Traumatic Brain InjuryRCBINCT04386681
Re-entry Continuum for Brain Injury
A study testing Reentry Continuum for Brain Injury (RCBI) in people with Traumatic Brain Injury and Recidivism, run by Rehabilitation Hospital of Indiana at 1 site in United States.
Trial summary
The overall research objectives of the proposed project are to decrease the rate of recidivism, defined as returning to incarceration within three years of release, as well as reduce the number of violent offenses, through the successful implementation of a continuum of services that addresses the unique needs of the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Traumatic Brain Injury, Recidivism
- What is being tested?
- Reentry Continuum for Brain Injury (RCBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Jan 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of moderate to severe TBI
- Ages 18 and older
- Offenders currently serving their sentence at PCF in Greencastle, Indiana
- Approximately twelve or less months remaining in their sentence, but no fewer than 5 months remaining in sentence.
Who cannot join
- In restricted housing (e.g., solitary confinement)
- Inability to comprehend the study
- Individuals requiring a legally authorized representative (LAR)
Trial locations and contacts
1 site in 1 country.
United States1 site
Putnamville Correctional Facility
Greencastle, Indiana, 46135
About this study
The overall research objectives of the proposed project are to decrease the rate of recidivism, defined as returning to incarceration within three years of release, as well as reduce the number of violent offenses, through the successful implementation of a continuum of services that addresses the unique needs of the TBI population. RHI, in partnership with PCF and IU, will work together to accomplish these goals. To meet study objectives, this randomized controlled trial (RCT) will enroll 102 individuals with TBI who will be randomized into the Reentry Continuum for Brain Injury (RCBI) intervention or a TAU-CG. Participants will be screened for TBI eight months prior to release from PCF. Upon consenting to participate, all subjects will be evaluated before, during, and after the intervention and recidivism data will be collected through IDOC's Data Analysis and Technology Department.
Read the detailed description
Specific aims of the current proposal are as follows:
Aim 1. To examine differences in recidivism [return to incarceration within 3 years] in participant offenders with TBI who are reentering the community and are either randomized to RCBI or TAU-CG.
Hypothesis 1 (H1): Participants in the RCBI group will demonstrate a lower proportion of recidivating participants than the TAU-CG one year, two years, and three years post release.
Aim 2. To examine differences in violent offenses [number of pre-release violent behavioral infractions; number of post-release felonies committed and their classifications] in participant offenders with TBI who are reentering the community and are either randomized to RCBI or TAU-CG during 3 months pre-release, and one, two, and three years post-release.
Hypothesis 2A (H2A): Participants in the RCBI group will demonstrate lower rates of in-prison violent behavioral infractions between enrollment and release than participants in the control group.
Hypothesis 2B (H2B): Participants in the RCBI will commit fewer and less serious level felonies post-release than participants in the TAU-CG 1, 2, and 3 years post-release demonstrated by a lower proportion of RCBI offenders committing violent crimes than TAU-CG.
Aim 3. Examine group differences in coping [Brain Injury Coping Skills Questionnaire], aggression [Buss Perry Aggression Questionnaire], community integration [Participation Assessment with Recombined Tools-Objective], and number of basic needs unmet [Survey of Unmet Needs and Services] at time of release and 1-year post-release as well as employment [Employment acquisition and sustainability] 1, 2, and 3 years post-release.
Hypothesis 3A (H3A): Participants in the treatment group will show better scores on measures of coping and aggression compared to controls at time of release.
Hypothesis 3B (H3B): The RCBI group will show a higher proportion of participants obtaining employment compared to the TAU-CG as well as higher employment durations (total months showing employment data) one year, two years, and three years post release and better community integration one-year post release.
Hypothesis 3C (H3C): Participants in the treatment group will show lower rates of unmet needs compared to the control group one-year post release.
Aim 4 (Exploratory). Identify which factors predict recidivism in the TBI population and investigate their relationship with a validated measure of recidivism risk [Level of Service Inventory-Revised7].
Hypothesis 4 (H4): While it is hypothesized that group assignment (RCBI vs. TAU-CG) in combination with criminality risk and select demographic, injury, and/or social variables will contribute significantly to a model predicting three-year recidivism outcome, a specific model is not hypothesized and detection of specific contributing variables will be exploratory.
