SchizophreniaPhase 2BetaNCT01874756
The Efficacy and Safety of a Selective Estrogen Receptor Beta Agonist (LY500307) for Negative Symptoms and Cognitive Impairment Associated With Schizophrenia
A Phase 2 study testing LY500307 150mg, LY500307 75mg and LY500307 25mg in people with Schizophrenia, run by Indiana University at 4 sites in United States.
Trial summary
The primary objectives of this application are to determine if the selective ERβ agonist LY500307, when added to antipsychotic medications, improves negative and/or cognitive symptoms in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- LY500307 150mg, LY500307 75mg and LY500307 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2013to Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age at study entry
- Male
- DSM IV-TR diagnosis of schizophrenia as confirmed by Structured Clinical Interview for DSM-IV-TR (SCID)
- Outpatient or inpatient status
- Mild to moderate overall disease severity as defined by a CGI-S score of less than or equal to 4 (moderately ill) at randomization
- Moderate levels of negative symptoms as defined by a PANSS negative symptom sub-score greater than or equal to 11.
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- Clinical stability as defined by:
- No exacerbation of illness leading to an intensification of treatment in the opinion of the investigator within four weeks prior to randomization, and
- No change in antipsychotic medication for at least four weeks prior to randomization
Who cannot join
- Subjects with current acute, serious, or unstable medical conditions, including, but not limited to: inadequately controlled diabetes, asthma, COPD, severe hypertriglyceridemia, recent cerebrovascular accidents, acute systemic infection or immunologic disease, unstable cardiovascular disorders, malnutrition, or hepatic, renal gastroenterologic, respiratory, endocrinologic, neurologic, hematologic, or infectious diseases
- Known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin)
- Known or suspected history of deep venous thrombosis, stroke, venous thromboembolism, pulmonary embolism, paresis or paralysis that may be thrombogenic in origin
- Subjects currently receiving testosterone replacement therapy or drugs that influence the hypothalamus-pituitary-gonadal axis.
- Subjects who have clinically significant extrapyramidal signs (EPS) as defined by a score of >20 on the Simpson-Angus Scale (SAS)
- Clinically significant electrocardiogram (ECG) abnormality, including, but not limited to, a corrected QT interval (Bazett's; QTcB) >450 msec. Repeat ECGs may be conducted at the discretion of the principal investigator.
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- Subjects with known medical history of Human Immunodeficiency Virus positive (HIV+) status
- Subjects with an active seizure disorder
- Subjects with implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, ventriculoperitoneal shunt, or other contraindication to undergoing an MRI scan
- Known IQ less than 70 based on medical history
- Current DSM IV-TR diagnosis of substance dependence (excluding caffeine and nicotine)
- Subjects who test positive for (1) Hepatitis C virus antibody or (2) Hepatitis B surface antigen (HBsAg) with or without positive Hepatitis B core total antibody
- Subjects with moderate to severe renal impairment as defined by creatinine clearance (CrCl) < 60 ml/min (measured by the Cockcroft-Gault equation) at screening. Repeat evaluation may be conducted at the discretion of the Principal Investigator.
- Subjects with hepatic impairment as defined by liver transaminases or total bilirubin > 3 × upper limit of normal (ULN). Repeat evaluation may be conducted at the discretion of the Principal Investigator.
- Subjects considered a high risk for suicidal acts - active suicidal ideation as determined by clinical interview OR any suicide attempt in 30 days prior to screening
- Subjects who have participated in a clinical trial with any pharmacological treatment intervention for which they received study-related medication in the four weeks prior to randomization OR subjects currently receiving treatment (within 1 dosing interval plus four weeks) with an investigational depot formulation of an antipsychotic medication
- Subjects who demonstrate overtly aggressive behavior or who are deemed to pose a substantial risk of danger in the Investigator's opinion
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University Center for NeuroImaging
Indianapolis, Indiana, 46202
IU Biostatistics
Indianapolis, Indiana, 46202
Prevention and Recovery Center for Early Psychosis
Indianapolis, Indiana, 46202
Larue D Carter Memorial Hospital
Indianapolis, Indiana, 46222
About this study
The primary objectives of this application are to determine if the selective ERβ agonist LY500307, when added to antipsychotic medications, improves negative and/or cognitive symptoms in patients with schizophrenia. The specific hypotheses to be tested are to determine if LY500307 is safe and well tolerated in this population and whether it elicits a sufficient efficacy signal to be advanced for further testing in schizophrenia. A two-stage Phase 1b/Phase 2a adaptive ("drop the inferior dose") experimental design is ongoing that combines three studies (clinical dose optimization, cortical target engagement confirmation and efficacy and safety assessment) into a single clinical trial.
