Status:

UNKNOWN

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

Lead Sponsor:

Isfahan University of Medical Sciences

Conditions:

Neuromuscular Diseases

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

PHASE3

Brief 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 r...

Eligibility Criteria

Inclusion

  • Patients diagnosed as definite or probable ALS according to El Escorial Criteria.
  • ALS patients who are graded as mild or moderate according to ALS Health State Scale.
  • Forced vital capacity of at least 80%
  • Desire of the patient to participate in this study and Signing Written Informed Consent.

Exclusion

  • 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).
  • Desire of the patient to discontinue participating in this study.
  • the patient starts another drug or herb for ALS during the study.

Key Trial Info

Start Date :

March 16 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 16 2019

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT03272802

Start Date

March 16 2017

End Date

September 16 2019

Last Update

March 27 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

EMG Department, Alzahra Hospital

Isfahan, Iran