- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03272802
Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)
March 25, 2019 updated by: Alireza Eishi Oskouei, Isfahan University of Medical Sciences
Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Isfahan, Iran, Islamic Republic of
- EMG Department, Alzahra Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients diagnosed as definite or probable ALS according to El Escorial Criteria.
- ALS patients who are graded as mild or moderate according to ALS Health State Scale.
- Forced vital capacity of at least 80%
- Desire of the patient to participate in this study and Signing Written Informed Consent.
Exclusion Criteria:
- 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).
- Desire of the patient to discontinue participating in this study.
- the patient starts another drug or herb for ALS during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Case group
ALS patients who receive the usual treatment option (Riluzole) for this disease and Edaravone. Instructions:
|
Edaravone is a free radical scavenger.
this drug showed desirable effects like slowing decline of physical function by 33 percent in previous studies.
Other Names:
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.
Other Names:
|
Active Comparator: Control group
ALS patients who receive the usual treatment option (Riluzole) for this disease. Instructions: 1. Tab. Rilutek 50 mg PO q12hr on empty stomach. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional evaluation of patient's muscle strength.
Time Frame: 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.
|
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.
Time Frame: 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.
|
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
Time Frame: 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.
|
At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Abe K, Itoyama Y, Sobue G, Tsuji S, Aoki M, Doyu M, Hamada C, Kondo K, Yoneoka T, Akimoto M, Yoshino H; Edaravone ALS Study Group. Confirmatory double-blind, parallel-group, placebo-controlled study of efficacy and safety of edaravone (MCI-186) in amyotrophic lateral sclerosis patients. Amyotroph Lateral Scler Frontotemporal Degener. 2014 Dec;15(7-8):610-7. doi: 10.3109/21678421.2014.959024. Epub 2014 Oct 6.
- Shamshiri H, Fatehi F, Davoudi F, Mir E, Pourmirza B, Abolfazli R, Etemadifar M, Harirchian MH, Gharagozli K, Ayromlou H, Basiri K, Zamani B, Rohani M, Sedighi B, Roudbari A, Delavar Kasmaei H, Nikkhah K, Ranjbar Naeini A, Nafissi S. Amyotrophic lateral sclerosis progression: Iran-ALS clinical registry, a multicentre study. Amyotroph Lateral Scler Frontotemporal Degener. 2015;16(7-8):506-11. doi: 10.3109/21678421.2015.1074698. Epub 2015 Oct 5.
- Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/S1474-4422(17)30115-1. Epub 2017 May 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 16, 2017
Primary Completion (Anticipated)
March 16, 2019
Study Completion (Anticipated)
September 16, 2019
Study Registration Dates
First Submitted
September 2, 2017
First Submitted That Met QC Criteria
September 2, 2017
First Posted (Actual)
September 6, 2017
Study Record Updates
Last Update Posted (Actual)
March 27, 2019
Last Update Submitted That Met QC Criteria
March 25, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurodegenerative Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Sclerosis
- Motor Neuron Disease
- Amyotrophic Lateral Sclerosis
- Neuromuscular Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Neuroprotective Agents
- Protective Agents
- Anticonvulsants
- Antioxidants
- Free Radical Scavengers
- Edaravone
- Riluzole
Other Study ID Numbers
- Isfahan ALS Registery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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