<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/NCT02259361</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-13-0380-AA-CTIL</org_study_id>
    <nct_id>NCT02259361</nct_id>
  </id_info>
  <brief_title>Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS</brief_title>
  <official_title>Efficacy of Sustained-release Oral Dalfampridine on Upper Extremity Function in Patients With Multiple Sclerosis: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effects of sustained-release oral dalfampridine in the treatment of&#xD;
      upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized&#xD;
      pilot study half of participants will dalfampridine, while the other half will receive a&#xD;
      placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dalfampridine (ampyra), a drug with a mechanism for symptomatic management of MS among blocks&#xD;
      potassium channels on demyelinated neurons, allows normal electrical conduction.&#xD;
&#xD;
      Dalfampridine has recently been found to be associated with improvements in visual function,&#xD;
      strength, ambulation, fatigue, and endurance in individuals with MS.&#xD;
&#xD;
      Although this medication has a widespread effect, its influence on upper extremity function&#xD;
      has never been investigated in a double blind randomized case control study.&#xD;
&#xD;
      Following the fact that during the disease course, approximately 3 out of 4 multiple&#xD;
      sclerosis patients encounter upper limb dysfunction the primary objective of this study will&#xD;
      be to investigate the efficacy of sustained-release oral dalfampridine on upper extremity&#xD;
      function in patients with MS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <phase>Phase 4</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>Nine-Hole Peg Test</measure>
    <time_frame>Changes in the Nine-Hole Peg Test from Baseline to end of Second week</time_frame>
    <description>The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nine-Hole Peg Test</measure>
    <time_frame>Changes in the Nine-Hole Peg Test from Baseline to end of first week</time_frame>
    <description>The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nine-Hole Peg Test</measure>
    <time_frame>Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase</time_frame>
    <description>The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Box and Block test</measure>
    <time_frame>Changes in the Box and Block Test from Baseline to end of Second week</time_frame>
    <description>The box and blocks test (BBT) examines manual dexterity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and Block test</measure>
    <time_frame>Changes in the Box and Block Test from Baseline to end of first week</time_frame>
    <description>The box and blocks test (BBT) examines manual dexterity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Box and Block test</measure>
    <time_frame>Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase</time_frame>
    <description>The box and blocks test (BBT) examines manual dexterity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric grip force and motor fatigue</measure>
    <time_frame>Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week</time_frame>
    <description>Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd., USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric grip force and motor fatigue</measure>
    <time_frame>Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week</time_frame>
    <description>Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Isometric grip force and motor fatigue</measure>
    <time_frame>Changes in the Isometric grip force and motor fatigue tests from end of second week to follow up 2-weeks after end of intervention phase</time_frame>
    <description>Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory evaluation</measure>
    <time_frame>Changes in the Sensory evaluation Test from Baseline to end of Second week</time_frame>
    <description>The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory evaluation</measure>
    <time_frame>Changes in the Sensory evaluation Test from Baseline to end of first week</time_frame>
    <description>The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensory evaluation</measure>
    <time_frame>Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase</time_frame>
    <description>The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)</measure>
    <time_frame>Changes in the DASH Test from Baseline to end of Second week</time_frame>
    <description>The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)</measure>
    <time_frame>Changes in the DASH Test from Baseline to end of first week</time_frame>
    <description>The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)</measure>
    <time_frame>Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase</time_frame>
    <description>The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: Sustained-release oral dalfampridine, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sustained-release oral dalfampridine</intervention_name>
    <description>One Sustained-release oral dalfampridine; 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.</description>
    <arm_group_label>Experimental</arm_group_label>
    <other_name>Prolonged-release Fampridine</other_name>
    <other_name>Ampyra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Active comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient must have the ability to understand the purpose and risks of the study&#xD;
             provide a signed and dated informed consent and authorize confidential health&#xD;
             information to be examined in accordance with national and local subject privacy&#xD;
             regulations.&#xD;
&#xD;
          2. The patient must have been diagnosed with clinically definite MS, at the time of&#xD;
             informed consent.&#xD;
&#xD;
          3. The patient must be between 18-70 years of age, inclusive, at the time of informed&#xD;
             consent.&#xD;
&#xD;
          4. The patient must have scored between 50 and 90 on the upper limb Motricity Index test,&#xD;
             at the time of informed consent. This test evaluates strength during three essential&#xD;
             movements (pinch grasp, elbow flexion and shoulder abduction). The selected score&#xD;
             range criteria determine patients who suffer a moderate decline in function abilities&#xD;
             of the upper limb.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Onset of multiple sclerosis exacerbation within 60 days of screening.&#xD;
&#xD;
          2. History of seizures or evidence of epileptic form activity found on a screened&#xD;
             electroencephalogram.&#xD;
&#xD;
          3. Changes in concomitant medications to avoid related changes in multiple sclerosis&#xD;
             symptoms during the study.&#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>Anat Achiron, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Multiple Sclerosis Center, Sheba Medical Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Shlomo Noy, MD, PhD</last_name>
    <phone>972-3-5305284</phone>
    <email>Shlomo.noy@sheba.health.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alon Kalron, PhD</last_name>
    <phone>972-2-2436839</phone>
    <email>alkalron@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Multiple Sclerosis Center</name>
      <address>
        <city>Tel-hashomer</city>
        <state>Ramat-gan</state>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Alon Kalron, PhD</last_name>
      <phone>972-52-2436839</phone>
      <email>alkalron@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Johansson S, Ytterberg C, Claesson IM, Lindberg J, Hillert J, Andersson M, Widen Holmqvist L, von Koch L. High concurrent presence of disability in multiple sclerosis. Associations with perceived health. J Neurol. 2007 Jun;254(6):767-73. doi: 10.1007/s00415-006-0431-5. Epub 2007 Apr 2.</citation>
    <PMID>17401746</PMID>
  </reference>
  <reference>
    <citation>Judge SI, Bever CT Jr. Potassium channel blockers in multiple sclerosis: neuronal Kv channels and effects of symptomatic treatment. Pharmacol Ther. 2006 Jul;111(1):224-59. doi: 10.1016/j.pharmthera.2005.10.006. Epub 2006 Feb 9.</citation>
    <PMID>16472864</PMID>
  </reference>
  <reference>
    <citation>Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.</citation>
    <PMID>19249634</PMID>
  </reference>
  <reference>
    <citation>van Diemen HA, Polman CH, van Dongen TM, van Loenen AC, Nauta JJ, Taphoorn MJ, van Walbeek HK, Koetsier JC. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992 Aug;32(2):123-30. doi: 10.1002/ana.410320203.</citation>
    <PMID>1510353</PMID>
  </reference>
  <reference>
    <citation>Stefoski D, Davis FA, Fitzsimmons WE, Luskin SS, Rush J, Parkhurst GW. 4-Aminopyridine in multiple sclerosis: prolonged administration. Neurology. 1991 Sep;41(9):1344-8. doi: 10.1212/wnl.41.9.1344.</citation>
    <PMID>1891078</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 5, 2014</last_update_submitted>
  <last_update_submitted_qc>October 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2014</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>4-Aminopyridine</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/NCT02259361
org study id: SHEBA-13-0380-AA-CTIL
nct id: NCT02259361
lead sponsor: 
has dmc: No
This study evaluates the effects of sustained-release oral dalfampridine in the treatment of
      upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized
      pilot study half of participants will dalfampridine, while the other half will receive a
      placebo.
Dalfampridine (ampyra), a drug with a mechanism for symptomatic management of MS among blocks
      potassium channels on demyelinated neurons, allows normal electrical conduction.

      Dalfampridine has recently been found to be associated with improvements in visual function,
      strength, ambulation, fatigue, and endurance in individuals with MS.

      Although this medication has a widespread effect, its influence on upper extremity function
      has never been investigated in a double blind randomized case control study.

