A Phase 2/3 interventional study of Edaravone and Riluzole in Neuromuscular Diseases, sponsored by Isfahan University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-27.
Sponsored by Isfahan University of Medical Sciences · Phase 2/3, Interventional, and Treatment
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.
Exclusion Criteria:
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).
Drug: Edaravone · Drug: Riluzole
ALS patients who receive the usual treatment option (Riluzole) for this disease. Instructions: 1. Tab. Rilutek 50 mg PO q12hr on empty stomach.
Drug: Riluzole
Edaravone is a free radical scavenger. this drug showed desirable effects like slowing decline of physical function by 33 percent in previous studies.
Also known as: Radicut, RADICAVA
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.
Also known as: Rilutek, Teglutik
Functional evaluation of patient's muscle strength.
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.
Time frame: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.
functional status of the patient.
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to evaluate functional status of the patient.
Time frame: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.
Quality of life in the patients
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.
Time frame: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.
Plan to share: No
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Isfahan University of Medical Sciences