Obsessive - Compulsive DisorderNCT07146438
Transcranial Magnetic Stimulation and Psychotherapy for Treating Obsessive-Compulsive Disorder
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), Supportive Therapy (ST) and Exposure and Response Prevention (ERP) Therapy in people with Obsessive - Compulsive Disorder, run by Adam Frank at 1 site in United States.
Trial summary
This study will test how people with OCD respond to a type of noninvasive brain stimulation, repetitive Transcranial Magnetic Stimulation (rTMS), when it is combined with psychotherapy. Participants will either engage in Exposure and Response Prevention (ERP) Therapy or supportive therapy (ST) while receiving rTMS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive - Compulsive Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS), Supportive Therapy (ST) and Exposure and Response Prevention (ERP) Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2025to Aug 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Obsessive-Compulsive Disorder (OCD) as determined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria.
- Live in Southern California and be willing to attend in-person to receive repetitive Transcranial Magnetic Stimulation (rTMS) 5 times per week for 6 weeks.
- Have completed a prior course of Exposure and Response Prevention (ERP) therapy (at least ten sessions)
- Currently take or have previously tried Serotonin Reuptake Inhibitor (SRI) medication for OCD
- Willing to maintain psychotropic medication levels throughout the 16 weeks of the study
Who cannot join
- Primary psychiatric diagnosis other than OCD
- Active substance use disorder
- Active suicidality
- Active psychosis
- History of seizures
- Severe neurological impairment
- Pregnant or planning to become pregnant
- Received a prior rTMS course
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California Health Sciences Campus
Los Angeles, California, 90033
Frank OCD Lab, 323-230-0162, frankocdlab@usc.edu
Emma Garland, 213-821-3120, emma.garland@med.usc.edu
About this study
Official title: Precision Medicine for OCD - Biobehavioral Tracking of Transcranial Magnetic Stimulation (TMS) With Exposure and Response Prevention (ERP) for Refractory OCD
This study will test how people with OCD respond to a type of noninvasive brain stimulation, repetitive Transcranial Magnetic Stimulation (rTMS), when it is combined with psychotherapy. Participants will either engage in Exposure and Response Prevention (ERP) Therapy or supportive therapy (ST) while receiving rTMS. Biobehavioral data from wearable devices and smartphones will be collected to better predict treatment responses. Participants will also undergo repeat resting state functional Magnetic Resonance Imaging (rsfMRI) in order to assess neural predictors and mechanisms of treatment response.
Read the detailed description
This is a randomized, controlled pilot study to evaluate the feasibility, tolerability, and preliminary effects of combining repetitive transcranial magnetic stimulation (rTMS) with one of two types of therapy for adults with Obsessive-Compulsive Disorder (OCD). All participants will receive rTMS targeted to a specific brain area (the dorsomedial prefrontal cortex/anterior cingulate cortex) five days per week (Monday through Friday) for six weeks, utilizing the FDA-cleared treatment protocol. In addition, participants will receive either Exposure and Response Prevention (ERP), a form of cognitive behavioral therapy, or supportive therapy (ST), delivered virtually twice per week during the rTMS treatment period.
The study lasts a total of 16 weeks. During the first week, participants will complete baseline assessments, including questionnaires about symptoms, functioning, quality of life, and treatment priorities. Participants will undergo a brain scan (rsfMRI) and receive a Fitbit device (Charge 6) to wear throughout the study. Participants will also be guided on how to complete daily self-report check-ins using their smartphone. These check-ins, along with the Fitbit, will collect information about behavior (e.g., sleep, physical activity), physiology (e.g., heart rate), and lived experience (e.g., stress, mood, and symptoms) throughout the study period.
rTMS treatment begins in week 2 and continues for six weeks. ERP or supportive therapy sessions are scheduled twice per week, on the same days as rTMS (Tuesdays and Thursdays), and take place while participants are receiving rTMS in the treatment room. Weekly assessments of OCD symptom severity will be conducted throughout the six-week treatment phase.
After the treatment phase ends in week 8, participants will repeat the brain scan and complete final symptom and functioning assessments. At this time, Fitbit data collection and daily surveys will cease. At week 16 (two months after treatment ends), participants will complete a follow-up assessment to evaluate longer-term outcomes.
- Conditions
- Obsessive - Compulsive Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Supportive Therapy (ST), Exposure and Response Prevention (ERP) Therapy
- Keywords
- TMS, Transcranial Magnetic Stimulation, OCD, Obsessive Compulsive Disorder, Obsessive-Compulsive Disorder, rTMS, repetitive Transcranial Magnetic Stimulation, psychotherapy, ERP, Magventure, Mental Disorders, Inhibitory Learning, Exposure and Response Prevention
- Medical subject headings
- Compulsive Personality Disorder, Obsessive-Compulsive Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
rTMS will be delivered with the MagPro X100 system equipped with a Cool-DB80 coil and a Localite neuronavigation system. Neuronavigation will be performed for anatomical landmarking and co-registration of the brain to Talairach stereotaxic space, with the co-registered coil vertex coordinate (x0, y+60, z+60) as performed in previously published work on dmPFC-rTMS and which represents ~25% of the nasion-inion distance. Posterior coil handle orientation will be used with stimulation parameters of 20Hz repetition rate, 2 second stimulation duration, 20 second inter-train interval, and 50 trains, for a total of 2000 pulses per day. Stimulation will be delivered at 100% of extensor hallucis longus muscle resting motor threshold (MT), as determined by the PI. rTMS will be delivered 5 days per week (Monday through Friday) for 6 weeks for a total of 30 treatment sessions, in keeping with established protocols. Trained research staff will perform daily rTMS treatments and monitor participants.
Supportive Therapy (ST)Behavioural
Supportive therapy (ST) is a nondirective "talk therapy" focused on enhancing coping skills, strengthening existing resources, and improving daily functioning. Core techniques will include active listening, encouragement, validation, reframing, clarification (summarizing and paraphrasing), and naming problems. Participants will receive two ST sessions per week during the 6-week rTMS course. General goals include using the therapeutic relationship to foster adaptation, improve self-esteem, and support overall well-being. Each session will last 53-60 minutes and take place concurrently with rTMS, with the participant remaining in the TMS treatment room throughout.
Exposure and Response Prevention (ERP) TherapyBehavioural
ERP is a form of cognitive-behavioral therapy designed to reduce obsessive-compulsive symptoms by weakening the association between feared stimuli and maladaptive responses. It promotes the formation and recall of non-threatening associations to counter fear-based learning. The participant and therapist will collaboratively create a hierarchy of OCD triggers, rated using the Subjective Units of Distress Scale (SUDS). ERP will begin with exposures rated 4-7 on the SUDS, while participants refrain from engaging in compulsions. Each trigger will be repeated until the SUDS rating decreases by at least 50% before progressing to the next item. Between-session ERP homework will be assigned, and participants will be provided self-monitoring homework rating forms to complete for subsequent review with the therapist. Each ERP session will last 53-60 minutes and will be conducted concurrently with rTMS, with the participant remaining in the TMS treatment room throughout.
| Study group | Role | What they receive |
|---|---|---|
| rTMS+ERP | Active comparator | Not described Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Exposure and Response Prevention (ERP) Therapy |
| rTMS+ST | Placebo comparator | Not described Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Supportive Therapy (ST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score
The investigators will use the Yale-Brown Obsessive-Compulsive Scale (YBOCS), the gold standard measure of OCD severity, to assess symptom levels. The YBOCS scale assesses five domains of obsessive and compulsive symptoms, which are each scored on a four-point scale, with 0 being "no symptoms" and 4 being "extreme symptoms". Combined scores range from 0 (no symptoms) to 40 (severe symptoms). A trained clinician, blinded to participant treatment, will administer the YBOCS at study enrollment, weekly during rTMS, at study end, and at 2-month follow-up to determine rate of change of YBOCS score, overall change after treatment, and durability of change at follow-up. Greater decreases in YBOCS scores sustained over time represent a better outcome.
Measured: From enrollment to end of study at 16 weeks.
Secondary outcomes (7)
Resting state functional connectivity
Resting state BOLD-signal fluctuations between hypothesis-driven brain regions-dmPFC (defined as center of mass = MNI X 0, Y+38, Z+24 in MNI-152) and bilateral caudate nucleus (defined as MNI X -8, Y+14, Z+6 and X+6, Y+14, Z+8)-will allow for calculation of functional connectivity between regions. The investigators will calculate change in functional connectivity from baseline to post-treatment.
Measured: From enrollment to the end of treatment at 8 weeks.
Recruitment rate
Recruitment rate will be calculated as the percentage of individuals enrolled in the study relative to total participants screened.
Measured: From screening to enrollment.
Adverse and serious adverse event rates
All adverse and serious adverse events will be recorded for each participant. Differences between treatment groups will be compared.
Measured: From enrollment to end of study at 16 weeks.
Study dropout rate
Rate of dropout from the study will be calculated for all treatment groups as number of individuals starting the study relative to those completing the study. Differences between groups will be compared.
Measured: From enrollment to end of study at 16 weeks.
Stanford Expectations of Treatment Scale (SETS)
SETS is a six-item scale used to determine positive and negative perspectives and expectations for treatment before participants begin treatment. Participants are asked to rate how much they agree with a statement based on a seven-point Likert-style scale. Responses are used to assess both positive and negative expectancy for treatment outcomes. The investigators will analyze results overall, based on treatment group, and based on response status.
Measured: Assessed at study start; 1 session.
Self-report priorities in treatment
The investigators will ask participants about their goals for treatment in the current study and their longer-term goals for treatment of OCD. Clinicians will ask about past treatments and provide participants space for free response to be completed via REDCap Survey.
Measured: Assessed at study start; 1 session.
Fidelity of Adherence to Therapy
Therapist fidelity, including ratings of therapist adherence and therapist competence to Exposure Response Prevention (ERP) therapy and Supportive Therapy (ST) manuals, and treatment differentiation will be monitored by supervising therapist via video from randomly recorded sessions, stored only until ratings are made. The assessments for the 3 components of treatment fidelity are derived from validated scales and tailored specifically for the elements of ERP and ST included in the treatment manuals for this study (a common practice for clinical research using specific treatment intervention modalities). When deviations from the manualized treatment are noted, supervising therapist will provide feedback and further training to the therapists.
Measured: From start of therapy at week 2 to end of therapy at end of week 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start10 Nov 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive - Compulsive DisorderStudies 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
- All participants will receive repetitive Transcranial Magnetic Stimulation (rTMS). Participants will be randomized to either receive concurrent Exposure and Response Prevention (ERP) Therapy or Supportive Therapy (ST).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adam Frank
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adam Frank, University of Southern California
- Investigators
- Adam C. Frank, MD, PhD, Principal investigator, Keck School of Medicine of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146438
- Sponsor's protocol ID
- HS-24-00659
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine for OCD - Biobehavioral Tracking of Transcranial Magnetic Stimulation (TMS) With Exposure and Response Prevention (ERP) for Refractory OCD
- ClinicalTrials.gov ID
- NCT07146438
- Acronym / sponsor ID
- HS-24-00659
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- TMS, Transcranial Magnetic Stimulation, OCD, Obsessive Compulsive Disorder, Obsessive-Compulsive Disorder, rTMS, repetitive Transcranial Magnetic Stimulation, psychotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Adam FrankUniversity, hospital or other
- Study start
- 10 Nov 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 28 Aug 2025 (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.
This study will test how people with OCD respond to a type of noninvasive brain stimulation, repetitive Transcranial Magnetic Stimulation (rTMS), when it is combined with psychotherapy. Participants will either engage in Exposure and Response Prevention (ERP) Therapy or supportive therapy (ST) while receiving rTMS. Biobehavioral data from wearable devices and smartphones will be collected to better predict treatment responses. Participants will also undergo repeat resting state functional Magnetic Resonance Imaging (rsfMRI) in order to assess neural predictors and mechanisms of treatment response.
Detailed description
This is a randomized, controlled pilot study to evaluate the feasibility, tolerability, and preliminary effects of combining repetitive transcranial magnetic stimulation (rTMS) with one of two types of therapy for adults with Obsessive-Compulsive Disorder (OCD). All participants will receive rTMS targeted to a specific brain area (the dorsomedial prefrontal cortex/anterior cingulate cortex) five days per week (Monday through Friday) for six weeks, utilizing the FDA-cleared treatment protocol. In addition, participants will receive either Exposure and Response Prevention (ERP), a form of cognitive behavioral therapy, or supportive therapy (ST), delivered virtually twice per week during the rTMS treatment period.
The study lasts a total of 16 weeks. During the first week, participants will complete baseline assessments, including questionnaires about symptoms, functioning, quality of life, and treatment priorities. Participants will undergo a brain scan (rsfMRI) and receive a Fitbit device (Charge 6) to wear throughout the study. Participants will also be guided on how to complete daily self-report check-ins using their smartphone. These check-ins, along with the Fitbit, will collect information about behavior (e.g., sleep, physical activity), physiology (e.g., heart rate), and lived experience (e.g., stress, mood, and symptoms) throughout the study period.
rTMS treatment begins in week 2 and continues for six weeks. ERP or supportive therapy sessions are scheduled twice per week, on the same days as rTMS (Tuesdays and Thursdays), and take place while participants are receiving rTMS in the treatment room. Weekly assessments of OCD symptom severity will be conducted throughout the six-week treatment phase.
After the treatment phase ends in week 8, participants will repeat the brain scan and complete final symptom and functioning assessments. At this time, Fitbit data collection and daily surveys will cease. At week 16 (two months after treatment ends), participants will complete a follow-up assessment to evaluate longer-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive repetitive Transcranial Magnetic Stimulation (rTMS). Participants will be randomized to either receive concurrent Exposure and Response Prevention (ERP) Therapy or Supportive Therapy (ST).
| Arm | Type | Receives |
|---|---|---|
| rTMS+ERP | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Exposure and Response Prevention (ERP) Therapy |
| rTMS+ST | Placebo comparator | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Supportive Therapy (ST) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Obsessive-Compulsive Disorder (OCD) as determined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria.
- Live in Southern California and be willing to attend in-person to receive repetitive Transcranial Magnetic Stimulation (rTMS) 5 times per week for 6 weeks.
