Efficacy and Safety of Tocotrienols in CADASIL

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.

Timeline

Start

2020-12-21

Primary completion

2024-02-28

Completion

2024-10-31

Outcome

Missed primary endpoint

paper Bayesian analysis indicated a low posterior probability of benefit, meeting the predefined futility criteria. PMID 42005919 ↗

Publications

• Chabriat H, Biard L, Guey S, Alili N, Machado C, Jabouley A, Reyes S, Lebenberg J, Guillonnet A, Dubus E, Taleb A, Julien F, Dias-Gastellier N, Fernandes F, Jouvent E, Herve D. Tocotrienol-rich vitamin E complex in CADASIL (T3CAD): a randomised, double-blind, placebo-controlled trial. EClinicalMedicine. 2026 Mar 30;94:103853. doi: 10.1016/j.eclinm.2026.103853. eCollection 2026 Apr.

Drugs

Indications