Refractory SchizophreniaPhase 2/3NCT03094429
An Adaptive Phase II/III, Two-Part, Double-Blind, Randomized, Placebo-controlled, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
A Phase 2/3 study testing NaBen® in people with Refractory Schizophrenia, run by SyneuRx International (Taiwan) Corp at 1 site in United States.
Trial summary
This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia. Part 1 Objectives: There are two primary objectives for Part 1 of this study: 1. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Refractory Schizophrenia
- What is being tested?
- NaBen®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2017to 31 Dec 2026
- Phase
- Phase 2/3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects who are between 18 and 55 years of age inclusive
- Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements, or the subject has a Legally Authorized Representative (LAR) who can provide consent to be enrolled into the study
- If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an Intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL
- The subject has Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject's recorded history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0)
- The subjects should have refractory schizophrenia as defined below (should meet at least two: either a and b; or a and c; or a and b and c):
- Prior non-response to at least 2 antipsychotic drugs of two different chemical classes for at least 4-6 weeks each at doses ≥ 400 mg equivalents of chlorpromazine or 4 mg/day risperidone, AND
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- No period of good functioning in previous 2 years; OR,
- Moderate to severe psychopathology (total PANSS score equal or more than 70): including persistent psychotic symptoms, recurrent mood symptoms, repeated suicide attempts or suicidal ideation, uncontrolled aggressive behavior, moderate to severe positive or negative symptoms or moderate-severe cognitive impairment
- The subject has been receiving clozapine for a minimum of 6 months with the dose range of 200-900 mg/day. The dose should have remained unchanged for at least 3 months prior to Screening and not expected to change during the study
- The subject is outpatient, and has been consistently symptomatic without significant fluctuation per the Investigator, with no hospitalization for worsening of schizophrenia within 3 months of the Screening. If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study
- The subject has a minimum PANSS total score of 70 at the Screening and Baseline Visits (Visits 1 and 2)
- Without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For ALT and AST, clinically significant is defined as above two and a half times the upper limit of normal
- Body Mass Index (BMI) between 17 and 38 inclusive
- Subject has a negative routine urine illicit drug screening test (including heroin, amphetamines (including MDMA/ecstasy), cocaine, cannabis or PCP)
- The subject has a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker, or nurse) as determined by the Investigator and per the local regulations. The identified caregiver should be considered reliable by the Investigator and per the local regulations in providing support to the subject to help ensure compliance with study treatment, study visits and protocol procedures who preferably is also able to provide input helpful for completing study rating scales
- The subject must not be a danger to themselves or others per the Investigator's judgment
Who cannot join
- Meets the DSM-V criteria at Screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation
- Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to Screening
- Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms or medication side effects within four (4) weeks prior to Screening
- The subject has previously received NaBen®
- History of epilepsy, major head trauma, or any neurological illness other than Tourette's syndrome which might impair the subject's cognition or psychiatric functioning per the Investigator's judgment
- History of allergic reaction to sodium benzoate
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- Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator, may interfere with the conduct of the study
- Any significant gastrointestinal disorders that, in the opinion of the Investigator, markedly alter the absorption, metabolism or elimination of sodium benzoate
- Any movement disorders with a total score higher than 6 on SAS scale, or more than 2 on any items of the AIMS scale
- Current substance abuse, or history of meeting criteria for moderate or severe substance abuse (including alcohol, but excluding nicotine and caffeine) in the past six (6) months prior to Screening
- Female subjects who are pregnant (as confirmed by serum pregnancy test performed at Screening Visit) or are breast feeding
- History of cancer not in remission for the last three (3) years except for basal cell carcinoma and squamous cell carcinoma
- Participation in a clinical trial within 3 months prior to Screening or more than two clinical trials within 12 months
- Electroconvulsive Therapy (ECT) within 6 months prior to Screening
- The subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to Screening (e.g. individual psychotherapy, cognitive behavioral therapy or rehabilitative therapy)
- The subject's anti-EPS medications dose or regimen has changed within 2 weeks prior to Screening
- The subject's PANSS total score has decreased more than 20 percent using PANSS score evaluations at Visit 1 and Visit 2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
For additional information regarding investigative sites for this trial, contact SyneuRx International Corp.
Pasadena, California, 91101
Felicia Yao, 027-742-2699 ext. 136, felicia.yao@syneurx.com
About this study
Official title: An Adaptive Phase II/III, Double-Blind, Randomized, Placebo-controlled, Two-Part, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®,a D-Amino Acid Oxidase Inhibitor, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
This is an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia.
Part 1 Objectives: There are two primary objectives for Part 1 of this study:
Read more
- To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults, and; to determine the optimal dose to be used in Part 2 of this study.
- Sample size re-assessment to evaluate the final sample size needed to proceed with Part 2 of the study The secondary objective of the Part 1 of this study is to evaluate the safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), in combination with clozapine.
Part 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), in combination with clozapine.
Read the detailed description
This is a Phase II/III, double-blind, randomized, placebo-controlled, two-part, dose-finding, Multi-center study, in which subjects with refractory schizophrenia will be enrolled.
This study will be conducted in two parts:
In Part 1 (i.e. dose finding portion) of the study One hundred seventy one (171) subjects will be randomized in a 1:1:1 ratio (NaBen® 2000 mg/day: NaBen® 1000 mg/day: Placebo).
All subjects, after signing the Informed Consent Form (ICF), will be assessed during the screening phase. This screening phase is designed to exclude subjects who have had more than 20 percent reduction in the PANSS total score using PANSS score evaluations at Visit 1 and Visit 2. Only those subjects who successfully complete the screening phase and still meet the study eligibility criteria will proceed with Randomization and the double-blind treatment. All randomized subjects will receive eight (8) weeks of randomized treatment (NaBen® 2000 mg/day, NaBen® 1000 mg/day or Placebo). Study treatments will be given twice daily.
An Interim Analysis (IA) will be conducted when 171 subjects in Part 1 of the study have been randomized and completed 8 weeks of treatment or early terminated, whichever occurs first. Randomization of subjects in the study will continue until the IA of the Part 1 data is completed. The data from the Part 1 analysis will be reviewed by an independent Data Safety and Monitoring Committee (DSMC) who would assess the data for both safety and efficacy trends. The DSMC responsibilities will be further elaborated in the DSMC charter. The DSMC will approve continuation of the study and recommend the optimal dose and sample size adjustment for the Part 2 of the study.
Assuming no sample size adjustment was made as a result of the IA, for Part 2 of the study a total of 116 subjects will be randomized in a 1:1 ratio, of which 58 subjects will be randomized to the NaBen® optimal dose group and 58 subjects to the Placebo group. The procedures and assessments for subjects in Part 1 and Part 2 of this study will be identical with the exception of the randomization schema.
- Conditions
- Refractory Schizophrenia
- Being tested
- NaBen®, Placebo
- Medical subject headings
- Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaBen®Drug
2000 mg/day or 1000 mg/day, twice daily
PlaceboOther
0 mg total, twice daily
| Study group | Role | What they receive |
|---|---|---|
| NaBen® - 2000 mg/day | Active comparator | Two NaBen® ( 500 mg) will be taken twice daily at a total dose of 2000 mg/day during this study. Receives: Drug: NaBen® |
| NaBen® - 1000 mg/day | Active comparator | One NaBen® (500 mg) and one placebo will be taken twice daily at a total dose of 1000 mg/day during this study. Receives: Drug: NaBen® |
| Placebo - 0 mg/day | Placebo comparator | The control treatment is placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Measured: 8 weeks after randomized treatment
Secondary outcomes (9)
Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Percent change from baseline in PANSS total score treatment
Measured: 8 weeks after randomized treatment
Percentage of subjects with 20% or more reduction from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Percentage of subjects with 20% or more reduction from baseline in PANSS total score after treatment
Measured: 8 weeks after randomized treatment
Percent change in PANSS sub-scales and Marder PANSS factor scores
Percent change in PANSS sub-scales and Marder PANSS factor scores
Measured: 8 weeks
Percent change in Personal and Social Performance (PSP) scale
Percent change in Personal and Social Performance (PSP) scale
Measured: 8 weeks
Percent change in Schizophrenia Quality of Life Scale (SQLS)
Percent change in Schizophrenia Quality of Life Scale (SQLS)
Measured: 8 weeks
Percent change in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)
Percent change in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)
Measured: 8 weeks
Percent change in Hamilton Depression Rating Scale (HDRS)
Percent change in Hamilton Depression Rating Scale (HDRS)
Measured: 8 weeks
Serum pharmacokinetic evaluations-Maximum Plasma Concentration [Cmax]
Serum pharmacokinetic evaluations-Maximum Plasma Concentration [Cmax]
Measured: 8 weeks
Serum pharmacokinetic evaluations-Area Under the Curve [AUC]
Serum pharmacokinetic evaluations-Area Under the Curve [AUC]
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start29 Mar 2017
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 287 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SyneuRx International (Taiwan) Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094429
- Sponsor's protocol ID
- SNR-05
- Status last verified
- Sep 2021
- First submitted
- 16 Nov 2015
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Phase II/III, Double-Blind, Randomized, Placebo-controlled, Two-Part, Dose-Finding, Multi-center Study of the Safety and Efficacy of NaBen®,a D-Amino Acid Oxidase Inhibitor, as an Add-on Therapy With Clozapine, for Residual Symptoms of Refractory Schizophrenia in Adults
- ClinicalTrials.gov ID
- NCT03094429
- Acronym / sponsor ID
- SNR-05
- Conditions
- Refractory Schizophrenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 287 participants (estimated)
- Lead sponsor
- SyneuRx International (Taiwan) CorpIndustry (pharma, biotech, devices)
- Collaborators
- Amarex Clinical Research
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Mar 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 an adaptive, Phase II/III study in 2 parts (i.e. Part 1 (dose ranging) and Part 2 (Hypothesis testing)). NaBen® is granted Breakthrough Therapy Designation by US FDA as treatment for refractory schizophrenia.
Part 1 Objectives: There are two primary objectives for Part 1 of this study:
- To evaluate, in terms of dose-response, the effectiveness of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults, and; to determine the optimal dose to be used in Part 2 of this study.
- Sample size re-assessment to evaluate the final sample size needed to proceed with Part 2 of the study The secondary objective of the Part 1 of this study is to evaluate the safety and tolerability of NaBen® (1000 and 2000 mg/day) compared to Placebo (0 mg/day), in combination with clozapine.
Part 2 Objectives: The primary objective of the Part 2 of this study is to evaluate the effectiveness of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), when combined with clozapine, in improving the residual symptoms associated with refractory schizophrenia in adults. The secondary objective of the Part 2 of this study is to evaluate the safety and tolerability of NaBen® (at the optimal dose determined in the Part 1 of this study) compared to Placebo (0 mg/day), in combination with clozapine.
Detailed description
This is a Phase II/III, double-blind, randomized, placebo-controlled, two-part, dose-finding, Multi-center study, in which subjects with refractory schizophrenia will be enrolled.
This study will be conducted in two parts:
In Part 1 (i.e. dose finding portion) of the study One hundred seventy one (171) subjects will be randomized in a 1:1:1 ratio (NaBen® 2000 mg/day: NaBen® 1000 mg/day: Placebo).
All subjects, after signing the Informed Consent Form (ICF), will be assessed during the screening phase. This screening phase is designed to exclude subjects who have had more than 20 percent reduction in the PANSS total score using PANSS score evaluations at Visit 1 and Visit 2. Only those subjects who successfully complete the screening phase and still meet the study eligibility criteria will proceed with Randomization and the double-blind treatment. All randomized subjects will receive eight (8) weeks of randomized treatment (NaBen® 2000 mg/day, NaBen® 1000 mg/day or Placebo). Study treatments will be given twice daily.
An Interim Analysis (IA) will be conducted when 171 subjects in Part 1 of the study have been randomized and completed 8 weeks of treatment or early terminated, whichever occurs first. Randomization of subjects in the study will continue until the IA of the Part 1 data is completed. The data from the Part 1 analysis will be reviewed by an independent Data Safety and Monitoring Committee (DSMC) who would assess the data for both safety and efficacy trends. The DSMC responsibilities will be further elaborated in the DSMC charter. The DSMC will approve continuation of the study and recommend the optimal dose and sample size adjustment for the Part 2 of the study.
Assuming no sample size adjustment was made as a result of the IA, for Part 2 of the study a total of 116 subjects will be randomized in a 1:1 ratio, of which 58 subjects will be randomized to the NaBen® optimal dose group and 58 subjects to the Placebo group. The procedures and assessments for subjects in Part 1 and Part 2 of this study will be identical with the exception of the randomization schema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NaBen® - 2000 mg/day | Active comparator | Drug: NaBen®Two NaBen® ( 500 mg) will be taken twice daily at a total dose of 2000 mg/day during this study. |
| NaBen® - 1000 mg/day | Active comparator | Drug: NaBen®One NaBen® (500 mg) and one placebo will be taken twice daily at a total dose of 1000 mg/day during this study. |
| Placebo - 0 mg/day | Placebo comparator | Other: PlaceboThe control treatment is placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male or female subjects who are between 18 and 55 years of age inclusive
- Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements, or the subject has a Legally Authorized Representative (LAR) who can provide consent to be enrolled into the study
- If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an Intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) "double-barrier" contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL
- The subject has Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject's recorded history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0)
- The subjects should have refractory schizophrenia as defined below (should meet at least two: either a and b; or a and c; or a and b and c):
Key exclusion criteria (17 listed)
- Meets the DSM-V criteria at Screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation
- Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to Screening
- Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms or medication side effects within four (4) weeks prior to Screening
- The subject has previously received NaBen®
- History of epilepsy, major head trauma, or any neurological illness other than Tourette's syndrome which might impair the subject's cognition or psychiatric functioning per the Investigator's judgment
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 |
|---|---|---|
| NaBen®2000 mg/day or 1000 mg/day, twice daily | Drug | NaBen® - 1000 mg/day, NaBen® - 2000 mg/day |
| Placebo0 mg total, twice daily | Other | Placebo - 0 mg/day |
Primary outcome
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: 8 weeks after randomized treatment
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
9 secondary outcomes
Percent change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: 8 weeks after randomized treatment
Percentage of subjects with 20% or more reduction from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: 8 weeks after randomized treatment
Percent change in PANSS sub-scales and Marder PANSS factor scores
Time frame: 8 weeks
Percent change in Personal and Social Performance (PSP) scale
Time frame: 8 weeks
Percent change in Schizophrenia Quality of Life Scale (SQLS)
Time frame: 8 weeks
Percent change in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)
Time frame: 8 weeks
Percent change in Hamilton Depression Rating Scale (HDRS)
Time frame: 8 weeks
Serum pharmacokinetic evaluations-Maximum Plasma Concentration [Cmax]
Time frame: 8 weeks
Serum pharmacokinetic evaluations-Area Under the Curve [AUC]
Time frame: 8 weeks
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 13 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NaBen® in people with Refractory Schizophrenia, run by SyneuRx International (Taiwan) Corp at 1 site 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 16 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: looking for participants now, as of the sponsor's last update on 13 Sep 2021. 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 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 combined 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.
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?
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 Yashar Salek, MD (1-301-956-2527, yashars@amarexcro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in Positive and Negative Syndrome Scale (PANSS) total score (time frame: 8 weeks after randomized treatment). 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 13 Sep 2021.