Complex Post-Traumatic Stress DisorderNCT07766265
NEST: A Group Intervention for Parents With Complex PTSD
A study testing Trauma-Informed Parenting Group Intervention in people with Complex Post-Traumatic Stress Disorder, run by St.Gallen University of Applied Sciences at 3 sites in Switzerland.
Trial summary
The goal of this pilot clinical trial is to learn whether NEST, a new trauma-informed group therapy program, is feasible and acceptable for parents with Complex PTSD, a condition that can develop after prolonged or repeated traumatic experiences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Post-Traumatic Stress Disorder
- What is being tested?
- Trauma-Informed Parenting Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Aug 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CPTSD according to ICD-11, confirmed by the treating psychotherapist or psychiatrist
- Caregiver of at least one child aged 0-18 years (including biological, adoptive, step-, or foster parents and other primary caregivers)
- Currently receiving individual psychotherapeutic treatment (outpatient or inpatient setting)
- Age 18 years or older
- Sufficient German language proficiency to participate in group sessions and complete study questionnaires
- Ability to provide written informed consent
Who cannot join
- Current acute psychosis or severe psychiatric instability requiring immediate intensive treatment
- Severe cognitive impairment or inability to participate adequately in group-based procedures
- No current contact with the child
- Insufficient German language proficiency
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites
Eastern Switzerland University of Applied Sciences (OST)
Sankt Gallen, Canton of St. Gallen, 9001
Joelle Schenkel, MSc, +41 58 257 32 99, joelle.schenkel@ost.ch
Psychiatrische Dienste Aargau (PDAG)
Windisch, Canton of Aargau, 5210
Nina Schweinfurth-Keck, MD, +41 56 481 61 81, nina.schweinfurth-keck@pdag.ch
Integrierte Psychiatrie Winterthur (ipw)
Winterthur, Canton of Zurich, 8400
Jochen Binder, MD, +41 52 264 38 60, jochen.binder@ipw.ch
About this study
Official title: NEST - Nurturing Emotional Safety in Trauma-Affected Parenting: A Pilot Feasibility and Acceptability Study of a Trauma-Informed Parenting Intervention for Parents With ICD-11 Complex Post-Traumatic Stress Disorder
The goal of this pilot clinical trial is to learn whether NEST, a new trauma-informed group therapy program, is feasible and acceptable for parents with Complex PTSD, a condition that can develop after prolonged or repeated traumatic experiences. Parenting can be especially challenging for people with this condition, and few treatment programs currently address this specific need. The main questions it aims to answer are:
- Is the NEST group intervention feasible to deliver and acceptable to parents with Complex PTSD?
- Do parents' trauma-related symptoms and their experience of the parenting role change from before to after the intervention?
Read more
Participants will:
- Complete online questionnaires about trauma-related symptoms and parenting before the group therapy, after it ends, and again three months later
- Take part in nine weekly 90-minute group therapy sessions, co-led by a member of the study team and a mental health professional from the treatment site
- Some participants will additionally be invited to a short interview about their experience with the group therapy
Read the detailed description
NEST (Nurturing Emotional Safety in Trauma-Affected Parenting) is a single-arm, multicenter pilot feasibility and acceptability study of a newly developed, manualized trauma-informed parenting group intervention for parents with ICD-11 Complex Post-Traumatic Stress Disorder (CPTSD).
The 9-session group intervention addresses core parenting-related challenges associated with CPTSD, including self-concept and self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, regulating closeness and distance in the parent-child relationship, and age-appropriate communication with children about the parent's diagnosis. Sessions are trauma-sensitive but not trauma-focused; traumatic memories themselves are not processed within the group. Each group is closed, comprises 6-8 participants, and is co-led by a member of the sponsor's (OST) study team together with a trained psychologist/psychotherapist affiliated with the respective treatment site.
The study is conducted at two clinical sites, the Psychiatric Services Aargau (PDAG) and the Integrated Psychiatry Winterthur (ipw). At each clinical site, the NEST group therapy forms part of participants' regular clinical care and is billed via mandatory health insurance; study-specific procedures are conducted separately by the OST study team. These study-specific procedures consist of self-report questionnaires completed by all participants and a semi-structured qualitative interview completed by a subset of participants after completing the group therapy, to explore their experience of the intervention in greater depth.
