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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 21, 2019
First Posted Date  ICMJE October 25, 2019
Last Update Posted Date October 25, 2019
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • Dietary Supplement: Tocotrienols
    Tocotrienols as a potent antioxidant to modulate oxidative stress and inflammatory response
  • Dietary Supplement: Placebo
    The placebo is similar in appearance, but does not contain tocotrienols and consist of palm oil
Study Arms  ICMJE
  • 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.
    Intervention: Dietary Supplement: Tocotrienols
  • 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.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 23, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Piek Lian Wang +603-79492622 wangpl@ummc.edu.my
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04140136
Other Study ID Numbers  ICMJE 2018613-6392
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Nortina Shahrizaila, University of Malaya
Study Sponsor  ICMJE University of Malaya
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Malaya
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP