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

NCT00424463 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Tanabe Pharma Corporation
Phase	Phase 3
Status	COMPLETED
Enrolment	181
Start date	2007-01
Completion	2009-05

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

• MCI-186
• Placebo of MCI-186

Primary outcomes

• 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.

Countries

Japan