- Conditions
- Complex Post-Traumatic Stress Disorder
- Being tested
- Trauma-Informed Parenting Group Intervention
- Keywords
- Complex Post-Traumatic Stress Disorder, CPTSD, ICD-11, Trauma-Informed Intervention, Parents, Parenting Intervention, Group Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed Parenting Group InterventionBehavioural
Also called NEST - Nurturing Emotional Safety in Trauma-Affected Parenting
The NEST group intervention is a manualized, trauma-informed program consisting of nine weekly 90-minute group sessions, co-led by a member of the study team and a mental health professional from the treatment site. Groups are closed and comprise 6-8 parents. Sessions address parenting-related challenges associated with Complex PTSD, including self-concept and self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, regulating closeness and distance in the parent-child relationship, and age-appropriate communication with children about the parent's diagnosis. Sessions are trauma-sensitive but not trauma-focused; traumatic memories are not processed within the group.
| Study group | Role | What they receive |
|---|---|---|
| NEST Group Intervention | Experimental | Participants receive the NEST group intervention, a manualized, trauma-informed program comprising nine weekly 90-minute group sessions co-led by a member of the study team and a mental health professional from the treatment site. Sessions address parenting-related challenges associated with Complex PTSD, including self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, and age-appropriate communication with children about the parent's diagnosis. All participants complete self-report questionnaires at three time points (T0, T1, T2) and a subset also completes a semi-structured qualitative interview at T1. Receives: Behavioral: Trauma-Informed Parenting Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Enrollment/ Recruitment Rate
Feasibility will be assessed descriptively by the number of participants enrolled and the time required to reach the planned sample size.
Measured: From day one of recruitment to baseline measurement T0
Feasibility - Retention Rate
Retention will be assessed as the proportion of participants completing the post-intervention assessment (T1). A retention rate ≥70% at T1 is defined a priori as the benchmark for implementation-readiness.
Measured: From enrollment through T1 (approximately 9-10 weeks after enrollment)
Feasibility - Intervention Adherence (Session Attendance)
Adherence will be assessed as the proportion of participants attending at least 7 of 9 group sessions. A rate of ≥70% of participants attending at least 7 of 9 sessions is defined a priori as the benchmark for implementation-readiness.
Measured: From enrollment through completion of the 9-session group intervention (approximately 9-10 weeks after enrollment)
Feasibility - Protocol Deviations
Feasibility will be assessed descriptively through documentation of protocol deviations occurring during the intervention.
Measured: From enrollment through T1 (approximately 9-10 weeks after enrollment)
Acceptability - TFA Questionnaire
Acceptability will be assessed using the generic Theoretical Framework of Acceptability questionnaire (TFA; Sekhon et al., 2022), translated into German and adapted to the group therapy context. The TFA covers seven constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy) plus a general acceptability item. Acceptability is considered sufficient if ratings indicate an overall positive evaluation.
Measured: Post-intervention (T1, approximately 9-10 weeks after enrollment)
Acceptability - Qualitative Interviews
A subset of participants will additionally complete a semi-structured qualitative interview (approximately 40-50 minutes) exploring their experience of the intervention. Acceptability is considered sufficient if no substantial recurring concerns regarding safety, burden, or contextual fit emerge in qualitative findings.
Measured: Post-intervention (T1, approximately 9-10 weeks after enrollment)
Secondary outcomes (6)
ICD-11 PTSD and Complex PTSD Symptom Severity
Assessed using the International Trauma Questionnaire with Clinical Checks (ITQ-CC; Shevlin et al., 2025; German version: Kratzer et al., 2025), which measures ICD-11 PTSD and Complex PTSD symptom severity, including disturbances in self-organisation. Changes in total and/or subscale scores across time points will be analysed descriptively and exploratively.
Measured: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Stress (PSS)
Assessed using the Parental Stress Scale (PSS; Berry \& Jones, 1995; German validation: Kölch et al., 2022), an 18-item measure of parenting-related stress across positive and negative dimensions of the parenting role. Changes in total and/or subscale scores across time points will be analysed descriptively and exploratively.
Measured: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Self-Efficacy
Assessed using the Brief Parental Self-Efficacy Scale (BPSES; Woolgar et al., 2025), a 5-item measure of parents' perceived competence and confidence in their parenting role. Changes in total score across time points will be analysed descriptively and exploratively.
Measured: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parenting Practices
Assessed using the Parenting Scale Short Form (PS-8; Kliem et al., 2018), an 8-item measure of dysfunctional discipline practices, comprising two subscales - laxness and overreactivity - developed and validated in a German representative population sample. Changes in total and/or subscale scores across time points will be analysed descriptively and exploratively.
Measured: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Reflective Functioning
Assessed using the Parental Reflective Functioning Questionnaire (PRFQ; Luyten et al., 2017; German validation: Wildner et al., 2024), a 16-item measure of parents' capacity to mentalise in relation to their child, across three subscales: certainty about mental states, interest and curiosity, and pre-mentalising modes. Changes in total and/or subscale scores across time points will be analysed descriptively and exploratively.
Measured: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Family Emotional Responsiveness
Assessed using the Family Assessment Device - Affective Responsiveness subscale (FAD-AR; Miller et al., 1985; German validation: Beierlein et al., 2017), a 7-item subscale assessing the quality of emotional responsiveness within the family. Changes in score across time points will be analysed descriptively and exploratively.
Measured: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St.Gallen University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Principal investigator, Joelle Schenkel, St.Gallen University of Applied Sciences
- Investigators
- Rahel Bachem, PhD, Study chair, Eastern Switzerland University of Applied SciencesJoelle Schenkel, MSc, Principal investigator, Eastern Switzerland University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766265
- Sponsor's protocol ID
- 2026-01379
- Other IDs
- 222855
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A data sharing plan has not yet been finalized. Quantitative outcome data will likely be made available to other researchers in de-identified form, in line with the Swiss National Science Foundation's Open Science requirements; the specific repository or platform has not yet been determined, though registration on the Open Science Framework (OSF) is planned. Sharing of qualitative interview data is expected to be more limited, given the sensitivity of the content and the increased risk of re-identification in a small qualitative sample. Further details will be specified once the data management and sharing plan has been finalized.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEST - Nurturing Emotional Safety in Trauma-Affected Parenting: A Pilot Feasibility and Acceptability Study of a Trauma-Informed Parenting Intervention for Parents With ICD-11 Complex Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT07766265
- Acronym / sponsor ID
- 2026-01379
- Conditions
- Complex Post-Traumatic Stress Disorder
- Keywords
- Complex Post-Traumatic Stress Disorder, CPTSD, ICD-11, Trauma-Informed Intervention, Parents, Parenting Intervention, Group Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- St.Gallen University of Applied SciencesUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Aug 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.
The goal of this pilot clinical trial is to learn whether NEST, a new trauma-informed group therapy program, is feasible and acceptable for parents with Complex PTSD, a condition that can develop after prolonged or repeated traumatic experiences. Parenting can be especially challenging for people with this condition, and few treatment programs currently address this specific need. The main questions it aims to answer are:
- Is the NEST group intervention feasible to deliver and acceptable to parents with Complex PTSD?
- Do parents' trauma-related symptoms and their experience of the parenting role change from before to after the intervention?
Participants will:
- Complete online questionnaires about trauma-related symptoms and parenting before the group therapy, after it ends, and again three months later
- Take part in nine weekly 90-minute group therapy sessions, co-led by a member of the study team and a mental health professional from the treatment site
- Some participants will additionally be invited to a short interview about their experience with the group therapy
Detailed description
NEST (Nurturing Emotional Safety in Trauma-Affected Parenting) is a single-arm, multicenter pilot feasibility and acceptability study of a newly developed, manualized trauma-informed parenting group intervention for parents with ICD-11 Complex Post-Traumatic Stress Disorder (CPTSD).
The 9-session group intervention addresses core parenting-related challenges associated with CPTSD, including self-concept and self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, regulating closeness and distance in the parent-child relationship, and age-appropriate communication with children about the parent's diagnosis. Sessions are trauma-sensitive but not trauma-focused; traumatic memories themselves are not processed within the group. Each group is closed, comprises 6-8 participants, and is co-led by a member of the sponsor's (OST) study team together with a trained psychologist/psychotherapist affiliated with the respective treatment site.