- Have completed a prior course of Exposure and Response Prevention (ERP) therapy (at least ten sessions)
- Currently take or have previously tried Serotonin Reuptake Inhibitor (SRI) medication for OCD
- Willing to maintain psychotropic medication levels throughout the 16 weeks of the study
Key exclusion criteria (8 listed)
- Primary psychiatric diagnosis other than OCD
- Active substance use disorder
- Active suicidality
- Active psychosis
- History of seizures
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)rTMS will be delivered with the MagPro X100 system equipped with a Cool-DB80 coil and a Localite neuronavigation system. Neuronavigation will be performed for anatomical landmarking and co-registration of the brain to Talairach stereotaxic space, with the co-registered coil vertex coordinate (x0, y+60, z+60) as performed in previously published work on dmPFC-rTMS and which represents ~25% of the nasion-inion distance. Posterior coil handle orientation will be used with stimulation parameters of 20Hz repetition rate, 2 second stimulation duration, 20 second inter-train interval, and 50 trains, for a total of 2000 pulses per day. Stimulation will be delivered at 100% of extensor hallucis longus muscle resting motor threshold (MT), as determined by the PI. rTMS will be delivered 5 days per week (Monday through Friday) for 6 weeks for a total of 30 treatment sessions, in keeping with established protocols. Trained research staff will perform daily rTMS treatments and monitor participants. | Device | rTMS+ERP, rTMS+ST |
| Supportive Therapy (ST)Supportive therapy (ST) is a nondirective "talk therapy" focused on enhancing coping skills, strengthening existing resources, and improving daily functioning. Core techniques will include active listening, encouragement, validation, reframing, clarification (summarizing and paraphrasing), and naming problems. Participants will receive two ST sessions per week during the 6-week rTMS course. General goals include using the therapeutic relationship to foster adaptation, improve self-esteem, and support overall well-being. Each session will last 53-60 minutes and take place concurrently with rTMS, with the participant remaining in the TMS treatment room throughout. | Behavioural | rTMS+ST |
| Exposure and Response Prevention (ERP) TherapyERP is a form of cognitive-behavioral therapy designed to reduce obsessive-compulsive symptoms by weakening the association between feared stimuli and maladaptive responses. It promotes the formation and recall of non-threatening associations to counter fear-based learning. The participant and therapist will collaboratively create a hierarchy of OCD triggers, rated using the Subjective Units of Distress Scale (SUDS). ERP will begin with exposures rated 4-7 on the SUDS, while participants refrain from engaging in compulsions. Each trigger will be repeated until the SUDS rating decreases by at least 50% before progressing to the next item. Between-session ERP homework will be assigned, and participants will be provided self-monitoring homework rating forms to complete for subsequent review with the therapist. Each ERP session will last 53-60 minutes and will be conducted concurrently with rTMS, with the participant remaining in the TMS treatment room throughout. | Behavioural | rTMS+ERP |
Primary outcome
Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score
Time frame: From enrollment to end of study at 16 weeks.
The investigators will use the Yale-Brown Obsessive-Compulsive Scale (YBOCS), the gold standard measure of OCD severity, to assess symptom levels. The YBOCS scale assesses five domains of obsessive and compulsive symptoms, which are each scored on a four-point scale, with 0 being "no symptoms" and 4 being "extreme symptoms". Combined scores range from 0 (no symptoms) to 40 (severe symptoms). A trained clinician, blinded to participant treatment, will administer the YBOCS at study enrollment, weekly during rTMS, at study end, and at 2-month follow-up to determine rate of change of YBOCS score, overall change after treatment, and durability of change at follow-up. Greater decreases in YBOCS scores sustained over time represent a better outcome.
7 secondary outcomes
Resting state functional connectivity
Time frame: From enrollment to the end of treatment at 8 weeks.
Recruitment rate
Time frame: From screening to enrollment.
Adverse and serious adverse event rates
Time frame: From enrollment to end of study at 16 weeks.
Study dropout rate
Time frame: From enrollment to end of study at 16 weeks.
Stanford Expectations of Treatment Scale (SETS)
Time frame: Assessed at study start; 1 session.
Self-report priorities in treatment
Time frame: Assessed at study start; 1 session.
Fidelity of Adherence to Therapy
Time frame: From start of therapy at week 2 to end of therapy at end of week 7.
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 27 Oct 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.
Adam C. Frank, MD, PhD principal investigator
Keck School of Medicine of USC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), Supportive Therapy (ST) and Exposure and Response Prevention (ERP) Therapy in people with Obsessive - Compulsive Disorder, run by Adam Frank 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 5 inclusion and 8 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 27 Oct 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. 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 USC Frank OCD Lab (323-442-3632, frankocdlab@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score (time frame: From enrollment to end of study at 16 weeks.). 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 27 Oct 2025.