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

Primary Purpose

Neuromuscular Diseases

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Edaravone
Riluzole
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Diseases focused on measuring Amyotrophic Lateral Sclerosis, Edaravone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • EMG Department, Alzahra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Case group

Control group

Arm Description

ALS patients who receive the usual treatment option (Riluzole) for this disease and Edaravone. Instructions: Tab. Rilutek 50 mg PO q12hr on empty stomach. Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 14 days in the first 28 day cycle. 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).

ALS patients who receive the usual treatment option (Riluzole) for this disease. Instructions: 1. Tab. Rilutek 50 mg PO q12hr on empty stomach.

Outcomes

Primary Outcome Measures

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.
functional status of the patient.
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
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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2017
Last Updated
March 25, 2019
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03272802
Brief Title
Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official Title
Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS) in a Representative Iranian Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2017 (Actual)
Primary Completion Date
March 16, 2019 (Anticipated)
Study Completion Date
September 16, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases
Keywords
Amyotrophic Lateral Sclerosis, Edaravone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case group
Arm Type
Experimental
Arm Description
ALS patients who receive the usual treatment option (Riluzole) for this disease and Edaravone. Instructions: Tab. Rilutek 50 mg PO q12hr on empty stomach. Amp. Edaravone 60 mg per day IV infusion (in normal saline during 1 hour) for 14 days in the first 28 day cycle. 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).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
ALS patients who receive the usual treatment option (Riluzole) for this disease. Instructions: 1. Tab. Rilutek 50 mg PO q12hr on empty stomach.
Intervention Type
Drug
Intervention Name(s)
Edaravone
Other Intervention Name(s)
Radicut, RADICAVA
Intervention Description
Edaravone is a free radical scavenger. this drug showed desirable effects like slowing decline of physical function by 33 percent in previous studies.
Intervention Type
Drug
Intervention Name(s)
Riluzole
Other Intervention Name(s)
Rilutek, Teglutik
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional evaluation of patient's muscle strength.
Description
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.
Title
functional status of the patient.
Description
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.
Title
Quality of life in the patients
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
EMG Department, Alzahra Hospital
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26437387
Citation
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.
Results Reference
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PubMed Identifier
25286015
Citation
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.
Results Reference
background
PubMed Identifier
28522181
Citation
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.
Results Reference
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Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)

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