CancerPhase 2NCT05584826
MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
A Phase 2 study testing MDMA in people with Cancer and Adjustment Disorders, run by Sunstone Medical at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of patients with cancer and a concerned significant other (CSO) (20 participants total). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Adjustment Disorders
- What is being tested?
- MDMA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are at least 18 years old
- Are considered important to their well-being by patient participants (e.g., spouse or close family member)
- Meet DSM-5 criteria for current AD (no criteria for another mental disorder and does not correspond to an exacerbation of a preexisting mental disorder. Does not represent a normal bereavement)
- Satisfies diagnostic criteria for AD using the ADNM-2020 (score ≥ 47.5 on the scale)
- Are able to swallow pills.
- Are willing to be driven home after the experimental sessions, either by a driver arranged by the participant or by the site personnel or taxi and agree not to drive after each Experimental Session until the therapists deem it safe to do so
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- If able to become pregnant (i.e. assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).
- Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures
- Are proficient in speaking and reading English
- Agree to have all clinic visit sessions recorded to audio and video
- Agree to the following lifestyle modifications (described in more detail in Section 4.3 Lifestyle Modifications): comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not enroll in any other interventional clinical trials during the duration of the study, be driven home after each Experimental Session, and commit to medication dosing, therapy, and study procedures.
- May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.
- May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.
- May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by investigator, therapy team, and study physician, to reduce use of alcohol or other substances and to manage symptoms without self-medicating. Enrollment will require that, in the judgment of the investigator, therapy team, and study physician, the plan for decreasing substance use is realistic and has a good chance of succeeding in order to prevent substance use from impacting the safety or efficacy of the investigational treatment.
- May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the study physician.
- May have hypothyroidism if taking adequate and stable thyroid replacement medication.
- May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.
Who cannot join
- Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation therapy, that impairs general level of physical functioning (index participant)
- Weigh less than 48 kg
- Condition impairing oral intake or digestive absorption
- Are not able to give adequate informed consent
- Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 6 months or at V0 (see Appendix A)
- Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation
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- Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.
- Have a history of, or a current primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder
- Require ongoing concomitant therapy with a psychiatric medication with exceptions described in Section 8.0: Concomitant Medications.
- Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
- Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session;
- Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
- Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
- Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.
- Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, and confirmed by a cardiologist.
- Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration (participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded). Note: if participants present with a history of glaucoma, enrollment would be allowed only with the approval of their ophthalmologist
- Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury [mmHg] or higher assessed on three separate occasions)
- Have a heart rate > 100 bpm on three separate occasions
- Have a marked Baseline prolongation of QT/QTc interval (For purposes of eligibility, this is defined as repeated demonstration of a QT interval corrected using Fridericia's formula [QTcF] >450 milliseconds [ms] and >460 ms in females. For transgender or non-binary participants, QTc interval will be evaluated based on sex assigned at birth, unless the participant has been on hormonal treatment for five or more years.
- Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- Require use of concomitant medications that prolong the QT/QTc interval during Experimental Sessions. Refer to Section 12.0 Concomitant Medications.
- Have symptomatic liver disease
- Have history of hyponatremia or hyperthermia
- Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control.
- Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).
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
Sunstone Medical, PC
Rockville, Maryland, 20850
Study Contact, 301-750-3401, clinical.specialists@sunstonetherapies.com
Manish Agrawal, MD
About this study
The goal of this clinical trial is to assess feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of patients with cancer and a concerned significant other (CSO) (20 participants total).
Participants will undergo an 8-week treatment period which will include two doses of MDMA, two Preparatory Sessions and four Integrative Sessions of non-drug therapy.
Read the detailed description
This open-label single site concurrent mixed-method phase 2 pilot trial will assess the feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of patients with cancer and a concerned significant other (CSO) (20 participants total). The intervention will include two doses of MDMA, administered during the Treatment Period with manualized therapy. This 8-week Treatment Period includes two Preparatory Sessions and four Integrative Sessions of non-drug therapy.
- Conditions
- Cancer, Adjustment Disorders
- Being tested
- MDMA
- Medical subject headings
- Neoplasms, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMADrug
Also called 3,4-methylenedioxymethamphetamine (MDMA)
On 2 separate treatment visits, participants will receive dosing of 100 mg MDMA HCl (~84 mg MDMA) + 40 mg MDMA HCl (~34 mg MDMA) supplement unless tolerability issues arise from the first dose or the participant declines
| Study group | Role | What they receive |
|---|---|---|
| MDMA-Assisted Therapy | Experimental | Participants will receive two doses of MDMA, administered during the Treatment Period with manualized therapy. This 8-week Treatment Period includes two Preparatory Sessions and four Integrative Sessions of non-drug therapy. Receives: Drug: MDMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.
The study will assess participants scores on The Adjustment Disorder New Module - 20 items (ADNM-20) from baseline to the primary time point (Visit 10, week 8 ± 2 days).
Measured: 8 weeks ± 2 days
To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.
The study will assess participants scores on the Couples Satisfaction Index (CSI-16) scores from baseline to the primary time point (Visit 10, week 8 ± 2 days).
Measured: 8 weeks ± 2 days
Secondary outcomes (16)
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 1)
Cancer patient: Edmonton Symptom Assessment System (ESAS)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 2)
Cancer Patient: Pain Interference Scale (PIS)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 3)
Cancer patient: Fatigue Assessment Scale (FAS)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 4)
Cancer patient: MAC scale
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 5)
Cancer patient and concerned significant other: Hospital Anxiety and Depression Scale (HADS A and D)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 6)
Cancer patient: Posttraumatic stress disorder CheckList-5 - Specific stressor (PCL-S)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 7)
Cancer patient and concerned significant other: Mystical Experience Questionnaire (MEQ)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 8)
Cancer patient and concerned significant other: Challenging Experience Questionnaire (CEQ)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 9)
Cancer patient: Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 10)
Cancer patient: Demoralization scale II (DS-II)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 11)
Cancer patient: Life Attitude Profile - revised, Death acceptance subscale (LAP-R; SAHD)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 12)
Cancer patient: Functional Assessment of Cancer Therapy - General (FACT-G)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 13)
Cancer patient: Family relationship Index (FRI)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 14)
Cancer patient and concerned significant other: Social Isolation Scale (SIS)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 15)
Cancer patient and concerned significant other: Everyday/illness-related disclosure (ELID)
Measured: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 16)
Concerned significant other: CareGiver Oncology Quality of Life questionnaire (CarGOQoL)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start6 Oct 2022
- Primary completionOct 2026 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunstone Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manish Agrawal, MD, Principal investigator, Sunstone Medical, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584826
- Sponsor's protocol ID
- IUSAD1
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2022
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other
- ClinicalTrials.gov ID
- NCT05584826
- Acronym / sponsor ID
- IUSAD1
- Conditions
- Cancer, Adjustment Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sunstone MedicalUniversity, hospital or other
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 Oct 2022 (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 goal of this clinical trial is to assess feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of patients with cancer and a concerned significant other (CSO) (20 participants total).
Participants will undergo an 8-week treatment period which will include two doses of MDMA, two Preparatory Sessions and four Integrative Sessions of non-drug therapy.
Detailed description
This open-label single site concurrent mixed-method phase 2 pilot trial will assess the feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of patients with cancer and a concerned significant other (CSO) (20 participants total). The intervention will include two doses of MDMA, administered during the Treatment Period with manualized therapy. This 8-week Treatment Period includes two Preparatory Sessions and four Integrative Sessions of non-drug therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDMA-Assisted Therapy | Experimental | Drug: MDMAParticipants will receive two doses of MDMA, administered during the Treatment Period with manualized therapy. This 8-week Treatment Period includes two Preparatory Sessions and four Integrative Sessions of non-drug therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Are at least 18 years old
- Are considered important to their well-being by patient participants (e.g., spouse or close family member)
- Meet DSM-5 criteria for current AD (no criteria for another mental disorder and does not correspond to an exacerbation of a preexisting mental disorder. Does not represent a normal bereavement)
- Satisfies diagnostic criteria for AD using the ADNM-2020 (score ≥ 47.5 on the scale)
- Are able to swallow pills.
Key exclusion criteria (25 listed)
- Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation therapy, that impairs general level of physical functioning (index participant)
- Weigh less than 48 kg
- Condition impairing oral intake or digestive absorption
- Are not able to give adequate informed consent
- Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 6 months or at V0 (see Appendix A)
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 |
|---|---|---|
| MDMAAlso: 3,4-methylenedioxymethamphetamine (MDMA)On 2 separate treatment visits, participants will receive dosing of 100 mg MDMA HCl (~84 mg MDMA) + 40 mg MDMA HCl (~34 mg MDMA) supplement unless tolerability issues arise from the first dose or the participant declines | Drug | MDMA-Assisted Therapy |
Primary outcome
To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.
Time frame: 8 weeks ± 2 days
The study will assess participants scores on The Adjustment Disorder New Module - 20 items (ADNM-20) from baseline to the primary time point (Visit 10, week 8 ± 2 days).
To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO.
Time frame: 8 weeks ± 2 days
The study will assess participants scores on the Couples Satisfaction Index (CSI-16) scores from baseline to the primary time point (Visit 10, week 8 ± 2 days).
16 secondary outcomes
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 1)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 2)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 3)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 4)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 5)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 6)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 7)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 8)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 9)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 10)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 11)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 12)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 13)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 14)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 15)
Time frame: 24 weeks
To assess the effect on psychological distress, Mental Adjustment to Cancer (MAC), relationship functioning and health-related quality of life in both patients and their concerned significant other (scale 16)
Time frame: 24 weeks
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 4 May 2026.
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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.
Manish Agrawal, MD principal investigator
Sunstone Medical, PC
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 MDMA in people with Cancer and Adjustment Disorders, run by Sunstone Medical 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 17 inclusion and 25 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 4 May 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. 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 Study Contact (301-750-3401, clinical.specialists@sunstonetherapies.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effectiveness of the intervention on Adjustment Disorder and relationship functioning in patients with cancer and a CSO. (time frame: 8 weeks ± 2 days). 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?
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 4 May 2026.