Clinical Trial

Tocotrienols in Parkinson's Disease (PD)

Active, Not Recruiting Phase 2
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Record status
This record was last updated December 2, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2020-07-27; most recent amendment 2025-11-24.
Status change: Recruiting → Active, Not Recruiting 2025-11-24
Status change: Not Yet Recruiting → Recruiting 2021-04-08
Trial Details
NCT Number NCT04491383
Lead Sponsor National Neuroscience Institute
Conditions Neuro-Degenerative Disease, Parkinson Disease
Enrollment 100 participants
Start Date 2021-04-01
Primary Completion 2026-07 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-02