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

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

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:

  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.

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:

  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).
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:
  • 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.
Other Names:
  • Rilutek
  • Teglutik
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:
  • Rilutek
  • Teglutik

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.

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

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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