- Conditions
- Traumatic Brain Injury, Recidivism
- Being tested
- Reentry Continuum for Brain Injury (RCBI)
- Keywords
- Offenders
- Medical subject headings
- Brain Injuries, Traumatic, Recidivism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reentry Continuum for Brain Injury (RCBI)Behavioural
Pre-Release RCBI Treatment Procedures (BICS and ICAN). BICS: consists of 12 weekly two- hour sessions. Sessions focus on brain injury education, coping skills for the various symptoms of brain injury, depression management, stress management, and self- advocacy.
ICAN: delivered once a week for 6 weeks for 2 hours per session. ICAN primarily focuses on poor perspective-taking and inability to make social inferences about others' behaviors that are related to negative attributions, and employs role playing exercises and a novel perspective-positioning technique to elicit affective and cognitive empathy to alter negative attributions and reduce anger.
Post-Release RCBI Resource Facilitation. Working with their resource facilitator, alongside their corrections case manager, to work on brain injury specific reentry planning, resource, and needs identification.
| Study group | Role | What they receive |
|---|---|---|
| RCBI | Experimental | Receiving RCBI intervention, including BICS, ICAN, and RF. Receives: Behavioral: Reentry Continuum for Brain Injury (RCBI) |
| Treatment as usual- Control group | No intervention | Not receiving the RCBI intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brain Injury Coping Skills Questionnaire (BICS-Q)
Designed to measure self-efficacy related to brain injury. BICS-Q was designed based on Bandura's Guide for developing self-efficacy scales. Participants rate 20 items using a 5-point Likert-scale resulting in a total score. BICS-Q has shown significant change across BICS participants in multiple studies. Participants rate each statement from 0 (Not at all) to 4 (Extremely). Higher scores suggest greater self-efficacy.
Measured: within 2 weeks, 3 months
Change in Aggression Questionnaire (AQ)
A standardized measure comprised of 34 statements to assess anger, hostile thoughts, and physical and verbal aggression.10 Participants rate statements using a 5-point scale (1 - Extremely uncharacteristic of me to 5 - Extremely characteristic of me). Raw and scaled scores (adjusted by age and gender) are provided for aggression subcomponents and total aggression. Total aggression will be used for our analyses. The AQ is a widely used measure, including for TBI studies.11 It has good test-retest reliability (.72-.80), and good internal consistency (.76-.94). Higher scores suggest higher aggression tendencies
Measured: within 2 weeks, 3 months
Change in Attributions of Intent Hostility Questionnaire (AIHQ)
This consists of 5 written vignettes describing ambiguous actions/ situations (unclear intent behind actions). After participants read each vignette and imagine the scenario happening to her or him, they are asked five questions: 1) why the other person (or persons) acted that way toward you (open-ended response later rated by an independent rater; score indicates ''hostility bias''); 2) Whether the other person (or persons) performed the action on purpose (1 ''definitely no'' to 6 ''definitely yes'') using a Likert Scale (Intent score); 3) how angry it would make them feel (1 ''not at all angry'' to 5 ''very angry'') using a Likert scale (anger score); 4) how much they would blame the other person (or persons) (1 ''not at all'' to 5 ''very much'') using a Likert scale (blame score); and 5) how she or he would respond to the situation, (open-ended response).
Measured: within 2 weeks, 3 months
Change in Participation Assessment with Combined Tools - Objective (PART-O)
This is a 17-item measure developed and validated by the NIDILRR-sponsored TBI Model Systems13 to evaluate participation in the community with three domains: Productivity, Social Relations, and Out and About. Each item is scored on a 0 to 5 scale. Total PART-O scores will be used for our analyses.
Measured: 3 months, 1 year
Change in Survey of Unmet Needs and Services Utilized (SUNSU)
This measure is designed to assess both the usage of and desire for services unique to brain injury. The SUNSU includes a comprehensive list of 27 service needs and results in two scores: the number of met needs and the number of unmet needs. The measure shows good internal consistency as well as validity when compared to other needs assessments in the brain injury population. Participants decide if they : currently want help for the need, currently receiving help for the need, or it is not a need at all.
