Stroke and Tocotrienol: Unique Role in Neuroprotection "SATURN"

Recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Tocotrienol Dietary Supplement
    Intervention Desc: Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months
    ARM 1: Kind: Experimental
    Label: Experimental: Tocotrienol
    Description: Mixed tocotrienol 200mg twice a day for 6 months
  • Placebo capsules Dietary Supplement
    Intervention Desc: Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months
    ARM 1: Kind: Experimental
    Label: Placebo (for tocotrienol)
    Description: Placebo capsules, 1 capsule twice a day for 6 months

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Rankin Score 3rd and 6th Month No
Secondary National Institute of Health Stroke Scale (NIHSS) 3rd and 6th months No
Secondary Modified Barthel Index 3rd and 6th months No
Secondary Volume of brain lesion (MRI scan) before dosing and at 6th month No
Secondary CLOX and TMT Part A&B before dosing and at 6th month No
Secondary NIHSS before dosing and at 6th month
Secondary Composite score (MRS, NIHSS, mBI) 6th month
Secondary MRI - Brain lesion volume 6th month
Secondary SF-36 6th month
Secondary CLOX and TMT Parts A & B 6th month
Secondary Adverse event monitoring 6 months

Sponsors