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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status

Unknown status

Phase

Phase 2

Locations

Malaysia

Study Type

Interventional

Intervention

Tocotrienols

Placebo

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring ALS

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinical Investigation Centre (CIC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean change of revised ALS Functional Rating Scale (ALSFRS-R) at baseline and 6 months between treatment group difference.

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

Number of participants with treatment-related adverse events,haematological,renal and liver profile monitored at every visit

Safety of oral mixed Tocotrienols in ALS patients

Full Information

NCT ID

NCT04140136

First Posted

October 21, 2019

Last Updated

October 23, 2019

Sponsor

University of Malaya

1. Study Identification

Unique Protocol Identification Number

NCT04140136

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 17, 2019 (Actual)

Primary Completion Date

April 1, 2020 (Anticipated)

Study Completion Date

September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis

Keywords

ALS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Tocotrienols

Intervention Description

Tocotrienols as a potent antioxidant to modulate oxidative stress and inflammatory response

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

The placebo is similar in appearance, but does not contain tocotrienols and consist of palm oil

Primary Outcome Measure Information:

Title

Mean change of revised ALS Functional Rating Scale (ALSFRS-R) at baseline and 6 months between treatment group difference.

Description

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.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events,haematological,renal and liver profile monitored at every visit

Description

Safety of oral mixed Tocotrienols in ALS patients

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Piek Lian Wang

Phone

+603-79492622

wangpl@ummc.edu.my

Facility Information:

Facility Name

Clinical Investigation Centre (CIC)

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Piek Lian Wang

Phone

+603-79492622

wangpl@ummc.edu.my

First Name & Middle Initial & Last Name & Degree

Nortina Shahrizaila

12. IPD Sharing Statement

Learn more about this trial

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

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