Stroke and Tocotrienol: Unique Role in Neuroprotection

Ischemic Stroke Clinical Trial

— SATURN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02263924
• Other study ID #: 2013-CRC-001-03
• Status: Recruiting
• Phase: Phase 3
• First received: September 23, 2014
• Last updated: February 9, 2018
• Start date: July 2015
• Est. completion date: December 2018

Study information

• Verified date: February 2018
• Source: Seberang Jaya Clinical Research Centre
• Contact: IRENE LOOI
• Email: irenelooi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Dietary Supplement:
• Tocotrienol
Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months
• Placebo capsules
Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months

Locations

Country	Name	City	State
Malaysia	Seberang Jaya Clinical Research Centre	Seberang Jaya	Pulau Pinang

Sponsors (3)

Lead Sponsor	Collaborator
Seberang Jaya Clinical Research Centre	Clinical Research Centre Hospital Taiping, University of Science Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Score	Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)	6th Month
Secondary	Modified Rankin Score	Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio)	3rd month
Secondary	Modified Barthel Index	• Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)	6th months
Secondary	NIHSS	Reduction in NIHSS at the end of 6 months of treatment from baseline	before dosing and at 6th month
Secondary	Composite score (MRS, NIHSS, mBI)	Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS <6, and mBI at least 95	6th month
Secondary	Modified Rankin Score	Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment	3rd month
Secondary	Modified Rankin Score	Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment	6th month
Secondary	MRI - Brain lesion volume	Change in stroke lesion volume	6th month
Secondary	SF-36	quality of life	6th month
Secondary	CLOX and TMT Parts A & B	Improvement in the score of CLOX and TMT Parts A & B at the end of 24-weeks of treatment from baseline	6th month
Secondary	Adverse event monitoring	Adverse event outcomes in both groups	6 months