<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/NCT04461119</url>
  </required_header>
  <id_info>
    <org_study_id>NW-3509/008/II/2019</org_study_id>
    <nct_id>NCT04461119</nct_id>
  </id_info>
  <brief_title>Study to Determine the Safety, Tolerability, and Efficacy of Evenamide in Patients With Chronic Schizophrenia</brief_title>
  <official_title>A Phase II, Randomized, 4-Week, Double-Blind, Placebo-Controlled, Multiple-Dose Study, Designed to Determine the Safety, Tolerability, EEG Effects and Preliminary Efficacy of Fixed Oral Doses of 7.5 and 15 MG BID of Evenamide in Patients With Chronic Schizophrenia Who Are Symptomatic on Their Current Second-Generation Antipsychotic Medication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Newron Pharmaceuticals SPA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Newron Pharmaceuticals SPA</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>
      This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy&#xD;
      of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic&#xD;
      schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed&#xD;
      to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed oral&#xD;
      doses of evenamide of 7.5 mg and 15 mg bid (15 and 30 mg/day) in outpatients with chronic&#xD;
      schizophrenia who are receiving treatment at constant doses of one of the following atypical&#xD;
      antipsychotics: aripiprazole, clozapine, quetiapine, olanzapine, paliperidone or risperidone.&#xD;
      Approximately 120 patients will be randomized in a 1:1:1 ratio to receive either evenamide&#xD;
      7.5 or 15 mg, or placebo, given bid.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Actual">March 13, 2021</completion_date>
  <primary_completion_date type="Actual">February 20, 2021</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability - incidence of Treatment-Emergent Adverse Events [TEAEs], Serious Adverse Events [AEs], and Adverse Events leading to discontinuation [ADOs]</measure>
    <time_frame>4 Week study</time_frame>
    <description>Comparison will be made between the evenamide and placebo groups in the proportion of patients experiencing Serious Adverse Events [SAEs], Adverse Events leading to discontinuation [ADOs] and, Treatment-Emergent Adverse Events [TEAEs].</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in Positive and Negative Syndrome Scale [PANSS] total score</measure>
    <time_frame>4 Week study</time_frame>
    <description>Efficacy measure of mean change from baseline to endpoint of Positive and Negative Syndrome Scale [PANSS] total score: this is a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Key secondary - Change from baseline in clinical global impression severity of Illness [CGI-S] score</measure>
    <time_frame>4 Week study</time_frame>
    <description>Efficacy measure by mean change from baseline top endpoint of the Clinical Global Impression Severity of Illness [CGI-S]: the investigator rates the severity of a subject's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rating at endpoint on the CGI - Change from baseline (CGI-C)</measure>
    <time_frame>4 Week study</time_frame>
    <description>Efficacy measured by Clinical Global Impression of Change [CGI-C]: 7-point scale requiring the clinician to rate how much the patient's illness has improved at endpoint relative to the baseline state (score of 1, 2, 3); CGI-C ranges from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating &quot;no change&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate plasma drug concentrations over time for evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid</measure>
    <time_frame>4 Week study</time_frame>
    <description>Determine the multiple-dose plasma concentrations of evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid, at the doses tested.&#xD;
Doses of evenamide to be evaluated in this study, compared to placebo, will be 7.5 mg bid, and 15 mg bid, with key information being collected at or near the time of the predicted maximal plasma concentration (Tmax) for evenamide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of plasma drug concentrations over time for evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid between the dosing arms 7.5 mg BID and 15.0 mg BID</measure>
    <time_frame>4 Week study</time_frame>
    <description>Determine if the PK parameters are dose proportional. Doses of evenamide to be evaluated in this study, compared to placebo, will be 7.5 mg bid, and 15 mg bid, with key information being collected at or near the time of the predicted maximal plasma concentration (Tmax) for evenamide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy - changes in daily functioning</measure>
    <time_frame>4 Week study</time_frame>
    <description>Determine the effect of evenamide, compared to placebo, on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale; The LOF is a semi-structured, clinician-administered scale of nine items. The individual items fall into four domains, with higher scores on a 5-point scale (0 - 4) reflecting better functioning. The subscales are Social Contacts (frequency and quality of social contacts), Work (quantity and quality of useful work), Symptomatology (absence of symptoms and recent hospitalization), and Function (ability to meet basic needs, fullness of life, and overall level of function). A total score is calculated as the sum of the raw scores across the nine items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy - rating score of patient satisfaction with the study medication</measure>
    <time_frame>4 Week study</time_frame>
    <description>Determine the patient's satisfaction with the study medication, compared to their previous treatment, based on improvements on the Medication Satisfaction Questionnaire (MSQ) which is a single-item, 7-point Likert-type scale for patients with schizophrenia to rate their satisfaction with their antipsychotic medication.&#xD;
The patient's response to the question &quot;Overall, how satisfied are you with your current antipsychotic medication(s)?&quot; is rated by the clinician as follows: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = very satisfied, and 7 = extremely satisfied</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Evenamide 7.5 mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evenamide capsules 7.5 mg BID for a total of 28 dosing days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evenamide 15 mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evenamide capsules 15.0 mg BID for a total of 28 dosing days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo capsules BID for a total of 28 dosing days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Evenamide</intervention_name>
    <description>oral capsules for 4 weeks of treatment</description>
    <arm_group_label>Evenamide 15 mg bid</arm_group_label>
    <arm_group_label>Evenamide 7.5 mg bid</arm_group_label>
    <other_name>NW-3509</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>oral capsules for 4 weeks of treatment</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Demographics&#xD;
&#xD;
          -  Age - 18 years, or older&#xD;
&#xD;
          -  Sex - male, or non-childbearing potential female unless practicing adequate&#xD;
             contraception&#xD;
&#xD;
        Psychiatric&#xD;
&#xD;
          -  Has a current diagnosis of schizophrenia in accordance with DSM-5.&#xD;
&#xD;
          -  Has been treated with antipsychotics for at least 2 years.&#xD;
&#xD;
          -  Has a total score on the PANSS &lt; 80.&#xD;
&#xD;
          -  Has a Clinical Global Impression - Severity of disease (CGI-S) rating of mildly,&#xD;
             moderately or moderately severely ill (score of 3, 4 or 5).&#xD;
&#xD;
          -  Needs antipsychotic treatment and is currently receiving a stable dose (minimally for&#xD;
             4 weeks prior to screening) of aripiprazole, clozapine, quetiapine, olanzapine,&#xD;
             paliperidone, or risperidone (at least 2 mg risperidone dose-equivalent)&#xD;
&#xD;
          -  Current symptoms have been stably present for at least one month&#xD;
&#xD;
        Procedural&#xD;
&#xD;
          -  Patient resides at home or in a residential care facility&#xD;
&#xD;
          -  If taking clozapine, patient agrees to blood monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Psychiatric&#xD;
&#xD;
          -  Severity of current episode of psychosis requires that the patient be hospitalized.&#xD;
             Patients who are chronically hospitalized or in psychiatric day-care, whose&#xD;
             hospitalization is for logistic reasons and not due to the severity of their illness,&#xD;
             will be eligible for the study.&#xD;
&#xD;
          -  Severity of psychosis is rated severe or higher (CGI-S of 6 or greater).&#xD;
&#xD;
          -  Known suicidal risk. A &quot;yes&quot; response on the C-SSRS Suicidal Ideation Item 4 or Item&#xD;
             5, or a &quot;yes&quot; response on any of the five C-SSRS Suicidal Behavior items, at&#xD;
             screening, or a suicide attempt within the past 6 months, excludes the patient from&#xD;
             the study.&#xD;
&#xD;
          -  Patients with a diagnosis of Treatment resistance&#xD;
&#xD;
          -  History of neuroleptic malignant syndrome, priapism.&#xD;
&#xD;
          -  Current moderate or severe tardive dyskinesia.&#xD;
&#xD;
        Medical Status&#xD;
&#xD;
          -  Abnormal epileptiform phenomena (3 per second spike and slow wave discharges) observed&#xD;
             on screening EEG. History or current diagnosis of epilepsy or seizure disorder (other&#xD;
             than febrile seizures in childhood)&#xD;
&#xD;
          -  Insulin-dependent diabetes mellitus&#xD;
&#xD;
          -  History or current diagnosis of any neurodegenerative illnesses&#xD;
&#xD;
          -  Loss of 500 ml or more of blood during the 3-month period before study enrollment,&#xD;
             e.g. as a donor&#xD;
&#xD;
        Cardiovascular&#xD;
&#xD;
          -  A current diagnosis of severe or unstable cardiovascular disease&#xD;
&#xD;
          -  Any clinically significant ECG abnormality&#xD;
&#xD;
          -  Abnormal vital signs&#xD;
&#xD;
        Laboratory abnormalities&#xD;
&#xD;
          -  Clinically significant abnormalities in routine laboratory examinations&#xD;
&#xD;
          -  History and/or presence of hepatitis B and/or C&#xD;
&#xD;
          -  Positive results from the HIV serology.&#xD;
&#xD;
          -  Positive results of the drug and alcohol tests&#xD;
&#xD;
          -  Clinically significant or unstable hypothyroidism or hyperthyroidism&#xD;
&#xD;
        Concomitant therapy&#xD;
&#xD;
          -  Treatment with SSRIs that are moderate/potent inhibitors of CYP2D6 (e.g. fluoxetine)&#xD;
&#xD;
          -  Treatment with drugs capable of inducing/inhibiting hepatic enzyme metabolism&#xD;
&#xD;
          -  Current treatment with sodium channel blockers&#xD;
&#xD;
          -  Exposure to any investigational drug within 5 weeks or 5 half-lives (whichever is&#xD;
             longer) prior to screening&#xD;
&#xD;
          -  A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar&#xD;
             to evenamide (e.g. lamotrigine, carbamazepine, oxcarbazepine, topiramate, etc.), or&#xD;
             any components of the evenamide or matching placebo capsules&#xD;
&#xD;
          -  Treatment with a drug or treatment known to cause major organ system toxicity, e.g.&#xD;
             tamoxifen, within 4 weeks, or received radiation therapy or a drug with cytotoxic&#xD;
             potential, e.g. chemotherapy, during the past year&#xD;
&#xD;
          -  Electroconvulsive therapy (ECT) or treatment with a transcranial magnetic stimulation&#xD;
             (TMS) device within 6 months prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ravi Anand, MD</last_name>
    <role>Study Director</role>
    <affiliation>Newron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Behavioral Research Specialists, LLC</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CBH Health, LLC</name>
      <address>
        <city>Gaithersburg</city>
        <state>Maryland</state>
        <zip>20877</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Clinical Research CCR</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78754</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Help Hospitals Clinical Research Department</name>
      <address>
        <city>Vijayawada</city>
        <state>Andhra Pradesh</state>
        <zip>520002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John's Medical College Hospital</name>
      <address>
        <city>Koramangala</city>
        <state>Karnataka</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mangala Hospital and Mangala Kidney Foundation, Department of Psychiatry</name>
      <address>
        <city>Mangalore</city>
        <state>Karnataka</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IQRAA Psychiatry Care and Rehabilitation Centre</name>
      <address>
        <city>Kozhikode</city>
        <state>Kerala</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deenanath Mangeshkar Hospital Research Center</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sujata Birla Hospital</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Post Graduate Institute of Medical Education and Research</name>
      <address>
        <city>Chandigarh</city>
        <state>Punjab</state>
        <zip>160012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayanand Medical College &amp; Hospital</name>
      <address>
        <city>Ludhiana</city>
        <state>Punjab</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sri Ramachandra Medical College, Department of Psychiatry</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600116</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ahana Hospital LLP</name>
      <address>
        <city>Madurai</city>
        <state>TamilNadu</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asha Hospital</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500034</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>May 17, 2021</last_update_submitted>
  <last_update_submitted_qc>May 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 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>
  <pending_results>
    <submitted>June 30, 2022</submitted>
    <returned>July 26, 2022</returned>
  </pending_results>
  <!-- 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/NCT04461119
org study id: NW-3509/008/II/2019
nct id: NCT04461119
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This 4-week study will evaluate the safety, tolerability and preliminary evidence of efficacy
      of evenamide (7.5,and 15 mg and placebo, bid) treatment in outpatients with chronic
      schizophrenia.
This is a prospective, 4-week, randomized, double-blind, placebo-controlled, study designed
      to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed oral
      doses of evenamide of 7.5 mg and 15 mg bid (15 and 30 mg/day) in outpatients with chronic
      schizophrenia who are receiving treatment at constant doses of one of the following atypical
      antipsychotics: aripiprazole, clozapine, quetiapine, olanzapine, paliperidone or risperidone.
      Approximately 120 patients will be randomized in a 1:1:1 ratio to receive either evenamide
      7.5 or 15 mg, or placebo, given bid.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Safety and tolerability - incidence of Treatment-Emergent Adverse Events [TEAEs], Serious Adverse Events [AEs], and Adverse Events leading to discontinuation [ADOs]
time frame: 4 Week study
description: Comparison will be made between the evenamide and placebo groups in the proportion of patients experiencing Serious Adverse Events [SAEs], Adverse Events leading to discontinuation [ADOs] and, Treatment-Emergent Adverse Events [TEAEs].
measure: Change from baseline in Positive and Negative Syndrome Scale [PANSS] total score
time frame: 4 Week study
description: Efficacy measure of mean change from baseline to endpoint of Positive and Negative Syndrome Scale [PANSS] total score: this is a 30-item scale that was designed to assess various symptoms of schizophrenia each rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
measure: Key secondary - Change from baseline in clinical global impression severity of Illness [CGI-S] score
time frame: 4 Week study
description: Efficacy measure by mean change from baseline top endpoint of the Clinical Global Impression Severity of Illness [CGI-S]: the investigator rates the severity of a subject's condition on a 7-point scale ranging from 1 (no symptoms) to 7 (very severe).
measure: Rating at endpoint on the CGI - Change from baseline (CGI-C)
time frame: 4 Week study
description: Efficacy measured by Clinical Global Impression of Change [CGI-C]: 7-point scale requiring the clinician to rate how much the patient's illness has improved at endpoint relative to the baseline state (score of 1, 2, 3); CGI-C ranges from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating "no change".
measure: Evaluate plasma drug concentrations over time for evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid
time frame: 4 Week study
description: Determine the multiple-dose plasma concentrations of evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid, at the doses tested.
Doses of evenamide to be evaluated in this study, compared to placebo, will be 7.5 mg bid, and 15 mg bid, with key information being collected at or near the time of the predicted maximal plasma concentration (Tmax) for evenamide.
measure: Comparison of plasma drug concentrations over time for evenamide and its major metabolite, (3-butoxy-phenyl)-acetic acid between the dosing arms 7.5 mg BID and 15.0 mg BID
time frame: 4 Week study
description: Determine if the PK parameters are dose proportional. Doses of evenamide to be evaluated in this study, compared to placebo, will be 7.5 mg bid, and 15 mg bid, with key information being collected at or near the time of the predicted maximal plasma concentration (Tmax) for evenamide.
measure: Efficacy - changes in daily functioning
time frame: 4 Week study
description: Determine the effect of evenamide, compared to placebo, on daily functioning, based on changes on the Strauss-Carpenter Level of Functioning (LOF) scale; The LOF is a semi-structured, clinician-administered scale of nine items. The individual items fall into four domains, with higher scores on a 5-point scale (0 - 4) reflecting better functioning. The subscales are Social Contacts (frequency and quality of social contacts), Work (quantity and quality of useful work), Symptomatology (absence of symptoms and recent hospitalization), and Function (ability to meet basic needs, fullness of life, and overall level of function). A total score is calculated as the sum of the raw scores across the nine items.
measure: Efficacy - rating score of patient satisfaction with the study medication
time frame: 4 Week study
description: Determine the patient's satisfaction with the study medication, compared to their previous treatment, based on improvements on the Medication Satisfaction Questionnaire (MSQ) which is a single-item, 7-point Likert-type scale for patients with schizophrenia to rate their satisfaction with their antipsychotic medication.
The patient's response to the question "Overall, how satisfied are you with your current antipsychotic medication(s)?" is rated by the clinician as follows: 1 = extremely dissatisfied, 2 = very dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = very satisfied, and 7 = extremely satisfied
arm group label: Evenamide 7.5 mg bid
arm group type: Experimental
description: Evenamide capsules 7.5 mg BID for a total of 28 dosing days
arm group label: Evenamide 15 mg bid
arm group type: Experimental
description: Evenamide capsules 15.0 mg BID for a total of 28 dosing days
arm group label: Placebo
arm group type: Placebo Comparator
description: Matching placebo capsules BID for a total of 28 dosing days
intervention type: Drug
intervention name: Evenamide
description: oral capsules for 4 weeks of treatment
arm group label: Evenamide 15 mg bid
arm group label: Evenamide 7.5 mg bid
other name: NW-3509
intervention type: Drug
intervention name: Placebo
description: oral capsules for 4 weeks of treatment
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ravi Anand, MD
role: Study Director
affiliation: Newron Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: India
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
submitted: June 30, 2022
returned: July 26, 2022