Alcohol Use Disorder, SevereW3-AUDNCT05899660
Impact of Omega 3 in Alcohol Use Disorder
A study testing Active Comparator: Omega-3 in people with Alcohol Use Disorder, Severe, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to investigate the biological pathways underlying the beneficial effect of omega-3 polyunsaturated fatty acids (n-3 PUFA) on mental health in patients with alcohol use disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Use Disorder, Severe
- What is being tested?
- Active Comparator: Omega-3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jun 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of alcohol use disorder (≥ 4 DSM-5 criteria)
- Patient at the hospital for a 3 week alcohol withdrawal program
- Gender : male and female
- Age : between 18 and 70 years old
- Language : french
- Alcohol consumption less than 48 jours before admission
Who cannot join
- Presence of another addiction, except for smoking and cannabis use
- Presence of a psychiatric comorbidity (axis 1 DSM-5)
- Current or recent use (< 2 months) of antibiotics, probiotics, fibre supplements
- Current or recent (< 2 months) use of omega-3 supplements
- Current or recent (< 2 months) use of oral anti-coagulants drugs
- Current or recent (< 2 months) double anti-platelet therapy
Show all 16Show fewer
- Coagulation disorders
- Current or recent (< 1 month) use of non-steroidal anti-inflammatory drugs and glucocorticoids
- Morbid obesity : body mass index > 35 kg.m-2
- Bariatric surgery
- Type I diabetes and type II diabetes not stabilised (i.e. glycated haemoglobin > 7.2 and unstable drug treatments)
- Chronic inflammatory diseases
- Cancer (less than 5 years before admission)
- Presence of cirrhosis (Fibroscan® = F4 and echodoppler performed as part of clinical routine on patient admission)
- Known allergy to fish and seafood
- Any other comorbidity that would be a contraindication to the study in the judgement of the principal investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie Mornard contact
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint Luc
Brussels, 1200
Sophie Leclercq, sophie.leclercq@uclouvain.be
Marie Mornard, marie.mornard@uclouvain.be
About this study
Official title: Impact of Omega-3 Polyunsaturated Fatty Acids on Emotional, Cognitive and Biological Alterations in Alcohol Use Disorder
The goal of this clinical trial is to investigate the biological pathways underlying the beneficial effect of omega-3 polyunsaturated fatty acids (n-3 PUFA) on mental health in patients with alcohol use disorder. The main questions this study aims to answer are:
- Can n-3 PUFA improve mood disorders (depression, anxiety), craving for alcohol, cognitive impairments and sociability disorders ?
- Are the beneficial effects of n-3 PUFAs due to a modification of the gut microbiota and/or the inflammatory status?
Read more
Participants will :
- take a supplementation of omega-3 or placebo during 3 months
- do a brain MRI
- be interviewed for a dietary anamnesis
- provide blood, stool and saliva samples
- perform psychological tests and neuropsychological tasks
Researchers will compare active comparator (omega-3) with placebo comparator (olive oil) to see if omega-3 can have a beneficial effect on AUD patients.
Read the detailed description
Alcohol use disorder (AUD) is the most widespread addiction in Belgium and Europe and constitutes a major public health problem with important physical, psychological and economic consequences for the consumer and his family, friends, co-workers.
For several years, the intestinal microbiota has been increasingly studied because it seems to play an indispensable role in the proper functioning of the body. Indeed, it is involved in the regulation of the immune system, metabolic reactions and the nervous system and therefore influences behaviour. The composition of the microbiota is specific to everyone and is influenced by many factors, such as diet, medication and lifestyle.
In the case of AUD, numerous studies have shown that alcohol and its metabolites alter the intestinal microbiota, leading to an increase in inflammation and changes in behaviour.
Nutritional intervention is an encouraging and innovative approach to alcohol addiction therapy. The main aim of this research is to see how a nutritional intervention could improve mood, cognition and social behaviour in AUD patients. The interest will therefore focus on Omega-3. These polyunsaturated fatty acids are found in the diet, mainly in fish oils, and are constituents of the body's cell membranes and perform many physiological functions. They also play an important role in the regulation of inflammation. Studies have shown that Omega-3 supplementation can reduce symptoms of depression and have beneficial effects in autism spectrum disorders, schizophrenia, bipolar disorders and neurodegenerative diseases. They have therefore been widely studied, but their role in social interactions, which is an important factor in many mental illnesses including AUD, has not yet been studied.
The investigators will conduct a randomised, placebo-controlled, double-blind study, testing the impact of Omega-3 supplementation on AUD patients undergoing a detoxification program at the Saint-Luc University Hospital, Brussels, Belgium. 100 patients will be enrolled and the Omega 3/placebo supplementation will last for 3 months. The patients will be tested 3 times: T1 (2nd day of withdrawal), T2 (18th-19th day of withdrawal) and T3 (after 3 months of supplementation). The investigators hope to see a beneficial effect of omega-3 on social, emotional and cognitive deficits as well as brain functioning (fMRI). They will investigate the mechanisms involved, namely, changes in the composition of the gut microbiota, reduction of systemic inflammation, and production of bacterial metabolites with immune or neuroactive properties.
- Conditions
- Alcohol Use Disorder, Severe
- Being tested
- Active Comparator: Omega-3, Placebo Comparator: olive oil
- Keywords
- gut microbiota, Omega 3, metabolomics, Depression, Anxiety, Alcohol craving, Sociability, Cognition, Inflammation, Brain imaging
- Medical subject headings
- Alcoholism, Depression, Anxiety Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Omega-3Dietary supplement
It is a dietary supplement made of fish oil rich in n-3 PUFA.
Placebo Comparator: olive oilDietary supplement
Refined olive oil is the usual placebo used in studies with n-3 PUFA.
| Study group | Role | What they receive |
|---|---|---|
| Olive oil | Placebo comparator | Dosage form : capsule Dosage : 1000 mg oleic acid (olive oil) + 3.6 mg D-α-tocopherol (vitamin E) Frequency : 4 capsules per day Duration : 3 months Receives: Dietary Supplement: Placebo Comparator: olive oil |
| Omega-3 | Active comparator | Dosage form : capsule Dosage : 330 mg EPA, 220 mg DHA, 100 mg other n-3 PUFA + 3.6 mg D-α-tocopherol (vitamin E) Frequency : 4 capsules per day Duration : 3 months Receives: Dietary Supplement: Active Comparator: Omega-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression
Beck Depression Inventory (BDI) (score 0-63) Higher score indicates higher depression level.
Measured: On day 2, day 19 and day 90
Change in anxiety
State-Trait Anxiety Inventory (STAI) (score 20-80) Higher score indicates higher anxiety level.
Measured: On day 2, day 19 and day 90
Change in fatigue
Multidimensional Fatigue Inventory (MFI) (score 20-140) Higher score indicates higher fatigue level.
Measured: On day 2, day 19 and day 90
Change in alcohol craving
Obsessive Compulsive Drinking Scale (OCDS) (score 0-40) Higher score indicates higher craving level.
Measured: On day 2, day 19 and day 90
Change in impulsivity
Urgency Premeditation Perseverance Sensation seeking impulsive behavior scale (UPPS) : score of different subscales are calculated : "ugency" (0-48), "lack of premeditation" (0-44), "lack of perseverance" (0-40), "sensation seeking) (0-48).
Higher score in the different subscales indicates higher impulsivity level.
Measured: On day 19 and day 90
Change in social anxiety
Liebowitz Scale of Social Anxiety (EASL) (score 0-144) Higher score indicates higher social anxiety level.
Measured: On day 19 and day 90
Change in trauma
Post-traumatic diagnostic scale (PDS-F): calculation of score is complex and described in the related publication
Measured: On day 19
Childhood trauma
Childhood Trauma Questionnaire (CTQ) (28-144) Higher score indicates higher childhood trauma level.
Measured: On day 19
Self-stigma
Self-Stigma in Alcohol Dependence (SSAD) (16-80) Higher score indicates higher self-stigma level.
Measured: On day 19
Change in work memory
Letter Memory Task
Measured: On day 2, day 19 and day 90
Change in inhibition
Stop Signal Task
Measured: On day 2, day 19 and day 90
Change in decision making
Fisher Task
Measured: On day 19 and day 90
Change in facial emotions recognition
Facial Emotions Recognition Task (TREF)
Measured: On day 19 and day 90
Change in visual perspective taking
Visual Perspective Taking Task
Measured: On day 19 and day 90
Sociability
Sociogram
Measured: On day 19
Emotional intelligence
Trait Emotional Intelligence Questionnaire (TEI Que-75) : calculation of score is complex and described in the related publication
Measured: Day 19
Change in social activity
Social Activities Questionnaire (28-196)
Measured: On day 2, day 19 and day 90
Secondary outcomes (7)
Change in markers of microbial translocation
measurement of sCD14, PGRP in blood sample using ELISA kits (pg/mL)
Measured: On day 2, day 19 and day 90
Change in inflammation
Circulating pro- and anti-inflammatory cytokines (TNFa, IL-6, IL-1b, IL-8, IL-10) levels in blood sample Isolation of PBMC to study intracellular inflammatory pathways by RT-qPCR
Measured: On day 2, day 19 and day 90
Change in gut microbiota composition
Analysis of gut microbiota (16S rDNA) by high-throughput sequencing (Illumina)
Measured: On day 2, day 19 and day 90
Intestinal permeability
a duodenal biopsy will be collected and the expression of the tight junctions regulation the intestinal permeability will be analyzed by sectional immunofluorescence and quantitative polymerase chain reaction
Measured: On day 19
Change in omega-3 levels
Omega-3 levels in plasma and red blood cells
Measured: On day 2, day 19 and day 90
Change in diet profile
The dietary anamnesis will consist of a 24-hour recall over 3 days (2 weekdays and 1 weekend day)
Measured: On day 2, day 19 and day 90
Change in brain functioning
Magnetic Resonance Imaging
Measured: On day 2, day 19 and day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start19 Jun 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder, SevereStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe de Timary, MD, PhD, Principal investigator, St Luc academic Hospital and Université Catholique de LouvainPeter Starkel, MD, PhD, Principal investigator, St Luc academic Hospital and Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899660
- Sponsor's protocol ID
- 2022/22DEC/502
- Acronym
- W3-AUD
- Status last verified
- Jun 2023
- First submitted
- 15 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hearn, M, Ceschi, G., Brillon, P, Fürst, G., & Van der Linden, M. (2012). A French adaptation of the Post-traumatic Diagnostic scale. Canadian Journal of Behavioural Science, 44, 16-28
Petrides KV (2009) Psychometric properties of the trait emotional intelligence questionnaire. In: Stough C, Saklofske DH, Parker JD (eds) Advances in the assessment of emotional intelligence. Springer, New York. 10.1007/978-0-387-88370-0_5
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Omega-3 Polyunsaturated Fatty Acids on Emotional, Cognitive and Biological Alterations in Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05899660
- Acronym / sponsor ID
- W3-AUD / 2022/22DEC/502
- Conditions
- Alcohol Use Disorder, Severe
- Keywords
- gut microbiota, Omega 3, metabolomics, Depression, Anxiety, Alcohol craving, Sociability, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the biological pathways underlying the beneficial effect of omega-3 polyunsaturated fatty acids (n-3 PUFA) on mental health in patients with alcohol use disorder. The main questions this study aims to answer are:
- Can n-3 PUFA improve mood disorders (depression, anxiety), craving for alcohol, cognitive impairments and sociability disorders ?
- Are the beneficial effects of n-3 PUFAs due to a modification of the gut microbiota and/or the inflammatory status?
Participants will :
- take a supplementation of omega-3 or placebo during 3 months
- do a brain MRI
- be interviewed for a dietary anamnesis
- provide blood, stool and saliva samples
- perform psychological tests and neuropsychological tasks
Researchers will compare active comparator (omega-3) with placebo comparator (olive oil) to see if omega-3 can have a beneficial effect on AUD patients.
Detailed description
Alcohol use disorder (AUD) is the most widespread addiction in Belgium and Europe and constitutes a major public health problem with important physical, psychological and economic consequences for the consumer and his family, friends, co-workers.
For several years, the intestinal microbiota has been increasingly studied because it seems to play an indispensable role in the proper functioning of the body. Indeed, it is involved in the regulation of the immune system, metabolic reactions and the nervous system and therefore influences behaviour. The composition of the microbiota is specific to everyone and is influenced by many factors, such as diet, medication and lifestyle.
In the case of AUD, numerous studies have shown that alcohol and its metabolites alter the intestinal microbiota, leading to an increase in inflammation and changes in behaviour.
Nutritional intervention is an encouraging and innovative approach to alcohol addiction therapy. The main aim of this research is to see how a nutritional intervention could improve mood, cognition and social behaviour in AUD patients. The interest will therefore focus on Omega-3. These polyunsaturated fatty acids are found in the diet, mainly in fish oils, and are constituents of the body's cell membranes and perform many physiological functions. They also play an important role in the regulation of inflammation. Studies have shown that Omega-3 supplementation can reduce symptoms of depression and have beneficial effects in autism spectrum disorders, schizophrenia, bipolar disorders and neurodegenerative diseases. They have therefore been widely studied, but their role in social interactions, which is an important factor in many mental illnesses including AUD, has not yet been studied.
The investigators will conduct a randomised, placebo-controlled, double-blind study, testing the impact of Omega-3 supplementation on AUD patients undergoing a detoxification program at the Saint-Luc University Hospital, Brussels, Belgium. 100 patients will be enrolled and the Omega 3/placebo supplementation will last for 3 months. The patients will be tested 3 times: T1 (2nd day of withdrawal), T2 (18th-19th day of withdrawal) and T3 (after 3 months of supplementation). The investigators hope to see a beneficial effect of omega-3 on social, emotional and cognitive deficits as well as brain functioning (fMRI). They will investigate the mechanisms involved, namely, changes in the composition of the gut microbiota, reduction of systemic inflammation, and production of bacterial metabolites with immune or neuroactive properties.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olive oil | Placebo comparator | Dietary Supplement: Placebo Comparator: olive oilDosage form : capsule Dosage : 1000 mg oleic acid (olive oil) + 3.6 mg D-α-tocopherol (vitamin E) Frequency : 4 capsules per day Duration : 3 months |
| Omega-3 | Active comparator | Dietary Supplement: Active Comparator: Omega-3Dosage form : capsule Dosage : 330 mg EPA, 220 mg DHA, 100 mg other n-3 PUFA + 3.6 mg D-α-tocopherol (vitamin E) Frequency : 4 capsules per day Duration : 3 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of alcohol use disorder (≥ 4 DSM-5 criteria)
- Patient at the hospital for a 3 week alcohol withdrawal program
- Gender : male and female
- Age : between 18 and 70 years old
- Language : french
Key exclusion criteria (16 listed)
- Presence of another addiction, except for smoking and cannabis use
- Presence of a psychiatric comorbidity (axis 1 DSM-5)
- Current or recent use (< 2 months) of antibiotics, probiotics, fibre supplements
- Current or recent (< 2 months) use of omega-3 supplements
- Current or recent (< 2 months) use of oral anti-coagulants drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: Omega-3It is a dietary supplement made of fish oil rich in n-3 PUFA. | Dietary supplement | Omega-3 |
| Placebo Comparator: olive oilRefined olive oil is the usual placebo used in studies with n-3 PUFA. | Dietary supplement | Olive oil |
Primary outcome
Change in depression
Time frame: On day 2, day 19 and day 90
Beck Depression Inventory (BDI) (score 0-63) Higher score indicates higher depression level.