The study is conducted at two clinical sites, the Psychiatric Services Aargau (PDAG) and the Integrated Psychiatry Winterthur (ipw). At each clinical site, the NEST group therapy forms part of participants' regular clinical care and is billed via mandatory health insurance; study-specific procedures are conducted separately by the OST study team. These study-specific procedures consist of self-report questionnaires completed by all participants and a semi-structured qualitative interview completed by a subset of participants after completing the group therapy, to explore their experience of the intervention in greater depth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEST Group Intervention | Experimental | Behavioral: Trauma-Informed Parenting Group InterventionParticipants receive the NEST group intervention, a manualized, trauma-informed program comprising nine weekly 90-minute group sessions co-led by a member of the study team and a mental health professional from the treatment site. Sessions address parenting-related challenges associated with Complex PTSD, including self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, and age-appropriate communication with children about the parent's diagnosis. All participants complete self-report questionnaires at three time points (T0, T1, T2) and a subset also completes a semi-structured qualitative interview at T1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of CPTSD according to ICD-11, confirmed by the treating psychotherapist or psychiatrist
- Caregiver of at least one child aged 0-18 years (including biological, adoptive, step-, or foster parents and other primary caregivers)
- Currently receiving individual psychotherapeutic treatment (outpatient or inpatient setting)
- Age 18 years or older
- Sufficient German language proficiency to participate in group sessions and complete study questionnaires
Key exclusion criteria (4 listed)
- Current acute psychosis or severe psychiatric instability requiring immediate intensive treatment
- Severe cognitive impairment or inability to participate adequately in group-based procedures
- No current contact with the child
- Insufficient German language proficiency
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 |
|---|---|---|
| Trauma-Informed Parenting Group InterventionAlso: NEST - Nurturing Emotional Safety in Trauma-Affected ParentingThe NEST group intervention is a manualized, trauma-informed program consisting of nine weekly 90-minute group sessions, co-led by a member of the study team and a mental health professional from the treatment site. Groups are closed and comprise 6-8 parents. Sessions address parenting-related challenges associated with Complex PTSD, including self-concept and self-efficacy as a parent, emotion regulation within the parent-child relationship, setting boundaries, regulating closeness and distance in the parent-child relationship, and age-appropriate communication with children about the parent's diagnosis. Sessions are trauma-sensitive but not trauma-focused; traumatic memories are not processed within the group. | Behavioural | NEST Group Intervention |
Primary outcome
Feasibility - Enrollment/ Recruitment Rate
Time frame: From day one of recruitment to baseline measurement T0
Feasibility will be assessed descriptively by the number of participants enrolled and the time required to reach the planned sample size.
Feasibility - Retention Rate
Time frame: From enrollment through T1 (approximately 9-10 weeks after enrollment)
Retention will be assessed as the proportion of participants completing the post-intervention assessment (T1). A retention rate ≥70% at T1 is defined a priori as the benchmark for implementation-readiness.
Feasibility - Intervention Adherence (Session Attendance)
Time frame: From enrollment through completion of the 9-session group intervention (approximately 9-10 weeks after enrollment)
Adherence will be assessed as the proportion of participants attending at least 7 of 9 group sessions. A rate of ≥70% of participants attending at least 7 of 9 sessions is defined a priori as the benchmark for implementation-readiness.
Feasibility - Protocol Deviations
Time frame: From enrollment through T1 (approximately 9-10 weeks after enrollment)
Feasibility will be assessed descriptively through documentation of protocol deviations occurring during the intervention.
Acceptability - TFA Questionnaire
Time frame: Post-intervention (T1, approximately 9-10 weeks after enrollment)
Acceptability will be assessed using the generic Theoretical Framework of Acceptability questionnaire (TFA; Sekhon et al., 2022), translated into German and adapted to the group therapy context. The TFA covers seven constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, self-efficacy) plus a general acceptability item. Acceptability is considered sufficient if ratings indicate an overall positive evaluation.
Acceptability - Qualitative Interviews
Time frame: Post-intervention (T1, approximately 9-10 weeks after enrollment)
A subset of participants will additionally complete a semi-structured qualitative interview (approximately 40-50 minutes) exploring their experience of the intervention. Acceptability is considered sufficient if no substantial recurring concerns regarding safety, burden, or contextual fit emerge in qualitative findings.
6 secondary outcomes
ICD-11 PTSD and Complex PTSD Symptom Severity
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Stress (PSS)
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Self-Efficacy
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parenting Practices
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Parental Reflective Functioning
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
Family Emotional Responsiveness
Time frame: Baseline (T0), post-intervention (T1, approximately 9-10 weeks after enrollment), and 3-month follow-up (T2)
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 Aug 2026.
- Individual participant dataSharing planned: Undecided. A data sharing plan has not yet been finalized. Quantitative outcome data will likely be made available to other researchers in de-identified form, in line with the Swiss National Science Foundation's Open Science requirements; the specific repository or platform has not yet been determined, though registration on the Open Science Framework (OSF) is planned. Sharing of qualitative interview data is expected to be more limited, given the sensitivity of the content and the increased risk of re-identification in a small qualitative sample. Further details will be specified once the data management and sharing plan has been finalized.
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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.
Rahel Bachem, PhD study chair
Eastern Switzerland University of Applied Sciences
Joelle Schenkel, MSc principal investigator
Eastern Switzerland University of Applied Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed Parenting Group Intervention in people with Complex Post-Traumatic Stress Disorder, run by St.Gallen University of Applied Sciences at 3 sites in Switzerland.
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 6 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: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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.
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 Joelle Schenkel, MSc (+41 58 257 32 99, joelle.schenkel@ost.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Enrollment/ Recruitment Rate (time frame: From day one of recruitment to baseline measurement T0). The study lists 6 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 14 Aug 2026.