Measured: 3 months, 1 year
Change in Recidivism
This is defined as return to incarceration within three years of release and is the primary outcome to be collected through the IDOC Research and Technology Division for all participants at three time points: one, two, and three years after release.
Measured: 1 year after release, 2 years after release, 3 years after release
Change in Behavioral Infractions
This is collected from PCF directly for each participant at time of release. The number and type of infractions will be counted between study enrollment and release.
Measured: 3 months
Change in Employment
This includes acquisition and sustainability (i.e., duration of employment) data will be collected through the IDOC Research and Technology Division for all offenders at three time points: one year, two years, and three years after release from IDOC.
Measured: Prior to release, 1 year after release, 2 years after release, and 3 years after release
Change in Violent Rearrests
This is collected for each participant through the IDOC Data Analysis and Technology Department for all offenders at three time points: one year, two years, and three years after release from IDOC. Offenses are coded between 1 and 6 with 1 being the highest level of violence and 6 being the lowest level/non-violent. Type of offense in criminal history (violent vs. nonviolent) will also be collected as a covariate.
Measured: 1 year after release, 2 years after release, 3 years after release
Secondary outcomes (2)
Level of Service Inventory - Revised (LSI-R)
This is a 54-item scale designed to measure criminal risk with ten subscales of criminogenic factors including Criminal History, Education/Employment, Financial, Family Marital, Accommodation, Leisure/Recreation, Companions, Alcohol/Drug Problems, Emotional/Personal, and Attitudes/Orientation. The items are scored utilizing a dichotomous rating system of 0 = absent and 1 = present with final scores ranging from 0 to 54. The LSI-R has been studied extensively and is considered one of the most used risk assessments in the offender population.15 Inter-rater reliability coefficients range from .80 to .96 with studies of validity showing that higher LSI-R scores have been associated with recidivism (short- and long-term), adjustment, and institutional misconduct. Higher scores suggest greater likelihood of recidivism, criminality, substance use, etc.
Measured: within 2 weeks
Change in Behavioral Rating Inventory of Executive Function-Adult Version (BRIEF-A)
This is a standardized measure published by Psychological Assessment Resources (PAR) designed to measure self-regulation in adults. The BRIEF-A consists of 75 items, takes 10 to 15 minutes to administer and generates nine subscales: Inhibit, Self-Monitor, Plan/Organize, Shift, Initiate, Task Monitor, Emotional Control, Working Memory, and Organization of Materials. Participants rate each item as 0 = Never, 1 = Sometimes, 2 = Often.
Measured: within 2 weeks, 3 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Mar 2021
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehabilitation Hospital of Indiana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Devan Parrott, Rehabilitation Hospital of Indiana
- Investigators
- Devan Parrott, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386681
- Sponsor's protocol ID
- 1909189045
- Acronym
- RCBI
- Status last verified
- Nov 2025
- First submitted
- 27 Apr 2020
- Last updated
- 25 Nov 2025
- Results posted
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-entry Continuum for Brain Injury
- ClinicalTrials.gov ID
- NCT04386681
- Acronym / sponsor ID
- RCBI / 1909189045
- Conditions
- Traumatic Brain Injury, Recidivism
- Keywords
- Offenders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Rehabilitation Hospital of IndianaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 May 2020 (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 overall research objectives of the proposed project are to decrease the rate of recidivism, defined as returning to incarceration within three years of release, as well as reduce the number of violent offenses, through the successful implementation of a continuum of services that addresses the unique needs of the TBI population. RHI, in partnership with PCF and IU, will work together to accomplish these goals. To meet study objectives, this randomized controlled trial (RCT) will enroll 102 individuals with TBI who will be randomized into the Reentry Continuum for Brain Injury (RCBI) intervention or a TAU-CG. Participants will be screened for TBI eight months prior to release from PCF. Upon consenting to participate, all subjects will be evaluated before, during, and after the intervention and recidivism data will be collected through IDOC's Data Analysis and Technology Department.
Detailed description
Specific aims of the current proposal are as follows:
Aim 1. To examine differences in recidivism [return to incarceration within 3 years] in participant offenders with TBI who are reentering the community and are either randomized to RCBI or TAU-CG.
