Clinical Trial: Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2
Brief Summary: The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186 to the ALS patients.
Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation
Current Primary Outcome: Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to death from date of randomization [ Time Frame: 24 weeks ]
- Time to a certain state from date of randomization [ Time Frame: 24 weeks ]inability to walk alone; failure of arm function; tracheostomy; respirator installation; tubal feeding replenishment
- % Forced Vital Capacity (%FVC) [ Time Frame: 24 weeks ]
- Modified Norris scale score [ Time Frame: 24 weeks ]
- Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40 score) [ Time Frame: 24 weeks ]
- Adverse events, adverse drug reactions, laboratory test and sensory examinations [ Time Frame: 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Mitsubishi Tanabe Pharma Corporation
Dates:
Date Received: December 11, 2011
Date Started: December 2011
Date Completion:
Last Updated: June 18, 2015
Last Verified: June 2015
