Binge-Eating DisorderNCT03094260
Light Therapy and Binge Eating Disorder Treatment (BED Light Study)
A study testing High intensity bright light therapy and Low intensity light therapy in people with Binge-Eating Disorder, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. Its pathophysiology remains poorly understood and the investigators have few therapeutic options. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- High intensity bright light therapy and Low intensity light therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2018to 9 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 55 years old
- Binge eating disorders or other eating disorders according to DSM V criteria
- Patient with BES score (with " Bing Eating Scale " ) > 18
- Patient with BMI > 18.5 kg/m2
- Patient who agrees to be included in the study and who signs the informed consent form
- Patient affiliated to a healthcare insurance plan
Who cannot join
- Patients with other psychiatric comorbidities, including a disorder bipolar mood
- Unstabilized diabetic patient with or retinopathy
- Patient with sleep disorder (delay or phase inversion)
- Patient with psychotropic treatment unstabilized (except anxiolytic treatment)
- Recent eye surgery or eye problem preventing exposure to bright light.
- Medication making the skin more sensitive to light (eg. Tablets against malaria)
Show all 10Show fewer
- Patient who does not understand French/is unable to give consent
- Mentally unbalanced patients, under supervision or guardianship
- Patient already included in a research study
- Pregnancy or desire to be pregnant during the study
Trial locations and contacts
1 site in 1 country.
France1 site
HCL Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)
Bron, 69500
About this study
Official title: Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial
Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. Its pathophysiology remains poorly understood and the investigators have few therapeutic options. Following a review of the literature, the investigators hypothesize that luminotherapy could be an innovative treatment of BED by its favorable effect on triggers of hyperphagic access, circadian disturbances, attention and impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (<500 lux). Treatment will be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main objective is to compare the evolution of the number of hyperphagic access before and after treatment between the two groups. Secondary objectives are to compare characteristics of hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety, cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time Estimation Task, Switching Task), liking / wanted for different food categories and carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid abnormalities, 25-OH vitamin D3).
- Conditions
- Binge-Eating Disorder
- Being tested
- High intensity bright light therapy, Low intensity light therapy
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity bright light therapyDevice
Treatment with light therapy in high intensity (10,000 lux), daily for 30 days between 6 am and 9 am for 30 minutes.
Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subject is sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position.
Low intensity light therapyDevice
Treatment with light therapy in low intensity (<500 lux), daily for 30 days between 6 am and 9 am for 30 minutes.
Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subjectis sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position.
| Study group | Role | What they receive |
|---|---|---|
| High intensity light therapy | Experimental | Treatment with light therapy in high intensity (10,000 lux) Receives: Device: High intensity bright light therapy |
| Low intensity light therapy | Placebo comparator | Treatment with light therapy in low intensity (<500 lux) Receives: Device: Low intensity light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Measured: Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0)
Secondary outcomes (33)
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Measured: Day-7 to Day-1 period compared to Day23 to Day30 period
Characteristics of hyperphagic access (severity of the disorder)
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Measured: Day 0
Characteristics of hyperphagic access (severity of the disorder)
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Measured: Day 30
Characteristics of hyperphagic access (severity of the disorder)
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale.
Measured: Day 60
Characteristics of hyperphagic access (duration of crisis)
Evaluation of the duration,by the crisis agenda.
Measured: Day 0
Characteristics of hyperphagic access (duration of crisis)
Evaluation of the duration,by the crisis agenda.
Measured: Day 30
Characteristics of hyperphagic access (duration of crisis)
Evaluation of the duration,by the crisis agenda.
Measured: Day 60
Characteristics of hyperphagic access (amount of food ingested )
Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Measured: Day 0
Characteristics of hyperphagic access (amount of food ingested )
Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Measured: Day 30
Characteristics of hyperphagic access (amount of food ingested )
Evaluation of the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda.
Measured: Day 60
Characteristics of hyperphagic access ( evolution of factors triggering)
Evaluation of the factors triggering by the "START" scale.
Measured: Day 0
Characteristics of hyperphagic access ( evolution of factors triggering)
Evaluation of the factors triggering by the "START" scale.
Measured: Day 30
Characteristics of hyperphagic access ( evolution of factors triggering)
Evaluation of the factors triggering by the "START" scale.
Measured: Day 60
Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)
Evaluation of the severity of bulimic hyperphagia by the Bing Eating Scale. Evaluation of the duration, the quantity of food ingested during the hyperphagic access and the delays between two accesses by the crisis agenda. Evaluation of the factors triggering by the "START" scale.
Measured: Day 30
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
Measured: Day-7 to Day-1 period (before Day 0) compared to Day53 to Day60 period (after Day 0)
Symptomatic development of BED
The symptomatic development of BED will be measured by evaluating :
- The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire
- The Body concerns based on the "Body sharpe" questionnaire
- The Addiction to food from the Yale Food Addiction scale
- The Diet-related impulsivity from the Three-Factor Eating Questionnaire
Measured: Day 0
Symptomatic development of BED
The symptomatic development of BED will be measured by evaluating the composite:
- The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire
- The Body concerns based on the "Body sharpe" questionnaire
- The Addiction to food from the Yale Food Addiction scale
- The Diet-related impulsivity from the Three-Factor Eating Questionnaire
Measured: Day 30
Symptomatic development of BED
The symptomatic development of BED will be measured by evaluating the composite:
- The psychopathology of the BED from the Eating Disorder Inventory 2 questionnaire
- The Body concerns based on the "Body sharpe" questionnaire
- The Addiction to food from the Yale Food Addiction scale
- The Diet-related impulsivity from the Three-Factor Eating Questionnaire
Measured: Day 60
Evolution of other psychological parameters related to BED
The evolution of other psychological parameters will be measured by evaluating the composite :the mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale
Measured: Day 0
Evolution of other psychological parameters related to BED
The evolution of other psychological parameters will be measured by evaluating the composite the mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale
Measured: Day 30
Evolution of other psychological parameters related to BED
The evolution of other psychological parameters will be measured by evaluating the composite mood from the Beck Depression Inventory scale, the anxiety from the "State Trait Anxiety Inventory or STAI-Y" scale, the clinical impulsivity from the "UPPS-P shortcut" scale
Measured: Day 60
Evolution of attentional cognitive profiles and impulsivity
The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task
Measured: Day 0
Evolution of attentional cognitive profiles and impulsivity
The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task
Measured: Day 30
Evolution of attentional cognitive profiles and impulsivity
The evolution of attentional and impulsive cognitive profiles will be measured from a computerized neurocognitive test battery whose order will be randomly fixed. The tests will be STROOP, The Go / No Go, The Stop Signal Task, The Balloon Analog Risk Task, The Prospective Time Estimation Task, The Set Switching Task
Measured: Day 60
Evolution of appetite for different categories of food
The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/
Measured: Day 0
Evolution of appetite for different categories of food
The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/
Measured: Day 30
Evolution of appetite for different categories of food
The evolution of appetite for different categories of food will be measured from a computerized task: the Leed Food Preference Questionnaire (LFPQ). A description of the test is available at: https://www.millisecond.com/download/library/
Measured: Day 60
Biological parameters may be impacted or mediated by part of the treatment efficiency
Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3
Measured: Day 0
Biological parameters may be impacted or mediated by part of the treatment efficiency
Inflammation parameters, glucose, insulinemia, insulin resistance, Profile of lipid abnormalities, 1-25-OH vitamin D3
Measured: Day 30
Weight (kilogramm)
Weight will be expressed in absolute value
Measured: Day 0
Weight (kilogramm)
Weight will be expressed in absolute value
Measured: Day 30
Weight (kilogramm)
Weight will be expressed in absolute value
Measured: Day 60
Observance rate to light therapy
The assessment of the adherence rate will be quantified by the average number of lux received over the 30 days of treatment. The exposure (expressed in lux number / session) in lux will be measured and recorded using a luxmeter
Measured: day1 to day30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start29 Mar 2018
- Primary completion9 Apr 2020
- Study completion9 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diane MORFIN, MD, Principal investigator, Hospices Civils de Lyon Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094260
- Sponsor's protocol ID
- 69HCL16_0626
- Other IDs
- 2016-A01768-43
- Status last verified
- Jun 2021
- First submitted
- 9 Mar 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Light Therapy in the Treatment of Binge Eating Disorder: Prospective Controlled Randomized Double-blind Trial
- ClinicalTrials.gov ID
- NCT03094260
- Acronym / sponsor ID
- 69HCL16_0626
- Conditions
- Binge-Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 9 Apr 2020 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 29 Mar 2017 (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.
Binge Eating Disorder (BED) is the most widespread food behavior disorder, with prevalence three times higher than anorexia. Its pathophysiology remains poorly understood and the investigators have few therapeutic options. Following a review of the literature, the investigators hypothesize that luminotherapy could be an innovative treatment of BED by its favorable effect on triggers of hyperphagic access, circadian disturbances, attention and impulsivity. The study is prospective, interventional, randomized, double-blind, monocentric (HCL). 52 patients with BED will be randomized to an active arm with intensive luminotherapy (1 daily 30 min, 10,000 lux in the morning) versus a placebo arm (<500 lux). Treatment will be delver every day during 30 days. Assessments will take place on D0, D30 and D60. The main objective is to compare the evolution of the number of hyperphagic access before and after treatment between the two groups. Secondary objectives are to compare characteristics of hyperphagic access, bodily concerns, food dependence and impulsivity, mood, anxiety, cognitive and attentional profiles (STROOP, Go / No Go, SST, BART, Prospective Time Estimation Task, Switching Task), liking / wanted for different food categories and carbohydrate metabolism (CRP, glucose, insulinemia, insulin resistance, profile of lipid abnormalities, 25-OH vitamin D3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity light therapy | Experimental | Device: High intensity bright light therapyTreatment with light therapy in high intensity (10,000 lux) |
| Low intensity light therapy | Placebo comparator | Device: Low intensity light therapyTreatment with light therapy in low intensity (<500 lux) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 18 and 55 years old
- Binge eating disorders or other eating disorders according to DSM V criteria
- Patient with BES score (with " Bing Eating Scale " ) > 18
- Patient with BMI > 18.5 kg/m2
- Patient who agrees to be included in the study and who signs the informed consent form
Key exclusion criteria (10 listed)
- Patients with other psychiatric comorbidities, including a disorder bipolar mood
- Unstabilized diabetic patient with or retinopathy
- Patient with sleep disorder (delay or phase inversion)
- Patient with psychotropic treatment unstabilized (except anxiolytic treatment)
- Recent eye surgery or eye problem preventing exposure to bright light.
