Tocotrienols in Parkinson's Disease (PD)

NCT ID: NCT04491383

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2027-07-31

Brief Summary

A study using Parkinson's disease animal model, transgenic fruit flies, demonstrated the potential of using tocotrienols (HOV-12020) as a therapeutic agent for delaying Parkinsonian motor dysfunctions. The proposed study aims to enrol 100 PD patients in a randomized placebo-controlled trial to investigate the effects of tocotrienols (HOV-12020) in motor and non-motor outcomes. Patients will be given oral tocotrienols (400mg/day) or placebo for 104 weeks. They will be assessed using the standard assessments scales in PD at baseline, Week 52 and Week 104. Neuropsychological evaluation will also be completed at these intervals to monitor progression of cognitive impairment (if any). Additional PD staging using MDSUPDRS (Part III), Hoehn & Yahr (H&Y) will be conducted at Week 26 and week 78. Blood samples will be collected to evaluate PD biomarkers and for safety monitoring (liver function, renal function and hematology).

Conditions

Neuro-Degenerative Disease; Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tocovid Suprabio (HOV-12020)

200mg, twice 1 day, 12 months

Group Type: EXPERIMENTAL

Tocovid Suprabio (HOV-12020)

Intervention Type: DRUG

Dietary supplement: Tocotrienol (HOV-12020) Palm oil-derived vitamin E, tocotrienol

Placebo

200mg, twice 1 day, 12 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Dietary supplement: Placebo. Placebo.

Interventions

Tocovid Suprabio (HOV-12020)

Dietary supplement: Tocotrienol (HOV-12020) Palm oil-derived vitamin E, tocotrienol

Intervention Type: DRUG

Placebo

Dietary supplement: Placebo. Placebo.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men or women aged between 40 - 90 years (inclusive).
• Able to provide written informed consent and able to comply with study protocol.
• Idiopathic PD of more than 1 years duration from diagnosis. The diagnosis must be confirmed by presence of bradykinesia and at least 1 other cardinal sign (resting tremor, rigidity), without any other known or suspected cause of parkinsonism.
• Hoehn & Yahr => 2 with treatment.
• Patients on PD medication(s) e.g. levodopa, dopamine agonists, amantadine and/or Monoamine oxidase (MAO)-B inhibitors, must be on stable dose, for at least 30 days prior to screening. Medication and dose adjustments are allowed but must be documented.
• Patients on anti-depressant or anxiolytic medication must be on stable dose for at least 90 days prior to screening.
• The patient is willing to abstain from Vitamin E supplements (tocopherols and tocotrienols) and other dietary supplements which contain Vitamin E (tocopherols and tocotrienols) up to 14 days before baseline visit, and throughout the clinical study, unless prescribed by their physician for medical reasons.

Exclusion Criteria

• Any other neurodegenerative disorder, such as Alzheimer's disease, Huntington's disease, or Creutzfeldt - Jakob disease.
• Current, clinically-significant hematological, cardiac, pulmonary, metabolic, neurologic or psychiatric disorders, uncontrolled seizures, untreated hypertension, disorders increasing risk of bleeding (Hemophilia), or any other significant active medical condition which, in the Investigator's opinion, would impact participation in this study.
• History of psychotic symptoms requiring treatment with a neuroleptic medication within the past 12 months.
• History of surgical or invasive intervention for PD (pallidotomy, thalamotomy, deep brain stimulation, etc.)
• Medical history indicating drug-induced parkinsonism (e.g., metoclopramide, flunarizine), metabolic identified neurogenetic disorders (e.g., Wilson's disease), encephalitis, or other atypical Parkinsonian syndromes (e.g., progressive supranuclear palsy, multiple system atrophy).
• History of myocardial infarction within 3 months prior to Screening, or current active angina pectoris, or symptomatic heart failure.
• Known liver disease or liver enzymes (AST, ALT) more than 5 times upper limit normal within 1 month of screening and enrolment.
• eGFR <60 within 1 month of screening and enrolment.
• Current participation in another investigational interventional study.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Neuroscience Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eng King Tan

Role: PRINCIPAL_INVESTIGATOR

National Neuroscience Institute Singapore

Adeline Su-Lyn Ng

Role: PRINCIPAL_INVESTIGATOR

National Neuroscience Institute Singapore

Locations

National Neuroscience Institute

Singapore, , Singapore

Singapore General Hospital

Singapore, , Singapore

Countries

Singapore

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Other Identifiers

T3-PD-01

Identifier Type: -

Identifier Source: org_study_id