<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/NCT01720849</url>
  </required_header>
  <id_info>
    <org_study_id>FampyraCSS</org_study_id>
    <nct_id>NCT01720849</nct_id>
  </id_info>
  <brief_title>Efficiency of 4-aminopyridin (Fampyra) on Gait, Vision, Cognition, Fatigue and Micturation in Patients With Multiple Sclerosis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vestre Viken Hospital Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vestre Viken Hospital Trust</source>
  <brief_summary>
    <textblock>
      The aim of the study is to assess improvement in visual evoked potential, cognition, fatigue,&#xD;
      micturation and walking impairment under 3 months of Fampyra treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <primary_completion_date type="Anticipated">May 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in visual evoked potential after 2 weeks and 3 months</measure>
    <time_frame>5 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Multiple Sclerosis</condition>
  <condition>EDSS 4-7</condition>
  <arm_group>
    <arm_group_label>Fampyra group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fampyra</intervention_name>
    <description>The will be given as per normal patient treatment plan</description>
    <arm_group_label>Fampyra group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who according to the compound's Norwegian prescription guidelines are deemed&#xD;
        eligible for the study, i.e. MS patients with impaired walking as determined by an EDSS&#xD;
        4-7. They do not need a past history of optic neuritis, cognitive failure, fatigue or&#xD;
        difficulties micturating.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients who according to the compound's Norwegian prescription guidelines are deemed&#xD;
        eligible for the study, i.e. MS patients with impaired walking as determined by an EDSS&#xD;
        4-7. They do not need a past history of optic neuritis, cognitive failure, fatigue or&#xD;
        difficulties micturating.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        MS patients with contraindications to the compound according to the prescription&#xD;
        guidelines.&#xD;
&#xD;
        Patients who have been exposed to Fampyra in the past Patients with an MS attack within&#xD;
        last 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vestre Viken Helseforetak</name>
      <address>
        <city>Drammen</city>
        <zip>3004</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cecilia S Simonsen, MBChB</last_name>
      <phone>+4798673256</phone>
      <email>ceciliasimonsen@yahoo.co.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>June 29, 2015</last_update_submitted>
  <last_update_submitted_qc>June 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple 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/NCT01720849
org study id: FampyraCSS
nct id: NCT01720849
lead sponsor: 
The aim of the study is to assess improvement in visual evoked potential, cognition, fatigue,
      micturation and walking impairment under 3 months of Fampyra treatment
observational model: Cohort
time perspective: Prospective
measure: change from baseline in visual evoked potential after 2 weeks and 3 months
time frame: 5 months
arm group label: Fampyra group
intervention type: Drug
intervention name: Fampyra
description: The will be given as per normal patient treatment plan
arm group label: Fampyra group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Norway
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis