Binge Eating DisorderNCT03234881
Weight Loss Treatment for Veterans With Binge Eating
A study testing MOVE! and MOVE!+CBT in people with Binge Eating Disorder, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
This study aims to adapt and test a cognitive behavioral therapy (CBT) treatment that can be administered concurrently with the Veteran's Health Administration (VHA) MOVE! weight management program for Veterans with DSM-5 Binge Eating Disorder (BED) and high weight. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- MOVE! and MOVE!+CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jan 2018to 23 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI>=25
- Presence of recurrent binge eating on the MOVE! Survey
Who cannot join
- More than 4 MOVE! sessions in the prior year
- Active psychosis or suicidal ideation
- Medical or psychiatric illness, or cognitive deficits that interfere with providing consent or completing assessments
- Pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
About this study
Official title: Weight Loss Treatment and CBT for Veterans With Binge Eating
This study aims to adapt and test a cognitive behavioral therapy (CBT) treatment that can be administered concurrently with the Veteran's Health Administration (VHA) MOVE! weight management program for Veterans with DSM-5 Binge Eating Disorder (BED) and high weight.
Read the detailed description
To date, there have been limited studies of Binge Eating Disorder (BED) and high weight utilizing combined eating disorder and weight management approaches in real-world settings, nor studies with complex and diverse samples. The objective of this project was to conduct a clinical trial that would produce evidence-based findings for a diverse patient group in a healthcare setting. Specifically, we aimed to address comorbid BED and high weight among Veterans in the Veteran's Health Administration (VHA), the largest integrated healthcare system in the U.S., by testing the effectiveness of VA's evidence-based weight management program, called MOVE!, versus MOVE! administered concurrent with a brief, clinician-led cognitive-behavioral therapy (CBT).
Aim 1: To assess the effectiveness of MOVE! (treatment-as-usual) to MOVE! plus brief, clinician-led CBT (MOVE!+CBT).
Hypothesis 1: It is hypothesized that MOVE!+CBT will have greater improvements on the primary outcomes of eating pathology and binge eating (reductions in binge frequency and percentage of participants who are binge remitted) than MOVE! alone.
Hypothesis 2: It is further hypothesized that MOVE!+CBT will have greater improvements on secondary measures of mental health, quality of life, and other eating behaviors.
Aim 2: To conduct exploratory analyses assessing the effectiveness of MOVE! to MOVE! vs. MOVE!+CBT on weight outcomes.
Hypothesis: It is hypothesized that MOVE!+CBT will have greater weight loss, and a larger percentage who achieve 5% weight loss, than MOVE! alone.
Note that several planned outcomes were not able to be analyzed for this project. Due to pandemic/COVID-19 related impacts, lipid profile data from in-person blood draws were inconsistently collected. Likewise, MOVE! adherence could not be measured with in-person session attendance as delivery for this intervention was expanded to include technology-delivered modalities. To fill these gaps, an "Impact of COVID-19" measure was added soon after the onset of the pandemic, but these questionnaire items did not hold up over the course of time and were removed. Finally, the 24-Hour Food Frequency Questionnaire (24 Hour-FFQ), a brief screening tool of food intake, was a measure specially designed for this study. Validation and publication of this screener was successful (The 24-hour food frequency assessment screening tool (FAST24): Development and evaluation of a novel dietary screener to identify foods associated with weight change - PubMed (nih.gov)), however, the lack of granular dietary data did not lend itself to measuring outcome. None of the measures removed represented primary or secondary outcomes for this project.
- Conditions
- Binge Eating Disorder
- Being tested
- MOVE!, MOVE!+CBT
- Keywords
- Binge Eating, Cognitive Behavioral Therapy, Weight Management, Veterans
- Medical subject headings
- Binge-Eating Disorder, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOVE!Behavioural
Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. *TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic.
