Tocotrienols in Parkinson's Disease (PD)

November 20, 2023 updated by: National Neuroscience Institute

Tocotrienols in Parkinson's Disease (PD): A Pilot, Randomised, Placebo-controlled Trial

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Singapore General Hospital
        • Contact:
          • Elaine Ang
        • Principal Investigator:
          • Eng King Tan
      • Singapore, Singapore
        • Recruiting
        • National Neuroscience Institute
        • Contact:
          • Elaine Ang
        • Principal Investigator:
          • Adeline Su Lyn Ng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tocovid Suprabio (HOV-12020)
200mg, twice 1 day, 12 months
Drug: Tocovid Suprabio (HOV-12020)
Dietary supplement: Tocotrienol (HOV-12020) Palm oil-derived vitamin E, tocotrienol
Placebo Comparator: Placebo
200mg, twice 1 day, 12 months
Other: Placebo
Dietary supplement: Placebo. Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from Baseline to Week 104 in Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Score
Time Frame: 104 weeks
Score range is 0 to 199, with severity increasing with higher scores.
104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline to week 104 in disease severity
Time Frame: 104 weeks
104 weeks
Mean change from baseline to week 104 in individual cognitive domain z scores on comprehensive neuropsychological testing mean score change from baseline to week 104 in the MDS-UPDRS score for total score
Time Frame: 104 weeks
Severity of disease increases with higher score.
104 weeks
Mean change from Baseline to Week 104 in quality of life, as measured by the Parkinson's Disease Questionnaire (PDQ-39)
Time Frame: 104 weeks
Score range is 0 to 100. A lower score will indicate a better quality of life.
104 weeks
Difference proportion of patients with change from Baseline to Week 104, above or equal to the minimal clinically important difference (MCID) of the motor score, as measured by Part II and III subscales of MDS-UPDRS.
Time Frame: 104 weeks
Severity of disease increases with higher score.
104 weeks
Mean change in levels of blood-based biomarkers (including total antioxidant status TAS, oxidative stress biomarkers and αsynuclein).
Time Frame: 104 weeks
104 weeks
Between treatment difference of type and incidence of Adverse Events (AEs) and Serious AEs (SAEs)
Time Frame: 104 weeks
104 weeks
Mean score change from Baseline to Week 104 in the MDS-UPDRS Part II scale
Time Frame: 104 weeks
Severity of disease increases with higher score.
104 weeks
Mean score change from Baseline to Week 104 in the Schwab and England Activities of Daily Living (SE-ADL) scale.
Time Frame: 104 weeks
The scale uses percentages to assess the difficulties completing daily activities/chores, from 0% to 100%. A higher percentage will indicate a better outcome (i.e. more independence for an individual).
104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Neuroscience Institute

Collaborators

Hovid Berhad

Investigators

  • Principal Investigator: Eng King Tan, National Neuroscience Institute Singapore
  • Principal Investigator: Adeline Su-Lyn Ng, National Neuroscience Institute Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

July 22, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T3-PD-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Tocovid Suprabio (HOV-12020)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe