Alcohol Use Disorder (AUD)Phase 2SUVNCT06679062
Suvorexant for Treatment of AUD and PTSD
A Phase 2 study testing Suvorexant in people with Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD), run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance at 2 sites in United States.
Trial summary
This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), Post Traumatic Stress Disorder (PTSD), Insomnia
- What is being tested?
- Suvorexant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jul 2025to Mar 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 and 65.
- Meet current (i.e., past 12-month at Day -7/-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.
- Currently experiencing PTSD symptoms at screening (Day -7/-6) as indicated by PCL-5 cut-score > 30.
- Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment.
- Must have an ISI score equal to or > 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day.
- Agree to abstain from all other sleep medications (starting at Day -7).
- Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s/he will lose his/her housing in the next month.
Who cannot join
- A current (past 12-month at Day -7/-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (< moderate level on DSM 5).
- A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.
- Positive urine test for any recreational drugs other than marijuana at screening (Day -7/-6).
- Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).
- Currently pregnant, nursing, or no reliable method of birth control (females only).
- Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders).
Show all 11Show fewer
- Use of suvorexant (within 30 days of Day -7).
- Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))
- Hepatic insufficiency (AST/ALT > 5x upper limit of normal (ULN)).
- Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.
- Inability to provide evidence of 48-hour alcohol abstinence (self-report, BrAC, EtG) at Day 0 AND failure after second attempt at 48-hour abstinence.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lara Ray, PhD contact
United States2 sites, 1 recruiting
- Recruiting
The University of Texas Health Science Center - Houston
Houston, Texas, 77054
Scott Lane, PhD, scott.d.lane@uth.tmc.edu
Jessica Vincent, jessica.n.vincent@uth.tmc.edu
- Terminated
University of California - Los Angeles
Los Angeles, California, 90095
About this study
Official title: A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)
This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.
Read the detailed description
This is a randomized, double-masked, placebo-controlled study to evaluate preliminary efficacy and safety of suvorexant (SUV) (20mg) for sleep disturbance in alcohol use disorder (AUD) and co-occurring posttraumatic stress disorder (PTSD) symptoms in approximately 76 randomized men and women veteran and non-veterans between the ages 21-65. Participants will be recruited from the University of Texas Health Science Center at Houston (UTHealth) Trauma and Recovery Center (TRC) and the University of California - Los Angeles (UCLA) (in collaboration with West Los Angeles VA Medical Center). Following a 7-day placebo run-in, participants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)) or matched placebo. Randomization will be stratified on sex and level of sleep disturbance (Insomnia Severity Index (ISI) score). Post-randomization, all participants will complete an alcohol cue-reactivity paradigm prior to the initial dose of study medication. The alcohol cue-reactivity paradigm is an established laboratory assessment of craving during which participants are exposed to real alcohol and water cues in a bar laboratory setting. Participants will then take their first dose of medication. Participants will begin the real-world quit attempt, during which they will attempt to stop drinking for two weeks. Participants will complete daily virtual diaries and visits to assess sleep, past-day drinking, and alcohol craving. Participants will return to one of the clinical sites on study Day 14 to complete an alcohol cue-reactivity session to assess post-medication craving. PTSD symptoms will be assessed via Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5) and Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) at baseline, at Day 7 and at Day 14 of treatment with SUV or matched placebo.
- Being tested
- Suvorexant, Placebo
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
Also called SUV, Dual orexin receptor antagonist
Suvorexant is described chemically as: [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol2-yl)phenyl]methanone. SUV's empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Each film coated tablet contains 10mg or 20mg of suvorexant.
PlaceboOther
Film coated tablet to match the active drug.
| Study group | Role | What they receive |
|---|---|---|
| 10mg and 20mg Suvorexant (SUV) | Active comparator | Participants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)). Receives: Drug: Suvorexant |
| Placebo | Placebo comparator | Participants will be randomly assigned to receive matched placebo (Days 0-13). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI) score from baseline to Day 14.
The Insomnia Severity Index (ISI) is a brief questionnaire to screen for insomnia in participants. A scoring system is used to identify what degree insomnia (if any detected) is affecting daily life and sleep patterns. A total score is derived by summing all seven items with a total score ranging from 0 to 28 (with higher scores indicative of worse insomnia symptoms).
Measured: Baseline (Day 0) and Day 14
Secondary outcomes (6)
Change in cue-induced alcohol craving, as assessed by the Alcohol Urge Questionnaire (AUQ) during the alcohol condition, from baseline to day 14.
The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by averaging the item scores. Higher scores reflect greater craving.
Measured: Baseline (Day 0) and Day 14
Change in mean number of drinks per drinking day from baseline to Day 14.
Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption per day. Participants are given a blank calendar covering the time interval to be re-constructed and are asked to reconstruct retrospectively their drinking behavior over that interval. The TLFB will be used to calculate the number of drinks per day and drinks per drinking day over the course of the study period.
Measured: Baseline (Day 0) and Day 14
Percent total days abstinent during the 14-day quit attempt period.
Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption per day. Participants are given a blank calendar covering the time interval to be re-constructed and are asked to reconstruct retrospectively their drinking behavior over that interval. The TLFB will be used to document the total number of abstinent days over the course of the study period.
Measured: Baseline (Day 0) through Day 14
Change in the mean number of days abstinent during the medication period (day 0 through 14) compared to the 30-days prior (screening period).
Timeline Follow Back (TLFB) is a calendar-based method of assessing drinking patterns used to document the frequency and amount of daily alcohol consumption per day. Participants are given a blank calendar covering the time interval to be re-constructed and are asked to reconstruct retrospectively their drinking behavior over that interval. The TLFB will be used to document the number of days with and without drinking from 30-days prior to baseline and 14-days post randomization.
Measured: Screening (30-days prior to baseline) and Baseline through Day 14
Change in PTSD total symptom severity score as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline to Day 14.
Gold-standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD, and assess PTSD symptoms over the past week. The symptom severity score ranges from 0 to 80 with higher score indicating worse PTSD symptoms.
Measured: Baseline (Day 0) through Day 14
Change in PTSD score as measured by the PTSD Checklist for DSM-5 (PCL-5) from baseline to Day 14.
The PCL-5 is a 20-item self-report measure that assesses DSM-5-based criteria for PTSD symptoms. Each item is rated on a 5-point Likert-type scale (0 = Not at all; 4 = Extremely) that indicates how much the participant has been bothered by an identified "worst" stressful event in the past month. The PTSD score ranges from 0 to 80 with higher score indication worse PTSD symptoms.
Measured: Baseline (Day 0) through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start16 Jul 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will be given a placebo run-in (Day -7 to Day -1). On baseline (Day 0), the participant will be randomized to receive SUV or placebo (1:1 ratio) and administered 10mg SUV or placebo for an additional 7 days (Day 0 to Day 6). On Day 7, the participant previously randomized to SUV will be given 20 mg SUV, and participant previously randomized to placebo will continue with placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, The University of Texas Health Science Center, Houston
- Responsible party
- Sponsor
- Investigators
- Scott Lane, PhD, Principal investigator, The University of Texas Health Science Center, HoustonLara Ray, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679062
- Sponsor's protocol ID
- AS210006-A10
- Acronym
- SUV
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ray LA, Nieto SJ, Miotto K, Mooney L, LeBeau R, Yoon JH, Schmitz JM, Acierno R, Bailey NW, Jenkins J, Vincent J, Nolen T, Hirsch S, Williams A, Lane SD. Suvorexant for alcohol use disorder and post-traumatic stress disorder: study protocol for a phase II randomized clinical trial. Trials. 2026 Feb 3;27(1):188. doi: 10.1186/s13063-026-09489-7.
PubMed 41630040
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT06679062
- Acronym / sponsor ID
- SUV / AS210006-A10
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Pharmacotherapies for Alcohol and Substance Use Disorders AllianceUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, The University of Texas Health Science Center, Houston
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Nov 2024 (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 to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.
Detailed description
This is a randomized, double-masked, placebo-controlled study to evaluate preliminary efficacy and safety of suvorexant (SUV) (20mg) for sleep disturbance in alcohol use disorder (AUD) and co-occurring posttraumatic stress disorder (PTSD) symptoms in approximately 76 randomized men and women veteran and non-veterans between the ages 21-65. Participants will be recruited from the University of Texas Health Science Center at Houston (UTHealth) Trauma and Recovery Center (TRC) and the University of California - Los Angeles (UCLA) (in collaboration with West Los Angeles VA Medical Center). Following a 7-day placebo run-in, participants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)) or matched placebo. Randomization will be stratified on sex and level of sleep disturbance (Insomnia Severity Index (ISI) score). Post-randomization, all participants will complete an alcohol cue-reactivity paradigm prior to the initial dose of study medication. The alcohol cue-reactivity paradigm is an established laboratory assessment of craving during which participants are exposed to real alcohol and water cues in a bar laboratory setting. Participants will then take their first dose of medication. Participants will begin the real-world quit attempt, during which they will attempt to stop drinking for two weeks. Participants will complete daily virtual diaries and visits to assess sleep, past-day drinking, and alcohol craving. Participants will return to one of the clinical sites on study Day 14 to complete an alcohol cue-reactivity session to assess post-medication craving. PTSD symptoms will be assessed via Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5) and Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) at baseline, at Day 7 and at Day 14 of treatment with SUV or matched placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Each participant will be given a placebo run-in (Day -7 to Day -1). On baseline (Day 0), the participant will be randomized to receive SUV or placebo (1:1 ratio) and administered 10mg SUV or placebo for an additional 7 days (Day 0 to Day 6). On Day 7, the participant previously randomized to SUV will be given 20 mg SUV, and participant previously randomized to placebo will continue with placebo.