MOVE!+CBTBehavioural
Participants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity.
| Study group | Role | What they receive |
|---|---|---|
| MOVE! | Active comparator | Weight management delivered as Treatment-as-Usual Receives: Behavioral: MOVE! |
| MOVE!+CBT | Experimental | Weight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating. Receives: Behavioral: MOVE!+CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
The EDE-Q is the self-report version of the more intensive EDE interview. Research has documented that the EDE-Q performs well as a measure of change in treatment trials and has adequate convergence with the interview format. The EDE-Q generates the same frequency data for eating behaviors (binge eating and overeating) in the past 28 days, and the same four subscales reflecting eating disorder pathology. Score on a scale 0-6; higher=worse
Measured: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in Binge Episodes From Eating Disorder Examination Interview
The EDE is a clinician administered interview that is considered to be the gold standard for diagnosing eating disorders and assessing binge frequency. Number of binges; higher=worse
Measured: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Secondary outcomes (6)
Change in Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-item version, is a self-report measure for the symptoms of depression. Score on scale from 0-27; higher=worse
Measured: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in PTSD Checklist (PCL-5)
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of Post Traumatic Stress Disorder (PTSD). Score on scale from 0-80; higher=worse
Measured: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Weight and Eating Quality of Life (WE-QoL)
The WE-QoL is an 8-item self-report instrument for measurement of the impact weight and eating has on quality-of-life outcomes. Score on scale from 0-4; higher=worse
Measured: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in European Quality of Life (EuroQoL-5D)
The EuroQol-5D is a 5-item self-report instrument for measurement of quality of life outcomes that has specifically been used in weight loss trials with Veterans. The EuroQoL-5D also includes the Visual Analogue Scale (VAS) which is a measure of overall self-rated health status on a 100-point scale. Units on a scale (0-100); higher=better
Measured: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Night Eating Questionnaire (NEQ)
The NEQ is a 14-item self-report instrument for the measurement of Night Eating Syndrome (NES). A total score of greater than or equal to 25 indicates NES. Score on scale 0-52; higher=worse
Measured: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
CBT Session Attendance (Treatment Dose)
CBT session attendance will be determined by the number of clinician-led individual sessions attended throughout the treatment.
Measured: 3 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start8 Jan 2018
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- This is a randomized RCT in which one half of participants will be assigned to MOVE! (treatment-as-usual weight management) and the other half will be assigned to MOVE! plus the experimental condition (clinician-led Cognitive Behavioral Therapy).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Robin M Masheb, PhD, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234881
- Sponsor's protocol ID
- IIR 15-349
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2017
- Last updated
- 9 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Unable to share Veteran data
Publications
Masheb RM, Chan SH, Raffa SD, Ackermann R, Damschroder LJ, Estabrooks PA, Evans-Hudnall G, Evans NC, Histon T, Littman AJ, Moin T, Nelson KM, Pagoto S, Pronk NP, Tate DF, Goldstein MG. State of the art conference on weight management in VA: Policy and research recommendations for advancing behavioral interventions. J Gen Intern Med. 2017 Apr;32(Suppl 1):74-78. doi: 10.1007/s11606-016-3965-y.
PubMed 28271431Masheb RM, Douglas ME, Kutz AM, Marsh AG, Driscoll M. Pain and emotional eating: further investigation of the Yale Emotional Overeating Questionnaire in weight loss seeking patients. J Behav Med. 2020 Jun;43(3):479-486. doi: 10.1007/s10865-020-00143-4. Epub 2020 Feb 27.
PubMed 32107681Masheb RM, Snow JL, Fenn LM, Antoniadis NE, Raffa SD, Ruser CB, Buta E. Development and Psychometric Assessment of the Weight and Eating Quality of Life (WE-QOL) Scale in US Military Veterans. J Gen Intern Med. 2023 Jul;38(9):2076-2081. doi: 10.1007/s11606-023-08132-4. Epub 2023 Mar 27.
PubMed 36973571Carr MM, Lou R, Macdonald-Gagnon G, Peltier MR, Funaro MC, Martino S, Masheb RM. Weight change among patients engaged in medication treatment for opioid use disorder: a scoping review. Am J Drug Alcohol Abuse. 2023 Sep 3;49(5):551-565. doi: 10.1080/00952990.2023.2207720. Epub 2023 May 18.
PubMed 37200510Masheb RM, Buta E, Snow JL, Munro LF, Lawless M, Abel EA, McWain NE, Marsh A, Cary A, Grilo CM, Raffa SD, Ruser CB. Randomized Controlled Trial of Weight Management Versus Weight Management With Concurrent Cognitive-Behavioral Therapy for Binge-Eating Disorder in US Veterans With High Weight. Int J Eat Disord. 2025 Sep;58(9):1777-1792. doi: 10.1002/eat.24476. Epub 2025 Jun 9.