Stage 1 was conducted in year 1 and Stage 2 will be conducted in years 2 and 3. The goal of Stage 1 was to identify and advance the highest dose that did not demonstrate a safety signal and had target selectivity as determined by lack of TT suppression. This criteria was fulfilled at both doses, the larger of the two (75 mg/day dose) was advanced to Stage 2. Furthermore, there was no suggestion of ERα receptor activation (i.e., no pattern of TT decreases or feminization AEs) at either dose (25 mg/day and 75 mg/day). A third arm of 150 mg/day was added to Stage 2 for evaluation. Stage 2 results in the following three arms: placebo, 75 mg/day and 150 mg/day. The goals of Stage 2 are to further assess LY500307 doses for safety and target selectivity, confirm cortical target engagement and assess efficacy.
Read more
Primary Aim 1: To determine if LY500307 demonstrates cortical target engagement as assessed by fMRI/N-back in frontal-parietal regions. Secondary measures of target engagement are fMRI episodic memory, Pseudo-Continuous Arterial Spin Labeling, Mismatch Negativity/evoked response potentials, Auditory Steady State Response, Auditory P300 and Quantitative EEG (QEEG).
Primary Aim 2: To determine if LY500307 is superior to placebo for one or more of the primary efficacy endpoints: negative symptoms (Negative Symptom Assessment Scale - 16-item total score), working memory (the composite score for the Letter Number Sequencing and Spatial Span tests) and verbal memory (Hopkins Verbal Learning Test).
Primary Aim 3: To determine if LY500307 reduces total testosterone (TT) plasma concentrations, which is indicative of loss of selectivity for ERβ and engagement of ERα, using the following criteria: Decrease in TT plasma concentrations of 50% from baseline in 50% of subjects per arm treated for two consecutive post-randomization values with LY500307 in Stage 1 and Stage 2 of the trial.
Primary Aim 4: To assess the safety of LY500307 by determining if there are SAEs, AEs "probably related to study drug," QTc prolongation, TT suppression (50% reduction from baseline) and to evaluate for other safety signals.
- Conditions
- Schizophrenia
- Being tested
- LY500307 150mg, LY500307 75mg, Placebo, LY500307 25mg
- Keywords
- schizophrenia, Estrogen receptor agonist, cognitive impairment, negative symptoms
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY500307 150mgDrug
LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
LY500307 75mgDrug
LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
PlaceboDrug
6 placebo capsules daily for 8 weeks
LY500307 25mgDrug
LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| LY500307 150mg | Experimental | LY500307 150mg Receives: Drug: LY500307 150mg |
| placebo | Placebo comparator | placebo 6 pills of inactive drug Receives: Drug: Placebo |
| LY500307 75mg | Experimental | LY500307 75mg Receives: Drug: LY500307 75mg |
| LY500307 25mg | Experimental | LY500307 25mg Receives: Drug: LY500307 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative Symptom Changes - Negative Symptom Assessment Scale - 16-item (NSA-16) Total Score
The Negative Symptom Assessment Scale - 16-item (NSA-16) is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates subjects on 16 "anchors," is a semi-structured, clinical interview, and each item is rated from 1 to 6. The total score is the sum of the 16 specific items and ranges from 16 to 96; a higher score indicates greater severity of illness. In addition, there is a global rating that represents the overall assessment of a subject's negative symptoms. The rating should not be an average of any particular behavior, but a gestalt of everything observed in the interview.
Measured: Baseline, week 2, week 4, week 6, week 8
Working Memory Composite Score Changes
Working memory (composite score of the Wechsler Memory Scale-III: Spatial Span (WMS) and Letter Number Span (LNS) tests). WMS has 2 sections in which a subject recalls increasingly difficult sequences. The total raw score range for both sections is 0-32. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance.
LNS consists of 24 increasingly difficult sequences of letters and numbers that a subject is to recall and repeat back in Numeric-Alpha sequential order. The total raw score range is 0-24. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance.
The Working Memory composite score is calculated by summing the WMS and LNS tscores, ranging from 0-200, a higher tscore reflects better performance.
Measured: Baseline, week 2, week 4, week 6, week 8
Verbal Learning Composite Score Changes
Verbal learning (composite score of the Hopkins Verbal Learning Test-Revised (HVLT-R)). The HVLT-R has 3 trials in which a subject recalls has many words from a list of 12 as they can. The total number recalled for each trial is summed and the score range is between 0-36. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance.
The verbal learning composite score is calculated by using the HVLT-R tscore, a higher tscore reflects better performance.
Measured: Baseline, week 2, week 4, week 6, week 8
Number of Subjects With Total Testosterone Reduction
Number of subjects with total testosterone reduction, as defined as a decrease in total testosterone plasma concentrations of 50% from baseline for two consecutive post-randomization values
Measured: week 2, week 4, week 8
Number of Subjects With QTc Prolongation
Number of subjects with QTc prolongation, as defined as any subject with a change from baseline of 60 msec or greater during the active treatment phases
Measured: Week 4, Week 8
Cortical Target Engagement
To determine if LY500307 demonstrates cortical target engagement as assessed by changes in the N-back in frontal-parietal regions during the MRI.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Funding ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Alan Breier, Indiana University
- Investigators
- Alan Breier, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874756
- Sponsor's protocol ID
- 1303010802
- Acronym
- Beta
- Status last verified
- Jun 2019
- First submitted
- 20 May 2013
- Last updated
- 2 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of a Selective Estrogen Receptor Beta Agonist (LY500307) for Negative Symptoms and Cognitive Impairment Associated With Schizophrenia
- ClinicalTrials.gov ID
- NCT01874756
- Acronym / sponsor ID
- Beta / 1303010802
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, Estrogen receptor agonist, cognitive impairment, negative symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ended
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this application are to determine if the selective ERβ agonist LY500307, when added to antipsychotic medications, improves negative and/or cognitive symptoms in patients with schizophrenia. The specific hypotheses to be tested are to determine if LY500307 is safe and well tolerated in this population and whether it elicits a sufficient efficacy signal to be advanced for further testing in schizophrenia. A two-stage Phase 1b/Phase 2a adaptive ("drop the inferior dose") experimental design is ongoing that combines three studies (clinical dose optimization, cortical target engagement confirmation and efficacy and safety assessment) into a single clinical trial.
Stage 1 was conducted in year 1 and Stage 2 will be conducted in years 2 and 3. The goal of Stage 1 was to identify and advance the highest dose that did not demonstrate a safety signal and had target selectivity as determined by lack of TT suppression. This criteria was fulfilled at both doses, the larger of the two (75 mg/day dose) was advanced to Stage 2. Furthermore, there was no suggestion of ERα receptor activation (i.e., no pattern of TT decreases or feminization AEs) at either dose (25 mg/day and 75 mg/day). A third arm of 150 mg/day was added to Stage 2 for evaluation. Stage 2 results in the following three arms: placebo, 75 mg/day and 150 mg/day. The goals of Stage 2 are to further assess LY500307 doses for safety and target selectivity, confirm cortical target engagement and assess efficacy.
Primary Aim 1: To determine if LY500307 demonstrates cortical target engagement as assessed by fMRI/N-back in frontal-parietal regions. Secondary measures of target engagement are fMRI episodic memory, Pseudo-Continuous Arterial Spin Labeling, Mismatch Negativity/evoked response potentials, Auditory Steady State Response, Auditory P300 and Quantitative EEG (QEEG).
Primary Aim 2: To determine if LY500307 is superior to placebo for one or more of the primary efficacy endpoints: negative symptoms (Negative Symptom Assessment Scale - 16-item total score), working memory (the composite score for the Letter Number Sequencing and Spatial Span tests) and verbal memory (Hopkins Verbal Learning Test).
Primary Aim 3: To determine if LY500307 reduces total testosterone (TT) plasma concentrations, which is indicative of loss of selectivity for ERβ and engagement of ERα, using the following criteria: Decrease in TT plasma concentrations of 50% from baseline in 50% of subjects per arm treated for two consecutive post-randomization values with LY500307 in Stage 1 and Stage 2 of the trial.