| Arm | Type | Receives |
|---|---|---|
| 10mg and 20mg Suvorexant (SUV) | Active comparator | Drug: SuvorexantParticipants will be randomly assigned to receive SUV (10mg (Days 0-6) and 20mg (Days 7-13)). |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be randomly assigned to receive matched placebo (Days 0-13). |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 21 and 65.
- Meet current (i.e., past 12-month at Day -7/-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.
- Currently experiencing PTSD symptoms at screening (Day -7/-6) as indicated by PCL-5 cut-score > 30.
- Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment.
- Must have an ISI score equal to or > 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day.
Key exclusion criteria (11 listed)
- A current (past 12-month at Day -7/-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (< moderate level on DSM 5).
- A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.
- Positive urine test for any recreational drugs other than marijuana at screening (Day -7/-6).
- Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).
- Currently pregnant, nursing, or no reliable method of birth control (females only).
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 |
|---|---|---|
| SuvorexantAlso: SUV, Dual orexin receptor antagonistSuvorexant is described chemically as: [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol2-yl)phenyl]methanone. SUV's empirical formula is C23H23ClN6O2 and the molecular weight is 450.92. Each film coated tablet contains 10mg or 20mg of suvorexant. | Drug | 10mg and 20mg Suvorexant (SUV) |
| PlaceboFilm coated tablet to match the active drug. | Other | Placebo |
Primary outcome
Change in Insomnia Severity Index (ISI) score from baseline to Day 14.
Time frame: Baseline (Day 0) and Day 14
The Insomnia Severity Index (ISI) is a brief questionnaire to screen for insomnia in participants. A scoring system is used to identify what degree insomnia (if any detected) is affecting daily life and sleep patterns. A total score is derived by summing all seven items with a total score ranging from 0 to 28 (with higher scores indicative of worse insomnia symptoms).
6 secondary outcomes
Change in cue-induced alcohol craving, as assessed by the Alcohol Urge Questionnaire (AUQ) during the alcohol condition, from baseline to day 14.
Time frame: Baseline (Day 0) and Day 14
Change in mean number of drinks per drinking day from baseline to Day 14.
Time frame: Baseline (Day 0) and Day 14
Percent total days abstinent during the 14-day quit attempt period.
Time frame: Baseline (Day 0) through Day 14
Change in the mean number of days abstinent during the medication period (day 0 through 14) compared to the 30-days prior (screening period).
Time frame: Screening (30-days prior to baseline) and Baseline through Day 14
Change in PTSD total symptom severity score as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline to Day 14.
Time frame: Baseline (Day 0) through Day 14
Change in PTSD score as measured by the PTSD Checklist for DSM-5 (PCL-5) from baseline to Day 14.
Time frame: Baseline (Day 0) through Day 14
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 14 Oct 2026.
- Derived from this study: PubMed 41630040Ray LA, Nieto SJ, Miotto K, Mooney L, LeBeau R, Yoon JH, Schmitz JM, Acierno R, Bailey NW, Jenkins J, Vincent J, Nolen T, Hirsch S, Williams A, Lane SD. Suvorexant for alcohol use disorder and post-traumatic stress disorder: study protocol for a phase II randomized clinical trial. Trials. 2026 Feb 3;27(1):188. doi: 10.1186/s13063-026-09489-7.
- 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.
Lara Ray, PhD contact
Scott Lane, PhD principal investigator
The University of Texas Health Science Center, Houston
Lara Ray, PhD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suvorexant in people with Alcohol Use Disorder (AUD) and Post Traumatic Stress Disorder (PTSD), run by Pharmacotherapies for Alcohol and Substance Use Disorders Alliance at 2 sites 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 7 inclusion and 11 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 14 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 2 sites 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 Scott Lane, PhD (713-486-2535, scott.d.lane@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) score from baseline to Day 14. (time frame: Baseline (Day 0) and Day 14). 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 NCT06679062, which also lists 1 linked publication.
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 14 Oct 2026.