Patient With Schizophrenia Spectrum DisorderPhase 2DREAMS-PhenNCT07152184
Study Comparing Antipsychotic Dose Reduction vs. Maintenance Treatment in Patients With Schizophrenia Spectrum Disorder: a Personalized Medicine Approach
A Phase 2 study testing Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - Flup in people with Patient With Schizophrenia Spectrum Disorder and NLM Classification WM 203, Psychology:Schizophrenic Psychology, run by University Hospital, Strasbourg, France.
Trial summary
The objective of this study is to respond to frequent requests from patients who wish to reduce or even stop their antipsychotic treatment once they have achieved clinical stability. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Patient With Schizophrenia Spectrum Disorder, NLM Classification WM 203, Psychology:Schizophrenic Psychology, Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - Flup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Feb 2032
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Patient 18-60 years of age;
- Patient affiliated to health insurance (beneficiary or beneficiary's family);
- Patient informed of the results of the preliminary medical examination;
- Patient able to understand the aims and risks of the research (assisted by his/her curator, if applicable (if subject under curatorship*))
- Informed consent signed by patient
- Patient with a diagnosis of schizophrenia spectrum disorder (SSD): schizophrenia, schizophreniform, schizoaffective disorder or brief psychotic episode according to DSM-5;
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- Patient with:
- Either a cycloid psychosis (CP) phenotype according to By-CP (score >=80%)
- Or another (non-CP) psychotic phenotype; (By-CP score < 80%)
- Outpatient followed by an ambulatory psychiatrist;
- Patient with an identified caregiver, defined as a person able to support the patient for the duration of the study, spending at least 8 hours per week with the patient or having easy access to the patient per phone.
- Patient clinically stabilized, for at least 6 months, as defined by
- low intensity of positive symptoms, i.e. PANSS P1, P2 and P3 items < 4.
- Patient treated with oral antipsychotics (in mono or polytherapy, with second- or first-generation antipsychotics);
- Patients with a PSP score >70 at baseline will also be included
- The participant agrees to follow the contraceptive requirements detailed in the protocol *Subjects under limited guardianship (i.e. French "curatelle") can participate to the study.
Who cannot join
- - Patient hospitalized in a psychiatric ward;
- Patient with a recent psychotic episode (during the last 6 months);
- Patient treated with long-acting injection of antipsychotics (due to feasibility constraints and to the fact that these treatments remain essentially proposed to non-compliant patients with high risk of acute cessation and loss to follow-up);
- Patient treated with clozapine (in mono or polytherapy - highly resistant patients, specificities of the relapses under clozapine
- Patient considered by his psychiatrists to be at serious risk of harm to self or others (e.g. previous aggressive or suicidal behaviors); notably, a patient answering "yes" to C-SSRS suicidal ideation Type 4 or 5, having any suicidal behavior assessment within 6 months at Screening, or having been hospitalized or treated for suicidal behavior in the past 5 years before Screening. The investigator will rely on the results of the C-SSRS questionnaire completed at the time of inclusion (after consent has been signed) or previously completed as part of the patient's follow-up according to current practice.
- Neurological or severe medical condition other than psychosis;
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- Pregnancy (verified by urinary test at enrollment for women of childbearing potential);
- Current breastfeeding;
- Patient involved in another Investigational Medicinal Product trial or having participated in another investigational drug trial, in which they received the investigational drug, within 60 days
- Patient in an exclusion period defined by another research protocol;
- Patient under guardianship (i.e. French 'tutelle');
- Patient with care under constraint
- Patients deprived of freedom because of a judicial measure.
- Inability to give the patient the written consent form (emergency situation)
- Patients with major depressive disorder (CDSS > 5) or manic episode (DSM-5-TR)
- Patients with any of the following signs of substance abuse:
- Current diagnosis or history of substance use disorder and/or substance intoxication as defined in the DSM-5-TR. If the history of substance use disorder is more than 12 months before baseline, the participant may be allowed to enroll in the trial after consultation with the sponsor (Participant must also have negative urine drug screen at the screening.)
- A positive urine screen for drugs of abuse at screening.
- A history of alcohol consumption exceeding 2 standard drinks per day on average (1 glass is approximately equivalent to the following: beer [354 mL/12 oz], wine or sake [118 mL/4 oz], or distilled spirits [29.5 mL/1 oz] per day).
