Obsessive - Compulsive DisorderPhase 2NCT07887633
SONATA Dose Duration LIFU for OCD
A Phase 2 study testing ATTN201 - Low Intensity Focused Ultrasound in people with Obsessive - Compulsive Disorder, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study is testing a new, non-invasive brain stimulation approach for adults with Obsessive Compulsive Disorder (OCD). Researchers are evaluating the safety, tolerability, and target engagement of low-intensity focused ultrasound (LIFU) directed at a brain region called the subthalamic nucleus (STN). Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Obsessive - Compulsive Disorder
- What is being tested?
- ATTN201 - Low Intensity Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 15 Sep 2028
- Phase
- Phase 2
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22-80
- Meet DSM-V criteria for OCD ≥ 1 year with a Y-BOCS score ≥ 16
- Must be on the same stable dose(s) of OCD medication for at least 4 weeks prior to screening and throughout the course of the study
Who cannot join
- Co-morbid psychiatric disorder other than depression or anxiety disorder
- Active suicidal risk (defined by C-SSRS)
- History of neurological condition
- Pregnant or breastfeeding, or planning to become pregnant during the study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giovanna Rocchio contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Rishi Suresh, 215-746-8901, rishi.suresh1@pennmedicine.upenn.edu
Giovanna Rocchio, giovanna.rocchio@pennmedicine.upenn.edu
About this study
Official title: Subcortical OCD Neuromodulation With Acoustic Therapy - Dose Duration Optimization
This study is testing a new, non-invasive brain stimulation approach for adults with Obsessive Compulsive Disorder (OCD). Researchers are evaluating the safety, tolerability, and target engagement of low-intensity focused ultrasound (LIFU) directed at a brain region called the subthalamic nucleus (STN). The ultrasound is delivered using a wearable device called ATTN201 (developed by Attune Neurosciences).
Read the detailed description
Twenty participants will take part in this randomized, sham-controlled trial. This means participants will be randomly assigned to receive either active LIFU or a sham (inactive) version of the treatment, and all participants will not know which one was given until the end of participation.
Participants will be seen multiple times a week for LIFU sessions, with a safety check completed halfway through the number of sessions. All participants will undergo MRI brain scans at the start of the study and at three follow-up checkpoints to help researchers understand how the treatment affects the brain.
- Conditions
- Obsessive - Compulsive Disorder
- Being tested
- ATTN201 - Low Intensity Focused Ultrasound
- Keywords
- Low Intensity Focused Ultrasound, LIFU, OCD
- Medical subject headings
- Compulsive Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATTN201 - Low Intensity Focused UltrasoundDevice
Low-intensity focused ultrasound (LIFU) will be administered using the Attune ATTN201 device. The intervention is targeted bilaterally to the Sub-thalamic Nucleus (STN) region of the brain. All participants receive 4 sessions in their assigned condition (active LIFU or Sham) and, if patient-level stopping criteria are not met, continue in that same assigned condition to a total of 8 sessions, twice weekly over approximately 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Participants receive low intensity focused ultrasound stimulation Receives: Device: ATTN201 - Low Intensity Focused Ultrasound |
| Sham Stimulation | Sham comparator | Participants received unfocused ultrasound, which mimic the auditory and peripheral sensations of active stimulation without delivering meaningful pressure to the brain target Receives: Device: ATTN201 - Low Intensity Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Report of Symptoms
The 22-item Participant Report of Symptoms questionnaire provides granular, visit-level characterization of tolerability and symptomatic response across the treatment course, complementing the primary tolerability endpoints.
Measured: 4 weeks
Visual Analog Scale
The Visual Analog Scale, which assesses on a scale from 0-10 the participants obsessions, compulsions, distress, depression, energy and anxiety. This survey provides granular, visit-level characterization of tolerability and symptomatic response across the treatment course, complementing the primary tolerability endpoints.
Measured: 4 weeks
Beck Depression Inventory
The Beck Depression Inventory (BDI-II)allows for monitoring of unintended effects on mood, given that the STN plays a role in emotional processing and provide a broader characterization of the clinical impact of treatment. The BDI-II is an assessment used to measure severity of depression
Measured: 4 weeks
Becks Anxiety Inventory
The Becks Anxiety Inventory (BAI) allows for monitoring of unintended effects on anxiety, given that the STN plays a role in emotional processing and provide a broader characterization of the clinical impact of treatment. The BAI is an assessment used to measure clinical anxiety.
Measured: 4 weeks
Clinical Global Impression Scale
The Clinical Global Impression scale asks two questions; the severity of illness and the change in illness. This scale allows a clinician completed score to monitor unintended effects on mood and anxiety. The Clinical Global Impressions - Improvement (CGI-I) scale is used to measure how much a patient's illness has improved or worsened. The Clinical Global Impressions - Severity (CGI-S) is used to measure how severe the patient's illness is.
Measured: 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start15 Sep 2026
- Primary completion15 Jun 2028 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Obsessive - Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 2
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants are randomized 1:1 to active or sham stimulation and remain in their assigned condition throughout
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Scangos, University of Pennsylvania
- Investigators
- Katherine Scangos, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887633
- Sponsor's protocol ID
- 26-7004
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with outside researchers at this time to ensure the protection of participant privacy and to maintain strict compliance with the University of Pennsylvania Institutional Review Board (IRB) approved protocol.
Publications
Gaur P, Casey KM, Kubanek J, Li N, Mohammadjavadi M, Saenz Y, Glover GH, Bouley DM, Pauly KB. Histologic safety of transcranial focused ultrasound neuromodulation and magnetic resonance acoustic radiation force imaging in rhesus macaques and sheep. Brain Stimul. 2020 May-Jun;13(3):804-814. doi: 10.1016/j.brs.2020.02.017. Epub 2020 Feb 21.
PubMed 32289711Pallanti S, Quercioli L. Treatment-refractory obsessive-compulsive disorder: methodological issues, operational definitions and therapeutic lines. Prog Neuropsychopharmacol Biol Psychiatry. 2006 May;30(3):400-12. doi: 10.1016/j.pnpbp.2005.11.028. Epub 2006 Feb 28.
PubMed 16503369Aubry JF, Attali D, Schafer ME, Fouragnan E, Caskey CF, Chen R, Darmani G, Bubrick EJ, Sallet J, Butler CR, Stagg CJ, Klein-Flugge MC, Yoo SS, Holland C, Treeby B, Martin E, Verhagen L, Pauly KB. ITRUSST Consensus on Biophysical Safety for Transcranial Ultrasound Stimulation. ArXiv [Preprint]. 2025 Oct 9:arXiv:2311.05359v3.
PubMed 41281204Darmani G, Bergmann TO, Butts Pauly K, Caskey CF, de Lecea L, Fomenko A, Fouragnan E, Legon W, Murphy KR, Nandi T, Phipps MA, Pinton G, Ramezanpour H, Sallet J, Yaakub SN, Yoo SS, Chen R. Non-invasive transcranial ultrasound stimulation for neuromodulation. Clin Neurophysiol. 2022 Mar;135:51-73. doi: 10.1016/j.clinph.2021.12.010. Epub 2021 Dec 31.
PubMed 35033772Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.
PubMed 34198105Kim H, Chiu A, Lee SD, Fischer K, Yoo SS. Focused ultrasound-mediated non-invasive brain stimulation: examination of sonication parameters. Brain Stimul. 2014 Sep-Oct;7(5):748-56. doi: 10.1016/j.brs.2014.06.011. Epub 2014 Jul 2.
PubMed 25088462Pasquinelli C, Hanson LG, Siebner HR, Lee HJ, Thielscher A. Safety of transcranial focused ultrasound stimulation: A systematic review of the state of knowledge from both human and animal studies. Brain Stimul. 2019 Nov-Dec;12(6):1367-1380. doi: 10.1016/j.brs.2019.07.024. Epub 2019 Jul 31.
PubMed 31401074Yoon K, Lee W, Lee JE, Xu L, Croce P, Foley L, Yoo SS. Effects of sonication parameters on transcranial focused ultrasound brain stimulation in an ovine model. PLoS One. 2019 Oct 24;14(10):e0224311. doi: 10.1371/journal.pone.0224311. eCollection 2019.
PubMed 31648261Caulfield KA, Sege CT, Weaver J, Murphy KR, Passaro T, Meads K, Dadgar-Kiani E, Antonucci MU, Good C, McTeague LM. Focused ultrasound to bilateral thalamic nuclei significantly improves human cognitive attention in a frequency- and intensity-dependent manner. Brain Stimul. 2026 Sep-Oct;19(5):103171. doi: 10.1016/j.brs.2026.103171. Epub 2026 Jul 21.
PubMed 42480914Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.
PubMed 19005196Alonso P, Cuadras D, Gabriels L, Denys D, Goodman W, Greenberg BD, Jimenez-Ponce F, Kuhn J, Lenartz D, Mallet L, Nuttin B, Real E, Segalas C, Schuurman R, du Montcel ST, Menchon JM. Deep Brain Stimulation for Obsessive-Compulsive Disorder: A Meta-Analysis of Treatment Outcome and Predictors of Response. PLoS One. 2015 Jul 24;10(7):e0133591. doi: 10.1371/journal.pone.0133591. eCollection 2015.
