Stroke and Tocotrienol: Unique Role in Neuroprotection

NCT02263924 | Unknown Phase 3

• 1 other identifier: 2013-CRC-001-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Score

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

  6th Month

Secondary Outcomes (10)

• Modified Rankin Score

  3rd month

• Modified Barthel Index

  6th months

• NIHSS

  before dosing and at 6th month

• Composite score (MRS, NIHSS, mBI)

  6th month

• Modified Rankin Score

  3rd month

Study Arms (2)

Experimental: Tocotrienol

EXPERIMENTAL

Mixed tocotrienol 200mg twice a day for 6 months

Dietary Supplement: Tocotrienol

Placebo (for tocotrienol)

PLACEBO COMPARATOR

Placebo capsules, 1 capsule twice a day for 6 months

Dietary Supplement: Placebo capsules

Interventions

Tocotrienol DIETARY_SUPPLEMENT

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

Experimental: Tocotrienol

Placebo capsules DIETARY_SUPPLEMENT

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

Placebo (for tocotrienol)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seberang Jaya Clinical Research Centre: lead
• Clinical Research Centre Hospital Taiping: collaborator
• Universiti Sains Malaysia: collaborator

Study Sites (1)

Seberang Jaya Clinical Research Centre

Seberang Jaya, Pulau Pinang, 13700, Malaysia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tocotrienols

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• IRENE LOOI

  SEBERANG JAYA HOSPITAL CLINICAL RESEARCH CENTRE

  PRINCIPAL INVESTIGATOR

• KAH HAY YUEN

  Universiti Sains Malaysia

  STUDY DIRECTOR

Central Study Contacts

IRENE LOOI

CONTACT

irenelooi@yahoo.com

WEN YAO MAK

CONTACT

makwenyao@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: October 13, 2014
• Study Start: July 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

MY (1)