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Efficacy and Safety of Tocotrienols in CADASIL

NCT04658823 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Hovid Berhad

    lead INDUSTRY

Principal Investigators

  • Pr Hugues Chabriat · Hôpital Lariboisière APHP

  • David Ho · Hovid Berhad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-21
Primary Completion
2024-02-28
Completion
2024-10-31
FDA Drug
Yes

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04658823 on ClinicalTrials.gov