<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20161212031362N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-05-10</date_registration>
      <primary_sponsor>Iranian Center of Neurological Research</primary_sponsor>
      <public_title>Evaluating the short-term effect of Fampridine on cognitive function in Multiple sclerosis patients</public_title>
      <acronym></acronym>
      <scientific_title>Assessing the effect of Fampridine on cognitive outcome measures in multiple sclerosis patients: A double-blind, randomized, placebo-controlled study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-05-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74578</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of the study is achieved by block randomization of patients in to blocks of 12 (6 in Fampridine group and 6 in Placebo group) by Web-based Randomization. each space in any given block is given a code consisting of 3 random digits or letters (fk8 for example). These codes are written on the drug labels as well and are given to patients enrolled in the study. The study coordinators will use a list containing the order of these codes, and according to this list and in sequence of entry into the study, they will deliver the vial to the participants, Blinding description: Study participants and other health care providers, including medical staff involved in the study, are blinded to the allocation of patients into either the Fampridine or placebo group. Medications and placebos are administered to patients by a clinical observer who remains unaware of the contents of the medication vials.</study_design>
      <phase>3</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Patients are given Placebo tablet for 12 weeks which is identical in shape and other physical characteristics as well as packaging. Drugs are instructed to be used every 12 hours, similar to the intervention group. Patients are instructed to take the tablet without food, on an empty stomach. Intervention 2: Intervention group: Patients are given Fampridine 10mg (Dalphyra, Cinnagen) for 12 weeks (instructed to be taken every 12 hours one in the morning and one in the afternoon). Patients are instructed to take the tablet without food, on an empty stomach.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sadra Hbibi Moini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>9, Ladan Aly, Valiasr St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1961713635</zip>
        <telephone>+98 21 2270 7188</telephone>
        <email>sadrahabibi@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Hossein Harirchian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini hospital, Keshavarz Blvd.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۱۹۷۳۳۱۴۱</zip>
        <telephone>+98 21 6694 8899</telephone>
        <email>harirchm@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Definite MS diagnosis according to McDonald 2017 criteria
Age between 18-60 years
SDMT score below the 20th percentile of normative values</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of relapse within 2 months
History of seizure/epilepsy
History of major depression or psychosis
Reluctance to enroll in the study
Moderate or higher renal dysfunction (eGFR=&lt; 50mL/min/1.73m2)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Patients are given Placebo tablet for 12 weeks which is identical in shape and other physical characteristics as well as packaging. Drugs are instructed to be used every 12 hours, similar to the intervention group. Patients are instructed to take the tablet without food, on an empty stomach</i_keyword>
      <i_keyword>Intervention group: Patients are given Fampridine 10mg (Dalphyra, Cinnagen) for 12 weeks (instructed to be taken every 12 hours one in the morning and one in the afternoon). Patients are instructed to take the tablet without food, on an empty stomach.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in (SDMT) Symbol Digit Modalities Test score (improvement of equal or greater than 4 points or more than 20% increase compared to baseline score is considered a meaningful change). Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: SDMT test which is scored based on the number of correct answers in 90 seconds.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in California Verbal Learning Test (CVLT) test score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: CVLT test.</sec_outcome>
      <sec_outcome>Change in Brief Visuospatial Memory Test (BVMT) test score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: BVMT test is performed three times consecutively and the sum of three scores is considered as total BVMT score.</sec_outcome>
      <sec_outcome>Change in Twelve Item MS Walking Scale (MSWS-12) test score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: MSWS-12 questionnaire.</sec_outcome>
      <sec_outcome>Timed 25-Foot Walk (T25-FW) test score improvement. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: Timed 25-Foot Walk (T25-FW).</sec_outcome>
      <sec_outcome>Improvement in 9-Hole Peg Test (9-HPT) score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: 9-Hole Peg Test (9-HPT) is performed twice for each hand and mean of 4 tests is considered total score.</sec_outcome>
      <sec_outcome>Modified Fatigue Impact Scale (MFIS) score change. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: Modified Fatigue Impact Scale (MFIS) questionnaire.</sec_outcome>
      <sec_outcome>Change in Insomnia Severity Index (ISI) questionnaire score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: Insomnia Severity Index (ISI) questionnaire.</sec_outcome>
      <sec_outcome>Change in Hospital Anxiety and Depression Scale (HADS) score. Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: Hospital Anxiety and Depression Scale (HADS) questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iranian Center of Neurological Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-16</approval_date>
        <contact_name>Ethic Committee of Neuroscience Institute , Tehran University of Medical Sciences</contact_name>
        <contact_address>Neuroscience Institute, Imam Khomeini Hospital complex; Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
