Trichotillomania (Hair-Pulling Disorder)Phase 2NCT05207085
Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
A Phase 2 study testing Valbenazine Oral Capsule in people with Trichotillomania (Hair-Pulling Disorder), run by Yale University at 1 site in United States.
Trial summary
This trial aims to evaluate the efficacy, safety and tolerability of valbenazine, titrated to the subject's optimal dose of 40mg or 80mg, administered once daily, for 12 weeks, for the treatment of trichotillomania (TTM) in a double blind placebo controlled design study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trichotillomania (Hair-Pulling Disorder)
- What is being tested?
- Valbenazine Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 15 Feb 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have documentation of written and witnessed consent from the subject.
- Male or female adult between the ages of 18-65, inclusive.
- Be in good health as determined by medical history, physical examination, laboratory assessments and 12-lead ECG.
- On stable psychiatric medication regime of 4 weeks prior to beginning the trial and not anticipating changes during the trial.
- Subjects of child-bearing potential must agree to use contraception (condoms for men, birth control pill or diaphragm for women) consistently from screening until 30 days (female) or 90 days (male) after the last dose of the study drug. A female subject of childbearing potential is defined as a female capable of becoming pregnant, which includes subjects who have had their first menstrual cycle (i.e., menarche) and are not surgically sterile (i.e., bilateral oophorectomy, hysterectomy or bilateral tubal ligation for at least 3 months prior to screening) or have not experienced menopause and subsequently are no longer of childbearing potential. A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to screening. Subjects who practice total abstinence from sexual intercourse as the preferred lifestyle are not required to use contraception (periodic abstinence is not acceptable).
- Female subjects must have a negative urine pregnancy test at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26.
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- Negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, or opiates) at screening, baseline and weeks 2, 4, 8, 12, 14, 16, 20, 24 and 26. Subjects on stable doses of prescribed and supervised (not as needed) benzodiazepines, opiates or psychostimulants (participants with ADHD) can participate in the study. Results from a positive drug screen will be discarded.
- Be willing to adhere to the study regime and study procedures described in the protocol and informed consent forms, including all requirements at the study center and return for the follow-up visit.
- Have symptoms that cause marked distress or significant impairment in occupational and/or social function.
- Have a stable psychiatric status (TTM) as clinically determined by the investigator.
- Meet DSM-5 criteria for TTM.
- Significant current TTM symptoms: 12 or greater score on MGH-HPS.
Who cannot join
- Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70).
- Recent changes in medications (less than 4 weeks) in other medications that have potential effects on TTM severity. Medication change is defined to include dose changes or medication discontinuation.
- Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications).
- Recent changes in behavior treatment (less than 4 weeks) or initiation of therapy (within 12 weeks) for TTM/Obsessive Compulsive Disorder (OCD).
- Taking co-medications (over the counter or prescription) that may have a drug interaction with valbenazine as described in the United States Prescribing Information for INGREZZA. Patients who are taking co-medications with the potential to cause QT prolongations will not be excluded unless their ECG shows QT prolongation already present.
- Positive pregnancy test or drug screening test.
Show all 18Show fewer
- Currently pregnant or lactating.
- Significant medical comorbidity.
- Excessive use of tobacco and/or nicotine-containing products (based on the investigator's assessment or more than 1½ pack of cigarettes per day, 1 can of chewing/dipping tobacco per day, 54mg of nicotine-containing smoking cessation products per day, or any nicotine products or combination of products that exceed 54mg per day) within 30 days of screening.
- History of substance (drug or alcohol) dependence or abuse within 3 months before Baseline, as defined by DSM-5 criteria for Substance Use Disorder.
- Known history of neuroleptic malignant syndrome.
- Known history of long QT syndrome or cardiac arrhythmia.
- Have a screening or Day 1 average triplicate ECG corrected QT interval using Fridericia's formula (QTcF) of >450msec or the presence of any clinically significant cardiac abnormality.
- Have a blood loss ≥250 mL or donated blood within 56 days or donated plasma within 7 days of Day 1 (baseline).
- Have a significant risk of suicidal or violent behavior based on prior medical history and clinical judgement.
- Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (e.g., tetrabenazine).
- Have a history of or suspected poor compliance in clinical research studies.
- Have previous experience with valbenazine or previously participated in a valbenazine clinical study.