Hypothesis 1 (H1): Participants in the RCBI group will demonstrate a lower proportion of recidivating participants than the TAU-CG one year, two years, and three years post release.
Aim 2. To examine differences in violent offenses [number of pre-release violent behavioral infractions; number of post-release felonies committed and their classifications] in participant offenders with TBI who are reentering the community and are either randomized to RCBI or TAU-CG during 3 months pre-release, and one, two, and three years post-release.
Hypothesis 2A (H2A): Participants in the RCBI group will demonstrate lower rates of in-prison violent behavioral infractions between enrollment and release than participants in the control group.
Hypothesis 2B (H2B): Participants in the RCBI will commit fewer and less serious level felonies post-release than participants in the TAU-CG 1, 2, and 3 years post-release demonstrated by a lower proportion of RCBI offenders committing violent crimes than TAU-CG.
Aim 3. Examine group differences in coping [Brain Injury Coping Skills Questionnaire], aggression [Buss Perry Aggression Questionnaire], community integration [Participation Assessment with Recombined Tools-Objective], and number of basic needs unmet [Survey of Unmet Needs and Services] at time of release and 1-year post-release as well as employment [Employment acquisition and sustainability] 1, 2, and 3 years post-release.
Hypothesis 3A (H3A): Participants in the treatment group will show better scores on measures of coping and aggression compared to controls at time of release.
Hypothesis 3B (H3B): The RCBI group will show a higher proportion of participants obtaining employment compared to the TAU-CG as well as higher employment durations (total months showing employment data) one year, two years, and three years post release and better community integration one-year post release.
Hypothesis 3C (H3C): Participants in the treatment group will show lower rates of unmet needs compared to the control group one-year post release.
Aim 4 (Exploratory). Identify which factors predict recidivism in the TBI population and investigate their relationship with a validated measure of recidivism risk [Level of Service Inventory-Revised7].
Hypothesis 4 (H4): While it is hypothesized that group assignment (RCBI vs. TAU-CG) in combination with criminality risk and select demographic, injury, and/or social variables will contribute significantly to a model predicting three-year recidivism outcome, a specific model is not hypothesized and detection of specific contributing variables will be exploratory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| RCBI | Experimental | Behavioral: Reentry Continuum for Brain Injury (RCBI)Receiving RCBI intervention, including BICS, ICAN, and RF. |
| Treatment as usual- Control group | No intervention | –Not receiving the RCBI intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of moderate to severe TBI
- Ages 18 and older
- Offenders currently serving their sentence at PCF in Greencastle, Indiana
- Approximately twelve or less months remaining in their sentence, but no fewer than 5 months remaining in sentence.
Key exclusion criteria (3 listed)
- In restricted housing (e.g., solitary confinement)
- Inability to comprehend the study
- Individuals requiring a legally authorized representative (LAR)
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 |
|---|---|---|
| Reentry Continuum for Brain Injury (RCBI)Pre-Release RCBI Treatment Procedures (BICS and ICAN). BICS: consists of 12 weekly two- hour sessions. Sessions focus on brain injury education, coping skills for the various symptoms of brain injury, depression management, stress management, and self- advocacy. ICAN: delivered once a week for 6 weeks for 2 hours per session. ICAN primarily focuses on poor perspective-taking and inability to make social inferences about others' behaviors that are related to negative attributions, and employs role playing exercises and a novel perspective-positioning technique to elicit affective and cognitive empathy to alter negative attributions and reduce anger. Post-Release RCBI Resource Facilitation. Working with their resource facilitator, alongside their corrections case manager, to work on brain injury specific reentry planning, resource, and needs identification. | Behavioural | RCBI |
Primary outcome
Change in Brain Injury Coping Skills Questionnaire (BICS-Q)
Time frame: within 2 weeks, 3 months
Designed to measure self-efficacy related to brain injury. BICS-Q was designed based on Bandura's Guide for developing self-efficacy scales. Participants rate 20 items using a 5-point Likert-scale resulting in a total score. BICS-Q has shown significant change across BICS participants in multiple studies. Participants rate each statement from 0 (Not at all) to 4 (Extremely). Higher scores suggest greater self-efficacy.
