Effect of Edaravone in treatment of ALS

Evaluation of the effectiveness of Edaravone compared with placebo in maintaining muscle strength, functional status, and quality of life in patients with amyotrophic lateral sclerosis

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190324043105N1

Enrollment

Registered

2019-04-26

Start date

2017-03-16

Completion date

Unknown

Last updated

2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis. Progressive muscular atrophy

Interventions

Intervention 1: Intervention group: Riluzule + Edaravone

In this group, patients treated with Iranian Riluzule (Rilumax 50 mg tablet, tehrandarou Pharma Corporation) and Edaravone (60 mg Radicut vial, Mitsubishi Tanabe Pharma Corporation, Japan). During the

In this group, patients treated with Iranian Riluzule (Rilumax 50 mg tablet, tehrandarou Pharma Corporation) and Placebo (normal saline). During the study period, patients will administer 50 mg Riluzu

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Eishi Oskouei

Esfahan University of Medical Sciences

alireza.eishi@yahoo.com+98 31 3620 2020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026