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

Isfahan University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Neuromuscular Diseases

Treatments: Drug: Riluzole; Drug: Edaravone

Study type: Interventional

Funder types: Other

Identifiers

NCT03272802

Isfahan ALS Registery

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Case group

Experimental group

Description:

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).

Treatment:

Drug: Edaravone

Drug: Riluzole

Control group

Active Comparator group

Description:

ALS patients who receive the usual treatment option (Riluzole) for this disease. Instructions: 1. Tab. Rilutek 50 mg PO q12hr on empty stomach.

Treatment:

Drug: Riluzole