<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02261519</url>
  </required_header>
  <id_info>
    <org_study_id>SNR-04</org_study_id>
    <nct_id>NCT02261519</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Safety &amp; Efficacy of NaBen® as Add-on Treatment for Schizophrenia in Adults</brief_title>
  <official_title>An Adaptive, Phase IIb/III, Multi-center, Prospective, Randomized, Double-Blind Placebo-controlled Study of the Safety and Efficacy of NaBen® (DAAO Inhibitor), as an Add-on Treatment for Schizophrenia in Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SyneuRx International (Taiwan) Corp</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SyneuRx International (Taiwan) Corp</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen® in&#xD;
      improving the symptoms of schizophrenia in adults. NaBen® is granted Breakthrough Therapy&#xD;
      Designation by US FDA as add-on treatment for schizophrenia. The trial is designed as a&#xD;
      multi-center, prospective, randomized, placebo-controlled, in which adult subjects with&#xD;
      schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a&#xD;
      4 week run-in part, an 8 week double-blind treatment part, and a 52 week Open-Label Extension&#xD;
      part.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an adaptive, phase IIb/III, multi-center, prospective, randomized, placebo-controlled&#xD;
      study, in which adult subjects with schizophrenia will be enrolled. The study will include&#xD;
      four parts: a 2 week Screening part, a 4 week run-in part, and 8 week double-blind treatment&#xD;
      part, and a 52 week Open-Label Extension part.&#xD;
&#xD;
      Screening part of the study:&#xD;
&#xD;
      The subjects will be evaluated for eligibility during the Screening part of the study.&#xD;
&#xD;
      Enrichment run-in part of the study:&#xD;
&#xD;
      Subjects who are determined to be eligible will enter the Run-in part of the study. A total&#xD;
      of 348 Subjects will be randomized. The randomized subjects will receive 4 weeks of NaBen® or&#xD;
      Placebo accordingly. The subjects who have completed 4 weeks of randomized treatment in both&#xD;
      groups (NaBen® or Placebo) will be assessed and categorized intoresponders and&#xD;
      non-responders, based on 20% or more reduction from baseline in their PANSS total scores as&#xD;
      per the evaluations at Visit 2 and Visit 4.&#xD;
&#xD;
      Double-Blind treatment part of the study :&#xD;
&#xD;
        -  Subjects who have successfully completed the Enrichment Run-in part will enter the&#xD;
           Double- Blind treatment part of the study per below: NaBen® treated subjects: Subjects&#xD;
           will continue receiving NaBen® for another 8 weeks.&#xD;
&#xD;
        -  Placebo treated subjects:&#xD;
&#xD;
             -  Placebo Responders: Subjects will continue receiving Placebo for another 8 weeks.&#xD;
&#xD;
             -  Placebo Non-responders: Subjects will be re-randomized to receive NaBen® or Placebo&#xD;
                in a 1:1 ratio for another 8 weeks.&#xD;
&#xD;
      Open-Label Extension part of the study:&#xD;
&#xD;
      All subjects who have completed the Double-Blind part of the study will continue with the&#xD;
      Open-Label Extension part of the study to receive NaBen® for an additional 52 weeks, plus a 2&#xD;
      week follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 29, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>8 weeks after randomized treatment</time_frame>
    <description>Mean change from baseline in PANSS total score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>8 weeks after treatment</time_frame>
    <description>Percent change from baseline in PANSS total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>8 weeks after treatment</time_frame>
    <description>Percentage of subjects with 20% or more reduction from baseline in PANSS total score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PANSS sub-scale scores and Marder PANSS factor scores</measure>
    <time_frame>8 weeks after treatment</time_frame>
    <description>Percent change in PANSS sub-scale scores and Marder PANSS factor scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal and Social Performance (PSP) scale</measure>
    <time_frame>8 weeks after treatment</time_frame>
    <description>Percent change of Personal and Social Performance (PSP) scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Maintenance of treatment effect for PANSS total score</description>
  </other_outcome>
  <other_outcome>
    <measure>Personal and Social Performance (PSP) scale</measure>
    <time_frame>64 weeks</time_frame>
    <description>Maintenance of treatment effect in PSP scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Schizophrenia Quality of Life Scale (SQLS)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Percent change and maintenance of treatment effect in Schizophrenia Quality of Life Scale (SQLS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Percent change and maintenance of treatment effect in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I) for both overall and negative symptoms</description>
  </other_outcome>
  <other_outcome>
    <measure>Hamilton Depression Rating Scale (HDRS)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Percent change in Hamilton Depression Rating Scale (HDRS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum analysis</measure>
    <time_frame>12 weeks</time_frame>
    <description>Serum pharmacokinetic evaluations, DNA evaluations and neurotransmitter markers evaluations</description>
  </other_outcome>
  <other_outcome>
    <measure>Treatment-Emergent Adverse Events (TEAE)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Incidence of TEAE and incidence of withdrawals from the study due to TEAEs</description>
  </other_outcome>
  <other_outcome>
    <measure>Simpson-Angus extrapyramidal side effects (SAS) scale</measure>
    <time_frame>64 weeks</time_frame>
    <description>Percent change in Simpson-Angus extrapyramidal side effects (SAS) scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Abnormal Involuntary Movement Scale (AIMS)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Percent change in Abnormal Involuntary Movement Scale (AIMS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Barnes Akathisia Rating Scale (BARS)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Percent change in Barnes Akathisia Rating Scale (BARS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Assessment of suicidality per the Columbia-Suicide Severity Rating Scale (C-SSRS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Laboratory measurements (e.g., Hematology, Biochemistry, Urine analysis)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Changes and shifts in laboratory measurements (e.g., Hematology, Biochemistry, Urine analysis) over time</description>
  </other_outcome>
  <other_outcome>
    <measure>Vital signs (e.g., Body temperature, Heart rate, Respiration rate, Blood pressure)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Changes in vital signs (e.g., Body temperature, Heart rate, Respiration rate, Blood pressure) over time</description>
  </other_outcome>
  <other_outcome>
    <measure>Weight (e.g., BMI in kg/m2)</measure>
    <time_frame>64 weeks</time_frame>
    <description>Changes in weight (e.g., BMI in kg/m2)over time</description>
  </other_outcome>
  <other_outcome>
    <measure>Electrocardiogram (ECG) parameters</measure>
    <time_frame>64 weeks</time_frame>
    <description>Changes in Electrocardiogram (ECG) parameters over time</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">348</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>NaBen®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NaBen® is a oral tablet (500 mg), which will be taken twice daily at a total dose of 1000 mg/day during this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control treatment is placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NaBen®</intervention_name>
    <description>500 mg twice daily (1000 mg total)</description>
    <arm_group_label>NaBen®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0 mg twice daily (0 mg total)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male/female subjects between 18 and 45 years of age&#xD;
&#xD;
          2. If female and not infertile (defined below), the subject must agree for the duration&#xD;
             of the study to use one of the following forms of contraception 1) systemic hormonal&#xD;
             treatment 2) an Intrauterine device (IUD) which was implanted at least 2 months prior&#xD;
             to screening or 3) &quot;double-barrier&quot; contraception (condom, diaphragm and spermicide&#xD;
             are each considered a barrier). Females are considered to be infertile if they are&#xD;
             either a) surgically sterile or b) have had spontaneous amenorrhea for at least the&#xD;
             last 2 years and at least 2 years after the onset of amenorrhea while not receiving&#xD;
             hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater&#xD;
             than 40 mIU/mL and an estradiol level less than 30 pg/mL&#xD;
&#xD;
          3. Subject is capable of providing informed consent and is willing to sign the ICF prior&#xD;
             to study Screening and agrees to comply with the study protocol requirements&#xD;
&#xD;
          4. Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on&#xD;
             subject's history and confirmed by psychiatric evaluation and MINI International&#xD;
             Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0&#xD;
             (MINI, Version 7.0)&#xD;
&#xD;
          5. The subject is outpatient with no hospitalization for worsening of schizophrenia&#xD;
             within 3 months of the screening.If the subject is hospitalized during the study for&#xD;
             worsening of schizophrenia symptoms the subject will be withdrawn from the study&#xD;
&#xD;
          6. The subject's schizophrenia condition is clinically stable with residual symptoms.&#xD;
             Residual symptoms will be defined as a total score of ≤110 and ≥ 60 of PANSS per Visit&#xD;
             1 evaluations&#xD;
&#xD;
          7. An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to&#xD;
             screening into the study and expected to remain unchanged during the study (longer for&#xD;
             depot or long-acting antipsychotics: ten (10) months for Aripiprazole and&#xD;
             Paliperidone; six (6) months for Olanzapine pamoate monohydrate; and at least 6 times&#xD;
             duration of the reported half life or minimum four (4) months for other depot or&#xD;
             long-acting antipsychotics)&#xD;
&#xD;
          8. In good general physical health and without clinically significant abnormalities in&#xD;
             physical exam, neurological exam and laboratory assessments (urine/blood routine,&#xD;
             biochemical tests and ECG) which would exclude the subject from the study in the&#xD;
             opinion of the Investigator. For ALT and AST, clinically significant is defined as&#xD;
             above twice the upper limit of normal.&#xD;
&#xD;
          9. BMI between 17 and 35 inclusive&#xD;
&#xD;
         10. Subject has a negative routine urine illicit drug screening test (including heroin,&#xD;
             amphetamines (including MDMA/ecstasy), cocaine, cannabis or PCP)&#xD;
&#xD;
         11. The subject has a caregiver or some other identified responsible person (e.g., family&#xD;
             member, social worker, caseworker or nurse) as determined by the Investigator and per&#xD;
             the local regulations. The identified caregiver should be considered reliable by the&#xD;
             Investigator and per the local regulations in providing support to the subject to help&#xD;
             ensure compliance with study treatment, study visits and protocol procedures who&#xD;
             preferably is also able to provide input helpful for completing study rating scales&#xD;
&#xD;
         12. The subject must not be a danger to self or others per the Investigator's judgment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Meets the DSM-IV or V criteria at screening for intellectual disability, dissociative&#xD;
             disorder, bipolar disorder, major depressive disorder, schizoaffective disorder,&#xD;
             schizophreniform disorder, autistic disorder, primary substance-induced psychotic&#xD;
             disorder, dementia, or any other comorbid mental disorders that in the opinion of the&#xD;
             Investigator may interfere with study conduct and results interpretation&#xD;
&#xD;
          2. Subjects whose illness was resistant to antipsychotics according to prior trials of&#xD;
             two different antipsychotics of adequate dose&#xD;
&#xD;
          3. Subjects who have been previously treated with or are receiving clozapine&#xD;
&#xD;
          4. Initiation or dose change of lithium, antidepressant or other mood stabilizers within&#xD;
             16 weeks prior to screening&#xD;
&#xD;
          5. Initiation or dose change of benzodiazepines or sleep medications due to worsening of&#xD;
             schizophrenia symptoms or medication side effects, or any other psychotropic&#xD;
             medications within 4 weeks prior to screening&#xD;
&#xD;
          6. The subject has previously received NaBen®&#xD;
&#xD;
          7. History of epilepsy, major head trauma, or any neurological illness other than&#xD;
             Tourette's syndrome which might impair the subject's cognition or psychiatric&#xD;
             functioning per the investigator's judgment&#xD;
&#xD;
          8. History of allergic reaction to sodium benzoate&#xD;
&#xD;
          9. Serious medical illnesses such as end-stage renal disease, liver failure or heart&#xD;
             failure that, in the opinion of the Investigator, may interfere with the conduct of&#xD;
             the study&#xD;
&#xD;
         10. Any significant gastrointestinal disorders that, in the opinion of the investigator,&#xD;
             markedly alter the absorption, metabolism or elimination of sodium benzoate&#xD;
&#xD;
         11. Any movement disorders with a total score higher than 6 on SAS scale, or more than 2&#xD;
             on any items of the AIMS scale&#xD;
&#xD;
         12. Current substance abuse, or history of meeting criteria for moderate or severe&#xD;
             substance abuse (including alcohol, but excluding nicotine and caffeine) in the past&#xD;
             six (6) months prior to screening&#xD;
&#xD;
         13. Female subjects who are pregnant (as confirmed by urine pregnancy test performed at&#xD;
             Screening Visit) or are breast feeding&#xD;
&#xD;
         14. History of cancer not in remission for the last 3 years except for basal cell&#xD;
             carcinoma and squamous cell carcinoma&#xD;
&#xD;
         15. Participation in a clinical trial within 3 months prior to screening or more than two&#xD;
             clinical trials within 12 months&#xD;
&#xD;
         16. Electroconvulsive Therapy within 6 months prior to screening&#xD;
&#xD;
         17. The subject started a new non-medication treatment for schizophrenia or other&#xD;
             psychiatric condition within the last 3 months prior to screening&#xD;
&#xD;
         18. The subject's anti-EPS medications dose or regimen has changed within 2 weeks prior to&#xD;
             screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yashar Salek, MD</last_name>
    <phone>1-301-956-2527</phone>
    <email>yashars@amarexcro.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Felicia Yao</last_name>
    <phone>886-2-77422699</phone>
    <phone_ext>136</phone_ext>
    <email>felicia.yao@syneurx.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact SyneuRx International Corp.</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felicia Yao</last_name>
      <phone>027-742-2699</phone>
      <phone_ext>136</phone_ext>
      <email>felicia.yao@syneurx.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>September 10, 2021</last_update_submitted>
  <last_update_submitted_qc>September 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02261519
org study id: SNR-04
nct id: NCT02261519
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The proposed Phase IIb/III study is designed to evaluate the safety and efficacy of NaBen® in
      improving the symptoms of schizophrenia in adults. NaBen® is granted Breakthrough Therapy
      Designation by US FDA as add-on treatment for schizophrenia. The trial is designed as a
      multi-center, prospective, randomized, placebo-controlled, in which adult subjects with
      schizophrenia will be enrolled. The study will include four parts: a 2 week Screening part, a
      4 week run-in part, an 8 week double-blind treatment part, and a 52 week Open-Label Extension
      part.
This is an adaptive, phase IIb/III, multi-center, prospective, randomized, placebo-controlled
      study, in which adult subjects with schizophrenia will be enrolled. The study will include
      four parts: a 2 week Screening part, a 4 week run-in part, and 8 week double-blind treatment
      part, and a 52 week Open-Label Extension part.

      Screening part of the study:

      The subjects will be evaluated for eligibility during the Screening part of the study.

      Enrichment run-in part of the study:

      Subjects who are determined to be eligible will enter the Run-in part of the study. A total
      of 348 Subjects will be randomized. The randomized subjects will receive 4 weeks of NaBen® or
      Placebo accordingly. The subjects who have completed 4 weeks of randomized treatment in both
      groups (NaBen® or Placebo) will be assessed and categorized intoresponders and
      non-responders, based on 20% or more reduction from baseline in their PANSS total scores as
      per the evaluations at Visit 2 and Visit 4.

      Double-Blind treatment part of the study :

        -  Subjects who have successfully completed the Enrichment Run-in part will enter the
           Double- Blind treatment part of the study per below: NaBen® treated subjects: Subjects
           will continue receiving NaBen® for another 8 weeks.

        -  Placebo treated subjects:

             -  Placebo Responders: Subjects will continue receiving Placebo for another 8 weeks.

             -  Placebo Non-responders: Subjects will be re-randomized to receive NaBen® or Placebo
                in a 1:1 ratio for another 8 weeks.

      Open-Label Extension part of the study:

      All subjects who have completed the Double-Blind part of the study will continue with the
      Open-Label Extension part of the study to receive NaBen® for an additional 52 weeks, plus a 2
      week follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Positive and Negative Syndrome Scale (PANSS)
time frame: 8 weeks after randomized treatment
description: Mean change from baseline in PANSS total score
measure: Positive and Negative Syndrome Scale (PANSS)
time frame: 8 weeks after treatment
description: Percent change from baseline in PANSS total score
measure: Positive and Negative Syndrome Scale (PANSS)
time frame: 8 weeks after treatment
description: Percentage of subjects with 20% or more reduction from baseline in PANSS total score
measure: PANSS sub-scale scores and Marder PANSS factor scores
time frame: 8 weeks after treatment
description: Percent change in PANSS sub-scale scores and Marder PANSS factor scores
measure: Personal and Social Performance (PSP) scale
time frame: 8 weeks after treatment
description: Percent change of Personal and Social Performance (PSP) scale
measure: Positive and Negative Syndrome Scale (PANSS)
time frame: 64 weeks
description: Maintenance of treatment effect for PANSS total score
measure: Personal and Social Performance (PSP) scale
time frame: 64 weeks
description: Maintenance of treatment effect in PSP scale
measure: Schizophrenia Quality of Life Scale (SQLS)
time frame: 64 weeks
description: Percent change and maintenance of treatment effect in Schizophrenia Quality of Life Scale (SQLS)
measure: Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I)
time frame: 64 weeks
description: Percent change and maintenance of treatment effect in Clinical Global Impression-Severity (CGI-S) and -improvement (CGI-I) for both overall and negative symptoms
measure: Hamilton Depression Rating Scale (HDRS)
time frame: 64 weeks
description: Percent change in Hamilton Depression Rating Scale (HDRS)
measure: Serum analysis
time frame: 12 weeks
description: Serum pharmacokinetic evaluations, DNA evaluations and neurotransmitter markers evaluations
measure: Treatment-Emergent Adverse Events (TEAE)
time frame: 64 weeks
description: Incidence of TEAE and incidence of withdrawals from the study due to TEAEs
measure: Simpson-Angus extrapyramidal side effects (SAS) scale
time frame: 64 weeks
description: Percent change in Simpson-Angus extrapyramidal side effects (SAS) scale
measure: Abnormal Involuntary Movement Scale (AIMS)
time frame: 64 weeks
description: Percent change in Abnormal Involuntary Movement Scale (AIMS)
measure: Barnes Akathisia Rating Scale (BARS)
time frame: 64 weeks
description: Percent change in Barnes Akathisia Rating Scale (BARS)
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
time frame: 64 weeks
description: Assessment of suicidality per the Columbia-Suicide Severity Rating Scale (C-SSRS)
measure: Laboratory measurements (e.g., Hematology, Biochemistry, Urine analysis)
time frame: 64 weeks
description: Changes and shifts in laboratory measurements (e.g., Hematology, Biochemistry, Urine analysis) over time
measure: Vital signs (e.g., Body temperature, Heart rate, Respiration rate, Blood pressure)
time frame: 64 weeks
description: Changes in vital signs (e.g., Body temperature, Heart rate, Respiration rate, Blood pressure) over time
measure: Weight (e.g., BMI in kg/m2)
time frame: 64 weeks
description: Changes in weight (e.g., BMI in kg/m2)over time
measure: Electrocardiogram (ECG) parameters
time frame: 64 weeks
description: Changes in Electrocardiogram (ECG) parameters over time
arm group label: NaBen®
arm group type: Experimental
description: NaBen® is a oral tablet (500 mg), which will be taken twice daily at a total dose of 1000 mg/day during this study.
arm group label: Placebo
arm group type: Placebo Comparator
description: The control treatment is placebo.
intervention type: Drug
intervention name: NaBen®
description: 500 mg twice daily (1000 mg total)
arm group label: NaBen®
intervention type: Other
intervention name: Placebo
description: 0 mg twice daily (0 mg total)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Yashar Salek, MD
phone: 1-301-956-2527
email: yashars@amarexcro.com
last name: Felicia Yao
phone: 886-2-77422699
phone ext: 136
email: felicia.yao@syneurx.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia