Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Phase 3

Completed

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

• Registration Number: NCT00330681
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in 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. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-26
• Study First Submitted QC: 2006-05-26
• Study First Posted: 2006-05-29
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2016-10-28
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-10
• Last Update Submitted: 2017-04-10
• Results First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• Patients who are defined as "definite ALS," "probable ALS" or "probable-laboratory-supported ALS," met diagnostic criteria revised EL Escorial for Airlie House.
• Patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life.
• Patients of less than 3 years after the onset of ALS.
• Patients whose progress of the condition during 12 weeks before administration meet other requirements.

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Exclusion Criteria

• Patients judged to be inadequate to participate in this study by their physician, because those patients' general condition deteriorated to the point that they need to be hospitalized for severe hepatic disease, severe heart disease, severe renal disease and so on, or they need to be administered antibiotics to infection.
• Patients who complain the difficulty in breathing caused by deteriorating the respiratory function.
• 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.
• Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
• Patients who have participated in other trials within 12 weeks before consent, or who are participating in other clinical trials at present.
• 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
1	MCI-186	MCI-186
2	Placebo of MCI-186	Placebo of 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 and 24 weeks	ALSFRS-R Score: 0=worst; 48=best

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events	24 weeks
Death or a Specified State of Disease Progression	24 weeks	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 and 24 weeks
Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks	baseline and 24 weeks	The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102
Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks	baseline and 24 weeks	The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40
Percentage of Participants With Adverse Drug Reactions	24 weeks
Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group	24 weeks
Percentage of Participants With Abnormal Changes in Sensory Examinations	24 weeks