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Stroke and Tocotrienol: Unique Role in Neuroprotection (SATURN)

Primary Purpose

Ischemic Stroke

Status

Unknown status

Phase

Phase 3

Locations

Malaysia

Study Type

Interventional

Intervention

Tocotrienol

Placebo capsules

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Inclusion Criteria:

Age 35 years old and above.
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.
Subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical conditions.
Subject has a modified Rankin Scale from 2-4.
Subject has a clinical stroke diagnosis according to WHO stroke diagnosis.
Subject is willing to attend at least four sessions of physiotherapy during the study or as deemed needed by the physiotherapist
Subjects or his/her legally acceptable representative is willing to provide written informed consent.

Exclusion Criteria:

Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
Recurrent stroke or previous hospitalisation due to suspected cerebrovascular event.
Severe stroke as assessed clinically and/or by appropriate imaging techniques
Subject has other significant non-ischemic brain lesion(s) which could affect function or disability.
Time of ischemic stroke onset not exactly known
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)
Subject has active systemic infection such as (but not limited to) hepatitis and pneumonia
Subject has definite indication for full dose or long term anti-coagulation therapy (such as warfarin)
Any condition that in the judgment of the investigator would place the patient under undue risk
Traumatic brain injury within the previous 30 days.
Symptoms which are rapidly improving (as in transient ischemic stroke)
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.
Patients who have been included in any other clinical trial within the previous three months.

Sites / Locations

Seberang Jaya Clinical Research CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental: Tocotrienol

Placebo (for tocotrienol)

Arm Description

Mixed tocotrienol 200mg twice a day for 6 months

Placebo capsules, 1 capsule twice a day for 6 months

Outcomes

Primary Outcome Measures

Modified Rankin Score

Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)

Secondary Outcome Measures

Modified Rankin Score

Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio)

Modified Barthel Index

• Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)

NIHSS

Reduction in NIHSS at the end of 6 months of treatment from baseline

Composite score (MRS, NIHSS, mBI)

Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS <6, and mBI at least 95

Modified Rankin Score

Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment

Modified Rankin Score

Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment

MRI - Brain lesion volume

Change in stroke lesion volume

SF-36

quality of life

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

Adverse event monitoring

Adverse event outcomes in both groups

Full Information

NCT ID

NCT02263924

First Posted

September 23, 2014

Last Updated

February 9, 2018

Sponsor

Seberang Jaya Clinical Research Centre

Collaborators

Clinical Research Centre Hospital Taiping, Universiti Sains Malaysia

1. Study Identification

Unique Protocol Identification Number

NCT02263924

Brief Title

Stroke and Tocotrienol: Unique Role in Neuroprotection

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seberang Jaya Clinical Research Centre

Collaborators

Clinical Research Centre Hospital Taiping, Universiti Sains Malaysia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomized to receive either placebo or investigational drug (mixed tocotrienols dietary supplement) for 6 months.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental: Tocotrienol

Arm Type

Experimental

Arm Description

Mixed tocotrienol 200mg twice a day for 6 months

Arm Title

Placebo (for tocotrienol)

Arm Type

Placebo Comparator

Arm Description

Placebo capsules, 1 capsule twice a day for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Tocotrienol

Intervention Description

Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo capsules

Intervention Description

Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months

Primary Outcome Measure Information:

Title

Modified Rankin Score

Description

Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)

Time Frame

6th Month

Secondary Outcome Measure Information:

Title

Modified Rankin Score

Description

Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio)

Time Frame

3rd month

Title

Modified Barthel Index

Description

• Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)

Time Frame

6th months

Title

NIHSS

Description

Reduction in NIHSS at the end of 6 months of treatment from baseline

Time Frame

before dosing and at 6th month

Title

Composite score (MRS, NIHSS, mBI)

Description

Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS <6, and mBI at least 95

Time Frame

6th month

Title

Modified Rankin Score

Description

Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment

Time Frame

3rd month

Title

Modified Rankin Score

Description

Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment

Time Frame

6th month

Title

MRI - Brain lesion volume

Description

Change in stroke lesion volume

Time Frame

6th month

Title

SF-36

Description

quality of life

Time Frame

6th month

Title

CLOX and TMT Parts A & B

Description

Improvement in the score of CLOX and TMT Parts A & B at the end of 24-weeks of treatment from baseline

Time Frame

6th month

Title

Adverse event monitoring

Description

Adverse event outcomes in both groups

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Adult patients within 1-10 days ischaemic stroke of moderate severity (NIHSS 6-20) Inclusion Criteria: Age 35 years old and above. 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. Subject is neurologically stable after stroke onset, i.e. no fluctuation in clinical conditions. Subject has a modified Rankin Scale from 2-4. Subject has a clinical stroke diagnosis according to WHO stroke diagnosis. Subject is willing to attend at least four sessions of physiotherapy during the study or as deemed needed by the physiotherapist Subjects or his/her legally acceptable representative is willing to provide written informed consent. Exclusion Criteria: Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI Recurrent stroke or previous hospitalisation due to suspected cerebrovascular event. Severe stroke as assessed clinically and/or by appropriate imaging techniques Subject has other significant non-ischemic brain lesion(s) which could affect function or disability. Time of ischemic stroke onset not exactly known 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) Subject has active systemic infection such as (but not limited to) hepatitis and pneumonia Subject has definite indication for full dose or long term anti-coagulation therapy (such as warfarin) Any condition that in the judgment of the investigator would place the patient under undue risk Traumatic brain injury within the previous 30 days. Symptoms which are rapidly improving (as in transient ischemic stroke) 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. Patients who have been included in any other clinical trial within the previous three months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

IRENE LOOI

irenelooi@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

WEN YAO MAK

makwenyao@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

IRENE LOOI

Organizational Affiliation

SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

KAH HAY YUEN

Organizational Affiliation

Universiti Sains Malaysia

Official's Role

Study Director

Facility Information:

Facility Name

Seberang Jaya Clinical Research Centre

City

Seberang Jaya

State/Province

Pulau Pinang

ZIP/Postal Code

13700

Country

Malaysia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

IRENE LOOI

irenelooi@yahoo.com

First Name & Middle Initial & Last Name & Degree

AWATIF RUSLI

awatif90rusli@gmail.com

First Name & Middle Initial & Last Name & Degree

Irene Looi

12. IPD Sharing Statement

Learn more about this trial

Stroke and Tocotrienol: Unique Role in Neuroprotection

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