Amyotrophic Lateral Sclerosis (ALS)Phase 3NCT00424463

Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)

A Phase 3 study testing MCI-186 in people with Amyotrophic Lateral Sclerosis (ALS), run by Shionogi at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Amyotrophic Lateral Sclerosis (ALS)
What is being tested?: MCI-186
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 181 participants
Where: 1 siteJapan
Study dates: 31 Jan 2007to 31 May 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.

Who cannot join

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.
Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT00330681.
Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
Patients who are participating in other clinical trials except the study NCT00330681.
In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

Trial locations and contacts

1 site in 1 country.

Japan1 site

National Hospital Organization Miyagi National Hospital
Watari-gun, Miyagi

Other trials in Japan

About this study

Official title: An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)

Conditions: Amyotrophic Lateral Sclerosis (ALS)
Being tested: MCI-186, Placebo of MCI-186
Keywords: Amyotrophic lateral sclerosis (ALS)
Medical subject headings: Amyotrophic Lateral Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MCI-186Drug
Also called Edaravone, Radicut
Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.
Placebo of MCI-186Drug
Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.

Study groups in NCT00424463
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: MCI-186
2	Placebo comparator	Not described Receives: Drug: Placebo of MCI-186

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
0=worst; 48=best To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.
Measured: baseline (seventh cycle) and at 24 week (twelfth cycle)

Secondary outcomes (6)

Number of Participants With 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.
Measured: 24 weeks (from seventh cycle to twelfth cycle)
Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.
Measured: baseline (seventh cycle) and at 24 week (twelfth cycle)
Percentage of Participants With Adverse Events
Measured: 36 weeks (from seventh cycle to fifteenth cycle)
Percentage of Participants With Adverse Drug Reactions
Measured: 36 weeks (from seventh cycle to fifteenth cycle)
Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group
Measured: 36 weeks (from seventh cycle to fifteenth cycle)
Percentage of Participants With Abnormal Changes in Sensory Examinations
Measured: 36 weeks (from seventh cycle to fifteenth cycle)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 200731 May 2009

First posted19 Jan 2007 (estimated)
Study start31 Jan 2007
Primary completion31 May 2009
Study completion31 May 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
More trials run by ShionogiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00424463
Sponsor's protocol ID: MCI186-17
Status last verified: Jun 2026
First submitted: 17 Jan 2007
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 17 STUDY GROUP. Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):20-31. doi: 10.1080/21678421.2017.1362000.
PubMed 28872918
Takahashi F, Takei K, Tsuda K, Palumbo J. Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):32-39. doi: 10.1080/21678421.2017.1361442.
PubMed 28872914

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Amyotrophic Lateral Sclerosis (ALS) trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)
ClinicalTrials.gov ID: NCT00424463
Acronym / sponsor ID: MCI186-17
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic lateral sclerosis (ALS)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Study start: 31 Jan 2007 (actual)
Primary completion: 31 May 2009 (actual)
Study completion: 31 May 2009 (actual)
First posted: 19 Jan 2007 (estimated)
Results: Posted 4 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: MCI-186
2	Placebo comparator	Drug: Placebo of MCI-186

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.

Key exclusion criteria (5 listed)

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.
Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT00330681.
Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
Patients who are participating in other clinical trials except the study NCT00330681.
In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MCI-186Also: Edaravone, RadicutTwo ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.	Drug	1
Placebo of MCI-186Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.	Drug	2

Primary outcome

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
Time frame: baseline (seventh cycle) and at 24 week (twelfth cycle)
0=worst; 48=best To investigate the sustainability of effects of edaravone, the analysis focusing on the comparison between the placebo and edaravone groups of patients who had received 6 cycles of edaravone treatment, i.e., the comparison of data from Cycles 7 to 12 between the edaravone-edaravone group and the edaravone-placebo group, was performed.

6 secondary outcomes

Number of Participants With Death or a Specified State of Disease Progression
Time frame: 24 weeks (from seventh cycle to twelfth cycle)
Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
Time frame: baseline (seventh cycle) and at 24 week (twelfth cycle)
Percentage of Participants With Adverse Events
Time frame: 36 weeks (from seventh cycle to fifteenth cycle)
Percentage of Participants With Adverse Drug Reactions
Time frame: 36 weeks (from seventh cycle to fifteenth cycle)
Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group
Time frame: 36 weeks (from seventh cycle to fifteenth cycle)
Percentage of Participants With Abnormal Changes in Sensory Examinations
Time frame: 36 weeks (from seventh cycle to fifteenth cycle)

Results and safety

Results posted to the registry on 4 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MCI-186 - Placebo of MCI-186	45	38
MCI-186 - MCI-186	48	34
Placebo of MCI-186 - MCI-186	88	72

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

Time frame: baseline (seventh cycle) and at 24 week (twelfth cycle). Mean (Standard Deviation). Unit: units on a scale

Measure	MCI-186 - Placebo of MCI-186 n = 40	MCI-186 - MCI-186 n = 43	Placebo of MCI-186 - MCI-186 n = 74
Value	-5.5 (4.6)	-4.2 (4)	-5.4 (4.5)

Population analysed: "1 patient with diseases other than ALS" and "4 patients with missing data" were excluded from the FAS in the MCI-186 - Placebo of MCI-186group. "5 patients with missing data" were excluded from the FAS in the MCI-186 - MCI-186 group. "14 patients with missing data" were excluded from the FAS in the Placebo of MCI-186 - MCI-186 group.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: from baseline (seventh cycle) to 36 weeks (fifteenth cycle). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MCI-186 - Placebo of MCI-186	13 of 45 (28.9%)	43 of 45 (95.6%)	Not reported
MCI-186 - MCI-186	25 of 48 (52.1%)	43 of 48 (89.6%)	Not reported
Placebo of MCI-186 - MCI-186	39 of 88 (44.3%)	74 of 88 (84.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28872918WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 17 STUDY GROUP. Exploratory double-blind, parallel-group, placebo-controlled extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):20-31. doi: 10.1080/21678421.2017.1362000.
Derived from this study: PubMed 28872914Takahashi F, Takei K, Tsuda K, Palumbo J. Post-hoc analysis of MCI186-17, the extension study to MCI186-16, the confirmatory double-blind, parallel-group, placebo-controlled study of edaravone in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):32-39. doi: 10.1080/21678421.2017.1361442.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shionogi Clinical Trials Administrator Clinical Support Help Line study director

Shionogi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MCI-186 in people with Amyotrophic Lateral Sclerosis (ALS), run by Shionogi at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks (time frame: baseline (seventh cycle) and at 24 week (twelfth cycle)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00424463, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.