<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/NCT01684657</url>
  </required_header>
  <id_info>
    <org_study_id>Asenapine Stuttering</org_study_id>
    <nct_id>NCT01684657</nct_id>
  </id_info>
  <brief_title>A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering</brief_title>
  <official_title>A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to find out the potential benefits and safety of&#xD;
      asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.&#xD;
&#xD;
      It is hypothesized that individuals who are randomly assigned to asenapine will have an&#xD;
      improvement in speech as compared to a placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Study transferring to another facility&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">May 2014</completion_date>
  <primary_completion_date type="Anticipated">May 2014</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stuttering Severity Instrument</measure>
    <time_frame>10 minutes</time_frame>
    <description>This is an objective measure of stuttering in which it captures verbal samples of five minutes speaking during a conversation and 5 minutes of reading a passage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression</measure>
    <time_frame>2 minutes</time_frame>
    <description>This is an evaluation of the patient by the investigator as to whether or not the subjects has improved, remained the same, or worsened while in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barnes Akathisia Scale</measure>
    <time_frame>3 minutes</time_frame>
    <description>Measures how restless the subject is during the examination.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Stuttering</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This is the comparator. Placebo will be matched to color, taste, size, and smell.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asenapine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Asenapine</intervention_name>
    <description>This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.</description>
    <arm_group_label>Asenapine</arm_group_label>
    <other_name>Saphris</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects can be enrolled in the study only if they meet all of the following criteria:&#xD;
&#xD;
          1. Subjects must satisfy DSM-IV criteria for stuttering.&#xD;
&#xD;
          2. The nature of stuttering must be developmental in origin with the onset prior to ten&#xD;
             years of age.&#xD;
&#xD;
          3. Subjects must have a score of moderate or higher on the SSI-IV. 4) Women of&#xD;
             child-bearing potential are eligible to participate as long as they are practicing a&#xD;
             medically accepted form of contraception (i.e. condom with spermicide or diaphragm,&#xD;
             oral or depot contraception, or an intrauterine device).&#xD;
&#xD;
        5)Subjects will be male or female from the ages of 18-70. 6)Subjects will be of only&#xD;
        English speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from the study for any of the following reasons:&#xD;
&#xD;
          1. Stuttering related to a known neurologic cause (e.g. head trauma, stroke).&#xD;
&#xD;
          2. Unstable medical or psychiatric illness.&#xD;
&#xD;
          3. Active substance abuse within three months prior to study inclusion.&#xD;
&#xD;
          4. Any illness that would require the concomitant use of a CNS active medication during&#xD;
             the course of the study.&#xD;
&#xD;
          5. Subjects with Parkinson's dementia or other degenerative neurologic illness.&#xD;
&#xD;
          6. Subjects who are pregnant or nursing an infant.&#xD;
&#xD;
          7. No minors (under the age of 18) will not be enrolled in this study as the research&#xD;
             with this compound in children and adolescents has not been fully performed.&#xD;
&#xD;
          8. Subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar&#xD;
             level (glucose).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gerald Maguire, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCIMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>July 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>May 19, 2014</last_update_submitted>
  <last_update_submitted_qc>May 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Gerald Maguire</investigator_full_name>
    <investigator_title>Senior Associate Dean</investigator_title>
  </responsible_party>
  <keyword>Stuttering</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stuttering</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asenapine</mesh_term>
  </intervention_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/NCT01684657
org study id: Asenapine Stuttering
nct id: NCT01684657
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this research study is to find out the potential benefits and safety of
      asenapine (Saphris®) in adults who suffer from the developmental form of stuttering.

      It is hypothesized that individuals who are randomly assigned to asenapine will have an
      improvement in speech as compared to a placebo.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Stuttering Severity Instrument
time frame: 10 minutes
description: This is an objective measure of stuttering in which it captures verbal samples of five minutes speaking during a conversation and 5 minutes of reading a passage.
measure: Clinical Global Impression
time frame: 2 minutes
description: This is an evaluation of the patient by the investigator as to whether or not the subjects has improved, remained the same, or worsened while in the study.
measure: Barnes Akathisia Scale
time frame: 3 minutes
description: Measures how restless the subject is during the examination.
arm group label: Placebo
arm group type: Placebo Comparator
description: This is the comparator. Placebo will be matched to color, taste, size, and smell.
arm group label: Asenapine
arm group type: Experimental
description: This is an atypical antipsychotic that blocks dopamine and increases serotonin. The dosage will be from 2.5 to 10mg daily throughout the study.
intervention type: Drug
intervention name: Asenapine
description: This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.
arm group label: Asenapine
other name: Saphris
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gerald Maguire, M.D.
role: Principal Investigator
affiliation: UCIMC
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Gerald Maguire
investigator title: Senior Associate Dean
mesh term: Stuttering
mesh term: Asenapine