Clinical trial NCT00424463: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic lateral sclerosis (ALS)
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2007-01-19
Enrollment: 181
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
timeFrame: baseline (seventh cycle) and at 24 week (twelfth cycle)
Secondary outcomes:
measure: Number of Participants With Death or a Specified State of Disease Progression
timeFrame: 24 weeks (from seventh cycle to twelfth cycle)
measure: Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
timeFrame: baseline (seventh cycle) and at 24 week (twelfth cycle)
measure: Percentage of Participants With Adverse Events
timeFrame: 36 weeks (from seventh cycle to fifteenth cycle)
measure: Percentage of Participants With Adverse Drug Reactions
timeFrame: 36 weeks (from seventh cycle to fifteenth cycle)
measure: Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group
timeFrame: 36 weeks (from seventh cycle to fifteenth cycle)
measure: Percentage of Participants With Abnormal Changes in Sensory Examinations
timeFrame: 36 weeks (from seventh cycle to fifteenth cycle)
Other outcomes:
Locations:
city: Watari-gun
country: Japan
facility: National Hospital Organization Miyagi National Hospital
state: Miyagi-ken
Study officials:
affiliation: Graduate School of Medicine and Dentistry, Okayama University
name: Koji Abe, professor
role: STUDY_CHAIR
References:
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.
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.