Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
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.
Amyotrophic Lateral Sclerosis (ALS)
Drug: Placebo of MCI-186
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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)|
- Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Period until death or a certain state (i.e., inability to walk alone, failure of arm function, tracheostomy, respirator installation, tubal feeding replenishment), ％FVC, etc. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Adverse events, adverse drug reactions, laboratory test and sensory examinations. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
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 Comparator: 2||
Drug: Placebo of MCI-186
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.
|National Hospital Organization Miyagi National Hospital|
|Watari-gun, Miyagi-ken, Japan|
|Study Chair:||Koji Abe, professor||Graduate School of Medicine and Dentistry, Okayama University|