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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | 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. |
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| Placebo group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocotrienols | Dietary Supplement | Tocotrienols as a potent antioxidant to modulate oxidative stress and inflammatory response |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piek Lian Wang | Contact | +603-79492622 | wangpl@ummc.edu.my |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Centre (CIC) | Recruiting | Kuala Lumpur | 59100 | Malaysia |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 27, 2021 | |
| Reset | May 19, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2021 | May 19, 2021 |
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D024508 | Tocotrienols |
| ID | Term |
|---|---|
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Dietary Supplement | The placebo is similar in appearance, but does not contain tocotrienols and consist of palm oil |
|
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |