NCT04658823

Efficacy and Safety of Tocotrienols in CADASIL

A Randomized Placebo-controlled Double-blind Pilot / Phase II Study to Assess the Efficacy and Safety of HOV-12020 in Patients With Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hovid Berhad · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

CADASIL is a paradigmatic cerebral small vessel disease responsible for white-matter lesions, accumulation of lacunes, microbleeds and cerebral atrophy. The disease is responsible for stroke and cognitive decline associated with motor disability. The number of incident lacunes, and amount of cerebral atrophy were recently found to have a strong relationship to cognitive decline and disability progression over 3 years in a large sample of patients. Palm tocotrienols has previously shown evidence of therapeutic effect in attenuating the progression of WMH related to sporadic cerebral small vessel disease in a randomized controlled clinical trial. We hypothesize that palm tocotrienols complex (HOV-12020) can reduce the clinical progression in CADASIL.

Conditions

• Cadasil

Interventions

Type	Name	Description
DRUG	HOV-12020 (Palm tocotrienols complex)	Oral Softgel capsule containing mixed tocotrienols and tocopherol with enhanced absorption delivery system; 1 capsule twice daily
DRUG	Placebo	Oral Softgel capsule containing soybean oil; 1 capsule twice daily

Timeline

• Start date: 2020-12-21
• Primary completion: 2024-02-28
• Completion: 2024-10-31
• First posted: 2020-12-09
• Last updated: 2026-02-02

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study