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Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

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Approved by FDA
Approved outside USA
Is a supplement

Details

Enrollment Criteria

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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.

Inclusion Criteria:
1. Patients diagnosed as definite or probable ALS according to El Escorial Criteria.
2. ALS patients who are graded as mild or moderate according to ALS Health State Scale.
3. Forced vital capacity of at least 80%
4. Desire of the patient to participate in this study and Signing Written Informed
Consent.
Exclusion Criteria:
1. Incidence of drug's side effects that requires discontinuation of the drug
(Edaravone's side effects: Acute kidney injury, Acute allergic reactions, DIC,
Thrombocytopenia, Leukopenia).
2. Desire of the patient to discontinue participating in this study.
3. the patient starts another drug or herb for ALS during the study.

Locations
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Join the ALS Research Collaborative (ARC) Study Today!
Ready to make a difference in ALS research?
Join the ARC Study! Whether you're living with ALS or an asymptomatic gene carrier, your participation can help inform ALS research and lead to new treatments.
ALS Research Collaborative
Thank You to Our Sponsors
Mitsubishi Tanabe Pharma