NCT03272802

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2019

Completed
Last Updated

March 27, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

September 2, 2017

Last Update Submit

March 25, 2019

Conditions

Neuromuscular Diseases

Keywords

Amyotrophic Lateral SclerosisEdaravone

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year.

Study Arms (2)

Case group

EXPERIMENTAL

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: EdaravoneDrug: Riluzole

Control group

ACTIVE COMPARATOR

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

Interventions

EdaravoneDRUG

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
Case group
RiluzoleDRUG

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
Case groupControl group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EMG Department, Alzahra Hospital

Isfahan, Iran

Location

Related Publications (4)

  • 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.

    PMID: 26437387BACKGROUND

  • 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.

    PMID: 25286015BACKGROUND

  • 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.

    PMID: 28522181BACKGROUND

  • Eishi-Oskouei A, Basiri K. Safety and efficacy of edaravone in well-defined Iranian patients with amyotrophic lateral sclerosis: A parallel-group single-blind trial. Curr J Neurol. 2021 Jan 4;20(1):1-7. doi: 10.18502/cjn.v20i1.6373.

    PMID: 38011420DERIVED

MeSH Terms

Conditions

Neuromuscular DiseasesAmyotrophic Lateral Sclerosis

Interventions

EdaravoneRiluzole

Condition Hierarchy (Ancestors)

Nervous System DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AntipyrinePyrazolonesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsThiazolesSulfur CompoundsOrganic ChemicalsBenzothiazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 2, 2017

First Posted

September 6, 2017

Study Start

March 16, 2017

Primary Completion

March 16, 2019

Study Completion

September 16, 2019

Last Updated

March 27, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)