Stroke and Tocotrienol: Unique Role in Neuroprotection

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2018

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Experimental: Tocotrienol
    • Mixed tocotrienol 200mg twice a day for 6 months
  • Placebo Comparator: Placebo (for tocotrienol)
    • Placebo capsules, 1 capsule twice a day for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • Modified Rankin Score
    • Time Frame: 6th Month
    • Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seberang Jaya Clinical Research Centre
  • Collaborator
    • Clinical Research Centre Hospital Taiping
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • IRENE LOOI, Principal Investigator, SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE
    • KAH HAY YUEN, Study Director, Universiti Sains Malaysia
  • Overall Contact(s)
    • IRENE LOOI, irenelooi@yahoo.com

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