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Status unknownNCT03272802Updated Mar 27, 2019

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

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.

Primary conditionAmyotrophic Lateral SclerosisRegistry: Neuromuscular DiseasesReclassifiedWhy we changed it
Registry
Neuromuscular Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Amyotrophic Lateral Sclerosis
Why
  1. The study's title name Amyotrophic Lateral Sclerosis, a narrower term within Neuromuscular Diseases.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Isfahan University of Medical Sciences · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Mar 2017, registered Sep 2017).

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Phase
Phase 2/3
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Neuromuscular Diseases

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Keywords

  • Amyotrophic Lateral Sclerosis
  • Edaravone
03

In context

Amyotrophic Lateral Sclerosis Reclassified

979 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 278 are open to participants now.

This study's planned enrollment of 20 is below the median of 38 across 663 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 150 studies on the registry; 8 are open to participants now.

Browse Isfahan University of Medical Sciences studies →

Compared within Amyotrophic Lateral Sclerosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neuromuscular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • 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).

    Drug: Edaravone · Drug: Riluzole

  • 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.

    Drug: Riluzole

Interventions

  • DrugEdaravone

    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

  • DrugRiluzole

    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

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

07

Study locations

1 site
  • EMG Department, Alzahra Hospital
    Isfahan, Iran, Islamic Republic of
08

References and documents

Publications

  • 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. PubMed 26437387 ↗
  • 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. PubMed 25286015 ↗
  • 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. PubMed 28522181 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2017 (actual). Primary completion is estimated for Mar 2019, 24 months after the start.

Of 22 phase 2/3 interventional studies under Amyotrophic Lateral Sclerosis, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 109. This study's planned 24 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2017
First posted
Sep 6, 2017
StartActual
Mar 16, 2017
Primary completionEst.
Mar 16, 2019
CompletionEst.
Sep 16, 2019
Last update
Mar 27, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03272802
Lead sponsor
Isfahan University of Medical Sciences
Responsible party
Alireza Eishi Oskouei (MD, Isfahan University of Medical Sciences) — Principal investigator
First posted
Sep 6, 2017
Start date
Mar 16, 2017
Primary completion
Mar 16, 2019 (estimated)
Completion
Sep 16, 2019 (estimated)
Last update
Mar 27, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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