      Following the fact that during the disease course, approximately 3 out of 4 multiple
      sclerosis patients encounter upper limb dysfunction the primary objective of this study will
      be to investigate the efficacy of sustained-release oral dalfampridine on upper extremity
      function in patients with MS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Nine-Hole Peg Test
time frame: Changes in the Nine-Hole Peg Test from Baseline to end of Second week
description: The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
measure: Nine-Hole Peg Test
time frame: Changes in the Nine-Hole Peg Test from Baseline to end of first week
description: The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
measure: Nine-Hole Peg Test
time frame: Changes in the Nine-Hole Peg Test from end of second week to follow up 2-weeks after end of intervention phase
description: The Nine-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function
measure: Box and Block test
time frame: Changes in the Box and Block Test from Baseline to end of Second week
description: The box and blocks test (BBT) examines manual dexterity
measure: Box and Block test
time frame: Changes in the Box and Block Test from Baseline to end of first week
description: The box and blocks test (BBT) examines manual dexterity
measure: Box and Block test
time frame: Changes in the Box and Block Test from end of second week to follow up 2-weeks after end of intervention phase
description: The box and blocks test (BBT) examines manual dexterity
measure: Isometric grip force and motor fatigue
time frame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of Second week
description: Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd., USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction
measure: Isometric grip force and motor fatigue
time frame: Changes in the Isometric grip force and motor fatigue tests from baseline to end of first week
description: Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction
measure: Isometric grip force and motor fatigue
time frame: Changes in the Isometric grip force and motor fatigue tests from end of second week to follow up 2-weeks after end of intervention phase
description: Peak isometric grip force (in NM) and isometric fatigue index will be determined by a hand-held dynamometer (Biometrics Ltd.,USA). The hand-held dynamometer is a medical device used to assess grip strength in functional assessment and in initial and ongoing evaluation of patients with hand dysfunction
measure: Sensory evaluation
time frame: Changes in the Sensory evaluation Test from Baseline to end of Second week
description: The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
measure: Sensory evaluation
time frame: Changes in the Sensory evaluation Test from Baseline to end of first week
description: The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
measure: Sensory evaluation
time frame: Changes in the Sensory evaluation Test from end of second week to follow up 2-weeks after end of intervention phase
description: The two-point discrimination test will be used to determine tactile sensation. Light-touch and pressure-sensation thresholds will be determined using monofilaments
measure: Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
time frame: Changes in the DASH Test from Baseline to end of Second week
description: The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5
measure: Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
time frame: Changes in the DASH Test from Baseline to end of first week
description: The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5
measure: Patient rating scale - Disabilities of the Arm, Shoulder and Hand (DASH)
time frame: Changes in the DASH Test from end of second week to follow up 2-weeks after end of intervention phase
description: The DASH (http://www.dash.iwh.on.ca/) has 30 items grouped into one scale aiming to measure 'physical function and symptoms' in people with disorders of the upper limb.15 Items are scored from 1 (no difficulty) to 5 (unable). A total 'disability/symptom' score is generated by summing items, and averaging to produce a mean item score between 1 and 5
arm group label: Experimental
arm group type: Active Comparator
description: Intervention: Sustained-release oral dalfampridine, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) for 14 consecutive days.
intervention type: Drug
intervention name: Sustained-release oral dalfampridine
description: One Sustained-release oral dalfampridine; 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
arm group label: Experimental
other name: Prolonged-release Fampridine
other name: Ampyra
intervention type: Drug
intervention name: Placebo
description: Placebo, 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
arm group label: Placebo
other name: Active comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Anat Achiron, MD, PhD
role: Study Director
affiliation: Multiple Sclerosis Center, Sheba Medical Hospital
last name: Shlomo Noy, MD, PhD
phone: 972-3-5305284
email: Shlomo.noy@sheba.health.gov.il
last name: Alon Kalron, PhD
phone: 972-2-2436839
email: alkalron@gmail.com
facility: 
contact: 
country: Israel
citation: Johansson S, Ytterberg C, Claesson IM, Lindberg J, Hillert J, Andersson M, Widen Holmqvist L, von Koch L. High concurrent presence of disability in multiple sclerosis. Associations with perceived health. J Neurol. 2007 Jun;254(6):767-73. doi: 10.1007/s00415-006-0431-5. Epub 2007 Apr 2.
PMID: 17401746
citation: Judge SI, Bever CT Jr. Potassium channel blockers in multiple sclerosis: neuronal Kv channels and effects of symptomatic treatment. Pharmacol Ther. 2006 Jul;111(1):224-59. doi: 10.1016/j.pharmthera.2005.10.006. Epub 2006 Feb 9.
PMID: 16472864
citation: Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8. doi: 10.1016/S0140-6736(09)60442-6.
PMID: 19249634
citation: van Diemen HA, Polman CH, van Dongen TM, van Loenen AC, Nauta JJ, Taphoorn MJ, van Walbeek HK, Koetsier JC. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992 Aug;32(2):123-30. doi: 10.1002/ana.410320203.
PMID: 1510353
citation: Stefoski D, Davis FA, Fitzsimmons WE, Luskin SS, Rush J, Parkhurst GW. 4-Aminopyridine in multiple sclerosis: prolonged administration. Neurology. 1991 Sep;41(9):1344-8. doi: 10.1212/wnl.41.9.1344.
PMID: 1891078
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
mesh term: 4-Aminopyridine