Change in anxiety
Time frame: On day 2, day 19 and day 90
State-Trait Anxiety Inventory (STAI) (score 20-80) Higher score indicates higher anxiety level.
Change in fatigue
Time frame: On day 2, day 19 and day 90
Multidimensional Fatigue Inventory (MFI) (score 20-140) Higher score indicates higher fatigue level.
Change in alcohol craving
Time frame: On day 2, day 19 and day 90
Obsessive Compulsive Drinking Scale (OCDS) (score 0-40) Higher score indicates higher craving level.
Change in impulsivity
Time frame: On day 19 and day 90
Urgency Premeditation Perseverance Sensation seeking impulsive behavior scale (UPPS) : score of different subscales are calculated : "ugency" (0-48), "lack of premeditation" (0-44), "lack of perseverance" (0-40), "sensation seeking) (0-48). Higher score in the different subscales indicates higher impulsivity level.
Change in social anxiety
Time frame: On day 19 and day 90
Liebowitz Scale of Social Anxiety (EASL) (score 0-144) Higher score indicates higher social anxiety level.
Change in trauma
Time frame: On day 19
Post-traumatic diagnostic scale (PDS-F): calculation of score is complex and described in the related publication
Childhood trauma
Time frame: On day 19
Childhood Trauma Questionnaire (CTQ) (28-144) Higher score indicates higher childhood trauma level.
Self-stigma
Time frame: On day 19
Self-Stigma in Alcohol Dependence (SSAD) (16-80) Higher score indicates higher self-stigma level.
Change in work memory
Time frame: On day 2, day 19 and day 90
Letter Memory Task
Change in inhibition
Time frame: On day 2, day 19 and day 90
Stop Signal Task
Change in decision making
Time frame: On day 19 and day 90
Fisher Task
Change in facial emotions recognition
Time frame: On day 19 and day 90
Facial Emotions Recognition Task (TREF)
Change in visual perspective taking
Time frame: On day 19 and day 90
Visual Perspective Taking Task
Sociability
Time frame: On day 19
Sociogram
Emotional intelligence
Time frame: Day 19
Trait Emotional Intelligence Questionnaire (TEI Que-75) : calculation of score is complex and described in the related publication
Change in social activity
Time frame: On day 2, day 19 and day 90
Social Activities Questionnaire (28-196)
7 secondary outcomes
Change in markers of microbial translocation
Time frame: On day 2, day 19 and day 90
Change in inflammation
Time frame: On day 2, day 19 and day 90
Change in gut microbiota composition
Time frame: On day 2, day 19 and day 90
Intestinal permeability
Time frame: On day 19
Change in omega-3 levels
Time frame: On day 2, day 19 and day 90
Change in diet profile
Time frame: On day 2, day 19 and day 90
Change in brain functioning
Time frame: On day 2, day 19 and day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- BackgroundHearn, M, Ceschi, G., Brillon, P, Fürst, G., & Van der Linden, M. (2012). A French adaptation of the Post-traumatic Diagnostic scale. Canadian Journal of Behavioural Science, 44, 16-28
- BackgroundPetrides KV (2009) Psychometric properties of the trait emotional intelligence questionnaire. In: Stough C, Saklofske DH, Parker JD (eds) Advances in the assessment of emotional intelligence. Springer, New York. 10.1007/978-0-387-88370-0_5
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Mornard contact
Philippe de Timary, MD, PhD principal investigator
St Luc academic Hospital and Université Catholique de Louvain
Peter Starkel, MD, PhD principal investigator
St Luc academic Hospital and Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Omega-3 in people with Alcohol Use Disorder, Severe, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Leclercq, PhD (+3224361023, sophie.leclercq@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression (time frame: On day 2, day 19 and day 90). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05899660, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.