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

Last updated: March 25, 2019
Sponsor: Isfahan University of Medical Sciences
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Dystonias

Amyotrophic Lateral Sclerosis (Als)

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT03272802
Isfahan ALS Registery
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 InformedConsent.

Exclusion

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.

Study Design

Total Participants: 20
Study Start date:
March 16, 2017
Estimated Completion Date:
September 16, 2019

Connect with a study center

  • EMG Department, Alzahra Hospital

    Isfahan,
    Iran, Islamic Republic of

    Site Not Available

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