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
Yale Child Study Center
New Haven, Connecticut, 06520
Angeli Landeros, MD, 203-737-4539, angeli.landeros@yale.edu
Michael Bloch, MD, (203)785-6906, michael.bloch@yale.edu
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Titration Study to Assess the Safety, Tolerability, and Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
This trial aims to evaluate the efficacy, safety and tolerability of valbenazine, titrated to the subject's optimal dose of 40mg or 80mg, administered once daily, for 12 weeks, for the treatment of trichotillomania (TTM) in a double blind placebo controlled design study. After week 12, subjects will begin a 12-week, open-label portion of the study. During the open-label portion of the study, all subjects will receive the study drug at their optimal dose. The primary endpoint of these studies will be the change from baseline of placebo vs. active scores utilizing the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) at the end of Week 12.
Read the detailed description
Eligible subjects will be randomized in a double-blind manner in a 1:1 ratio to once-daily doses of valbenazine or placebo for 12 weeks. After week 12, all subjects will begin the 12-week, open-label portion of the study in which they all get their optimal dose. Follow-up assessments will be conducted at the end of week 26 (2 weeks after the last dose of the study drug). For subjects randomized to active treatment, the starting dose will be valbenazine 40mg, which may be escalated to 80mg to achieve an optimal dose of valbenazine for each subject. Dose escalation will occur at the end of week 2 based on the following criteria: 1) the subject's TTM symptoms are not sufficiently controlled per physician investigator assessment and 2) an evaluation by the physician investigator indicates that the subject is tolerating the study drug at the current dose and would likely be able to tolerate the higher dose level. At week 4, the physician investigator may choose to keep the subject at the higher dose or may reduce to the subject's prior tolerated dose (in subjects who have had dose escalation). If a subject's optimal dose was established as 40mg at week 2, no dose escalation will be allowed at week 4. At any time after week 2, the physician investigator may decrease the dose to the previous dose for any subject who had a dose escalation and who is unable to tolerate a given dose increase. The investigator may reduce the subject's dose only one time. Subjects who are unable to tolerate the starting dose or resumption of the 40mg dose will be discontinued from the study. The subject will continue at the dose reached during the optimization period for the remainder of the 12-week treatment period. To maintain the study blind, subjects randomized to placebo in each weight group will be subjected to the same dose escalation requirements, but will receive only placebo during the treatment period. Following the 12-week, double-blind study, all subjects will be offered the option to receive open-label valbenazine for 12 weeks. In order to protect the blind in the first phase of the trial all subjects will receive 40mg of valbenazine from week 12 to week 14 and then be titrated on the study medication similar to the first phase of the trial from that point forward.
- Conditions
- Trichotillomania (Hair-Pulling Disorder)
- Being tested
- Valbenazine Oral Capsule, Placebo Oral capsule
- Keywords
- trichotillomania, hair-pulling disorder, valbenazine
- Medical subject headings
- Trichotillomania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valbenazine Oral CapsuleDrug
Also called Ingrezza
Participants randomized to active treatment will be given a starting dose of 40mg of valbenazine , which may be escalated to 80mg to achieve an optimal dose of the medication for each subject.
Placebo Oral capsuleOther
Participants randomized to placebo will be given a capsule that is the same shape and color as the active medication and will subject to the same dose escalation requirements as the other arm but will receive placebo during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Valbenazine | Experimental | Participants randomized1:1 to receive valbenazine Receives: Drug: Valbenazine Oral Capsule |
| Placebo | Placebo comparator | Participants randomized 1:1 to receive placebo Receives: Other: Placebo Oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12
Massachusetts General Hospital Hairpulling Scale (MGH-HPS) scores range from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 12 weeks.
Measured: baseline to week12
Secondary outcomes (1)
Clinical Global Improvement Scale - Trichotillomania Severity (CGI-TTM) score at endpoint
Each of the Clinical Global Improvement Scale -Trichotillomania (CGI-TTM) response categories was assigned a numerical score as follows: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = Not changed; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse. Responder status on Clinical Global Improvement Scale as having a CGI-TTM score at endpoint less than or equal to 2.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start2 Feb 2024
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Trichotillomania (Hair-Pulling Disorder)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Neurocrine Biosciences
- Responsible party
- Sponsor
- Investigators
- Michael H. Bloch, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207085
- Sponsor's protocol ID
- 2000034993
- Other IDs
- 2000026788
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
United States Prescribing Information for INGREZZA. San Diego, CA 92130: Neurocrine Biosciences, Inc.; 2020.
Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.
PubMed 27581696Bloch MH, Landeros-Weisenberger A, Dombrowski P, Kelmendi B, Wegner R, Nudel J, Pittenger C, Leckman JF, Coric V. Systematic review: pharmacological and behavioral treatment for trichotillomania. Biol Psychiatry. 2007 Oct 15;62(8):839-46. doi: 10.1016/j.biopsych.2007.05.019. Epub 2007 Aug 28.
PubMed 17727824McGuire JF, Ung D, Selles RR, Rahman O, Lewin AB, Murphy TK, Storch EA. Treating trichotillomania: a meta-analysis of treatment effects and moderators for behavior therapy and serotonin reuptake inhibitors. J Psychiatr Res. 2014 Nov;58:76-83. doi: 10.1016/j.jpsychires.2014.07.015. Epub 2014 Jul 26.
PubMed 25108618Franklin ME, Zagrabbe K, Benavides KL. Trichotillomania and its treatment: a review and recommendations. Expert Rev Neurother. 2011 Aug;11(8):1165-74. doi: 10.1586/ern.11.93.
PubMed 21797657Sarva H, Henchcliffe C. Valbenazine as the first and only approved treatment for adults with tardive dyskinesia. Expert Rev Clin Pharmacol. 2018 Mar;11(3):209-217. doi: 10.1080/17512433.2018.1429264. Epub 2018 Jan 23.
PubMed 29338466
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Titration Study to Assess the Safety, Tolerability, and Efficacy of Valbenazine for the Treatment of Trichotillomania in Adults
- ClinicalTrials.gov ID
- NCT05207085
- Acronym / sponsor ID
- 2000034993
- Conditions
- Trichotillomania (Hair-Pulling Disorder)
- Keywords
- trichotillomania, hair-pulling disorder, valbenazine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Neurocrine Biosciences
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 26 Jan 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.
This trial aims to evaluate the efficacy, safety and tolerability of valbenazine, titrated to the subject's optimal dose of 40mg or 80mg, administered once daily, for 12 weeks, for the treatment of trichotillomania (TTM) in a double blind placebo controlled design study. After week 12, subjects will begin a 12-week, open-label portion of the study. During the open-label portion of the study, all subjects will receive the study drug at their optimal dose. The primary endpoint of these studies will be the change from baseline of placebo vs. active scores utilizing the Massachusetts General Hospital Hairpulling Scale (MGH-HPS) at the end of Week 12.
Detailed description
Eligible subjects will be randomized in a double-blind manner in a 1:1 ratio to once-daily doses of valbenazine or placebo for 12 weeks. After week 12, all subjects will begin the 12-week, open-label portion of the study in which they all get their optimal dose. Follow-up assessments will be conducted at the end of week 26 (2 weeks after the last dose of the study drug). For subjects randomized to active treatment, the starting dose will be valbenazine 40mg, which may be escalated to 80mg to achieve an optimal dose of valbenazine for each subject. Dose escalation will occur at the end of week 2 based on the following criteria: 1) the subject's TTM symptoms are not sufficiently controlled per physician investigator assessment and 2) an evaluation by the physician investigator indicates that the subject is tolerating the study drug at the current dose and would likely be able to tolerate the higher dose level. At week 4, the physician investigator may choose to keep the subject at the higher dose or may reduce to the subject's prior tolerated dose (in subjects who have had dose escalation). If a subject's optimal dose was established as 40mg at week 2, no dose escalation will be allowed at week 4. At any time after week 2, the physician investigator may decrease the dose to the previous dose for any subject who had a dose escalation and who is unable to tolerate a given dose increase. The investigator may reduce the subject's dose only one time. Subjects who are unable to tolerate the starting dose or resumption of the 40mg dose will be discontinued from the study. The subject will continue at the dose reached during the optimization period for the remainder of the 12-week treatment period. To maintain the study blind, subjects randomized to placebo in each weight group will be subjected to the same dose escalation requirements, but will receive only placebo during the treatment period. Following the 12-week, double-blind study, all subjects will be offered the option to receive open-label valbenazine for 12 weeks. In order to protect the blind in the first phase of the trial all subjects will receive 40mg of valbenazine from week 12 to week 14 and then be titrated on the study medication similar to the first phase of the trial from that point forward.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valbenazine | Experimental | Drug: Valbenazine Oral CapsuleParticipants randomized1:1 to receive valbenazine |
| Placebo | Placebo comparator | Other: Placebo Oral capsuleParticipants randomized 1:1 to receive placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have documentation of written and witnessed consent from the subject.
- Male or female adult between the ages of 18-65, inclusive.
- Be in good health as determined by medical history, physical examination, laboratory assessments and 12-lead ECG.
- On stable psychiatric medication regime of 4 weeks prior to beginning the trial and not anticipating changes during the trial.
- Subjects of child-bearing potential must agree to use contraception (condoms for men, birth control pill or diaphragm for women) consistently from screening until 30 days (female) or 90 days (male) after the last dose of the study drug. A female subject of childbearing potential is defined as a female capable of becoming pregnant, which includes subjects who have had their first menstrual cycle (i.e., menarche) and are not surgically sterile (i.e., bilateral oophorectomy, hysterectomy or bilateral tubal ligation for at least 3 months prior to screening) or have not experienced menopause and subsequently are no longer of childbearing potential. A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to screening. Subjects who practice total abstinence from sexual intercourse as the preferred lifestyle are not required to use contraception (periodic abstinence is not acceptable).
Key exclusion criteria (18 listed)
- Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70).
- Recent changes in medications (less than 4 weeks) in other medications that have potential effects on TTM severity. Medication change is defined to include dose changes or medication discontinuation.
- Currently taking antipsychotic medications or other medications that affect the dopamine system (e.g. psychostimulant medications).
- Recent changes in behavior treatment (less than 4 weeks) or initiation of therapy (within 12 weeks) for TTM/Obsessive Compulsive Disorder (OCD).
- Taking co-medications (over the counter or prescription) that may have a drug interaction with valbenazine as described in the United States Prescribing Information for INGREZZA. Patients who are taking co-medications with the potential to cause QT prolongations will not be excluded unless their ECG shows QT prolongation already present.
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 |
|---|---|---|
| Valbenazine Oral CapsuleAlso: IngrezzaParticipants randomized to active treatment will be given a starting dose of 40mg of valbenazine , which may be escalated to 80mg to achieve an optimal dose of the medication for each subject. | Drug | Valbenazine |
| Placebo Oral capsuleParticipants randomized to placebo will be given a capsule that is the same shape and color as the active medication and will subject to the same dose escalation requirements as the other arm but will receive placebo during the treatment period. | Other | Placebo |
Primary outcome
Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12
Time frame: baseline to week12
Massachusetts General Hospital Hairpulling Scale (MGH-HPS) scores range from 0-28 with 28 being the most severe. The lower the total score, the lower the severity level. This scale is given and measured once every 2 weeks for a total of 12 weeks.
1 secondary outcome
Clinical Global Improvement Scale - Trichotillomania Severity (CGI-TTM) score at endpoint
Time frame: Week 12
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 3 Feb 2026.
- BackgroundUnited States Prescribing Information for INGREZZA. San Diego, CA 92130: Neurocrine Biosciences, Inc.; 2020.
- Background: PubMed 27581696Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.
- Background: PubMed 17727824Bloch MH, Landeros-Weisenberger A, Dombrowski P, Kelmendi B, Wegner R, Nudel J, Pittenger C, Leckman JF, Coric V. Systematic review: pharmacological and behavioral treatment for trichotillomania. Biol Psychiatry. 2007 Oct 15;62(8):839-46. doi: 10.1016/j.biopsych.2007.05.019. Epub 2007 Aug 28.
- Background: PubMed 25108618McGuire JF, Ung D, Selles RR, Rahman O, Lewin AB, Murphy TK, Storch EA. Treating trichotillomania: a meta-analysis of treatment effects and moderators for behavior therapy and serotonin reuptake inhibitors. J Psychiatr Res. 2014 Nov;58:76-83. doi: 10.1016/j.jpsychires.2014.07.015. Epub 2014 Jul 26.
- Background: PubMed 21797657Franklin ME, Zagrabbe K, Benavides KL. Trichotillomania and its treatment: a review and recommendations. Expert Rev Neurother. 2011 Aug;11(8):1165-74. doi: 10.1586/ern.11.93.
- Background: PubMed 29338466Sarva H, Henchcliffe C. Valbenazine as the first and only approved treatment for adults with tardive dyskinesia. Expert Rev Clin Pharmacol. 2018 Mar;11(3):209-217. doi: 10.1080/17512433.2018.1429264. Epub 2018 Jan 23.
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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.
Michael H. Bloch, MD principal investigator
Yale University
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 Valbenazine Oral Capsule in people with Trichotillomania (Hair-Pulling Disorder), run by Yale University 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 12 inclusion and 18 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 3 Feb 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 Angeli Landeros, MD (203737-4539, blochresearch@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Massachusetts General Hospital Hairpulling Scale (MGH-HPS) from baseline to Week 12 (time frame: baseline to week12). 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 NCT05207085, which also lists 6 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 3 Feb 2026.