CompletedNCT00330681Updated Jul 21, 2026Results posted

Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

A Phase 3 interventional study of MCI-186 and Placebo of MCI-186 in Amyotrophic Lateral Sclerosis (ALS), sponsored by Shionogi. Completed. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Shionogi · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 206
Allocation: Randomized
Ages: 20 Years to 75 Years
Sex: All

Study summary

The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.

Conditions studied

Amyotrophic Lateral Sclerosis (ALS)

Browse trials for

Amyotrophic Lateral Sclerosis 981

Keywords

Amyotrophic lateral sclerosis
free radical scavenger

In context

Amyotrophic Lateral Sclerosis

981 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 283 are open to participants now.

This study's enrollment of 206 is above the median of 36 across 667 interventional studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

Shionogi is the lead sponsor of 104 studies on the registry; 10 are open to participants now.

Of its 39 completed or terminated interventional studies of FDA-regulated products, 21 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House.
Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life.
Patients of less than 3 years after the onset of ALS.
Patients whose progress of the condition during 12 weeks before administration meet other requirements.

Exclusion criteria

Exclusion Criteria:

Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, severe heart disease, severe renal disease and so on, or they need to be administered antibiotics to infection.
Patients who complain the difficulty in breathing caused by deteriorating the respiratory function.
Patients with such complications as Parkinson's disease, schizophrenia, dementia, renal failure, or other severe complication, and patients who have the anamnesis of hypersensitivity to edaravone.
Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
Patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present.
In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 206 participants (actual)

Study arms

Experimental
1
MCI-186
Drug: MCI-186
Placebo comparator
2
Placebo of MCI-186
Drug: Placebo of MCI-186

Interventions

DrugMCI-186
Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
Also known as: Edaravone, Radicut
DrugPlacebo of MCI-186
Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

What researchers measure

Primary outcomes

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
ALSFRS-R Score: 0=worst; 48=best
Time frame: baseline and 24 weeks

Secondary outcomes

Death or a Specified State of Disease Progression
Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event.
Time frame: 24 weeks
Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
Time frame: baseline and 24 weeks
Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks
The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102
Time frame: baseline and 24 weeks
Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks
The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40
Time frame: baseline and 24 weeks
Percentage of Participants With Adverse Events
Time frame: 24 weeks
Percentage of Participants With Adverse Drug Reactions
Time frame: 24 weeks
Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group
Time frame: 24 weeks
Percentage of Participants With Abnormal Changes in Sensory Examinations
Time frame: 24 weeks

Results

Posted May 17, 2017

Participant flow

Participant flow — Overall Study
Milestone	MCI-186	Placebo of MCI-186
Started	102	104
Completed	93	90
Not completed	9	14
Withdrew: Adverse event	3	6
Withdrew: Protocol violation	0	1
Withdrew: Withdrawal by subject	5	5
Withdrew: Tracheotomy due to worsening of als	1	2

Outcome measures

PrimaryChange From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks

ALSFRS-R Score: 0=worst; 48=best

Time frame:: baseline and 24 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
units on a scale	MCI-186	Placebo of MCI-186
Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks	-5.7 ± 0.85	-6.35 ± 0.84

SecondaryDeath or a Specified State of Disease Progression

Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event.

Time frame:: 24 weeks
Reported as:: Number · participants

Death or a Specified State of Disease Progression
participants	MCI-186	Placebo of MCI-186
death	2	2
disability of independent ambulation	28	23
loss of upper arm function	2	4
tracheotomy	0	2
use of respirator	1	3
use of tube feeding	5	3

SecondaryChange From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks

Time frame:: baseline and 24 weeks
Reported as:: Least squares mean · percentage of FVC

Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
percentage of FVC	MCI-186	Placebo of MCI-186
Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks	-14.57 ± 2.41	-17.49 ± 2.39

SecondaryChange From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks

The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102

Time frame:: baseline and 24 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks
units on a scale	MCI-186	Placebo of MCI-186
Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks	-14.12 ± 2.05	-16.15 ± 2

