Tocotrienols in Parkinson's Disease (PD)

National Neuroscience Institute

Status and phase: Enrolling; Phase 2

Conditions: Neuro-Degenerative Disease; Parkinson Disease

Treatments: Other: Placebo; Drug: Tocovid Suprabio (HOV-12020)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04491383

T3-PD-01

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Tocovid Suprabio (HOV-12020)

Experimental group

Description:

200mg, twice 1 day, 12 months

Treatment:

Drug: Tocovid Suprabio (HOV-12020)

Placebo

Placebo Comparator group

Description:

200mg, twice 1 day, 12 months

Treatment:

Other: Placebo