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

Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03272802

Enrollment

Registered

2017-09-06

Start date

2017-03-16

Completion date

2019-09-16

Last updated

2019-03-27

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

Conditions

Neuromuscular Diseases

Keywords

Amyotrophic Lateral Sclerosis, Edaravone

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.

Interventions

DRUGEdaravone

Edaravone is a free radical scavenger. this drug showed desirable effects like slowing decline of physical function by 33 percent in previous studies.

DRUGRiluzole

Riluzole is a treatment option for amyotrophic lateral sclerosis. The occurrence of ventilator-dependence or tracheostomy is delayed in selected patients who treated with this drug.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026