<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/NCT02263924</url>
  </required_header>
  <id_info>
    <org_study_id>2013-CRC-001-03</org_study_id>
    <nct_id>NCT02263924</nct_id>
  </id_info>
  <brief_title>Stroke and Tocotrienol: Unique Role in Neuroprotection</brief_title>
  <acronym>SATURN</acronym>
  <official_title>Phase III, Single Centre, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial to Evaluate the Efficacy and Safety of Oral Vitamin E (Mixed Tocotrienol) for 6 Months in Patients With Moderate Acute Ischemic Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seberang Jaya Clinical Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Research Centre Hospital Taiping</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Universiti Sains Malaysia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seberang Jaya Clinical Research Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase III, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial&#xD;
      to evaluate the efficacy and safety of oral Vitamin E (Mixed Tocotrienol) for 6 months in&#xD;
      patients with moderate ischemic stroke.&#xD;
&#xD;
      150 patients will be recruited and randomized to receive either placebo or mixed tocotrienol&#xD;
      200mg twice a day for 6 months. Patients will be followed up and assessed on their functional&#xD;
      recovery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2015</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>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>
    <intervention_model_description>Patients will be randomized to receive either placebo or investigational drug (mixed tocotrienols dietary supplement) for 6 months.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Rankin Score</measure>
    <time_frame>6th Month</time_frame>
    <description>Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Score</measure>
    <time_frame>3rd month</time_frame>
    <description>Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Barthel Index</measure>
    <time_frame>6th months</time_frame>
    <description>• Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIHSS</measure>
    <time_frame>before dosing and at 6th month</time_frame>
    <description>Reduction in NIHSS at the end of 6 months of treatment from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite score (MRS, NIHSS, mBI)</measure>
    <time_frame>6th month</time_frame>
    <description>Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS &lt;6, and mBI at least 95</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Score</measure>
    <time_frame>3rd month</time_frame>
    <description>Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Rankin Score</measure>
    <time_frame>6th month</time_frame>
    <description>Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI - Brain lesion volume</measure>
    <time_frame>6th month</time_frame>
    <description>Change in stroke lesion volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-36</measure>
    <time_frame>6th month</time_frame>
    <description>quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CLOX and TMT Parts A &amp; B</measure>
    <time_frame>6th month</time_frame>
    <description>Improvement in the score of CLOX and TMT Parts A &amp; B at the end of 24-weeks of treatment from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event monitoring</measure>
    <time_frame>6 months</time_frame>
    <description>Adverse event outcomes in both groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>Experimental: Tocotrienol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mixed tocotrienol 200mg twice a day for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (for tocotrienol)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo capsules, 1 capsule twice a day for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Tocotrienol</intervention_name>
    <description>Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months</description>
    <arm_group_label>Experimental: Tocotrienol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo capsules</intervention_name>
    <description>Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months</description>
    <arm_group_label>Placebo (for tocotrienol)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Adult patients within 1-10 days ischaemic stroke of moderate severity (NIHSS 6-20)&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 35 years old and above.&#xD;
&#xD;
          2. Subject will be included within the time frame of 1-10 days after the first onset of&#xD;
             acute cerebral ischaemic stroke with NIHSS between 6 - 20.&#xD;
&#xD;
          3. Subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical&#xD;
             conditions.&#xD;
&#xD;
          4. Subject has a modified Rankin Scale from 2-4.&#xD;
&#xD;
          5. Subject has a clinical stroke diagnosis according to WHO stroke diagnosis.&#xD;
&#xD;
          6. Subject is willing to attend at least four sessions of physiotherapy during the study&#xD;
             or as deemed needed by the physiotherapist&#xD;
&#xD;
          7. Subjects or his/her legally acceptable representative is willing to provide written&#xD;
             informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI&#xD;
&#xD;
          2. Recurrent stroke or previous hospitalisation due to suspected cerebrovascular event.&#xD;
&#xD;
          3. Severe stroke as assessed clinically and/or by appropriate imaging techniques&#xD;
&#xD;
          4. Subject has other significant non-ischemic brain lesion(s) which could affect function&#xD;
             or disability.&#xD;
&#xD;
          5. Time of ischemic stroke onset not exactly known&#xD;
&#xD;
          6. Subject has documented underlying medical conditions which may affect assessment or&#xD;
             follow-up such as (but not limited to) terminal cancer, liver cirrhosis, severe&#xD;
             dementia or psychosis, connective tissue disease, rheumatoid arthritis, severe heart&#xD;
             disease, severe liver disease or renal failure (based on recent medical history)&#xD;
&#xD;
          7. Subject has active systemic infection such as (but not limited to) hepatitis and&#xD;
             pneumonia&#xD;
&#xD;
          8. Subject has definite indication for full dose or long term anti-coagulation therapy&#xD;
             (such as warfarin)&#xD;
&#xD;
          9. Any condition that in the judgment of the investigator would place the patient under&#xD;
             undue risk&#xD;
&#xD;
         10. Traumatic brain injury within the previous 30 days.&#xD;
&#xD;
         11. Symptoms which are rapidly improving (as in transient ischemic stroke)&#xD;
&#xD;
         12. The patient is pregnant, breast feeding or female of childbearing potential (unless&#xD;
             the subject is willing to practice on double contraception measures for the study&#xD;
             duration) until up to 1 month (30 days) after last treatment dose.&#xD;
&#xD;
         13. Patients who have been included in any other clinical trial within the previous three&#xD;
             months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>IRENE LOOI</last_name>
    <role>Principal Investigator</role>
    <affiliation>SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE</affiliation>
  </overall_official>
  <overall_official>
    <last_name>KAH HAY YUEN</last_name>
    <role>Study Director</role>
    <affiliation>Universiti Sains Malaysia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>IRENE LOOI</last_name>
    <email>irenelooi@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>WEN YAO MAK</last_name>
    <email>makwenyao@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Seberang Jaya Clinical Research Centre</name>
      <address>
        <city>Seberang Jaya</city>
        <state>Pulau Pinang</state>
        <zip>13700</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>IRENE LOOI</last_name>
      <email>irenelooi@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>AWATIF RUSLI</last_name>
      <email>awatif90rusli@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Irene Looi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>February 9, 2018</last_update_submitted>
  <last_update_submitted_qc>February 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</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>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tocotrienols</mesh_term>
    <mesh_term>Vitamin E</mesh_term>
    <mesh_term>Tocopherols</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/NCT02263924
org study id: 2013-CRC-001-03
nct id: NCT02263924
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Phase III, single-centre, double-blind, randomised, placebo-controlled, parallel-group trial
      to evaluate the efficacy and safety of oral Vitamin E (Mixed Tocotrienol) for 6 months in
      patients with moderate ischemic stroke.

      150 patients will be recruited and randomized to receive either placebo or mixed tocotrienol
      200mg twice a day for 6 months. Patients will be followed up and assessed on their functional
      recovery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized to receive either placebo or investigational drug (mixed tocotrienols dietary supplement) for 6 months.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Modified Rankin Score
time frame: 6th Month
description: Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)
measure: Modified Rankin Score
time frame: 3rd month
description: Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio)
measure: Modified Barthel Index
time frame: 6th months
description: • Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)
measure: NIHSS
time frame: before dosing and at 6th month
description: Reduction in NIHSS at the end of 6 months of treatment from baseline
measure: Composite score (MRS, NIHSS, mBI)
time frame: 6th month
description: Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS <6, and mBI at least 95
measure: Modified Rankin Score
time frame: 3rd month
description: Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment
measure: Modified Rankin Score
time frame: 6th month
description: Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment
measure: MRI - Brain lesion volume
time frame: 6th month
description: Change in stroke lesion volume
measure: SF-36
time frame: 6th month
description: quality of life
measure: CLOX and TMT Parts A & B
time frame: 6th month
description: Improvement in the score of CLOX and TMT Parts A & B at the end of 24-weeks of treatment from baseline
measure: Adverse event monitoring
time frame: 6 months
description: Adverse event outcomes in both groups
arm group label: Experimental: Tocotrienol
arm group type: Experimental
description: Mixed tocotrienol 200mg twice a day for 6 months
arm group label: Placebo (for tocotrienol)
arm group type: Placebo Comparator
description: Placebo capsules, 1 capsule twice a day for 6 months
intervention type: Dietary Supplement
intervention name: Tocotrienol
description: Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months
arm group label: Experimental: Tocotrienol
intervention type: Dietary Supplement
intervention name: Placebo capsules
description: Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months
arm group label: Placebo (for tocotrienol)
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
last name: IRENE LOOI
role: Principal Investigator
affiliation: SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE
last name: KAH HAY YUEN
role: Study Director
affiliation: Universiti Sains Malaysia
last name: IRENE LOOI
email: irenelooi@yahoo.com
last name: WEN YAO MAK
email: makwenyao@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Malaysia
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Tocotrienols
mesh term: Vitamin E
mesh term: Tocopherols