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

Phase 3

Completed

• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Interventions: Drug: Placebo of MCI-186; Drug: MCI-186

• Registration Number: NCT00424463
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-17
• Study First Submitted QC: 2007-01-17
• Study First Posted: 2007-01-19
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2017-09-06
• Results First Submitted QC: 2017-09-06
• Results First Posted: 2018-06-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-24
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo of MCI-186	-
1	MCI-186	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Abnormal Changes in Sensory Examinations	36 weeks (from seventh cycle to fifteenth cycle)
Percentage of Participants With Adverse Events	36 weeks (from seventh cycle to fifteenth cycle)
Number of Participants With Death or a Specified State of Disease Progression	24 weeks (from seventh cycle to twelfth cycle)	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	baseline (seventh cycle) and at 24 week (twelfth cycle)	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 Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group	36 weeks (from seventh cycle to fifteenth cycle)
Percentage of Participants With Adverse Drug Reactions	36 weeks (from seventh cycle to fifteenth cycle)

Trial Locations

Locations (1)

National Hospital Organization Miyagi National Hospital; 🇯🇵 Watari-gun, Miyagi-ken, Japan