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The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS)

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ClinicalTrials.gov Identifier: NCT04140136
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Professor Nortina Shahrizaila, University of Malaya

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Dietary Supplement: Tocotrienols Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory Study
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : September 1, 2020


Arm Intervention/treatment
Active Comparator: Treatment group
This is a pilot randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effects of 24-weeks tocotrienols (Tocovid Suprabio) supplementation in ALS patients.The investigational product is to be administered twice daily, at a dose of 400mg per day.
Dietary Supplement: Tocotrienols
Tocotrienols as a potent antioxidant to modulate oxidative stress and inflammatory response

Placebo Comparator: Placebo group
This is a pilot randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effects of 24-weeks tocotrienols (Tocovid Suprabio) supplementation in ALS patients. The placebo is similar in appearance but does not contain tocotrienols and consist of palm oil.
Dietary Supplement: Placebo
The placebo is similar in appearance, but does not contain tocotrienols and consist of palm oil




Primary Outcome Measures :
  1. Mean change of revised ALS Functional Rating Scale (ALSFRS-R) at baseline and 6 months between treatment group difference. [ Time Frame: 6 months ]
    Efficacy of oral mixed Tocotrienols in patients with ALS in delaying disease progression as assess based on the cumulative score of ALSFRS-R between treatment group difference at specific time point.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events,haematological,renal and liver profile monitored at every visit [ Time Frame: 6 months ]
    Safety of oral mixed Tocotrienols in ALS patients



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have a decrease of 1 to 4 points on the ALSFRS-R score during the 12-weeks observation period prior to screening and enrollment
  • Patients of less than 2 years after the diagnosis of ALS.
  • Patients without respiratory symptoms (orthopnea, dyspnea)
  • Capable of giving signed informed consent

Exclusion Criteria:

  • Patients who have developed respiratory failure necessitating ventilation
  • Patients who have developed unsafe swallowing necessitating enteral feeding tube insertion
  • Patients with other neurodegenerative disease such as Parkinson's disease and significant mental health illness
  • Patients with certain concomitant diseases which may affect the assessment of safety/efficacy i.e. malignancy within the last 5 years, congestive heart disease, liver disease, kidney failure, bleeding disorders and other autoimmune diseases etc.
  • Pregnant, lactating, and probably pregnant patients.
  • Patients taking vitamin E tocopherol or tocotrienols supplements within 1 month from screening and randomisation.
  • Patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present.
  • Women of child bearing potential or nursing mother, unless they are willing to practice effective contraceptive measures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140136


Contacts
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Contact: Piek Lian Wang +603-79492622 wangpl@ummc.edu.my

Locations
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Malaysia
Clinical Investigation Centre (CIC) Recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Piek Lian Wang    +603-79492622    wangpl@ummc.edu.my   
Principal Investigator: Nortina Shahrizaila         
Sponsors and Collaborators
University of Malaya

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Responsible Party: Professor Nortina Shahrizaila, Professor, University of Malaya
ClinicalTrials.gov Identifier: NCT04140136     History of Changes
Other Study ID Numbers: 2018613-6392
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Professor Nortina Shahrizaila, University of Malaya:
ALS
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Vitamin E
Tocopherols
Tocotrienols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents