Clinical trial NCT02263924: Stroke and Tocotrienol: Unique Role in Neuroprotection
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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ischemic Stroke
Lead sponsor: Seberang Jaya Clinical Research Centre
Sponsor class: OTHER_GOV
Collaborators: name: Clinical Research Centre Hospital Taiping
name: Universiti Sains Malaysia
First posted: 2014-10-13
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive either placebo or investigational drug (mixed tocotrienols dietary supplement) for 6 months.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Modified Rankin Score
timeFrame: 6th Month
Secondary outcomes:
measure: Modified Rankin Score
timeFrame: 3rd month
measure: Modified Barthel Index
timeFrame: 6th months
measure: NIHSS
timeFrame: before dosing and at 6th month
measure: Composite score (MRS, NIHSS, mBI)
timeFrame: 6th month
measure: Modified Rankin Score
timeFrame: 3rd month
measure: Modified Rankin Score
timeFrame: 6th month
measure: MRI - Brain lesion volume
timeFrame: 6th month
measure: SF-36
timeFrame: 6th month
measure: CLOX and TMT Parts A & B
timeFrame: 6th month
measure: Adverse event monitoring
timeFrame: 6 months
Other outcomes:
Locations:
city: Seberang Jaya
country: Malaysia
facility: Seberang Jaya Clinical Research Centre
state: Pulau Pinang
Study officials:
affiliation: SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE
name: IRENE LOOI
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Sains Malaysia
name: KAH HAY YUEN
role: STUDY_DIRECTOR
References: