Ischemic StrokePhase 3SATURNNCT02263924
Stroke and Tocotrienol: Unique Role in Neuroprotection
A Phase 3 study testing Tocotrienol in people with Ischemic Stroke, run by Seberang Jaya Clinical Research Centre at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Tocotrienol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteMalaysia
- Study dates
- Jul 2015to Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
IRENE LOOI contact
WEN YAO MAK contact
Malaysia1 site, 1 recruiting
- Recruiting
Seberang Jaya Clinical Research Centre
Seberang Jaya, Pulau Pinang, 13700
IRENE LOOI, irenelooi@yahoo.com
AWATIF RUSLI, awatif90rusli@gmail.com
About this study
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
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
- Ischemic Stroke
- Being tested
- Tocotrienol, Placebo capsules
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocotrienolDietary supplement
Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months
Placebo capsulesDietary supplement
Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Tocotrienol | Experimental | Mixed tocotrienol 200mg twice a day for 6 months Receives: Dietary Supplement: Tocotrienol |
| Placebo (for tocotrienol) | Placebo comparator | Placebo capsules, 1 capsule twice a day for 6 months Receives: Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Score
Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)
Measured: 6th Month
Secondary outcomes (10)
Modified Rankin Score
Shift in modified Rankin Score (mRS) at 3 months of treatment (odds ratio)
Measured: 3rd month
Modified Barthel Index
- Increment in the score of Modified Barthel Index at the end of 6 months of treatment from baseline (before treatment)
Measured: 6th months
NIHSS
Reduction in NIHSS at the end of 6 months of treatment from baseline
Measured: before dosing and at 6th month
Composite score (MRS, NIHSS, mBI)
Proportion of patients achieving favourable composite score of mRS 0 - 2, NIHSS <6, and mBI at least 95
Measured: 6th month
Modified Rankin Score
Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 3 months of treatment
Measured: 3rd month
Modified Rankin Score
Proportion of patients achieving modified Rankin Score (mRS) of 0 - 2 at 6 months of treatment
Measured: 6th month
MRI - Brain lesion volume
Change in stroke lesion volume
Measured: 6th month
SF-36
quality of life
Measured: 6th month
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
Measured: 6th month
Adverse event monitoring
Adverse event outcomes in both groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startJul 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive either placebo or investigational drug (mixed tocotrienols dietary supplement) for 6 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seberang Jaya Clinical Research Centre
- Sponsor type
- Other government
- Collaborators
- Clinical Research Centre Hospital Taiping, Universiti Sains Malaysia
- Responsible party
- Sponsor
- Investigators
- IRENE LOOI, Principal investigator, SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTREKAH HAY YUEN, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263924
- Sponsor's protocol ID
- 2013-CRC-001-03
- Acronym
- SATURN
- Status last verified
- Feb 2018
- First submitted
- 23 Sep 2014
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02263924
- Acronym / sponsor ID
- SATURN / 2013-CRC-001-03
- Conditions
- Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seberang Jaya Clinical Research CentreOther government
- Collaborators
- Clinical Research Centre Hospital Taiping, Universiti Sains Malaysia
- Study start
- Jul 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive either placebo or investigational drug (mixed tocotrienols dietary supplement) for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Tocotrienol | Experimental | Dietary Supplement: TocotrienolMixed tocotrienol 200mg twice a day for 6 months |
| Placebo (for tocotrienol) | Placebo comparator | Dietary Supplement: Placebo capsulesPlacebo capsules, 1 capsule twice a day for 6 months |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocotrienolSubjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months | Dietary supplement | Experimental: Tocotrienol |
| Placebo capsulesSubjects in the placebo arm will take one capsule of placebo twice daily for 6 months | Dietary supplement | Placebo (for tocotrienol) |
Primary outcome
Modified Rankin Score
Time frame: 6th Month
Shift in modified Rankin Score (mRS) at 6 months of treatment (odds ratio)
10 secondary outcomes
Modified Rankin Score
Time frame: 3rd month
Modified Barthel Index
Time frame: 6th months
NIHSS
Time frame: before dosing and at 6th month
Composite score (MRS, NIHSS, mBI)
Time frame: 6th month
Modified Rankin Score
Time frame: 3rd month
Modified Rankin Score
Time frame: 6th month
MRI - Brain lesion volume
Time frame: 6th month
SF-36
Time frame: 6th month
CLOX and TMT Parts A & B
Time frame: 6th month
Adverse event monitoring
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IRENE LOOI contact
WEN YAO MAK contact
IRENE LOOI principal investigator
SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE
KAH HAY YUEN study director
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocotrienol in people with Ischemic Stroke, run by Seberang Jaya Clinical Research Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact IRENE LOOI (irenelooi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Score (time frame: 6th Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.