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 |
|---|---|---|
| High intensity bright light therapyTreatment with light therapy in high intensity (10,000 lux), daily for 30 days between 6 am and 9 am for 30 minutes. Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subject is sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position. | Device | High intensity light therapy |
| Low intensity light therapyTreatment with light therapy in low intensity (<500 lux), daily for 30 days between 6 am and 9 am for 30 minutes. Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subjectis sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position. | Device | Low intensity light therapy |
Primary outcome
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment
Time frame: Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0)
The number of hyperphagic access will be determined using a crisis agenda filled out by patients each day
33 secondary outcomes
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment
Time frame: Day-7 to Day-1 period compared to Day23 to Day30 period
Characteristics of hyperphagic access (severity of the disorder)
Time frame: Day 0
Characteristics of hyperphagic access (severity of the disorder)
Time frame: Day 30
Characteristics of hyperphagic access (severity of the disorder)
Time frame: Day 60
Characteristics of hyperphagic access (duration of crisis)
Time frame: Day 0
Characteristics of hyperphagic access (duration of crisis)
Time frame: Day 30
Characteristics of hyperphagic access (duration of crisis)
Time frame: Day 60
Characteristics of hyperphagic access (amount of food ingested )
Time frame: Day 0
Characteristics of hyperphagic access (amount of food ingested )
Time frame: Day 30
Characteristics of hyperphagic access (amount of food ingested )
Time frame: Day 60
Characteristics of hyperphagic access ( evolution of factors triggering)
Time frame: Day 0
Characteristics of hyperphagic access ( evolution of factors triggering)
Time frame: Day 30
Characteristics of hyperphagic access ( evolution of factors triggering)
Time frame: Day 60
Characteristics of hyperphagic access (severity of the disorder, duration of crisis, amount of food ingested and evolution of factors triggering)
Time frame: Day 30
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and 30 days after discontinuation of treatment
Time frame: Day-7 to Day-1 period (before Day 0) compared to Day53 to Day60 period (after Day 0)
Symptomatic development of BED
Time frame: Day 0
Symptomatic development of BED
Time frame: Day 30
Symptomatic development of BED
Time frame: Day 60
Evolution of other psychological parameters related to BED
Time frame: Day 0
Evolution of other psychological parameters related to BED
Time frame: Day 30
Evolution of other psychological parameters related to BED
Time frame: Day 60
Evolution of attentional cognitive profiles and impulsivity
Time frame: Day 0
Evolution of attentional cognitive profiles and impulsivity
Time frame: Day 30
Evolution of attentional cognitive profiles and impulsivity
Time frame: Day 60
Evolution of appetite for different categories of food
Time frame: Day 0
Evolution of appetite for different categories of food
Time frame: Day 30
Evolution of appetite for different categories of food
Time frame: Day 60
Biological parameters may be impacted or mediated by part of the treatment efficiency
Time frame: Day 0
Biological parameters may be impacted or mediated by part of the treatment efficiency
Time frame: Day 30
Weight (kilogramm)
Time frame: Day 0
Weight (kilogramm)
Time frame: Day 30
Weight (kilogramm)
Time frame: Day 60
Observance rate to light therapy
Time frame: day1 to day30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- 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. This study is not recruiting at the moment.
Diane MORFIN, MD principal investigator
Hospices Civils de Lyon Centre REférent pour l'Anorexie et les Troubles du Comportement Alimentaire de Lyon (CREATyon)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity bright light therapy and Low intensity light therapy in people with Binge-Eating Disorder, run by Hospices Civils de Lyon at 1 site in France.
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 10 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: finished, as of the sponsor's last update on 18 Jun 2021. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the number of hyperphagic access, over 7 consecutive days, before starting therapy with light therapy and discontinuation of treatment (time frame: Day-7 to Day-1 period (before Day 0) compared to Day23 to Day30 period (after Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2021.