Change in Aggression Questionnaire (AQ)
Time frame: within 2 weeks, 3 months
A standardized measure comprised of 34 statements to assess anger, hostile thoughts, and physical and verbal aggression.10 Participants rate statements using a 5-point scale (1 - Extremely uncharacteristic of me to 5 - Extremely characteristic of me). Raw and scaled scores (adjusted by age and gender) are provided for aggression subcomponents and total aggression. Total aggression will be used for our analyses. The AQ is a widely used measure, including for TBI studies.11 It has good test-retest reliability (.72-.80), and good internal consistency (.76-.94). Higher scores suggest higher aggression tendencies
Change in Attributions of Intent Hostility Questionnaire (AIHQ)
Time frame: within 2 weeks, 3 months
This consists of 5 written vignettes describing ambiguous actions/ situations (unclear intent behind actions). After participants read each vignette and imagine the scenario happening to her or him, they are asked five questions: 1) why the other person (or persons) acted that way toward you (open-ended response later rated by an independent rater; score indicates ''hostility bias''); 2) Whether the other person (or persons) performed the action on purpose (1 ''definitely no'' to 6 ''definitely yes'') using a Likert Scale (Intent score); 3) how angry it would make them feel (1 ''not at all angry'' to 5 ''very angry'') using a Likert scale (anger score); 4) how much they would blame the other person (or persons) (1 ''not at all'' to 5 ''very much'') using a Likert scale (blame score); and 5) how she or he would respond to the situation, (open-ended response).
Change in Participation Assessment with Combined Tools - Objective (PART-O)
Time frame: 3 months, 1 year
This is a 17-item measure developed and validated by the NIDILRR-sponsored TBI Model Systems13 to evaluate participation in the community with three domains: Productivity, Social Relations, and Out and About. Each item is scored on a 0 to 5 scale. Total PART-O scores will be used for our analyses.
Change in Survey of Unmet Needs and Services Utilized (SUNSU)
Time frame: 3 months, 1 year
This measure is designed to assess both the usage of and desire for services unique to brain injury. The SUNSU includes a comprehensive list of 27 service needs and results in two scores: the number of met needs and the number of unmet needs. The measure shows good internal consistency as well as validity when compared to other needs assessments in the brain injury population. Participants decide if they : currently want help for the need, currently receiving help for the need, or it is not a need at all.
Change in Recidivism
Time frame: 1 year after release, 2 years after release, 3 years after release
This is defined as return to incarceration within three years of release and is the primary outcome to be collected through the IDOC Research and Technology Division for all participants at three time points: one, two, and three years after release.
Change in Behavioral Infractions
Time frame: 3 months
This is collected from PCF directly for each participant at time of release. The number and type of infractions will be counted between study enrollment and release.
Change in Employment
Time frame: Prior to release, 1 year after release, 2 years after release, and 3 years after release
This includes acquisition and sustainability (i.e., duration of employment) data will be collected through the IDOC Research and Technology Division for all offenders at three time points: one year, two years, and three years after release from IDOC.
Change in Violent Rearrests
Time frame: 1 year after release, 2 years after release, 3 years after release
This is collected for each participant through the IDOC Data Analysis and Technology Department for all offenders at three time points: one year, two years, and three years after release from IDOC. Offenses are coded between 1 and 6 with 1 being the highest level of violence and 6 being the lowest level/non-violent. Type of offense in criminal history (violent vs. nonviolent) will also be collected as a covariate.
2 secondary outcomes
Level of Service Inventory - Revised (LSI-R)
Time frame: within 2 weeks
Change in Behavioral Rating Inventory of Executive Function-Adult Version (BRIEF-A)
Time frame: within 2 weeks, 3 months, 1 year
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 25 Nov 2025.
- 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.
Devan Parrott, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reentry Continuum for Brain Injury (RCBI) in people with Traumatic Brain Injury and Recidivism, run by Rehabilitation Hospital of Indiana at 1 site 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 25 Nov 2025. 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 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?
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?
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 Brain Injury Coping Skills Questionnaire (BICS-Q) (time frame: within 2 weeks, 3 months). The study lists 9 primary outcomes in all. 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 25 Nov 2025; AzTrials last refreshed its copy on 28 Oct 2026.