PubMed 26208305
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcortical OCD Neuromodulation With Acoustic Therapy - Dose Duration Optimization
- ClinicalTrials.gov ID
- NCT07887633
- Acronym / sponsor ID
- 26-7004
- Conditions
- Obsessive - Compulsive Disorder
- Keywords
- Low Intensity Focused Ultrasound, LIFU, OCD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 15 Jun 2028 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 21 Oct 2026 (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 is testing a new, non-invasive brain stimulation approach for adults with Obsessive Compulsive Disorder (OCD). Researchers are evaluating the safety, tolerability, and target engagement of low-intensity focused ultrasound (LIFU) directed at a brain region called the subthalamic nucleus (STN). The ultrasound is delivered using a wearable device called ATTN201 (developed by Attune Neurosciences).
Detailed description
Twenty participants will take part in this randomized, sham-controlled trial. This means participants will be randomly assigned to receive either active LIFU or a sham (inactive) version of the treatment, and all participants will not know which one was given until the end of participation.
Participants will be seen multiple times a week for LIFU sessions, with a safety check completed halfway through the number of sessions. All participants will undergo MRI brain scans at the start of the study and at three follow-up checkpoints to help researchers understand how the treatment affects the brain.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- participants are randomized 1:1 to active or sham stimulation and remain in their assigned condition throughout
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: ATTN201 - Low Intensity Focused UltrasoundParticipants receive low intensity focused ultrasound stimulation |
| Sham Stimulation | Sham comparator | Device: ATTN201 - Low Intensity Focused UltrasoundParticipants received unfocused ultrasound, which mimic the auditory and peripheral sensations of active stimulation without delivering meaningful pressure to the brain target |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 22-80
- Meet DSM-V criteria for OCD ≥ 1 year with a Y-BOCS score ≥ 16
- Must be on the same stable dose(s) of OCD medication for at least 4 weeks prior to screening and throughout the course of the study
Key exclusion criteria (4 listed)
- Co-morbid psychiatric disorder other than depression or anxiety disorder
- Active suicidal risk (defined by C-SSRS)
- History of neurological condition
- Pregnant or breastfeeding, or planning to become pregnant during the study period
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 |
|---|---|---|
| ATTN201 - Low Intensity Focused UltrasoundLow-intensity focused ultrasound (LIFU) will be administered using the Attune ATTN201 device. The intervention is targeted bilaterally to the Sub-thalamic Nucleus (STN) region of the brain. All participants receive 4 sessions in their assigned condition (active LIFU or Sham) and, if patient-level stopping criteria are not met, continue in that same assigned condition to a total of 8 sessions, twice weekly over approximately 4 weeks. | Device | Active Stimulation, Sham Stimulation |
Primary outcome
Participant Report of Symptoms
Time frame: 4 weeks
The 22-item Participant Report of Symptoms questionnaire provides granular, visit-level characterization of tolerability and symptomatic response across the treatment course, complementing the primary tolerability endpoints.
Visual Analog Scale
Time frame: 4 weeks
The Visual Analog Scale, which assesses on a scale from 0-10 the participants obsessions, compulsions, distress, depression, energy and anxiety. This survey provides granular, visit-level characterization of tolerability and symptomatic response across the treatment course, complementing the primary tolerability endpoints.
Beck Depression Inventory
Time frame: 4 weeks
The Beck Depression Inventory (BDI-II)allows for monitoring of unintended effects on mood, given that the STN plays a role in emotional processing and provide a broader characterization of the clinical impact of treatment. The BDI-II is an assessment used to measure severity of depression
Becks Anxiety Inventory
Time frame: 4 weeks
The Becks Anxiety Inventory (BAI) allows for monitoring of unintended effects on anxiety, given that the STN plays a role in emotional processing and provide a broader characterization of the clinical impact of treatment. The BAI is an assessment used to measure clinical anxiety.
Clinical Global Impression Scale
Time frame: 4 weeks.
The Clinical Global Impression scale asks two questions; the severity of illness and the change in illness. This scale allows a clinician completed score to monitor unintended effects on mood and anxiety. The Clinical Global Impressions - Improvement (CGI-I) scale is used to measure how much a patient's illness has improved or worsened. The Clinical Global Impressions - Severity (CGI-S) is used to measure how severe the patient's illness is.
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 21 Oct 2026.
- Background: PubMed 32289711Gaur P, Casey KM, Kubanek J, Li N, Mohammadjavadi M, Saenz Y, Glover GH, Bouley DM, Pauly KB. Histologic safety of transcranial focused ultrasound neuromodulation and magnetic resonance acoustic radiation force imaging in rhesus macaques and sheep. Brain Stimul. 2020 May-Jun;13(3):804-814. doi: 10.1016/j.brs.2020.02.017. Epub 2020 Feb 21.
- Background: PubMed 16503369Pallanti S, Quercioli L. Treatment-refractory obsessive-compulsive disorder: methodological issues, operational definitions and therapeutic lines. Prog Neuropsychopharmacol Biol Psychiatry. 2006 May;30(3):400-12. doi: 10.1016/j.pnpbp.2005.11.028. Epub 2006 Feb 28.
- Background: PubMed 41281204Aubry JF, Attali D, Schafer ME, Fouragnan E, Caskey CF, Chen R, Darmani G, Bubrick EJ, Sallet J, Butler CR, Stagg CJ, Klein-Flugge MC, Yoo SS, Holland C, Treeby B, Martin E, Verhagen L, Pauly KB. ITRUSST Consensus on Biophysical Safety for Transcranial Ultrasound Stimulation. ArXiv [Preprint]. 2025 Oct 9:arXiv:2311.05359v3.
- Background: PubMed 35033772Darmani G, Bergmann TO, Butts Pauly K, Caskey CF, de Lecea L, Fomenko A, Fouragnan E, Legon W, Murphy KR, Nandi T, Phipps MA, Pinton G, Ramezanpour H, Sallet J, Yaakub SN, Yoo SS, Chen R. Non-invasive transcranial ultrasound stimulation for neuromodulation. Clin Neurophysiol. 2022 Mar;135:51-73. doi: 10.1016/j.clinph.2021.12.010. Epub 2021 Dec 31.
- Background: PubMed 34198105Stern JM, Spivak NM, Becerra SA, Kuhn TP, Korb AS, Kronemyer D, Khanlou N, Reyes SD, Monti MM, Schnakers C, Walshaw P, Keselman I, Cohen MS, Yong W, Fried I, Jordan SE, Schafer ME, Engel J Jr, Bystritsky A. Safety of focused ultrasound neuromodulation in humans with temporal lobe epilepsy. Brain Stimul. 2021 Jul-Aug;14(4):1022-1031. doi: 10.1016/j.brs.2021.06.003. Epub 2021 Jun 23.
- Background: PubMed 25088462Kim H, Chiu A, Lee SD, Fischer K, Yoo SS. Focused ultrasound-mediated non-invasive brain stimulation: examination of sonication parameters. Brain Stimul. 2014 Sep-Oct;7(5):748-56. doi: 10.1016/j.brs.2014.06.011. Epub 2014 Jul 2.
- Background: PubMed 31401074Pasquinelli C, Hanson LG, Siebner HR, Lee HJ, Thielscher A. Safety of transcranial focused ultrasound stimulation: A systematic review of the state of knowledge from both human and animal studies. Brain Stimul. 2019 Nov-Dec;12(6):1367-1380. doi: 10.1016/j.brs.2019.07.024. Epub 2019 Jul 31.
- Background: PubMed 31648261Yoon K, Lee W, Lee JE, Xu L, Croce P, Foley L, Yoo SS. Effects of sonication parameters on transcranial focused ultrasound brain stimulation in an ovine model. PLoS One. 2019 Oct 24;14(10):e0224311. doi: 10.1371/journal.pone.0224311. eCollection 2019.
- Background: PubMed 42480914Caulfield KA, Sege CT, Weaver J, Murphy KR, Passaro T, Meads K, Dadgar-Kiani E, Antonucci MU, Good C, McTeague LM. Focused ultrasound to bilateral thalamic nuclei significantly improves human cognitive attention in a frequency- and intensity-dependent manner. Brain Stimul. 2026 Sep-Oct;19(5):103171. doi: 10.1016/j.brs.2026.103171. Epub 2026 Jul 21.
- Background: PubMed 19005196Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514.
- Background: PubMed 26208305Alonso P, Cuadras D, Gabriels L, Denys D, Goodman W, Greenberg BD, Jimenez-Ponce F, Kuhn J, Lenartz D, Mallet L, Nuttin B, Real E, Segalas C, Schuurman R, du Montcel ST, Menchon JM. Deep Brain Stimulation for Obsessive-Compulsive Disorder: A Meta-Analysis of Treatment Outcome and Predictors of Response. PLoS One. 2015 Jul 24;10(7):e0133591. doi: 10.1371/journal.pone.0133591. eCollection 2015.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with outside researchers at this time to ensure the protection of participant privacy and to maintain strict compliance with the University of Pennsylvania Institutional Review Board (IRB) approved protocol.
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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.
Giovanna Rocchio contact
Katherine Scangos, MD, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ATTN201 - Low Intensity Focused Ultrasound in people with Obsessive - Compulsive Disorder, run by University of Pennsylvania 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 3 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rishi Suresh (215-746-8901, rishi.suresh1@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Report of Symptoms (time frame: 4 weeks). The study lists 5 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 NCT07887633, which also lists 11 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 21 Oct 2026.