SecondaryChange From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks

The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40

Time frame:: baseline and 24 weeks
Reported as:: Least squares mean · units on a scale

Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks
units on a scale	MCI-186	Placebo of MCI-186
Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks	19.6 ± 3.82	19.13 ± 3.79

SecondaryPercentage of Participants With Adverse Events

Time frame:: 24 weeks
Reported as:: Number · percentage of participants

Percentage of Participants With Adverse Events
percentage of participants	MCI-186	Placebo of MCI-186
Percentage of Participants With Adverse Events	89.2	88.5

SecondaryPercentage of Participants With Adverse Drug Reactions

Time frame:: 24 weeks
Reported as:: Number · percentage of participants

Percentage of Participants With Adverse Drug Reactions
percentage of participants	MCI-186	Placebo of MCI-186
Percentage of Participants With Adverse Drug Reactions	13.7	19.2

SecondaryPercentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group

Time frame:: 24 weeks
Reported as:: Number · percentage of participants

Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group
percentage of participants	MCI-186	Placebo of MCI-186
White blood cell count	2	5.8
urinary glucose	6.9	2.9

SecondaryPercentage of Participants With Abnormal Changes in Sensory Examinations

Time frame:: 24 weeks
Reported as:: Number · percentage of participants

Percentage of Participants With Abnormal Changes in Sensory Examinations
percentage of participants	MCI-186	Placebo of MCI-186
Numbness	1	1
Staggering	2	3.8
Vibratory sensation	0	1

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MCI-186	—	18/102 (17.6%)	88/102 (86.3%)
Placebo of MCI-186	—	24/104 (23.1%)	91/104 (87.5%)

Most frequent serious events

Showing 10 of 28

Most frequent serious events
Event	MCI-186	Placebo of MCI-186
DysphagiaGastrointestinal disorders	8/102	11/104
Respiratory failureRespiratory, thoracic and mediastinal disorders	1/102	5/104
Respiratory disorderRespiratory, thoracic and mediastinal disorders	4/102	0/104
Gait disturbanceGeneral disorders	3/102	2/104
Musculoskeletal disorderMusculoskeletal and connective tissue disorders	3/102	3/104
DyspnoeaRespiratory, thoracic and mediastinal disorders	2/102	0/104
DyslaliaNervous system disorders	1/102	2/104
Abdominal painGastrointestinal disorders	1/102	0/104
Intestinal ischaemiaGastrointestinal disorders	1/102	0/104
AbasiaGeneral disorders	1/102	0/104

Most frequent other events

Showing 10 of 180

Most frequent other events
Event	MCI-186	Placebo of MCI-186
NasopharyngitisInfections and infestations	22/102	22/104
Gait disturbanceGeneral disorders	17/102	14/104
ConstipationGastrointestinal disorders	13/102	17/104
ContusionInjury, poisoning and procedural complications	12/102	5/104
InsomniaPsychiatric disorders	9/102	10/104
HeadacheNervous system disorders	8/102	3/104
Muscular weaknessMusculoskeletal and connective tissue disorders	6/102	8/104
EczemaSkin and subcutaneous tissue disorders	7/102	2/104
Glucose urine presentInvestigations	6/102	3/104
DiarrhoeaGastrointestinal disorders	4/102	5/104

Baseline characteristics

Age, Customized
Age, Customized(Participants)	MCI-186	Placebo of MCI-186	Total
<=18 years	0	0	0
Between 19 and 64 years	74	71	145
>=65 years	28	33	61

Sex: Female, Male
Sex: Female, Male(Participants)	MCI-186	Placebo of MCI-186	Total
Female	38	35	73
Male	64	69	133

Study locations

No study locations are listed for this record.

References and documents

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. PubMed 25286015 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00330681
Lead sponsor: Shionogi
Responsible party: Sponsor
First posted: May 29, 2006
Start date: May 31, 2006
Primary completion: Sep 30, 2008
Completion: Sep 30, 2008
Results posted: May 17, 2017
Last update: Jul 21, 2026

Study contacts

Shionogi Clinical Trials Administrator Clinical Support Help Line

study director · Shionogi

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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