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

Primary Purpose

Amyotrophic Lateral Sclerosis (ALS)

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

MCI-186

Placebo of MCI-186

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS) focused on measuring Amyotrophic lateral sclerosis (ALS)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

National Hospital Organization Miyagi National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Percentage of Participants With Adverse Events

Percentage of Participants With Adverse Drug Reactions

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

Percentage of Participants With Abnormal Changes in Sensory Examinations

Full Information

NCT ID

NCT00424463

First Posted

January 17, 2007

Last Updated

July 24, 2018

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00424463

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amyotrophic Lateral Sclerosis (ALS)

Keywords

Amyotrophic lateral sclerosis (ALS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

181 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

MCI-186

Other Intervention Name(s)

Edaravone, Radicut

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo of MCI-186

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

baseline (seventh cycle) and at 24 week (twelfth cycle)

Secondary Outcome Measure Information:

Title

Number of Participants With Death or a Specified State of Disease Progression

Description

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 (from seventh cycle to twelfth cycle)

Title

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

Description

Time Frame

baseline (seventh cycle) and at 24 week (twelfth cycle)

Title

Percentage of Participants With Adverse Events

Time Frame

36 weeks (from seventh cycle to fifteenth cycle)

Title

Percentage of Participants With Adverse Drug Reactions

Time Frame

36 weeks (from seventh cycle to fifteenth cycle)

Title

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)

Title

Percentage of Participants With Abnormal Changes in Sensory Examinations

Time Frame

36 weeks (from seventh cycle to fifteenth cycle)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Koji Abe, professor

Organizational Affiliation

Graduate School of Medicine and Dentistry, Okayama University

Official's Role

Study Chair

Facility Information:

Facility Name

National Hospital Organization Miyagi National Hospital

City

Watari-gun

State/Province

Miyagi-ken

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

28872918

Citation

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.

Results Reference

result

PubMed Identifier

28872914

Citation

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.

Results Reference

derived

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

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