Stroke and Tocotrienol: Unique Role in Neuroprotection

Phase 3

• Conditions: Ischemic Stroke
• Interventions: Dietary Supplement: Placebo capsules; Dietary Supplement: Tocotrienol

• Registration Number: NCT02263924
• Lead Sponsor: Seberang Jaya Clinical Research Centre

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 available

Study Timeline

• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Study Start: 2015-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-13
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Modified Rankin Score	6th Month	Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Score	6th month	Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment
Adverse event monitoring	6 months	Adverse event outcomes in both groups
NIHSS	before dosing and at 6th month	Reduction in NIHSS at the end of 6 months of treatment from baseline
SF-36	6th month	quality of life
CLOX and TMT Parts A & B	6th month	Improvement in the score of CLOX and TMT Parts A \& B at the end of 24-weeks of treatment from baseline
Composite score (MRS, NIHSS, mBI)	6th month	Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS \<6, and mBI at least 95
Modified Barthel Index	6th months	• Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)
MRI - Brain lesion volume	6th month	Change in stroke lesion volume

Trial Locations

Locations (1)

Seberang Jaya Clinical Research Centre; 🇲🇾 Seberang Jaya, Pulau Pinang, Malaysia