Clinical Trial Results:
TACT –Thiamine in Anorexia Clinical Trial
Summary
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EudraCT number |
2017-004831-35 |
Trial protocol |
SE |
Global end of trial date |
17 Dec 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Jan 2023
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First version publication date |
01 Jan 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TACT
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
Umeå University Hospital
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Sponsor organisation address |
Dept of Psychiatry, Umeå University Hospital, Umeå, Sweden, 90185
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Public contact |
Peter Asellus, Dept of Psychiatry, Umeå University Hospital, peter.asellus@umu.se
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Scientific contact |
Peter Asellus, Dept of Psychiatry, Umeå University Hospital, peter.asellus@umu.se
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Dec 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Dec 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Dec 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To study the effects of thiamine on weight in Anorexia Nervosa and controls and the tolerability of thiamine treatment.
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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.
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Background therapy |
- | ||
Evidence for comparator |
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Actual start date of recruitment |
24 Sep 2018
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Sweden: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
30
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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
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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
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Patients with Anorexia Nervosa | ||||||||||||||||||
Arm description |
Patients with Anorexia Nervosa | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Tiacur
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Investigational medicinal product code |
A11DA01
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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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)
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Arm title
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Normal weight controls | ||||||||||||||||||
Arm description |
Normal weight controls | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Tiacur
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Investigational medicinal product code |
A11DA01
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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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)
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Baseline characteristics reporting groups
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Reporting group title |
Patients with Anorexia Nervosa
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Reporting group description |
Patients with Anorexia Nervosa | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Normal weight controls
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Reporting group description |
Normal weight controls | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Patients with Anorexia Nervosa
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Reporting group description |
Patients with Anorexia Nervosa | ||
Reporting group title |
Normal weight controls
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Reporting group description |
Normal weight controls |
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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.
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End point type |
Primary
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End point timeframe |
Weight-gain recorded closest to day 42 of treatment
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Notes [1] - Data-analysis planned for January/February 2023 [2] - Data-analysis planned for January/February 2023 |
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Statistical analysis title |
Change in weight | ||||||||||||
Comparison groups |
Patients with Anorexia Nervosa v Normal weight controls
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Number of subjects included in analysis |
28
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Analysis specification |
Pre-specified
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Analysis type |
other [3] | ||||||||||||
P-value |
≤ 0.05 [4] | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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Notes [3] - Descriptive statistical analysis [4] - The most commonly used threshold |
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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.
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End point type |
Secondary
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End point timeframe |
At start of study and after 6 weeks.
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No statistical analyses for this end point |
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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
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End point type |
Secondary
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End point timeframe |
At inclusion to study and after 6 weeks
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Notes [5] - Analysis to be completed in 2023 [6] - Analysis to be completed in 2023 |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
At inclusion to study and after 6 weeks
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Notes [7] - Analysis to be performed in 2023 [8] - Analaysis to be performed in 2023 |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
At inclusion to study and after 6 weeks
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Notes [9] - Analysis to be done in 2023 [10] - Analysis to be done in 2023 |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
At inclusion to study and after 6 weeks
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Notes [11] - Analaysis to be completed in 2023 [12] - Analysis to be completed in 2023 |
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No statistical analyses for this end point |
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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
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End point type |
Secondary
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End point timeframe |
At inclusion to study and after 6 weeks
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From the time of the first injection until the subject completed the trial
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
5.0
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Reporting groups
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Reporting group title |
Patients with Anorexia Nervosa
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Reporting group description |
Patients with Anorexia Nervosa | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Normal weight controls
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Reporting group description |
Normal weight controls | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |