<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/NCT02966808</url>
  </required_header>
  <id_info>
    <org_study_id>RETROFAM</org_study_id>
    <nct_id>NCT02966808</nct_id>
  </id_info>
  <brief_title>Retrospective Observational Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis</brief_title>
  <acronym>RETROFAM</acronym>
  <official_title>Retrospective Study About Long-term Effect of Fampridine in Patients With Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Gregorio Marañon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Gregorio Marañon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in almost&#xD;
      93% of patients in the first 15 years of the disease, being a clear problem for their normal&#xD;
      living. Nevertheless, therapeutic options for this symptom are few and optimal for only some&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mechanism of action of fampridine has a direct effect on mobility and it´s based on&#xD;
      voltage-dependent potassium channels functioning, causing an improvement of conductivity of&#xD;
      action-potential in neurons. This is why nowadays is the only approved drug to treat walking&#xD;
      and mobility problems in MS. Results obtained after Phase III randomized clinical trials&#xD;
      proved improvement in walking ability measured using the Timed 25 Walking Feet test (T25WF).&#xD;
&#xD;
      There are few studies regarding fampridine effects on symptoms different from mobility. The&#xD;
      ENABLE Phase VI study found the first data related with the long-term impact of this&#xD;
      treatment in physical and psychological function in patients according to their own&#xD;
      perception. Results from this study indicated that, after one year of treatment, patients&#xD;
      perceived a sustained benefit in their health, both physical and psychologically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in speed of processing</measure>
    <time_frame>change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.</time_frame>
    <description>Symbol Digit Modality Test (SDMT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in attention</measure>
    <time_frame>change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.</time_frame>
    <description>Paced Auditory Serial Addition Test (PASAT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in walking ability</measure>
    <time_frame>change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.</time_frame>
    <description>Timed 25 walking feet (T25WF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in perception of walking ability</measure>
    <time_frame>change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.</time_frame>
    <description>Multiple Sclerosis Walking Scale 12 (MSWS12)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in fatigue</measure>
    <time_frame>change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.</time_frame>
    <description>Multiple Sclerosis Fatigue Impact Scale (MSFIS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in quality of life</measure>
    <time_frame>change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.</time_frame>
    <description>Multiple Sclerosis Quality of Life 54 (MSQoL-54)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Clinical measures</arm_group_label>
    <description>multiple sclerosis patients in treatment with fampridine</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cognitive and behavioural questionnaires</intervention_name>
    <arm_group_label>Clinical measures</arm_group_label>
    <other_name>PASAT, SDMT, MSQoL-54, MSFIS, T25WF, MSWS12</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with multiple sclerosis elegible for fampridine treatment according to drug lable.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with multiple sclerosis with fampridine treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Luisa Martínez-Ginés, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neurologist</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yolanda Higueras, PhD</last_name>
    <email>yolanda.higueras@iisgm.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>María Luisa Martínez-Ginés, MD</last_name>
    <email>marisamgines@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yolanda Higueras, PhD</last_name>
      <phone>+34654129540</phone>
      <email>yolandahigueras@googlemail.com</email>
    </contact>
    <contact_backup>
      <last_name>María Luisa Martínez-Ginés, MD</last_name>
      <phone>+34914269610</phone>
      <email>marisamgines@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>February 9, 2021</last_update_submitted>
  <last_update_submitted_qc>February 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Gregorio Marañon</investigator_affiliation>
    <investigator_full_name>María Luisa Martinez Gines</investigator_full_name>
    <investigator_title>Medical Doctor in Neurology</investigator_title>
  </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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02966808
org study id: RETROFAM
nct id: NCT02966808
lead sponsor: 
has dmc: No
Mobility problems in multiple sclerosis (MS) is a frequent symptom. It might appear in almost
      93% of patients in the first 15 years of the disease, being a clear problem for their normal
      living. Nevertheless, therapeutic options for this symptom are few and optimal for only some
      patients.
The mechanism of action of fampridine has a direct effect on mobility and it´s based on
      voltage-dependent potassium channels functioning, causing an improvement of conductivity of
      action-potential in neurons. This is why nowadays is the only approved drug to treat walking
      and mobility problems in MS. Results obtained after Phase III randomized clinical trials
      proved improvement in walking ability measured using the Timed 25 Walking Feet test (T25WF).

      There are few studies regarding fampridine effects on symptoms different from mobility. The
      ENABLE Phase VI study found the first data related with the long-term impact of this
      treatment in physical and psychological function in patients according to their own
      perception. Results from this study indicated that, after one year of treatment, patients
      perceived a sustained benefit in their health, both physical and psychologically.
observational model: Cohort
time perspective: Retrospective
measure: Change in speed of processing
time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
description: Symbol Digit Modality Test (SDMT)
measure: change in attention
time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
description: Paced Auditory Serial Addition Test (PASAT)
measure: change in walking ability
time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
description: Timed 25 walking feet (T25WF)
measure: change in perception of walking ability
time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
description: Multiple Sclerosis Walking Scale 12 (MSWS12)
measure: change in fatigue
time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
description: Multiple Sclerosis Fatigue Impact Scale (MSFIS)
measure: change in quality of life
time frame: change from baseline to 15 days, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months and 36 moths after initiating treatment.
description: Multiple Sclerosis Quality of Life 54 (MSQoL-54)
arm group label: Clinical measures
description: multiple sclerosis patients in treatment with fampridine
intervention type: Behavioral
intervention name: cognitive and behavioural questionnaires
arm group label: Clinical measures
other name: PASAT, SDMT, MSQoL-54, MSFIS, T25WF, MSWS12
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Maria Luisa Martínez-Ginés, MD
role: Principal Investigator
affiliation: Neurologist
last name: Yolanda Higueras, PhD
email: yolanda.higueras@iisgm.com
last name: María Luisa Martínez-Ginés, MD
email: marisamgines@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Gregorio Marañon
investigator full name: María Luisa Martinez Gines
investigator title: Medical Doctor in Neurology
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided