<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/NCT01674868</url>
  </required_header>
  <id_info>
    <org_study_id>FLAN SpauldingRH</org_study_id>
    <nct_id>NCT01674868</nct_id>
  </id_info>
  <brief_title>Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke</brief_title>
  <acronym>FLAN</acronym>
  <official_title>Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Spaulding Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Spaulding Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME&#xD;
      study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the&#xD;
      effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American&#xD;
      sample of post-acute stroke patients. This trial will in addition examine the effect of&#xD;
      treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial&#xD;
      attention, as well as post-stroke fatigue and will evaluate the durability of observed&#xD;
      effects. The results of this pilot trial will be used to develop power estimates for a larger&#xD;
      trial and to evaluate recruitment and intervention completion rates for subjects in an&#xD;
      American post-acute environment. There are two additional substudies: the first will use MRI&#xD;
      to assess structural changes at the beginning and end of the intervention; the second will&#xD;
      examine the relationship of serum biomarkers of inflammation to the intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    unable to find patients meeting inclusion/exclusion criteria&#xD;
  </why_stopped>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2015</primary_completion_date>
  <phase>N/A</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>Fugl-Meyer Motor Scale (FMMS)</measure>
    <time_frame>baseline to 90 days</time_frame>
    <description>change in FMMS score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fugl-Meyer Motor Scale (FMMS)</measure>
    <time_frame>baseline to 180 days</time_frame>
    <description>change in FMMS</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Western Aphasia Battery</measure>
    <time_frame>baseline to 90 days</time_frame>
    <description>change in Western Aphasia Quotient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Inattention Test (BIT)</measure>
    <time_frame>baseline to 90 days</time_frame>
    <description>change in BIT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Inattention Test (BIT)</measure>
    <time_frame>baseline to 180 days</time_frame>
    <description>change in BIT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure</measure>
    <time_frame>baseline to discharge</time_frame>
    <description>change in FIM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity Scale</measure>
    <time_frame>baseline to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>baseline to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Aphasia Battery</measure>
    <time_frame>baseline to 180 days</time_frame>
    <description>change in Western Aphasia Quotient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>baseline to 180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity Scale</measure>
    <time_frame>baseline to 180 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Rankin Scale</measure>
    <time_frame>baseline to 90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>modified Rankin Scale</measure>
    <time_frame>baseline to 180 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Fluoxetine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will take 20 mg fluoxetine daily for 90 days after stroke</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will take one pill daily for 90 days after stroke.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fluoxetine</intervention_name>
    <description>20 mg daily for 90 days starting day 5-10 after stroke.</description>
    <arm_group_label>Fluoxetine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>subjects will take one pill po daily for 90 days.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischemic infarction within 15 days&#xD;
&#xD;
          -  Admission NIHSS item 5 score equal to or &gt;2 -Able to give informed consent, with&#xD;
             surrogate consent acceptable-&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-stroke modified Rankin Scale score equal or .3&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Taking an SSRI on admission to SRH&#xD;
&#xD;
          -  Taking a medication likely to have adverse interaction with an SSRI&#xD;
&#xD;
          -  Unable to return for follow-up testing days 90,180&#xD;
&#xD;
          -  Concurrent medial condition likely to worsen patient's functional status over next 6&#xD;
             months&#xD;
&#xD;
          -  Unable to competently participate in testing for 45min-2hrs with rest breaks&#xD;
&#xD;
          -  for MRI substudy: contraindication to MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Spaulding Rehabilitation Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>June 14, 2015</last_update_submitted>
  <last_update_submitted_qc>June 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Spaulding Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>Randie Black-Schaffer MD</investigator_full_name>
    <investigator_title>Medical Director, Stroke Program</investigator_title>
  </responsible_party>
  <keyword>stroke</keyword>
  <keyword>recovery</keyword>
  <keyword>fluoxetine</keyword>
  <keyword>aphasia</keyword>
  <keyword>neglect</keyword>
  <keyword>motor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluoxetine</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/NCT01674868
org study id: FLAN SpauldingRH
nct id: NCT01674868
lead sponsor: 
has dmc: No
This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME
      study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the
      effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American
      sample of post-acute stroke patients. This trial will in addition examine the effect of
      treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial
      attention, as well as post-stroke fatigue and will evaluate the durability of observed
      effects. The results of this pilot trial will be used to develop power estimates for a larger
      trial and to evaluate recruitment and intervention completion rates for subjects in an
      American post-acute environment. There are two additional substudies: the first will use MRI
      to assess structural changes at the beginning and end of the intervention; the second will
      examine the relationship of serum biomarkers of inflammation to the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Fugl-Meyer Motor Scale (FMMS)
time frame: baseline to 90 days
description: change in FMMS score
measure: Fugl-Meyer Motor Scale (FMMS)
time frame: baseline to 180 days
description: change in FMMS
measure: Western Aphasia Battery
time frame: baseline to 90 days
description: change in Western Aphasia Quotient
measure: Behavioral Inattention Test (BIT)
time frame: baseline to 90 days
description: change in BIT
measure: Behavioral Inattention Test (BIT)
time frame: baseline to 180 days
description: change in BIT
measure: Functional Independence Measure
time frame: baseline to discharge
description: change in FIM
measure: Fatigue Severity Scale
time frame: baseline to 90 days
measure: Beck Depression Inventory
time frame: baseline to 90 days
measure: Western Aphasia Battery
time frame: baseline to 180 days
description: change in Western Aphasia Quotient
measure: Beck Depression Inventory
time frame: baseline to 180 days
measure: Fatigue Severity Scale
time frame: baseline to 180 days
measure: modified Rankin Scale
time frame: baseline to 90 days
measure: modified Rankin Scale
time frame: baseline to 180 days
arm group label: Fluoxetine
arm group type: Experimental
description: Subjects will take 20 mg fluoxetine daily for 90 days after stroke
arm group label: placebo
arm group type: Placebo Comparator
description: Subjects will take one pill daily for 90 days after stroke.
intervention type: Drug
intervention name: fluoxetine
description: 20 mg daily for 90 days starting day 5-10 after stroke.
arm group label: Fluoxetine
intervention type: Drug
intervention name: placebo
description: subjects will take one pill po daily for 90 days.
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Spaulding Rehabilitation Hospital
investigator full name: Randie Black-Schaffer MD
investigator title: Medical Director, Stroke Program
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Fluoxetine