PubMed 40485646
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Treatment and CBT for Veterans With Binge Eating
- ClinicalTrials.gov ID
- NCT03234881
- Acronym / sponsor ID
- IIR 15-349
- Conditions
- Binge Eating Disorder
- Keywords
- Binge Eating, Cognitive Behavioral Therapy, Weight Management, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to adapt and test a cognitive behavioral therapy (CBT) treatment that can be administered concurrently with the Veteran's Health Administration (VHA) MOVE! weight management program for Veterans with DSM-5 Binge Eating Disorder (BED) and high weight.
Detailed description
To date, there have been limited studies of Binge Eating Disorder (BED) and high weight utilizing combined eating disorder and weight management approaches in real-world settings, nor studies with complex and diverse samples. The objective of this project was to conduct a clinical trial that would produce evidence-based findings for a diverse patient group in a healthcare setting. Specifically, we aimed to address comorbid BED and high weight among Veterans in the Veteran's Health Administration (VHA), the largest integrated healthcare system in the U.S., by testing the effectiveness of VA's evidence-based weight management program, called MOVE!, versus MOVE! administered concurrent with a brief, clinician-led cognitive-behavioral therapy (CBT).
Aim 1: To assess the effectiveness of MOVE! (treatment-as-usual) to MOVE! plus brief, clinician-led CBT (MOVE!+CBT).
Hypothesis 1: It is hypothesized that MOVE!+CBT will have greater improvements on the primary outcomes of eating pathology and binge eating (reductions in binge frequency and percentage of participants who are binge remitted) than MOVE! alone.
Hypothesis 2: It is further hypothesized that MOVE!+CBT will have greater improvements on secondary measures of mental health, quality of life, and other eating behaviors.
Aim 2: To conduct exploratory analyses assessing the effectiveness of MOVE! to MOVE! vs. MOVE!+CBT on weight outcomes.
Hypothesis: It is hypothesized that MOVE!+CBT will have greater weight loss, and a larger percentage who achieve 5% weight loss, than MOVE! alone.
Note that several planned outcomes were not able to be analyzed for this project. Due to pandemic/COVID-19 related impacts, lipid profile data from in-person blood draws were inconsistently collected. Likewise, MOVE! adherence could not be measured with in-person session attendance as delivery for this intervention was expanded to include technology-delivered modalities. To fill these gaps, an "Impact of COVID-19" measure was added soon after the onset of the pandemic, but these questionnaire items did not hold up over the course of time and were removed. Finally, the 24-Hour Food Frequency Questionnaire (24 Hour-FFQ), a brief screening tool of food intake, was a measure specially designed for this study. Validation and publication of this screener was successful (The 24-hour food frequency assessment screening tool (FAST24): Development and evaluation of a novel dietary screener to identify foods associated with weight change - PubMed (nih.gov)), however, the lack of granular dietary data did not lend itself to measuring outcome. None of the measures removed represented primary or secondary outcomes for this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- This is a randomized RCT in which one half of participants will be assigned to MOVE! (treatment-as-usual weight management) and the other half will be assigned to MOVE! plus the experimental condition (clinician-led Cognitive Behavioral Therapy).
