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Stroke and Tocotrienol: Unique Role in Neuroprotection (SATURN)

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ClinicalTrials.gov Identifier: NCT02263924
Recruitment Status : Unknown
Verified February 2018 by Seberang Jaya Clinical Research Centre.
Recruitment status was:  Recruiting
First Posted : October 13, 2014
Last Update Posted : February 13, 2018
Sponsor:
Collaborators:
Clinical Research Centre Hospital Taiping
Universiti Sains Malaysia
Information provided by (Responsible Party):
Seberang Jaya Clinical Research Centre

Tracking Information
First Submitted Date  ICMJE September 23, 2014
First Posted Date  ICMJE October 13, 2014
Last Update Posted Date February 13, 2018
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
Modified Rankin Score [ Time Frame: 6th Month ]
Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
Modified Rankin Score [ Time Frame: 3rd and 6th Month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • Modified Rankin Score [ Time Frame: 3rd month ]
    Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio)
  • Modified Barthel Index [ Time Frame: 6th months ]
    • Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)
  • NIHSS [ Time Frame: before dosing and at 6th month ]
    Reduction in NIHSS at the end of 6 months of treatment from baseline
  • Composite score (MRS, NIHSS, mBI) [ Time Frame: 6th month ]
    Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS <6, and mBI at least 95
  • Modified Rankin Score [ Time Frame: 3rd month ]
    Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment
  • Modified Rankin Score [ Time Frame: 6th month ]
    Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment
  • MRI - Brain lesion volume [ Time Frame: 6th month ]
    Change in stroke lesion volume
  • SF-36 [ Time Frame: 6th month ]
    quality of life
  • CLOX and TMT Parts A & B [ Time Frame: 6th month ]
    Improvement in the score of CLOX and TMT Parts A & B at the end of 24-weeks of treatment from baseline
  • Adverse event monitoring [ Time Frame: 6 months ]
    Adverse event outcomes in both groups
Original Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
  • National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 3rd and 6th months ]
  • Modified Barthel Index [ Time Frame: 3rd and 6th months ]
  • Volume of brain lesion (MRI scan) [ Time Frame: before dosing and at 6th month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stroke and Tocotrienol: Unique Role in Neuroprotection
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • Dietary Supplement: Tocotrienol
    Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months
  • Dietary Supplement: Placebo capsules
    Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months
Study Arms  ICMJE
  • Experimental: Experimental: Tocotrienol
    Mixed tocotrienol 200mg twice a day for 6 months
    Intervention: Dietary Supplement: Tocotrienol
  • Placebo Comparator: Placebo (for tocotrienol)
    Placebo capsules, 1 capsule twice a day for 6 months
    Intervention: Dietary Supplement: Placebo capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 8, 2014)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Adult patients within 1-10 days ischaemic stroke of moderate severity (NIHSS 6-20)

Inclusion Criteria:

  1. Age 35 years old and above.
  2. Subject will be included within the time frame of 1-10 days after the first onset of acute cerebral ischaemic stroke with NIHSS between 6 - 20.
  3. Subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical conditions.
  4. Subject has a modified Rankin Scale from 2-4.
  5. Subject has a clinical stroke diagnosis according to WHO stroke diagnosis.
  6. Subject is willing to attend at least four sessions of physiotherapy during the study or as deemed needed by the physiotherapist
  7. Subjects or his/her legally acceptable representative is willing to provide written informed consent.

Exclusion Criteria:

  1. Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
  2. Recurrent stroke or previous hospitalisation due to suspected cerebrovascular event.
  3. Severe stroke as assessed clinically and/or by appropriate imaging techniques
  4. Subject has other significant non-ischemic brain lesion(s) which could affect function or disability.
  5. Time of ischemic stroke onset not exactly known
  6. Subject has documented underlying medical conditions which may affect assessment or follow-up such as (but not limited to) terminal cancer, liver cirrhosis, severe dementia or psychosis, connective tissue disease, rheumatoid arthritis, severe heart disease, severe liver disease or renal failure (based on recent medical history)
  7. Subject has active systemic infection such as (but not limited to) hepatitis and pneumonia
  8. Subject has definite indication for full dose or long term anti-coagulation therapy (such as warfarin)
  9. Any condition that in the judgment of the investigator would place the patient under undue risk
  10. Traumatic brain injury within the previous 30 days.
  11. Symptoms which are rapidly improving (as in transient ischemic stroke)
  12. The patient is pregnant, breast feeding or female of childbearing potential (unless the subject is willing to practice on double contraception measures for the study duration) until up to 1 month (30 days) after last treatment dose.
  13. Patients who have been included in any other clinical trial within the previous three months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02263924
Other Study ID Numbers  ICMJE 2013-CRC-001-03
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seberang Jaya Clinical Research Centre
Study Sponsor  ICMJE Seberang Jaya Clinical Research Centre
Collaborators  ICMJE
  • Clinical Research Centre Hospital Taiping
  • Universiti Sains Malaysia
Investigators  ICMJE
Principal Investigator: IRENE LOOI SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE
Study Director: KAH HAY YUEN Universiti Sains Malaysia
PRS Account Seberang Jaya Clinical Research Centre
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP