SchizophreniaPhase 3NCT03172871
Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia
A Phase 3 study testing Aripiprazole IM Depot and Aripiprazole tablet in people with Schizophrenia, run by Otsuka Beijing Research Institute at 1 site in China.
Trial summary
This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment phase with a 14(±2)-day safety follow-up. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Aripiprazole IM Depot and Aripiprazole tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2017to 30 Sep 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Provide written informed consent form by subjects and subject's legal guardian or legally acceptable representative.
- The subjects and subject's legal guardian or legally acceptable representative have the ability to understand the nature of the trial, agree to comply with the prescribed medication and dosage regimens, complete the schedule visit, report the adverse event and concomitant medication to investigator, and to be reliably rated on psychiatrically scales.
- Male and female subjects 18 to 65 years of age, at the time of informed consent.
- Subjects with a diagnosis of schizophrenia as defined by DSM-IV-TR criteria and confirmed by the MINI for Schizophrenia and Psychotic Disorders Studies.
- Subjects with a stable living environment when not in hospital, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
- Subjects who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting BOTH of the following at screening and baseline:
Show all 10Show fewer
- Currently experiencing an acute exacerbation of psychotic symptoms accompanied by significant deterioration in the subject's clinical and/or functional status from their baseline clinical presentation with a Positive and Negative Syndrome Scale (PANSS) Total Score≥ 70 AND
- Specific psychotic symptoms on the PANSS as measured by a score of > 4 on at least two of the following items (possible scores of 1 to 7 for each item) Conceptual disorganization (P2) Hallucinatory behavior (P3) Suspiciousness/persecution (P6) Unusual thought content (G9)
- According to the investigator's opinion, subjects who have received antipsychotic treatment (except clozapine) with good response. (this criteria only applicable for the schizophrenia recurrence subject).
- Subjects willing to discontinue all prohibited psychotropic medications to meet protocol requirements prior to and during the trial period.
Who cannot join
- Woman and men subjects with Child-bear potential, unwilling or unable to take effective contraception within 1 year after signing informed consent form.
- Women who are pregnant or breastfeeding.
- Subjects with improvement of ≥ 30% in total PANSS score between the screening and baseline assessments.
- Subjects hospitalized for ≥ 30 days out of the last 90 days prior to screening visit. Subjects who have been hospitalized > 5 days for the current acute episode at the time of the screening visit (ie, signing the informed consent).
- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history of failure to respond to 2 adequate trials with different antipsychotic medications with a minimum of 6 weeks at clinically efficacious tolerated doses. Subjects who have a history of response to clozapine treatment only.
- Subjects with a current Axis I (DSM-IV-TR) diagnosis other than schizophrenia including, but not limited to:
Show all 31Show fewer
- Delirium, dementia, amnesic or other cognitive disorder MDD, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder Eating disorder (including anorexia nervosa or bulimia) Obsessive compulsive disorder Panic disorder Post-traumatic stress disorder
- Subjects with a current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
- Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.
- Subjects who present a serious risk of suicide, as follows:
- Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 6 months, OR Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 6 months OR Subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Subjects who, in the opinion of the investigator, present a serious risk of suicide.
- Subjects with clinically significant tardive dyskinesia, as determined by a score of ≥ 3 on Item 8 of the AIMS at the screening visit.
- Subjects with a score of 5 (severe akathisia) on the BARS global clinical assessment of akathisia at screening or baseline.
- Subjects who have met DSM-IV-TR criteria for substance abuse with the past 3 months prior to screening or dependence within the past 6 months; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
- Subjects who have a history or severe organic disease of vital organs (including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease ).
- Subjects with insulin-dependent diabetes mellitus or non-insulin-dependent diabetes mellitus are excluded if their illness is unstable as evidenced by any of the following:
- HbA1c≥ 7.0% OR Screening glucose ≥ 125 mg/dL or ≥ 6.94 mmol/L (fasting) or ≥ 200 mg/dL or ≥ 11.1 mmol/L (nonfasting). If the fasting or nonfasting screening glucose is greater than the above values, subjects must be retested in a fasted state and the retest value must be ≥125 mg/dL or ≥ 6.94 mmol/L, OR Subject's diabetes is newly diagnosed during screening for the trial.
- Subjects with uncontrolled hypertension (DBP > 95 mmHg in any position) or symptomatic hypotension, or orthostatic hypotension which is defined as a decrease of ≥ 30 mmHg in SBP and/or a decrease of ≥ 20 mmHg in DBP after at least 3 minutes standing compared to the previous supine blood pressure, OR development of symptoms.
- Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure (whether controlled or uncontrolled), angioplasty, stenting, or coronary artery bypass surgery.
- Subjects with epilepsy or a history of seizures, except for a single seizure episode, for instance childhood febrile seizure, post traumatic, or alcohol withdrawal.
- The following laboratory test and ECG results are exclusionary 1) Platelets ≤ 75 000/mm3 OR ≤ 75 × 109 /L 2) Hemoglobin ≤9 g/dL OR ≤90 g/L 3) Neutrophils, absolute ≤ 1 000/mm3 OR ≤ 1 × 109 /L 4) AST > 3 × ULN OR ALT > 3 × ULN 5) CPK > 3 × ULN 6) Creatinine≥ 2 mg/dL OR ≥ 176.8 µmol/L 7) HbA1c ≥ 7.0% 8) QTc ≥450 msec (male) OR QTc ≥470 msec (female)
- BMI> 40 kg/m2 (morbid obesity)at screening
- Prohibited concomitant medications used prior to randomization or anticipated need for such medications during the trial, including, but not limited to, the following:
- Medication Required Washout Antipsychotics Oral (or IR IM) aripiprazole 3∼7 days Other oral (or IR IM) antipsychotics 3∼7 days Depot or long-acting injectable antipsychotics One full cycle plus 14 days (length of 1 cycle plus 14 days base on the prescribing label） Antidepressants Fluoxetine or Symbyax® 28 days Venlafaxina and desvenlafaxine 3 days All other andtidepressants including MAOIs 3∼7 days Mood stabilizers(ie，lithium and/or anticonvulsants） 3∼7 days Psychostimulants 3∼7 days Varenicine 3∼7 days Benzodiazepines Lorazepam, oxazepam, diazepam, or clonazepam (rescue therapy during washout) 12 hours before scales Other benzodiazepines 3∼7 days CYP3A4 inhibitors and inducers and CYP2D6 inhibitors 3∼7 days
- Subjects who received electroconvulsive therapy within 60 days of screening.
- Subjects who previously enrolled in any prior aripiprazole IM depot clinical trial regardless if they received an injection of investigational medicinal product (IMP) or not.
- Subjects with a history of neuroleptic malignant syndrome (NMS)
- Subjects with a history of true allergic response (ie, not intolerance) to more than 1 class of medications.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this trial.
- Subjects who anticipated any other clinical trial within 3 months prior to the informed consent form.
- Any subject who, in the opinion of the investigator, should not participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anding Hospital of Capital Medical University
Beijing, Beijing Municipality, 100088
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Aripiprazole Intramuscular Depot in the Acute Treatment of Adults With Schizophrenia
This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment phase with a 14(±2)-day safety follow-up.
Read the detailed description
Screening Phase: The screening phase will begin when informed consent is signed and be a maximum of 13 days. The investigators will assess the subjects who meet all eligibility criteria and collect the characteristic information of the subjects, such as demographic, medical history, etc. If subjects have been exposed to aripiprazole in the past (ie, tolerability has been established), then subjects will enter a washout period for 3～7 days from prior antipsychotic medications and other prohibited concomitant medications. If the investigator may reasonably verify that subject has been off antipsychotics for at least 3～7 days and has a history of tolerating aripiprazole, then the subject may have a screening phase of < 7 days as long as the subject has had at least a 3～7-day washout phase from other antipsychotic medications. Subjects are required to be hospitalized during the entire screening phase.
12-week Acute Treatment Phase: At baseline, eligible subjects will be randomized in a 1:1 ratio to either aripiprazole IM depot or aripiprazole tablet. For 14 days beginning with the first injection, subjects randomized aripiprazole IM depot will receive concomitant oral aripiprazole and subjects randomized to aripiprazole tablet will receive 12 weeks concomitant injection placebo.
Safety Follow-up Phase: All subjects will be followed-up for safety via telephone contact 14(±2) days after the last trial visit.
- Conditions
- Schizophrenia
- Being tested
- Aripiprazole IM Depot, Aripiprazole tablet
- Keywords
- Schizophrenia, Aripiprazole Intramuscular Depot, Acute treatment
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aripiprazole IM DepotDrug
Also called Aripiprazole Intramuscular Depot
Aripiprazole IM depot 400 mg/300 mg (when not tolerated)
Aripiprazole tabletDrug
Also called Aripiprazole TAB
Oral aripiprazole tablets 10 to 20 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Aripiprazole IM Depot | Experimental | Aripiprazole IM depot group (Aripiprazole IM Depot):
The first 2 weeks of the acute treatment phase IM Injection 400 mg every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase IM Injection 400/300 mg every 4 weeks + placebo（tablets）(once a day) Receives: Drug: Aripiprazole IM Depot; Drug: Aripiprazole tablet |
| Aripiprazole tablet | Active comparator | Oral aripiprazole group (Aripiprazole tablet):
The first 2 weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day Receives: Drug: Aripiprazole IM Depot; Drug: Aripiprazole tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline to endpoint(10th week)in PANSS Total Score.
The primary efficacy outcome variable is mean change from baseline to endpoint (Week 10) in PANSS Total Score. The objective of the primary analysis is to compare the efficacy of aripiprazole IM depot (400 mg or 300 mg) with that of placebo with regard to mean change from baseline to endpoint (Week 10) in PANSS Total Score.
Measured: 1st,2nd,4th,6th,8th,10th,12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start15 May 2017
- Primary completion22 Jul 2019
- Study completion30 Sep 2019
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 SchizophreniaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Beijing Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patyman Juma, Study director, Otsuka Beijing Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172871
- Sponsor's protocol ID
- 031-403-00048
- Status last verified
- Aug 2020
- First submitted
- 11 May 2017
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiao L, Zhao Q, Li AN, Sun J, Wu B, Wang L, Zhang H, Zhang R, Li K, Xu X, Liu T, Zhang W, Xie S, Xu X, Tan Y, Zhang K, Zhang H, Guan N, Xian M, Uki M, Wang G. Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study. Psychopharmacology (Berl). 2022 Jan;239(1):243-251. doi: 10.1007/s00213-021-06044-x. Epub 2022 Jan 6.
PubMed 34989824
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Aripiprazole Intramuscular Depot in the Acute Treatment of Adults With Schizophrenia
- ClinicalTrials.gov ID
- NCT03172871
- Acronym / sponsor ID
- 031-403-00048
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Aripiprazole Intramuscular Depot, Acute treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Otsuka Beijing Research InstituteIndustry (pharma, biotech, devices)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 1 Jun 2017 (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 is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment phase with a 14(±2)-day safety follow-up.
Detailed description
Screening Phase: The screening phase will begin when informed consent is signed and be a maximum of 13 days. The investigators will assess the subjects who meet all eligibility criteria and collect the characteristic information of the subjects, such as demographic, medical history, etc. If subjects have been exposed to aripiprazole in the past (ie, tolerability has been established), then subjects will enter a washout period for 3～7 days from prior antipsychotic medications and other prohibited concomitant medications. If the investigator may reasonably verify that subject has been off antipsychotics for at least 3～7 days and has a history of tolerating aripiprazole, then the subject may have a screening phase of < 7 days as long as the subject has had at least a 3～7-day washout phase from other antipsychotic medications. Subjects are required to be hospitalized during the entire screening phase.
12-week Acute Treatment Phase: At baseline, eligible subjects will be randomized in a 1:1 ratio to either aripiprazole IM depot or aripiprazole tablet. For 14 days beginning with the first injection, subjects randomized aripiprazole IM depot will receive concomitant oral aripiprazole and subjects randomized to aripiprazole tablet will receive 12 weeks concomitant injection placebo.
Safety Follow-up Phase: All subjects will be followed-up for safety via telephone contact 14(±2) days after the last trial visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aripiprazole IM Depot | Experimental | Drug: Aripiprazole IM Depot, Drug: Aripiprazole tabletAripiprazole IM depot group (Aripiprazole IM Depot): The first 2 weeks of the acute treatment phase IM Injection 400 mg every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase IM Injection 400/300 mg every 4 weeks + placebo（tablets）(once a day) |
| Aripiprazole tablet | Active comparator | Drug: Aripiprazole IM Depot, Drug: Aripiprazole tabletOral aripiprazole group (Aripiprazole tablet): The first 2 weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provide written informed consent form by subjects and subject's legal guardian or legally acceptable representative.
- The subjects and subject's legal guardian or legally acceptable representative have the ability to understand the nature of the trial, agree to comply with the prescribed medication and dosage regimens, complete the schedule visit, report the adverse event and concomitant medication to investigator, and to be reliably rated on psychiatrically scales.
- Male and female subjects 18 to 65 years of age, at the time of informed consent.
- Subjects with a diagnosis of schizophrenia as defined by DSM-IV-TR criteria and confirmed by the MINI for Schizophrenia and Psychotic Disorders Studies.
- Subjects with a stable living environment when not in hospital, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
Key exclusion criteria (31 listed)
- Woman and men subjects with Child-bear potential, unwilling or unable to take effective contraception within 1 year after signing informed consent form.
- Women who are pregnant or breastfeeding.
- Subjects with improvement of ≥ 30% in total PANSS score between the screening and baseline assessments.
- Subjects hospitalized for ≥ 30 days out of the last 90 days prior to screening visit. Subjects who have been hospitalized > 5 days for the current acute episode at the time of the screening visit (ie, signing the informed consent).
- Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history of failure to respond to 2 adequate trials with different antipsychotic medications with a minimum of 6 weeks at clinically efficacious tolerated doses. Subjects who have a history of response to clozapine treatment 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 |
|---|---|---|
| Aripiprazole IM DepotAlso: Aripiprazole Intramuscular DepotAripiprazole IM depot 400 mg/300 mg (when not tolerated) | Drug | Aripiprazole IM Depot, Aripiprazole tablet |
| Aripiprazole tabletAlso: Aripiprazole TABOral aripiprazole tablets 10 to 20 mg daily | Drug | Aripiprazole IM Depot, Aripiprazole tablet |
Primary outcome
Mean change from baseline to endpoint(10th week)in PANSS Total Score.
Time frame: 1st,2nd,4th,6th,8th,10th,12th week
The primary efficacy outcome variable is mean change from baseline to endpoint (Week 10) in PANSS Total Score. The objective of the primary analysis is to compare the efficacy of aripiprazole IM depot (400 mg or 300 mg) with that of placebo with regard to mean change from baseline to endpoint (Week 10) in PANSS Total Score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Derived from this study: PubMed 34989824Xiao L, Zhao Q, Li AN, Sun J, Wu B, Wang L, Zhang H, Zhang R, Li K, Xu X, Liu T, Zhang W, Xie S, Xu X, Tan Y, Zhang K, Zhang H, Guan N, Xian M, Uki M, Wang G. Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study. Psychopharmacology (Berl). 2022 Jan;239(1):243-251. doi: 10.1007/s00213-021-06044-x. Epub 2022 Jan 6.
- 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. This study is not recruiting at the moment.
Patyman Juma study director
Otsuka Beijing Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aripiprazole IM Depot and Aripiprazole tablet in people with Schizophrenia, run by Otsuka Beijing Research Institute at 1 site in China.
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 10 inclusion and 31 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: finished, as of the sponsor's last update on 29 Dec 2020. 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 China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline to endpoint(10th week)in PANSS Total Score. (time frame: 1st,2nd,4th,6th,8th,10th,12th week). 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 NCT03172871, 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 29 Dec 2020.