| Arm | Type | Receives |
|---|---|---|
| MOVE! | Active comparator | Behavioral: MOVE!Weight management delivered as Treatment-as-Usual |
| MOVE!+CBT | Experimental | Behavioral: MOVE!+CBTWeight management delivered as Treatment-as-Usual plus use of a short duration, low-intensity CBT for recurrent binge eating. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI>=25
- Presence of recurrent binge eating on the MOVE! Survey
Key exclusion criteria (4 listed)
- More than 4 MOVE! sessions in the prior year
- Active psychosis or suicidal ideation
- Medical or psychiatric illness, or cognitive deficits that interfere with providing consent or completing assessments
- Pregnancy or lactation
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 |
|---|---|---|
| MOVE!Participants randomized to the MOVE!(or TeleMOVE!) arm only. MOVE! is 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries. TeleMOVE! is a 90-day program utilizing technology to provide home-based messaging focusing on health education and as needed clinician contact. *TeleMOVE! was added as an option since many in-person MOVE! programs were on pause due to the pandemic. | Behavioural | MOVE! |
| MOVE!+CBTParticipants randomized to the MOVE!+CBT arm will attend the 16 weeks of 60-minute weekly MOVE! or 90-days of the TeleMOVE! Treatment groups, along with up to 10 clinician-led individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and gradually increase daily physical activity. | Behavioural | MOVE!+CBT |
Primary outcome
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
Time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The EDE-Q is the self-report version of the more intensive EDE interview. Research has documented that the EDE-Q performs well as a measure of change in treatment trials and has adequate convergence with the interview format. The EDE-Q generates the same frequency data for eating behaviors (binge eating and overeating) in the past 28 days, and the same four subscales reflecting eating disorder pathology. Score on a scale 0-6; higher=worse
Change in Binge Episodes From Eating Disorder Examination Interview
Time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The EDE is a clinician administered interview that is considered to be the gold standard for diagnosing eating disorders and assessing binge frequency. Number of binges; higher=worse
6 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in PTSD Checklist (PCL-5)
Time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Weight and Eating Quality of Life (WE-QoL)
Time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Change in European Quality of Life (EuroQoL-5D)
Time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
Night Eating Questionnaire (NEQ)
Time frame: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
CBT Session Attendance (Treatment Dose)
Time frame: 3 month post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28271431Masheb RM, Chan SH, Raffa SD, Ackermann R, Damschroder LJ, Estabrooks PA, Evans-Hudnall G, Evans NC, Histon T, Littman AJ, Moin T, Nelson KM, Pagoto S, Pronk NP, Tate DF, Goldstein MG. State of the art conference on weight management in VA: Policy and research recommendations for advancing behavioral interventions. J Gen Intern Med. 2017 Apr;32(Suppl 1):74-78. doi: 10.1007/s11606-016-3965-y.
- Results publication: PubMed 32107681Masheb RM, Douglas ME, Kutz AM, Marsh AG, Driscoll M. Pain and emotional eating: further investigation of the Yale Emotional Overeating Questionnaire in weight loss seeking patients. J Behav Med. 2020 Jun;43(3):479-486. doi: 10.1007/s10865-020-00143-4. Epub 2020 Feb 27.
- Results publication: PubMed 36973571Masheb RM, Snow JL, Fenn LM, Antoniadis NE, Raffa SD, Ruser CB, Buta E. Development and Psychometric Assessment of the Weight and Eating Quality of Life (WE-QOL) Scale in US Military Veterans. J Gen Intern Med. 2023 Jul;38(9):2076-2081. doi: 10.1007/s11606-023-08132-4. Epub 2023 Mar 27.
- Results publication: PubMed 37200510Carr MM, Lou R, Macdonald-Gagnon G, Peltier MR, Funaro MC, Martino S, Masheb RM. Weight change among patients engaged in medication treatment for opioid use disorder: a scoping review. Am J Drug Alcohol Abuse. 2023 Sep 3;49(5):551-565. doi: 10.1080/00952990.2023.2207720. Epub 2023 May 18.
- Results publication: PubMed 40485646Masheb RM, Buta E, Snow JL, Munro LF, Lawless M, Abel EA, McWain NE, Marsh A, Cary A, Grilo CM, Raffa SD, Ruser CB. Randomized Controlled Trial of Weight Management Versus Weight Management With Concurrent Cognitive-Behavioral Therapy for Binge-Eating Disorder in US Veterans With High Weight. Int J Eat Disord. 2025 Sep;58(9):1777-1792. doi: 10.1002/eat.24476. Epub 2025 Jun 9.
- Individual participant dataSharing planned: No. Unable to share Veteran data
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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.
Robin M Masheb, PhD principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOVE! and MOVE!+CBT in people with Binge Eating Disorder, run by VA Office of Research and Development at 2 sites in United States.
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 2 inclusion and 4 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 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. 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?
Yes. Results are posted in the registry (first posted 28 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q) (time frame: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment). The study lists 2 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 NCT03234881, which also lists 5 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 9 Jul 2025.