- A positive Breathalyzer test for alcohol at screening. The investigator will screen urine for drug abuse and perform an alcohol test at the inclusion visit (after consent has been signed), and may also rely on previous results obtained in the course of patient follow-up according to standard practice.
- The participant is a trial site employee, a site employee's immediate family member (for example, spouse, parent, child, sibling), or is in a dependent relationship with a site employee who is involved in conduct of this trial or may consent under duress.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Randomized, and Controlled Study Comparing Two Treatment Strategies (Dose REduction of Antipsychotics vs. Maintenance Treatment) in Patients With Schizophrenia Spectrum Disorder After Stratification Based on Patients' Psychotic PHENotype: a Personalized Medicine Approach
The objective of this study is to respond to frequent requests from patients who wish to reduce or even stop their antipsychotic treatment once they have achieved clinical stability. Psychiatrists are reluctant to respond to these requests because the method for safely reducing or stopping antipsychotic treatment remains poorly understood.
The investigators want to verify the existence of an interaction between treatment strategy and psychotic phenotype (cycloid psychosis vs. non-CP), i.e., in terms of functional remission, the benefit of the dose reduction strategy compared to the maintenance strategy will be greater in the CP group than in the non-CP group.
Read more
To this end, patients will be randomly assigned to four groups based on their phenotype and treatment strategy (CP-dose reduction; CP-dose maintenance; non-CP-dose reduction; and non-CP-dose maintenance).
Several hospitals throughout France are participating in this study, in which a random draw (called randomization) will be conducted to determine whether the physician will propose reducing the antipsychotic dose or maintaining it at the same dose for the patient.
Patients included in this study will be adults aged 18 to 60 who have been diagnosed with a schizophrenic spectrum disorder (SS): schizophrenia, schizophreniform disorder, schizoaffective disorder, or brief psychotic episode.
The antipsychotics studied are:
- second-generation antipsychotics: amisulpride, aripiprazole, olanzapine, quetiapine, risperidone;
- first-generation antipsychotics: chlorpromazine, flupentixol, haloperidol, levomepromazine, loxapine, pipotiazine, zuclopenthixol. 288 patients will be included and followed for 24 months. The inclusion period is 48 months.
Fourteen follow-up visits are planned, every month for four months and then every two months. During these visits, self-questionnaires or cognitive tests will have to be completed by the patient, the caregiver, and/or the treating psychiatrist.
Three blood samples will be taken at inclusion, at 6 months, and at the end of the study, in particular to measure the level of medication in the blood.
- Conditions
- Patient With Schizophrenia Spectrum Disorder, NLM Classification WM 203, Psychology:Schizophrenic Psychology, Schizophrenia Spectrum and Other Psychotic Disorders
- Being tested
- Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - Flup
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - FlupDrug
Biological A blood sample of up to 5 mL will be taken at visits V0, V5, and V14, for a maximum total volume of 15 mL for the study.
Behavioral Quality of life and disease assessment questionnaires will need to be completed by the patient and their caregiver.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cycloid Psychosis receiving the Dose Reduction strategy (CP-DR) | Experimental | After verifying the patient's phenotype, only those with cycloid psychosis will be included in this arm. The patient's usual antipsychotic dose will be gradually reduced to doses lower than those recommended by the marketing authorization (AMM). Receives: Drug: Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - Flup |
| Patients with Cycloid Psychosis receiving the Maintenance Treatment strategy (CP-MT) | Active comparator | After verifying the patient's phenotype, only those with cycloid psychosis will be included in this arm. The patient's usual antipsychotic dose will be maintained in accordance with those recommended by the marketing authorization (AMM). Receives: Drug: Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - Flup |
| Patients with Non-Cycloid Psychosis receiving the Dose Reduction strategy (Non-CP-DR) | Experimental | After verifying the patient's phenotype, only those without cycloid psychosis will be included in this arm. The patient's usual antipsychotic dose will be gradually reduced to doses lower than those recommended by the marketing authorization (AMM). Receives: Drug: Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - Flup |
| patients with Non-Cycloid Psychosis receiving the Maintenance Treatment strategy (Non-CP-MT) | Active comparator | After verifying the patient's phenotype, only those without cycloid psychosis will be included in this arm. The patient's usual antipsychotic dose will be maintained in accordance with those recommended by the marketing authorization (AMM). Receives: Drug: Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - Flup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with functional remission as defined by a Personal and Social Performance Scale score >70 (minimal 1 max 100) at 24 months follow-up (study endpoint).
