NCT03272802

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Isfahan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuromuscular Diseases

Interventions

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

Timeline

• Start date: 2017-03-16
• Primary completion: 2019-03-16
• Completion: 2019-09-16
• First posted: 2017-09-06
• Last updated: 2019-03-27

Locations

1 site across 1 country: Iran