Trials / Active Not Recruiting
Active Not RecruitingNCT04491383
Tocotrienols in Parkinson's Disease (PD)
Tocotrienols in Parkinson's Disease (PD): A Pilot, Randomised, Placebo-controlled Trial
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- National Neuroscience Institute · Academic / Other
- Sex
- All
- Age
- 40 Years – 90 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tocovid Suprabio (HOV-12020) | Dietary supplement: Tocotrienol (HOV-12020) Palm oil-derived vitamin E, tocotrienol |
| OTHER | Placebo | Dietary supplement: Placebo. Placebo. |
Timeline
- Start date
- 2021-04-01
- Primary completion
- 2026-07-01
- Completion
- 2027-07-31
- First posted
- 2020-07-29
- Last updated
- 2025-12-02
Locations
2 sites across 1 country: Singapore
Source: ClinicalTrials.gov record NCT04491383. Inclusion in this directory is not an endorsement.