The Personal and Social Performance will be assessed at different times of the study, both by the treating psychiatrist of the patients (i.e. who is not blind to patients' treatment arm) and by the Dreams-Phen evaluation team (who will be blind to patients' treatment arm). The primary endpoint will rely ONLY on the PSP scores at 24 months assessed by the Dreams-Phen evaluation team.
This evaluation will be performed during a webmeeting with the patient and his/her caregiver and will be based on the patient's functioning during the month preceding the evaluation.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start1 Oct 2026 (estimated)
- Primary completion1 Feb 2032 (estimated)
- Study completion1 Feb 2032 (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 Patient With Schizophrenia Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152184
- Sponsor's protocol ID
- 8669
- Other IDs
- 2023-509558-80-00, 2023
- Acronym
- DREAMS-Phen
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berna F, Horowitz MA, Javelot H, Meyer N, Foucher JR. DREAMSPHEN: a randomised controlled study comparing dose reduction of antipsychotics vs maintenance treatment in schizophrenia spectrum disorder after stratification based on patients' psychotic phenotype - study protocol of a personalised medicine approach. BMJ Open. 2026 Jun 12;16(6):e117593. doi: 10.1136/bmjopen-2026-117593.
PubMed 42285570
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, and Controlled Study Comparing Two Treatment Strategies (Dose REduction of Antipsychotics vs. Maintenance Treatment) in Patients With Schizophrenia Spectrum Disorder After Stratification Based on Patients' Psychotic PHENotype: a Personalized Medicine Approach
- ClinicalTrials.gov ID
- NCT07152184
- Acronym / sponsor ID
- DREAMS-Phen / 8669
- Conditions
- Patient With Schizophrenia Spectrum Disorder, NLM Classification WM 203, Psychology:Schizophrenic Psychology, Schizophrenia Spectrum and Other Psychotic Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Feb 2032 (estimated)
- Study completion
- 1 Feb 2032 (estimated)
- First posted
- 3 Sep 2025 (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 objective of this study is to respond to frequent requests from patients who wish to reduce or even stop their antipsychotic treatment once they have achieved clinical stability. Psychiatrists are reluctant to respond to these requests because the method for safely reducing or stopping antipsychotic treatment remains poorly understood.
The investigators want to verify the existence of an interaction between treatment strategy and psychotic phenotype (cycloid psychosis vs. non-CP), i.e., in terms of functional remission, the benefit of the dose reduction strategy compared to the maintenance strategy will be greater in the CP group than in the non-CP group.
To this end, patients will be randomly assigned to four groups based on their phenotype and treatment strategy (CP-dose reduction; CP-dose maintenance; non-CP-dose reduction; and non-CP-dose maintenance).
Several hospitals throughout France are participating in this study, in which a random draw (called randomization) will be conducted to determine whether the physician will propose reducing the antipsychotic dose or maintaining it at the same dose for the patient.
Patients included in this study will be adults aged 18 to 60 who have been diagnosed with a schizophrenic spectrum disorder (SS): schizophrenia, schizophreniform disorder, schizoaffective disorder, or brief psychotic episode.
The antipsychotics studied are:
- second-generation antipsychotics: amisulpride, aripiprazole, olanzapine, quetiapine, risperidone;
- first-generation antipsychotics: chlorpromazine, flupentixol, haloperidol, levomepromazine, loxapine, pipotiazine, zuclopenthixol. 288 patients will be included and followed for 24 months. The inclusion period is 48 months.
Fourteen follow-up visits are planned, every month for four months and then every two months. During these visits, self-questionnaires or cognitive tests will have to be completed by the patient, the caregiver, and/or the treating psychiatrist.
Three blood samples will be taken at inclusion, at 6 months, and at the end of the study, in particular to measure the level of medication in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with Cycloid Psychosis receiving the Dose Reduction strategy (CP-DR) | Experimental | Drug: Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - FlupAfter verifying the patient's phenotype, only those with cycloid psychosis will be included in this arm. The patient's usual antipsychotic dose will be gradually reduced to doses lower than those recommended by the marketing authorization (AMM). |
| Patients with Cycloid Psychosis receiving the Maintenance Treatment strategy (CP-MT) | Active comparator | Drug: Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - FlupAfter verifying the patient's phenotype, only those with cycloid psychosis will be included in this arm. The patient's usual antipsychotic dose will be maintained in accordance with those recommended by the marketing authorization (AMM). |
| Patients with Non-Cycloid Psychosis receiving the Dose Reduction strategy (Non-CP-DR) | Experimental | Drug: Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - FlupAfter verifying the patient's phenotype, only those without cycloid psychosis will be included in this arm. The patient's usual antipsychotic dose will be gradually reduced to doses lower than those recommended by the marketing authorization (AMM). |
| patients with Non-Cycloid Psychosis receiving the Maintenance Treatment strategy (Non-CP-MT) | Active comparator | Drug: Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - FlupAfter verifying the patient's phenotype, only those without cycloid psychosis will be included in this arm. The patient's usual antipsychotic dose will be maintained in accordance with those recommended by the marketing authorization (AMM). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- - Patient 18-60 years of age;
- Patient affiliated to health insurance (beneficiary or beneficiary's family);
- Patient informed of the results of the preliminary medical examination;
- Patient able to understand the aims and risks of the research (assisted by his/her curator, if applicable (if subject under curatorship*))
- Informed consent signed by patient
Key exclusion criteria (21 listed)
- - Patient hospitalized in a psychiatric ward;
- Patient with a recent psychotic episode (during the last 6 months);
- Patient treated with long-acting injection of antipsychotics (due to feasibility constraints and to the fact that these treatments remain essentially proposed to non-compliant patients with high risk of acute cessation and loss to follow-up);
- Patient treated with clozapine (in mono or polytherapy - highly resistant patients, specificities of the relapses under clozapine
- Patient considered by his psychiatrists to be at serious risk of harm to self or others (e.g. previous aggressive or suicidal behaviors); notably, a patient answering "yes" to C-SSRS suicidal ideation Type 4 or 5, having any suicidal behavior assessment within 6 months at Screening, or having been hospitalized or treated for suicidal behavior in the past 5 years before Screening. The investigator will rely on the results of the C-SSRS questionnaire completed at the time of inclusion (after consent has been signed) or previously completed as part of the patient's follow-up according to current practice.
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 |
|---|---|---|
| Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - FlupBiological A blood sample of up to 5 mL will be taken at visits V0, V5, and V14, for a maximum total volume of 15 mL for the study. Behavioral Quality of life and disease assessment questionnaires will need to be completed by the patient and their caregiver. | Drug | Patients with Cycloid Psychosis receiving the Dose Reduction strategy (CP-DR), Patients with Cycloid Psychosis receiving the Maintenance Treatment strategy (CP-MT), Patients with Non-Cycloid Psychosis receiving the Dose Reduction strategy (Non-CP-DR), patients with Non-Cycloid Psychosis receiving the Maintenance Treatment strategy (Non-CP-MT) |
Primary outcome
Percentage of patients with functional remission as defined by a Personal and Social Performance Scale score >70 (minimal 1 max 100) at 24 months follow-up (study endpoint).
Time frame: 24 months
The Personal and Social Performance will be assessed at different times of the study, both by the treating psychiatrist of the patients (i.e. who is not blind to patients' treatment arm) and by the Dreams-Phen evaluation team (who will be blind to patients' treatment arm). The primary endpoint will rely ONLY on the PSP scores at 24 months assessed by the Dreams-Phen evaluation team. This evaluation will be performed during a webmeeting with the patient and his/her caregiver and will be based on the patient's functioning during the month preceding the evaluation.
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 26 May 2026.
- Derived from this study: PubMed 42285570Berna F, Horowitz MA, Javelot H, Meyer N, Foucher JR. DREAMSPHEN: a randomised controlled study comparing dose reduction of antipsychotics vs maintenance treatment in schizophrenia spectrum disorder after stratification based on patients' psychotic phenotype - study protocol of a personalised medicine approach. BMJ Open. 2026 Jun 12;16(6):e117593. doi: 10.1136/bmjopen-2026-117593.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Use of antipsychotic treatment with marketing authorization at doses lower than those recommended: - Olanzapine - Zuclopenthixol - Risperidone - Pipotiazine palmitate / Pipotiazine - Quetiapine - Flup in people with Patient With Schizophrenia Spectrum Disorder and NLM Classification WM 203, Psychology:Schizophrenic Psychology, run by University Hospital, Strasbourg, France.
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 16 inclusion and 21 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 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Fabrice BERNA, MD (+33388116462, fabrice.berna@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with functional remission as defined by a Personal and Social Performance Scale score >70 (minimal 1 max 100) at 24 months follow-up (study endpoint). (time frame: 24 months). 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 NCT07152184, 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 26 May 2026.