<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/NCT01714661</url>
  </required_header>
  <id_info>
    <org_study_id>EVP-6124-015</org_study_id>
    <secondary_id>2012-003208-10</secondary_id>
    <nct_id>NCT01714661</nct_id>
  </id_info>
  <brief_title>Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Parallel, 26-Week, Phase 3 Study of 2 Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo as an Adjunctive Pro-cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FORUM Pharmaceuticals Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syneos Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NeuroCog Trials, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>FORUM Pharmaceuticals Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the&#xD;
      cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic&#xD;
      therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) to Day 182</measure>
    <time_frame>Baseline to Day 182 or Early Termination</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in the Schizophrenia Cognition Rating Scale (SCoRs) to Day 182</measure>
    <time_frame>Baseline to Day 182 or Early Terminiation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia</measure>
    <time_frame>Screening (Day -42 to Day -15) to Day 182 or Early Terminiation</time_frame>
    <description>All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood/chemistry/urinalysis)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Positive and Negative Symptom Scale (PANSS) to Day 182</measure>
    <time_frame>Baseline to Day 182 or Early Termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Clinical Global Impression-Severity (CGI-S) to Day 182</measure>
    <time_frame>Baseline to Day 182 or Early Termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the Clinical Global Impression Change Scale (CGI-C) to Day 182</measure>
    <time_frame>Baseline to Day 182 or Early Termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the EuroQOL-5D (EQ-5D) to Day 182</measure>
    <time_frame>Baseline to Day 182 or Early Termination</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">753</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Impaired Cognition</condition>
  <arm_group>
    <arm_group_label>EVP-6124, low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>low dose, Tablet, Once Daily, Day 1 through Day 182</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EVP-6124, high dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>high dose, Tablet, Once Daily, Day 1 through Day 182</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EVP-6124, Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, Tablet, Once Daily, Day -14 through Day 182</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EVP-6124</intervention_name>
    <description>Arms 1, 2</description>
    <arm_group_label>EVP-6124, high dose</arm_group_label>
    <arm_group_label>EVP-6124, low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Arm 3</description>
    <arm_group_label>EVP-6124, Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 50 years of age, inclusive&#xD;
&#xD;
          -  Signed informed consent, indicating that the subject understands the purpose of and&#xD;
             procedures required for the study, before the initiation of any study specific&#xD;
             procedures. Subjects who are unable to provide informed consent will not be included&#xD;
             in the study.&#xD;
&#xD;
          -  Resides in a stable living situation, according to the investigator's judgment, and&#xD;
             must have an identified informant who should be consistent throughout the study. If&#xD;
             possible, the informant should accompany the subject or be available for in person&#xD;
             ratings at the screening, baseline (Day 1), and final study visits. In person&#xD;
             informant ratings on all relevant study visits are preferred whenever possible.&#xD;
             However, if the informant is not available for in person ratings, telephone interview&#xD;
             is acceptable. The informant must be available for a telephone interview throughout&#xD;
             the study at all visits. As long as both the informant visit and subject visit are&#xD;
             within the study visit windows, it is not necessary that they occur on the same day.&#xD;
             The informant must interact with the subject at least 2 times a week.&#xD;
&#xD;
          -  Diagnosis of Schizophrenia of at least 3 years duration. This diagnosis can be&#xD;
             established utilizing the SCID-I, direct clinical assessments, family, informants, and&#xD;
             confirmation of diagnosis from clinical sources. These may include medical records,&#xD;
             confirmation of diagnosis by treating clinician through telephone contact, or written&#xD;
             confirmation from treating clinic. If the listed sources are not available, other&#xD;
             sources of diagnostic confirmation may also be acceptable after discussion with the&#xD;
             medical monitor.&#xD;
&#xD;
          -  Treated with atypical antipsychotic drug (in any approved dosage form) other than&#xD;
             Clozapine at a stable dose for at least 8 weeks prior to screening and be clinically&#xD;
             stable; the subject must remain clinically stable (in the opinion of the principal&#xD;
             investigator) through randomization. The use of up to 2 atypical antipsychotic drugs&#xD;
             is permitted, as long as in the opinion of the investigator, the second medication is&#xD;
             not required to control treatment-resistant or intractable psychotic symptoms. No&#xD;
             subject will be washed off antipsychotic therapy to become eligible for this study.&#xD;
&#xD;
          -  Schizophrenia clinical symptom burden severity defined by the following: a Brief&#xD;
             Psychiatric Rating Scale (BPRS) Conceptual Disorganization item score ≤ 4; and a BPRS&#xD;
             Hallucinatory Behavior item score ≤ 5, or an Unusual Thought Content item score ≤ 5.&#xD;
             Either Hallucinatory Behavior or Unusual Thought Content, but not both, may have a&#xD;
             score of 6 (but not &gt; 6).&#xD;
&#xD;
          -  Simpson-Angus Scale (SAS) total score ≤ 6&#xD;
&#xD;
          -  Calgary Depression Scale for Schizophrenia (CDSS) total score ≤ 10&#xD;
&#xD;
          -  General health status acceptable for participation in a 26-week clinical study&#xD;
&#xD;
          -  Fertile, sexually active subjects (men and women) must use an effective method of&#xD;
             contraception during the study&#xD;
&#xD;
          -  Fluency (oral and written) in the language in which the standardized tests will be&#xD;
             administered&#xD;
&#xD;
          -  The ability to refrain from using any tobacco or other nicotine-containing products&#xD;
             for at least 30 minutes before any cognitive testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospitalization within 12 weeks before screening or during the screening period, or&#xD;
             change of antipsychotic medication or dose within 8 weeks before screening or during&#xD;
             the screening period.&#xD;
&#xD;
          -  Participation in another therapeutic (medication administration) clinical study within&#xD;
             the past 2 months.&#xD;
&#xD;
          -  Psychiatric hospitalization or incarcerations due to breakthrough symptoms or acute&#xD;
             exacerbations for a period of 3 months before screening. Subjects with a recent&#xD;
             &quot;social&quot; hospitalization or incarceration may be entered into screening after&#xD;
             consultation with the medical monitor&#xD;
&#xD;
          -  Likelihood, in the opinion of the investigator, that either the subject or informant&#xD;
             will be unable to complete a 26-week study&#xD;
&#xD;
          -  Treatment with prohibited antipsychotic drug, and/or treatment with more than 2&#xD;
             permitted antipsychotic drugs. Treatment with a first-generation antipsychotic drug&#xD;
             (typical antipsychotic) is prohibited unless it is administered at a low dose after&#xD;
             discussion with the medical monitor&#xD;
&#xD;
          -  Current treatment with any anticholinergic agent&#xD;
&#xD;
          -  Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)&#xD;
             criteria met for alcohol abuse within the past 3 months or substance abuse (other than&#xD;
             nicotine) within the last 6 months before screening&#xD;
&#xD;
          -  Significant suicide risk as defined by 1) suicidal ideation as endorsed on items 4 or&#xD;
             5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past year; 2)&#xD;
             suicidal behavior detected by the C-SSRS during the past 2 years, or 3) psychiatric&#xD;
             interview and examination&#xD;
&#xD;
          -  Stroke within 6 months before screening, history of brain tumor, subdural hematoma, or&#xD;
             other clinically significant neurological condition, head trauma with loss of&#xD;
             consciousness within 12 months before screening&#xD;
&#xD;
          -  Monoamine oxidase inhibitor antidepressants or tricyclic medications used in&#xD;
             antidepressant doses are excluded. Other antidepressant medications are allowed if the&#xD;
             subject has been treated with a stable dose for at least 3 months before screening&#xD;
&#xD;
          -  Immunosuppressants, mood stabilizers, chronic use of a sedative hypnotic drug, chronic&#xD;
             intake of clinically significant doses of opioid containing analgesics or any current&#xD;
             methadone treatment all in the judgment of the investigator may be permitted depending&#xD;
             on the circumstance&#xD;
&#xD;
          -  Use of Central Nervous System(CNS) stimulants&#xD;
&#xD;
          -  Nicotine therapy (including patches), varenicline (Chantix), or similar therapeutic&#xD;
             agent within the last six months before screening&#xD;
&#xD;
          -  Use of a benzodiazepine medication is allowed if the subject has not had a change in&#xD;
             medication or dose for at least 3 months. For subjects prescribed benzodiazepines,&#xD;
             short-acting benzodiazepines are to be used whenever possible. Use of longer-acting&#xD;
             benzodiazepines may be acceptable if prior authorization is obtained from the medical&#xD;
             monitor. When possible, benzodiazepines should not be administered within 3 hours&#xD;
             before cognitive testing. The use of more than one sedative-hypnotic medication is not&#xD;
             allowed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bellflower</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Costa Mesa</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Culver City</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Downey</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Escondido</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orange</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lauderhill</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Orange City</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>O'Fallon</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cedarhurst</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Conshohocken</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norristown</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Plata</city>
        <state>Buenos Aires</state>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Caba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cordoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mendoza</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Itapira</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rio de Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Penticton</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chatham</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Achim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dusseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Freiburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mittweida</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Munchen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Regebsburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stralsund</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wiesbaden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mexico</city>
        <state>D.F</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Monterrey</city>
        <state>Neuvo Leon</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gdansk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Torun</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tuszyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Talagi</city>
        <state>Arkangelsk region</state>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint-Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stavropol</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Belgrade</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kragujevac</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nis</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Novi Knezevac</city>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mataro</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salamanca</city>
        <state>Castilla y Leon</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zamora</city>
        <state>Castilla y Leon</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alcorcon</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coslada</city>
        <state>Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Donetsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ivano-Frankivsk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kharkiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyiv</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lugansk</city>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Serbia</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>May 2, 2016</last_update_submitted>
  <last_update_submitted_qc>May 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Cognition</keyword>
  <keyword>Cognition Impairment</keyword>
  <keyword>Alpha-7 nAChR</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT01714661
org study id: EVP-6124-015
secondary id: 2012-003208-10
nct id: NCT01714661
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the
      cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic
      therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change from Baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) to Day 182
time frame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in the Schizophrenia Cognition Rating Scale (SCoRs) to Day 182
time frame: Baseline to Day 182 or Early Terminiation
measure: Safety and Tolerability of EVP-6124 or Placebo in Subjects with Schizophrenia
time frame: Screening (Day -42 to Day -15) to Day 182 or Early Terminiation
description: All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood/chemistry/urinalysis)
measure: Change from Baseline in the Positive and Negative Symptom Scale (PANSS) to Day 182
time frame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in the Clinical Global Impression-Severity (CGI-S) to Day 182
time frame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in the Clinical Global Impression Change Scale (CGI-C) to Day 182
time frame: Baseline to Day 182 or Early Termination
measure: Change from Baseline in the EuroQOL-5D (EQ-5D) to Day 182
time frame: Baseline to Day 182 or Early Termination
arm group label: EVP-6124, low dose
arm group type: Experimental
description: low dose, Tablet, Once Daily, Day 1 through Day 182
arm group label: EVP-6124, high dose
arm group type: Experimental
description: high dose, Tablet, Once Daily, Day 1 through Day 182
arm group label: EVP-6124, Placebo
arm group type: Placebo Comparator
description: Placebo, Tablet, Once Daily, Day -14 through Day 182
intervention type: Drug
intervention name: EVP-6124
description: Arms 1, 2
arm group label: EVP-6124, high dose
arm group label: EVP-6124, low dose
intervention type: Drug
intervention name: Placebo
description: Arm 3
arm group label: EVP-6124, Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
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country: Argentina
country: Australia
country: Brazil
country: Canada
country: Germany
country: Mexico
country: Poland
country: Russian Federation
country: Serbia
country: Singapore
country: Spain
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Cognitive Dysfunction