<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/NCT01667484</url>
  </required_header>
  <id_info>
    <org_study_id>102774</org_study_id>
    <nct_id>NCT01667484</nct_id>
  </id_info>
  <brief_title>Adderall XR and Processing Speed in Multiple Sclerosis (MS)</brief_title>
  <official_title>Does Adderall XR Improve Processing Speed in Cognitively Impaired MS Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>London Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>London Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis&#xD;
      (MS) and can occur independently of physical disability. It is the most common reason, along&#xD;
      with physical fatigue, for MS patients to stop working. The most frequent complaint is&#xD;
      problems with multi-tasking or thinking quickly, which corresponds to impairment in the&#xD;
      cognitive domain of processing speed. Currently there is treatment available to prevent&#xD;
      relapses and physical disability but there are no medications that have been shown to treat&#xD;
      cognitive impairment. Amphetamines have been beneficial for selective attention and&#xD;
      processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain&#xD;
      injury. This is study will determine whether Adderall XR improves objective measures of&#xD;
      processing speed and attention in MS patients impaired in this cognitive domain, by comparing&#xD;
      two doses of Adderall XR (5 and 10mg) to placebo before and after the medication is&#xD;
      administered. The results of this study will help provide data to design a larger study to&#xD;
      determine if Adderall XR, and potentially other amphetamine drugs, will help treat cognitive&#xD;
      impairment in MS patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in score of Paced Auditory Serial Addition Test (PASAT)</measure>
    <time_frame>pre and 7 hours post dose</time_frame>
    <description>measure of processing speed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Score of Symbol Digit Modalities Test (SDMT)</measure>
    <time_frame>pre and 7 hours post dose</time_frame>
    <description>measure of processing speed</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Impaired Processing Speed</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>treatment group #1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adderall XR 5mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>treatment group #2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adderal XR 10mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>treatment group #3</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adderall XR 5mg</intervention_name>
    <arm_group_label>Adderall XR 5mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adderall XR 10 mg</intervention_name>
    <arm_group_label>Adderal XR 10mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  - Males/Females who are ≥ 18 years old and ≤ 59 years old&#xD;
&#xD;
          -  Relapsing Remitting, Secondary Progressive or Primary Progressive MS, as per revised&#xD;
             McDonald's Criteria&#xD;
&#xD;
          -  Have not received corticosteroids in last thirty days or a relapse in the last ninety&#xD;
             days&#xD;
&#xD;
          -  An Expanded Disability Status Scale (EDSS) of ≤ 6.5&#xD;
&#xD;
          -  If female, must neither be pregnant nor breast-feeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  - Have evidence of other medical cause(s) of cognitive impairment&#xD;
&#xD;
          -  Have evidence of major depression as determined by a positive Beck Depression&#xD;
             Index-Fast screen ≥ 13and/or by clinician interview or evidence of severe fatigue with&#xD;
             a Fatigue Severity Scale ≥ 5.&#xD;
&#xD;
          -  Have demonstrated a hypersensitivity to amphetamines in the past&#xD;
&#xD;
          -  Have uncontrolled or labile hypertension (&gt; 135/85 mm Hg, treated or untreated)&#xD;
&#xD;
          -  Have a history of structural heart disease, including atherosclerosis or angina&#xD;
&#xD;
          -  Have a diagnosis of bipolar disorder or a history of a psychotic episode&#xD;
&#xD;
          -  The following medications are not permitted to be used within 14 days the study&#xD;
&#xD;
               1. Monoamine Oxidase Inhibitors&#xD;
&#xD;
               2. Sympathomimetics or methadone&#xD;
&#xD;
               3. Antipsychotic agents&#xD;
&#xD;
               4. Modafinil&#xD;
&#xD;
          -  The following medications are permitted if the dose has been stable for ≥ 28 days&#xD;
&#xD;
               1. Short acting benzodiazepines, qhs administration only&#xD;
&#xD;
               2. Anticonvulsants, including gabapentin and pregabalin&#xD;
&#xD;
               3. Bupropion&#xD;
&#xD;
               4. Tricyclic Antidepressants&#xD;
&#xD;
               5. Anti-spasmodics such as baclofen or tizanidine&#xD;
&#xD;
               6. Anticholinergic medication&#xD;
&#xD;
               7. Selective serotonin(-norepinephrine) reuptake inhibitors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah A Morrow, MD, MS, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Center and St. Joseph's Heathcare Center (Parkwood)</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6G 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>May 7, 2015</last_update_submitted>
  <last_update_submitted_qc>May 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>London Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Sarah Morrow</investigator_full_name>
    <investigator_title>Assistant Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>Cognitive Impairment</keyword>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>Processing Speed</keyword>
  <keyword>Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adderall</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/NCT01667484
org study id: 102774
nct id: NCT01667484
lead sponsor: 
has dmc: No
Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis
      (MS) and can occur independently of physical disability. It is the most common reason, along
      with physical fatigue, for MS patients to stop working. The most frequent complaint is
      problems with multi-tasking or thinking quickly, which corresponds to impairment in the
      cognitive domain of processing speed. Currently there is treatment available to prevent
      relapses and physical disability but there are no medications that have been shown to treat
      cognitive impairment. Amphetamines have been beneficial for selective attention and
      processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain
      injury. This is study will determine whether Adderall XR improves objective measures of
      processing speed and attention in MS patients impaired in this cognitive domain, by comparing
      two doses of Adderall XR (5 and 10mg) to placebo before and after the medication is
      administered. The results of this study will help provide data to design a larger study to
      determine if Adderall XR, and potentially other amphetamine drugs, will help treat cognitive
      impairment in MS patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in score of Paced Auditory Serial Addition Test (PASAT)
time frame: pre and 7 hours post dose
description: measure of processing speed
measure: Change in Score of Symbol Digit Modalities Test (SDMT)
time frame: pre and 7 hours post dose
description: measure of processing speed
arm group label: Placebo
arm group type: Placebo Comparator
description: treatment group #1
arm group label: Adderall XR 5mg
arm group type: Active Comparator
description: treatment group #2
arm group label: Adderal XR 10mg
arm group type: Active Comparator
description: treatment group #3
intervention type: Drug
intervention name: Adderall XR 5mg
arm group label: Adderall XR 5mg
intervention type: Drug
intervention name: Adderall XR 10 mg
arm group label: Adderal XR 10mg
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
last name: Sarah A Morrow, MD, MS, FRCPC
role: Principal Investigator
affiliation: London Health Sciences Center
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: London Health Sciences Centre
investigator full name: Sarah Morrow
investigator title: Assistant Professor of Neurology
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: Cognitive Dysfunction
mesh term: Adderall