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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT04140136 |
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Date of registration:
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21/10/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS)
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Scientific title:
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The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory Study |
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Date of first enrolment:
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June 17, 2019 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04140136 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Piek Lian Wang |
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Address:
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Telephone:
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+603-79492622 |
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Email:
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wangpl@ummc.edu.my |
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Affiliation:
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Name:
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Piek Lian Wang |
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Address:
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Telephone:
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+603-79492622 |
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Email:
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wangpl@ummc.edu.my |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Amyotrophic Lateral Sclerosis
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Tocotrienols
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Primary Outcome(s)
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Mean change of revised ALS Functional Rating Scale (ALSFRS-R) at baseline and 6 months between treatment group difference.
[Time Frame: 6 months]
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Secondary Outcome(s)
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Number of participants with treatment-related adverse events,haematological,renal and liver profile monitored at every visit
[Time Frame: 6 months]
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Secondary ID(s)
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2018613-6392
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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