The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory Study

Study Purpose:

There is currently no effective treatment in ALS. Oxidative stress, probably interacting with other neurodegenerative processes, is hypothesized to play a leading role in pathogenesis. These include mechanisms that promote glutamate excitotoxicity, mitochondrial dysfunction and axonal dysfunction.

In a transgenic mouse model of fALS that develops a disease with a clinical phenotype similar to ALS, dietary vitamin E supplementation delayed disease onset and slowed progression, although it did not prolong survival. When used as an experimental therapy in human trials, vitamin E did not affect survival significantly, but possibly slowed ALS progression. Two large, prospective epidemiologic studies suggest that longterm use of vitamin E supplements could be inversely associated with risk of ALS or ALS death. In another study, higher baseline serum α-tocopherol was associated with lower subsequent risk of ALS. A modest, non-significant protective effect from supplementation was seen in subjects with baseline serum α-tocopherol levels below median levels. In the current study, we aim to investigate the effects of tocotrienols in patients with ALS, particularly in delaying disease progression as well as assessing its safety profile in this group of patients.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Dietary Supplement

Intervention Name:

Tocotrienols, Placebo

Placebo:

Yes

Phase:

Phase 2

Study Chair(s)/Principal Investigator(s):

N/A

Clinicaltrials.gov ID:

NCT04140136

Neals Affiliated?

No

Coordinating Center Contact Information

Study Sponsor:

University of Malaya

Estimated Enrollment:

20

Estimated Study Start Date:

06 / 17 / 2019

Estimated Study Completion Date:

09 / 01 / 2020

Posting Last Modified Date:

10 / 25 / 2019

Date Study Added to neals.org:

10 / 25 / 2019