<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/NCT03793868</url>
  </required_header>
  <id_info>
    <org_study_id>17-002396</org_study_id>
    <nct_id>NCT03793868</nct_id>
  </id_info>
  <brief_title>Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis</brief_title>
  <official_title>Perampanel Single Ascending Dose Transcranial Magnetic Stimulation Biomarker Study in Amyotrophic Lateral Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate if transcranial magnetic stimulation can be used as a biomarker in Amyotrophic&#xD;
      Lateral sclerosis (ALS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To measure the effect on motor threshold (MT) by transcranial magnetic stimulation (TMS)&#xD;
      after a single dose of perampanel at two dose levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2018</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>This is a pilot study for the assessment of transcranial magnetic stimulation as a biomarker for ALS and to obtain information to guide a dose selection for future biomarker driven Phase 2 studies of Perampanel in ALS.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Matching placebo</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Motor threshold (MT)</measure>
    <time_frame>at 4 hours post dose</time_frame>
    <description>Transcranial Magnetic stimulation motor threshold change from baseline</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Amyotrophic Lateral Sclerosis</condition>
  <arm_group>
    <arm_group_label>Low dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perampanel 4mg PO x1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Receiving placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perampanel 8 mg PO x1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Perampanel</intervention_name>
    <description>Oral tablet</description>
    <arm_group_label>High dose</arm_group_label>
    <arm_group_label>Low dose</arm_group_label>
    <other_name>Fycompa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo (not drug)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A probable laboratory supported, probable or definitive ALS diagnosis by revised El&#xD;
             Escorial criteria.&#xD;
&#xD;
          2. Sporadic or familial ALS.&#xD;
&#xD;
          3. Ages of 18-70.&#xD;
&#xD;
          4. Agree to use reliable contraception&#xD;
&#xD;
          5. Randomization will occur after a baseline MT has been established; any subject in whom&#xD;
             a MT cannot be established will be excluded.&#xD;
&#xD;
          6. Caregiver willing to report adverse behavioral events. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of epilepsy.&#xD;
&#xD;
          2. Significant laboratory abnormality (AST or alanine aminotransferase &gt;3x upper limit of&#xD;
             normal, or glomerular filtration rate &lt;60)&#xD;
&#xD;
          3. History of aggressive behavior.&#xD;
&#xD;
          4. Subject unwilling to abstain from alcohol for 2 weeks after each dosing.&#xD;
&#xD;
          5. History of drug abuse in the last 5 years&#xD;
&#xD;
          6. Other severe medical conditions, including psychiatric conditions, which would cause&#xD;
             an increased risk in the opinion of the investigator, including but not limited to&#xD;
             renal failure and liver failure.&#xD;
&#xD;
          7. Skull defect or other physical contraindication for TMS&#xD;
&#xD;
          8. Pacemaker or implanted defibrillator&#xD;
&#xD;
          9. Inability to take study capsule by mouth&#xD;
&#xD;
        Females only: Subject is pregnant [as confirmed by a positive serum human chorionic&#xD;
        gonadotropin (hCG) test for females of reproductive potential (FRP) only], subject is&#xD;
        breastfeeding, or subject is of reproductive potential and does not agree to follow use of&#xD;
        reliable contraception.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bjorn E Oskarsson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>September 26, 2020</last_update_submitted>
  <last_update_submitted_qc>September 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Bjorn E. Oskarsson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Motor Neuron Disease</mesh_term>
    <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
    <mesh_term>Sclerosis</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/NCT03793868
org study id: 17-002396
nct id: NCT03793868
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
To evaluate if transcranial magnetic stimulation can be used as a biomarker in Amyotrophic
      Lateral sclerosis (ALS).
To measure the effect on motor threshold (MT) by transcranial magnetic stimulation (TMS)
      after a single dose of perampanel at two dose levels.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a pilot study for the assessment of transcranial magnetic stimulation as a biomarker for ALS and to obtain information to guide a dose selection for future biomarker driven Phase 2 studies of Perampanel in ALS.
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Matching placebo
measure: Motor threshold (MT)
time frame: at 4 hours post dose
description: Transcranial Magnetic stimulation motor threshold change from baseline
arm group label: Low dose
arm group type: Experimental
description: Perampanel 4mg PO x1
arm group label: Placebo
arm group type: Placebo Comparator
description: Receiving placebo
arm group label: High dose
arm group type: Experimental
description: Perampanel 8 mg PO x1
intervention type: Drug
intervention name: Perampanel
description: Oral tablet
arm group label: High dose
arm group label: Low dose
other name: Fycompa
intervention type: Other
intervention name: Placebo
description: Placebo (not drug)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Bjorn E Oskarsson, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Bjorn E. Oskarsson
investigator title: Principal Investigator
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Sclerosis