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Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease that causes the death of 30,000 affected individual every year. Complex nature and unknown pathogenesis of this disease are 2 major reasons for failure of therapeutic interventions. Edaravone is a free radical scavenger that slows down functional decline and prevents from disease progression in ALS patients. FDA newly approved this drug in these patients (2017/5/5). In this study, investigators aimed to assess the treatment effect of this newly approved drug in patients with ALS in a representative Iranian population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case group | Experimental | ALS patients who receive the usual treatment option (Riluzole) for this disease and Edaravone. Instructions:
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| Control group | Active Comparator | ALS patients who receive the usual treatment option (Riluzole) for this disease. Instructions: 1. Tab. Rilutek 50 mg PO q12hr on empty stomach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edaravone | Drug | Edaravone is a free radical scavenger. this drug showed desirable effects like slowing decline of physical function by 33 percent in previous studies. |
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| Measure | Description | Time Frame |
|---|---|---|
| Functional evaluation of patient's muscle strength. | Manual Muscle Testing (MMT) will be used to evaluate functional muscle strength. This procedure evaluates the strength of some proximal and distal muscles of each limb and also the neck region. | At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. |
| functional status of the patient. | Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to evaluate functional status of the patient. | At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. |
| Quality of life in the patients | Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) will be used to assess Quality of life in the patients. The Persian version of this questionare will be used in this study. | At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMG Department, Alzahra Hospital | Isfahan | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26437387 | Background | Shamshiri H, Fatehi F, Davoudi F, Mir E, Pourmirza B, Abolfazli R, Etemadifar M, Harirchian MH, Gharagozli K, Ayromlou H, Basiri K, Zamani B, Rohani M, Sedighi B, Roudbari A, Delavar Kasmaei H, Nikkhah K, Ranjbar Naeini A, Nafissi S. Amyotrophic lateral sclerosis progression: Iran-ALS clinical registry, a multicentre study. Amyotroph Lateral Scler Frontotemporal Degener. 2015;16(7-8):506-11. doi: 10.3109/21678421.2015.1074698. Epub 2015 Oct 5. | |
| 25286015 |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D000077553 | Edaravone |
| D019782 | Riluzole |
| ID | Term |
|---|---|
| D000983 | Antipyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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|
| Riluzole | Drug | Riluzole is a treatment option for amyotrophic lateral sclerosis. The occurrence of ventilator-dependence or tracheostomy is delayed in selected patients who treated with this drug. |
|
|
| Background |
| Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, Hamada C, Kondo K, Yoneoka T, Akimoto M, Yoshino H; Edaravone ALS Study Group. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):610-7. doi: 10.3109/21678421.2014.959024. Epub 2014 Oct 6. |
| 28522181 | Background | Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/S1474-4422(17)30115-1. Epub 2017 May 15. |
| 38011420 | Derived | Eishi-Oskouei A, Basiri K. Safety and efficacy of edaravone in well-defined Iranian patients with amyotrophic lateral sclerosis: A parallel-group single-blind trial. Curr J Neurol. 2021 Jan 4;20(1):1-7. doi: 10.18502/cjn.v20i1.6373. |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D052160 | Benzothiazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |