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    Summary
    EudraCT Number:2017-004831-35
    Sponsor's Protocol Code Number:TACT
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-02-13
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-004831-35
    A.3Full title of the trial
    TACT –Thiamine in Anorexia Clinical Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TACT –Thiamine in Anorexia Clinical Trial
    A.4.1Sponsor's protocol code numberTACT
    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 SponsorDept of Psychiatry, Umeå University Hospital
    B.1.3.4CountrySweden
    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 supportVästerbotten county council
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportUmeå University
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept of Psychiatry, Umeå University Hospital
    B.5.2Functional name of contact pointPeter Asellus
    B.5.3 Address:
    B.5.3.1Street AddressUmeå University Hospital
    B.5.3.2Town/ cityUmeå
    B.5.3.3Post code90185
    B.5.3.4CountrySweden
    B.5.6E-mailpeter.asellus@umu.se
    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 Tiacur®
    D.2.1.1.2Name of the Marketing Authorisation holderAbcur AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular 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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Anorexia Nervosa and Healthy Controls
    E.1.1.1Medical condition in easily understood language
    Anorexia Nervosa
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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 study the effects of thiamine on weight in Anorexia Nervosa and controls and the tolerability of thiamine treatment.
    E.2.2Secondary objectives of the trial
    a) To study if addition of thiamine treatment has beneficial neurocognitive effects in patients with Anorexia Nervosa.
    b) To study thiamine status in patients with Anorexia Nervosa at inclusion to study, and after six weeks of treatment.
    c) An explorative study of biochemical and genetic markers in relation to Anorexia Nervosa, with a special focus on mitochondrial DNA and factors related to thiamine regulation of glucose metabolism.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female, 18-65 years of age, who has given written con-sent for his/her participation to the study¸ Women of Childbearing Capacity (WOCBC) only if willing to comply with effective contra-ception methods during the course of the trial. Acceptable methods are such as oral contraceptives, contraceptive patches, contracep-tive implant, vaginal contraceptive, double-barrier methods (for example, condom and spermicide), intrauterine device (IUD), hor-monal IUD
    2) A diagnosis of Anorexia Nervosa. An age of 18 or older. A verified duration of symptoms of at least 3 months. A minimum BMI of 13 and a BMI less than 19. A written consent to participate in the study and to adhere to the study protocol, a willingness to start treatment as usual and to receive three intramuscular injections of 100mg thiamine.

    3) Normal-weight Controls. An age of 18 or older. No current severe somatic or psychiatric illness. A written consent to participate in the study and to adhere to the study protocol and a willingness to receive three intramuscular injections with thiamine.
    E.4Principal exclusion criteria
    1) Short life expectancy due to other comorbidity
    2) Contraindication for or otherwise not compliant with the thiamine injections or other investigations
    3) Documented allergy or intolerance to study drug
    4) Severe psychiatric condition or other reason that jeopardize compliance with follow up.
    5) On fertile females, pregnancy assessed by anamnesis and pregnancy test
    6) Current high-dose treatment with thiamine, or recent (within the last month), high-dose treatment with thiamine.
    7) Current diagnosis of alcoholism, drug abuse or mental retardation. A current prescription of atypical neuroleptics or benzodiaz-epines. Positive drug screening.


    7) Current diagnosis of alcoholism, drug abuse or mental retardation. A current prescription of atypical neurolep-tics or benzodiazepines. Positive drug-screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is to evaluate the treatment-effect of thiamine in Anorexia Nervosa. The main outcome is weight-gain, as measured by increase in kilograms, which is a fairly standard way of evaluating the efficacy of treatment for anorexia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weight-gain recorded closest to day 42 of treatment.
    E.5.2Secondary end point(s)
    a) Change in appetite. Based on scores on the “appetite”-item in MADRS-s, at start of study and after 6 weeks.
    b) Change in mood and anxiety, as measured by total MADRS-s-score at inclusion to study and after 6 weeks.
    c) Change in neurocognitive function, with a specific focus on learning and memory.
    d) Thiamine levels and thiamine metabolism in patients having been treated for Anorexia Nervosa. Measure-ments of serum thiamine levels and transketolase-activity at inclusion and after 6 weeks.
    e) Epigenetic effects of treatment with thiamine and treatment-as-usual for Anorexia Nervosa. Analysis of DNA and mitochondrial DNA associated with the uptake and function of thiamine.
    f) Effects of treatment on lipids, cortisol and oxysterols.

    g) Compliance to treatment
    o Adverse events
    o Compliance to drug prescription
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) At start of study and after 6 weeks.
    b) At inclusion to study and after 6 weeks.
    c) At inclusion to study and after 6 weeks.
    d) At inclusion to study and after 6 weeks.
    e) At inclusion to study.
    f) At inclusion to study and after 6 weeks
    g) From the time a patient receives the first injection until up to 30 day follow-up period after completion of the trial
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Case-control study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    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.8.5The 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 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 study will be formally closed when 15 patients and 15 controls have been recruited and completed the study, or 2 years after recruitment has started, whichever comes first.
    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 months
    E.8.9.1In the Member State concerned days
    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: 30
    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 Yes
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    Treatment according to standard care will continue for as long as deemed necessary.
    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 Decision2018-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-17
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