Primary Aim 4: To assess the safety of LY500307 by determining if there are SAEs, AEs "probably related to study drug," QTc prolongation, TT suppression (50% reduction from baseline) and to evaluate for other safety signals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY500307 150mg | Experimental | Drug: LY500307 150mgLY500307 150mg |
| placebo | Placebo comparator | Drug: Placeboplacebo 6 pills of inactive drug |
| LY500307 75mg | Experimental | Drug: LY500307 75mgLY500307 75mg |
| LY500307 25mg | Experimental | Drug: LY500307 25mgLY500307 25mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 65 years of age at study entry
- Male
- DSM IV-TR diagnosis of schizophrenia as confirmed by Structured Clinical Interview for DSM-IV-TR (SCID)
- Outpatient or inpatient status
- Mild to moderate overall disease severity as defined by a CGI-S score of less than or equal to 4 (moderately ill) at randomization
Key exclusion criteria (17 listed)
- Subjects with current acute, serious, or unstable medical conditions, including, but not limited to: inadequately controlled diabetes, asthma, COPD, severe hypertriglyceridemia, recent cerebrovascular accidents, acute systemic infection or immunologic disease, unstable cardiovascular disorders, malnutrition, or hepatic, renal gastroenterologic, respiratory, endocrinologic, neurologic, hematologic, or infectious diseases
- Known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin)
- Known or suspected history of deep venous thrombosis, stroke, venous thromboembolism, pulmonary embolism, paresis or paralysis that may be thrombogenic in origin
- Subjects currently receiving testosterone replacement therapy or drugs that influence the hypothalamus-pituitary-gonadal axis.
- Subjects who have clinically significant extrapyramidal signs (EPS) as defined by a score of >20 on the Simpson-Angus Scale (SAS)
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 |
|---|---|---|
| LY500307 150mgLY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks | Drug | LY500307 150mg |
| LY500307 75mgLY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks | Drug | LY500307 75mg |
| Placebo6 placebo capsules daily for 8 weeks | Drug | placebo |
| LY500307 25mgLY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks | Drug | LY500307 25mg |
Primary outcome
Negative Symptom Changes - Negative Symptom Assessment Scale - 16-item (NSA-16) Total Score
Time frame: Baseline, week 2, week 4, week 6, week 8
The Negative Symptom Assessment Scale - 16-item (NSA-16) is used to help clinicians rate behaviors (not psychopathology) commonly associated with negative symptoms of schizophrenia. The scale rates subjects on 16 "anchors," is a semi-structured, clinical interview, and each item is rated from 1 to 6. The total score is the sum of the 16 specific items and ranges from 16 to 96; a higher score indicates greater severity of illness. In addition, there is a global rating that represents the overall assessment of a subject's negative symptoms. The rating should not be an average of any particular behavior, but a gestalt of everything observed in the interview.
Working Memory Composite Score Changes
Time frame: Baseline, week 2, week 4, week 6, week 8
Working memory (composite score of the Wechsler Memory Scale-III: Spatial Span (WMS) and Letter Number Span (LNS) tests). WMS has 2 sections in which a subject recalls increasingly difficult sequences. The total raw score range for both sections is 0-32. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. LNS consists of 24 increasingly difficult sequences of letters and numbers that a subject is to recall and repeat back in Numeric-Alpha sequential order. The total raw score range is 0-24. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. The Working Memory composite score is calculated by summing the WMS and LNS tscores, ranging from 0-200, a higher tscore reflects better performance.
Verbal Learning Composite Score Changes
Time frame: Baseline, week 2, week 4, week 6, week 8
Verbal learning (composite score of the Hopkins Verbal Learning Test-Revised (HVLT-R)). The HVLT-R has 3 trials in which a subject recalls has many words from a list of 12 as they can. The total number recalled for each trial is summed and the score range is between 0-36. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. The verbal learning composite score is calculated by using the HVLT-R tscore, a higher tscore reflects better performance.
Number of Subjects With Total Testosterone Reduction
Time frame: week 2, week 4, week 8
Number of subjects with total testosterone reduction, as defined as a decrease in total testosterone plasma concentrations of 50% from baseline for two consecutive post-randomization values
Number of Subjects With QTc Prolongation
Time frame: Week 4, Week 8
Number of subjects with QTc prolongation, as defined as any subject with a change from baseline of 60 msec or greater during the active treatment phases
Cortical Target Engagement
Time frame: Baseline, 8 weeks
To determine if LY500307 demonstrates cortical target engagement as assessed by changes in the N-back in frontal-parietal regions during the MRI.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alan Breier, MD principal investigator
Indiana University
4 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 LY500307 150mg, LY500307 75mg and LY500307 25mg in people with Schizophrenia, run by Indiana University at 4 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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Negative Symptom Changes - Negative Symptom Assessment Scale - 16-item (NSA-16) Total Score (time frame: Baseline, week 2, week 4, week 6, week 8). 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 2 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.