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

Phase 2

• Conditions: Neuromuscular Diseases
• Interventions: Drug: Edaravone; Drug: Riluzole

• Registration Number: NCT03272802
• Lead Sponsor: Isfahan University of Medical Sciences

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-16
• Study First Submitted: 2017-09-02
• Study First Submitted QC: 2017-09-02
• Study First Posted: 2017-09-06
• Status Verified: 2019-03
• Primary Completion: 2019-03-16
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-27
• Study Completion: 2019-09-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case group	Edaravone	ALS patients who receive the usual treatment option (Riluzole) for this disease and Edaravone. Instructions: 1. Tab. Rilutek 50 mg PO q12hr on empty stomach. 2. Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 14 days in the first 28 day cycle. 3. Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 10 days in the following 28 day cycles after the first cycle (for 11 cycles).
Case group	Riluzole	ALS patients who receive the usual treatment option (Riluzole) for this disease and Edaravone. Instructions: 1. Tab. Rilutek 50 mg PO q12hr on empty stomach. 2. Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 14 days in the first 28 day cycle. 3. Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 10 days in the following 28 day cycles after the first cycle (for 11 cycles).
Control group	Riluzole	ALS patients who receive the usual treatment option (Riluzole) for this disease. Instructions: 1. Tab. Rilutek 50 mg PO q12hr on empty stomach.

Primary Outcome Measures

Name	Time	Method
Functional evaluation of patient's muscle strength.	At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.	Manual Muscle Testing (MMT) will be used to evaluate functional muscle strength. This procedure evaluates the strength of some proximal and distal muscles of each limb and also the neck region.
functional status of the patient.	At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.	Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to evaluate functional status of the patient.
Quality of life in the patients	At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.	Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) will be used to assess Quality of life in the patients. The Persian version of this questionare will be used in this study.

Trial Locations

Locations (1)

EMG Department, Alzahra Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of