<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/NCT04487275</url>
  </required_header>
  <id_info>
    <org_study_id>23-299</org_study_id>
    <nct_id>NCT04487275</nct_id>
  </id_info>
  <brief_title>MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)</brief_title>
  <acronym>MLC901</acronym>
  <official_title>MLC901 for Moderate to Severe Traumatic Brain Injury: Pilot, Randomized, Double-Masked, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ali Amini Harandi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Beheshti University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be&#xD;
      enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code)&#xD;
      or placebo capsules three times per day over 6 months. Evaluation of patients will be carried&#xD;
      out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale&#xD;
      (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be&#xD;
      evaluated by comparing these two scores between the 2 groups at follow-up visits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 20, 2018</start_date>
  <completion_date type="Anticipated">October 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>functional outcome 1</measure>
    <time_frame>at baseline</time_frame>
    <description>functional outcome scales of GOS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional outcome 2</measure>
    <time_frame>at 3rd month post-injury</time_frame>
    <description>functional outcome scales of GOS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional outcome 3</measure>
    <time_frame>at 6th month post-injury</time_frame>
    <description>functional outcome scales of GOS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional outcome 4</measure>
    <time_frame>at baseline</time_frame>
    <description>functional outcome scales of MRS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional outcome 5</measure>
    <time_frame>at 3rd month post-injury</time_frame>
    <description>functional outcome scales of MRS</description>
  </primary_outcome>
  <primary_outcome>
    <measure>functional outcome 6</measure>
    <time_frame>at 6th month post-injury</time_frame>
    <description>functional outcome scales of MRS</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Drug</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MLC901 capsules three times per day over 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules three times per day over 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MLC901 or Placebo</intervention_name>
    <description>groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months</description>
    <arm_group_label>Drug</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age between 15 and 65&#xD;
&#xD;
          -  non-penetrating moderate (Glasgow Coma Scale score [GCS] 9-12) or severe (GCS 3-8)&#xD;
             traumatic brain&#xD;
&#xD;
          -  injury less than 24 hrs from traumatic injury&#xD;
&#xD;
          -  anticipated intensive care unit length of stay at least 48 hrs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  GCS = 3 and fixed dilated pupils or penetrating injury&#xD;
&#xD;
          -  coexisting injury or medical conditions which could adversely affect our study outcome&#xD;
             measures&#xD;
&#xD;
          -  dependence for everyday activities before the injury&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
&#xD;
          -  known allergy to any of MLC901 components&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ali Amini Harandi, MD</last_name>
    <phone>+989126026214</phone>
    <email>amini_alli@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brain Mapping Research Center</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Amini Harandi, MD</last_name>
      <phone>+989126026214</phone>
      <email>amini_alli@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Beheshti University</investigator_affiliation>
    <investigator_full_name>Ali Amini Harandi</investigator_full_name>
    <investigator_title>Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT04487275
org study id: 23-299
nct id: NCT04487275
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be
      enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code)
      or placebo capsules three times per day over 6 months. Evaluation of patients will be carried
      out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale
      (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be
      evaluated by comparing these two scores between the 2 groups at follow-up visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: functional outcome 1
time frame: at baseline
description: functional outcome scales of GOS
measure: functional outcome 2
time frame: at 3rd month post-injury
description: functional outcome scales of GOS
measure: functional outcome 3
time frame: at 6th month post-injury
description: functional outcome scales of GOS
measure: functional outcome 4
time frame: at baseline
description: functional outcome scales of MRS
measure: functional outcome 5
time frame: at 3rd month post-injury
description: functional outcome scales of MRS
measure: functional outcome 6
time frame: at 6th month post-injury
description: functional outcome scales of MRS
arm group label: Drug
arm group type: Experimental
description: MLC901 capsules three times per day over 6 months
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo capsules three times per day over 6 months
intervention type: Drug
intervention name: MLC901 or Placebo
description: groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months
arm group label: Drug
arm group label: Placebo
other name: Placebo
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ali Amini Harandi, MD
phone: +989126026214
email: amini_alli@yahoo.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Shahid Beheshti University
investigator full name: Ali Amini Harandi
investigator title: Prof
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
sharing ipd: Undecided