Effect of Edaravone in treatment of ALS

Phase 2

Recruiting

Conditions: Amyotrophic Lateral Sclerosis.
Progressive muscular atrophy
Restrictive lung disease due to amyotrophic lateral sclerosis
Restrictive lung mechanics due to als
G12.21

Registration Number: IRCT20190324043105N1

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Patients diagnosed as definite or probable ALS disease according to El Escorial Criteria
ALS patients who are graded as mild or moderate according to ALS Health State Scale.
The patient gets at least 2 points on all 12 items of the ALSFRS-R.
Forced vital capacity of at least 80% in spirometry.
Desire of the patient to participate in this study and Signing Written Informed Consent.

Exclusion Criteria

Patients diagnosed as possible ALS disease according to El Escorial Criteria
ALS patients who are graded as severe or terminal according to ALS Health State Scale.
The patient can't get at least 2 points on all 12 items of the ALSFRS-R.
The patient administers another drug or herb for ALS treatment.
Unwillingness of patient to enter the clinical trial

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional evaluation of patient's muscle strength. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: Manual Muscle Testing (MMT).;Functional status of the patient. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R).;Quality of life in the patients. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40).

Secondary Outcome Measures