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    Clinical Trial Results:
    TACT –Thiamine in Anorexia Clinical Trial

    Summary
    EudraCT number
    2017-004831-35
    Trial protocol
    SE  
    Global end of trial date
    17 Dec 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Jan 2023
    First version publication date
    01 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TACT
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Umeå University Hospital
    Sponsor organisation address
    Dept of Psychiatry, Umeå University Hospital, Umeå, Sweden, 90185
    Public contact
    Peter Asellus, Dept of Psychiatry, Umeå University Hospital, peter.asellus@umu.se
    Scientific contact
    Peter Asellus, Dept of Psychiatry, Umeå University Hospital, peter.asellus@umu.se
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the effects of thiamine on weight in Anorexia Nervosa and controls and the tolerability of thiamine treatment.
    Protection of trial subjects
    For safety evaluation, the subjects were monitored for compliance including adverse events occurrence. Subjects remained under supervision for 30 minutes after injection of thiamine, in order to monitor for anaphylactic reaction or bleeding. Adverse events were registrered from the time a patient received the first dose of thiamine in the trial until he/she had completed the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Sep 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were recruited among new patients at the Freja Clinic in Umeå, currently not receiving any form of active treatment for an eating disorder. Recruitment of normal weight controls was done by posters in public settings.

    Pre-assignment
    Screening details
    Screening of patients included a structured diagnostic interview and a number of self assessment tests (i.e. self-injury behaviour and body attitude) and a diagnostic round. Controls were screened for any history of psychiatric or somatic illness by the sponsor.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Patients with Anorexia Nervosa
    Arm description
    Patients with Anorexia Nervosa
    Arm type
    Experimental

    Investigational medicinal product name
    Tiacur
    Investigational medicinal product code
    A11DA01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    100 mg (2 ml of Tiacur 50 mg/ml) intramuscular injection given three times, once in 24h (total dose 300 mg)

    Arm title
    Normal weight controls
    Arm description
    Normal weight controls
    Arm type
    Active comparator

    Investigational medicinal product name
    Tiacur
    Investigational medicinal product code
    A11DA01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    100 mg (2 ml of Tiacur 50 mg/ml) intramuscular injection given three times, once in 24h (total dose 300 mg)

    Number of subjects in period 1
    Patients with Anorexia Nervosa Normal weight controls
    Started
    14
    16
    Completed
    13
    15
    Not completed
    1
    1
         Lack of time
    1
    -
         Breastfeeding
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Patients with Anorexia Nervosa
    Reporting group description
    Patients with Anorexia Nervosa

    Reporting group title
    Normal weight controls
    Reporting group description
    Normal weight controls

    Reporting group values
    Patients with Anorexia Nervosa Normal weight controls Total
    Number of subjects
    14 16 30
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    14 16 30
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    12 12 24
        Male
    2 4 6

    End points

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    End points reporting groups
    Reporting group title
    Patients with Anorexia Nervosa
    Reporting group description
    Patients with Anorexia Nervosa

    Reporting group title
    Normal weight controls
    Reporting group description
    Normal weight controls

    Primary: Evaluate the treatment-effect of thiamine in Anorexia Nervosa

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    End point title
    Evaluate the treatment-effect of thiamine in Anorexia Nervosa
    End point description
    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.
    End point type
    Primary
    End point timeframe
    Weight-gain recorded closest to day 42 of treatment
    End point values
    Patients with Anorexia Nervosa Normal weight controls
    Number of subjects analysed
    13 [1]
    15 [2]
    Units: kilogram(s)
        number (not applicable)
    13
    15
    Notes
    [1] - Data-analysis planned for January/February 2023
    [2] - Data-analysis planned for January/February 2023
    Statistical analysis title
    Change in weight
    Comparison groups
    Patients with Anorexia Nervosa v Normal weight controls
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    P-value
    ≤ 0.05 [4]
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - Descriptive statistical analysis
    [4] - The most commonly used threshold

    Secondary: Change in appetite

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    End point title
    Change in appetite
    End point description
    Change in appetite. Based on scores on the "appetite"-item in MADRSs.
    End point type
    Secondary
    End point timeframe
    At start of study and after 6 weeks.
    End point values
    Patients with Anorexia Nervosa Normal weight controls
    Number of subjects analysed
    13
    15
    Units: Points
    13
    15
    No statistical analyses for this end point

    Secondary: Change in mood and anxiety

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    End point title
    Change in mood and anxiety
    End point description
    Change in mood and anxiety, as measured by total MADRS-s-score
    End point type
    Secondary
    End point timeframe
    At inclusion to study and after 6 weeks
    End point values
    Patients with Anorexia Nervosa Normal weight controls
    Number of subjects analysed
    14 [5]
    15 [6]
    Units: Scores
    14
    15
    Notes
    [5] - Analysis to be completed in 2023
    [6] - Analysis to be completed in 2023
    No statistical analyses for this end point

    Secondary: Change in neurocognitive function, with a specific focus on learning and memory

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    End point title
    Change in neurocognitive function, with a specific focus on learning and memory
    End point description
    Change in neurocognitive function, with a specific focus on learning and memory.
    End point type
    Secondary
    End point timeframe
    At inclusion to study and after 6 weeks
    End point values
    Patients with Anorexia Nervosa Normal weight controls
    Number of subjects analysed
    14 [7]
    15 [8]
    Units: Number
    14
    15
    Notes
    [7] - Analysis to be performed in 2023
    [8] - Analaysis to be performed in 2023
    No statistical analyses for this end point

    Secondary: Thiamine levels and thiamine metabolism

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    End point title
    Thiamine levels and thiamine metabolism
    End point description
    Thiamine levels and thiamine metabolism in patients having been treated for Anorexia Nervosa. Measure-ments of serum thiamine levels and transketolase-activity.
    End point type
    Secondary
    End point timeframe
    At inclusion to study and after 6 weeks
    End point values
    Patients with Anorexia Nervosa Normal weight controls
    Number of subjects analysed
    14 [9]
    15 [10]
    Units: number
    14
    15
    Notes
    [9] - Analysis to be done in 2023
    [10] - Analysis to be done in 2023
    No statistical analyses for this end point

    Secondary: Epigenetic effects of treatment with thiamine and treatment-as-usual for Anorexia Nervosa

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    End point title
    Epigenetic effects of treatment with thiamine and treatment-as-usual for Anorexia Nervosa
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    At inclusion to study and after 6 weeks
    End point values
    Patients with Anorexia Nervosa Normal weight controls
    Number of subjects analysed
    14 [11]
    15 [12]
    Units: number
    14
    15
    Notes
    [11] - Analaysis to be completed in 2023
    [12] - Analysis to be completed in 2023
    No statistical analyses for this end point

    Secondary: Effects of treatment on lipids, cortisol and oxysterols

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    End point title
    Effects of treatment on lipids, cortisol and oxysterols
    End point description
    Effects of treatment on lipids, cortisol and oxysterols
    End point type
    Secondary
    End point timeframe
    At inclusion to study and after 6 weeks
    End point values
    Patients with Anorexia Nervosa Normal weight controls
    Number of subjects analysed
    13
    15
    Units: Number
    13
    15
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of the first injection until the subject completed the trial
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    5.0
    Reporting groups
    Reporting group title
    Patients with Anorexia Nervosa
    Reporting group description
    Patients with Anorexia Nervosa

    Reporting group title
    Normal weight controls
    Reporting group description
    Normal weight controls

    Serious adverse events
    Patients with Anorexia Nervosa Normal weight controls
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Patients with Anorexia Nervosa Normal weight controls
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 13 (61.54%)
    9 / 15 (60.00%)
    Vascular disorders
    Hematoma
    Additional description: Bruise after blood sampling
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    Vascular disorders - other
    Additional description: Tiny leakage of injected fluid and/or blood at the injection site
         subjects affected / exposed
    0 / 13 (0.00%)
    5 / 15 (33.33%)
         occurrences all number
    0
    6
    Renal and urinary disorders
    Urine discoloration
    Additional description: Gritty urine for 1 week after injection of thiamine
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
    Additional description: Discomfort shile waiting at the clinic before and after the injection
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Buttock pain
    Additional description: Pain/tenderness in the muscle after injection of thiamine
         subjects affected / exposed
    6 / 13 (46.15%)
    4 / 15 (26.67%)
         occurrences all number
    13
    9
    Pain in extremity
    Additional description: Pain after blood sampling
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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