to DSM-4 Diagnostic Classification system). • Significant abnormalities on physical examination at the commencement of the trial, necessitating further investigation by a General Practitioner. • Patients currently taking Beta-blocker type medication . Patients suffering from auto-immune disease. • Patients taking the SSRI anti-depressant fluvoxamine, 5- and 8- methoxypsoralens, hormonal medications, quinolones or cimetidine, as these could interact with the drug to increase melatonin levels. • Patients taking carbamazepine or rifampicin, as these could interact with the drug to reduce melatonin levels.. . Females who are pregnant or breast-feeding. . Patients who have to undertake tasks where drowsiness could increase risk.
    E.5 End points
    E.5.1Primary end point(s)
    A reduction of three points on the Young Mania Rating Scale (YMRS).
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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) 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.8.3 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.8.6 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 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
    Last visit of the last subject undergoing the trial.
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) No
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Mental illness
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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)
    The drug can be continued after the trial but only in an off-licence capacity,(as the licence stipulates patients must be over 55 years of age) prescribed by a doctor involved with the patient's clinical care. According to the arrangements for the trial - only a three week supply of either active drug or placebo will be provided.
    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 Decision2009-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-31
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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