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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04140136
Date of registration: 21/10/2019
Prospective Registration: No
Primary sponsor: University of Malaya
Public title: The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS)
Scientific title: The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory Study
Date of first enrolment: June 17, 2019
Target sample size: 20
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04140136
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 2
Countries of recruitment
Malaysia
Contacts
Name:     Piek Lian Wang
Address: 
Telephone: +603-79492622
Email: wangpl@ummc.edu.my
Affiliation: 
Name:     Piek Lian Wang
Address: 
Telephone: +603-79492622
Email: wangpl@ummc.edu.my
Affiliation: 
Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Amyotrophic Lateral Sclerosis
Intervention(s)
Dietary Supplement: Placebo
Dietary Supplement: Tocotrienols
Primary Outcome(s)
Mean change of revised ALS Functional Rating Scale (ALSFRS-R) at baseline and 6 months between treatment group difference. [Time Frame: 6 months]
Secondary Outcome(s)
Number of participants with treatment-related adverse events,haematological,renal and liver profile monitored at every visit [Time Frame: 6 months]
Secondary ID(s)
2018613-6392
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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