<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/NCT03272802</url>
  </required_header>
  <id_info>
    <org_study_id>Isfahan ALS Registery</org_study_id>
    <nct_id>NCT03272802</nct_id>
  </id_info>
  <brief_title>Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)</brief_title>
  <official_title>Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease that causes the death of&#xD;
      30,000 affected individual every year. Complex nature and unknown pathogenesis of this&#xD;
      disease are 2 major reasons for failure of therapeutic interventions. Edaravone is a free&#xD;
      radical scavenger that slows down functional decline and prevents from disease progression in&#xD;
      ALS patients. FDA newly approved this drug in these patients (2017/5/5). In this study,&#xD;
      investigators aimed to assess the treatment effect of this newly approved drug in patients&#xD;
      with ALS in a representative Iranian population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 16, 2017</start_date>
  <completion_date type="Anticipated">September 16, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 16, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional evaluation of patient's muscle strength.</measure>
    <time_frame>At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.</time_frame>
    <description>Manual Muscle Testing (MMT) will be used to evaluate functional muscle strength. This procedure evaluates the strength of some proximal and distal muscles of each limb and also the neck region.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional status of the patient.</measure>
    <time_frame>At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.</time_frame>
    <description>Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to evaluate functional status of the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life in the patients</measure>
    <time_frame>At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.</time_frame>
    <description>Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) will be used to assess Quality of life in the patients. The Persian version of this questionare will be used in this study.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <arm_group>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALS patients who receive the usual treatment option (Riluzole) for this disease and Edaravone. Instructions:&#xD;
Tab. Rilutek 50 mg PO q12hr on empty stomach.&#xD;
Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 14 days in the first 28 day cycle.&#xD;
Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 10 days in the following 28 day cycles after the first cycle (for 11 cycles).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ALS patients who receive the usual treatment option (Riluzole) for this disease.&#xD;
Instructions:&#xD;
1. Tab. Rilutek 50 mg PO q12hr on empty stomach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Edaravone</intervention_name>
    <description>Edaravone is a free radical scavenger. this drug showed desirable effects like slowing decline of physical function by 33 percent in previous studies.</description>
    <arm_group_label>Case group</arm_group_label>
    <other_name>Radicut</other_name>
    <other_name>RADICAVA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Riluzole</intervention_name>
    <description>Riluzole is a treatment option for amyotrophic lateral sclerosis. The occurrence of ventilator-dependence or tracheostomy is delayed in selected patients who treated with this drug.</description>
    <arm_group_label>Case group</arm_group_label>
    <arm_group_label>Control group</arm_group_label>
    <other_name>Rilutek</other_name>
    <other_name>Teglutik</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed as definite or probable ALS according to El Escorial Criteria.&#xD;
&#xD;
          2. ALS patients who are graded as mild or moderate according to ALS Health State Scale.&#xD;
&#xD;
          3. Forced vital capacity of at least 80%&#xD;
&#xD;
          4. Desire of the patient to participate in this study and Signing Written Informed&#xD;
             Consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Incidence of drug's side effects that requires discontinuation of the drug&#xD;
             (Edaravone's side effects: Acute kidney injury, Acute allergic reactions, DIC,&#xD;
             Thrombocytopenia, Leukopenia).&#xD;
&#xD;
          2. Desire of the patient to discontinue participating in this study.&#xD;
&#xD;
          3. the patient starts another drug or herb for ALS during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>EMG Department, Alzahra Hospital</name>
      <address>
        <city>Isfahan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <reference>
    <citation>Shamshiri H, Fatehi F, Davoudi F, Mir E, Pourmirza B, Abolfazli R, Etemadifar M, Harirchian MH, Gharagozli K, Ayromlou H, Basiri K, Zamani B, Rohani M, Sedighi B, Roudbari A, Delavar Kasmaei H, Nikkhah K, Ranjbar Naeini A, Nafissi S. Amyotrophic lateral sclerosis progression: Iran-ALS clinical registry, a multicentre study. Amyotroph Lateral Scler Frontotemporal Degener. 2015;16(7-8):506-11. doi: 10.3109/21678421.2015.1074698. Epub 2015 Oct 5.</citation>
    <PMID>26437387</PMID>
  </reference>
  <reference>
    <citation>Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, Hamada C, Kondo K, Yoneoka T, Akimoto M, Yoshino H; Edaravone ALS Study Group. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):610-7. doi: 10.3109/21678421.2014.959024. Epub 2014 Oct 6.</citation>
    <PMID>25286015</PMID>
  </reference>
  <reference>
    <citation>Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/S1474-4422(17)30115-1. Epub 2017 May 15.</citation>
    <PMID>28522181</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Alireza Eishi Oskouei</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Amyotrophic Lateral Sclerosis</keyword>
  <keyword>Edaravone</keyword>
  <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>Neuromuscular Diseases</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Riluzole</mesh_term>
    <mesh_term>Edaravone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03272802
org study id: Isfahan ALS Registery
nct id: NCT03272802
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease that causes the death of
      30,000 affected individual every year. Complex nature and unknown pathogenesis of this
      disease are 2 major reasons for failure of therapeutic interventions. Edaravone is a free
      radical scavenger that slows down functional decline and prevents from disease progression in
      ALS patients. FDA newly approved this drug in these patients (2017/5/5). In this study,
      investigators aimed to assess the treatment effect of this newly approved drug in patients
      with ALS in a representative Iranian population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Functional evaluation of patient's muscle strength.
time frame: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.
description: Manual Muscle Testing (MMT) will be used to evaluate functional muscle strength. This procedure evaluates the strength of some proximal and distal muscles of each limb and also the neck region.
measure: functional status of the patient.
time frame: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.
description: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to evaluate functional status of the patient.
measure: Quality of life in the patients
time frame: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.
description: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) will be used to assess Quality of life in the patients. The Persian version of this questionare will be used in this study.
arm group label: Case group
arm group type: Experimental
description: ALS patients who receive the usual treatment option (Riluzole) for this disease and Edaravone. Instructions:
Tab. Rilutek 50 mg PO q12hr on empty stomach.
Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 14 days in the first 28 day cycle.
Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 10 days in the following 28 day cycles after the first cycle (for 11 cycles).
arm group label: Control group
arm group type: Active Comparator
description: ALS patients who receive the usual treatment option (Riluzole) for this disease.
Instructions:
1. Tab. Rilutek 50 mg PO q12hr on empty stomach.
intervention type: Drug
intervention name: Edaravone
description: Edaravone is a free radical scavenger. this drug showed desirable effects like slowing decline of physical function by 33 percent in previous studies.
arm group label: Case group
other name: Radicut
other name: RADICAVA
intervention type: Drug
intervention name: Riluzole
description: Riluzole is a treatment option for amyotrophic lateral sclerosis. The occurrence of ventilator-dependence or tracheostomy is delayed in selected patients who treated with this drug.
arm group label: Case group
arm group label: Control group
other name: Rilutek
other name: Teglutik
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Iran, Islamic Republic of
citation: Shamshiri H, Fatehi F, Davoudi F, Mir E, Pourmirza B, Abolfazli R, Etemadifar M, Harirchian MH, Gharagozli K, Ayromlou H, Basiri K, Zamani B, Rohani M, Sedighi B, Roudbari A, Delavar Kasmaei H, Nikkhah K, Ranjbar Naeini A, Nafissi S. Amyotrophic lateral sclerosis progression: Iran-ALS clinical registry, a multicentre study. Amyotroph Lateral Scler Frontotemporal Degener. 2015;16(7-8):506-11. doi: 10.3109/21678421.2015.1074698. Epub 2015 Oct 5.
PMID: 26437387
citation: Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, Hamada C, Kondo K, Yoneoka T, Akimoto M, Yoshino H; Edaravone ALS Study Group. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):610-7. doi: 10.3109/21678421.2014.959024. Epub 2014 Oct 6.
PMID: 25286015
citation: Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/S1474-4422(17)30115-1. Epub 2017 May 15.
PMID: 28522181
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Alireza Eishi Oskouei
investigator title: MD
mesh term: Motor Neuron Disease
mesh term: Amyotrophic Lateral Sclerosis
mesh term: Neuromuscular Diseases
mesh term: Sclerosis
mesh term: Riluzole
mesh term: Edaravone
sharing ipd: No