Phase 3 N=25 Randomized Quadruple-blind Treatment

Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III

Amyotrophic Lateral Sclerosis (ALS)

Bottom Line

View on ClinicalTrials.gov: NCT00415519 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Dec 2017

Primary outcome: Primary: Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks — -6.52; -6 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: MCI-186 (Drug); Placebo of MCI-186 (Drug)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Tanabe Pharma Corporation
Primary completion: Jul 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks	-6.52; -6	—
PRIMARY Death or a Specified State of Disease Progression	1; 0; 4; 2; 1; 2	—
PRIMARY Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks	-18.75; -15.69	—
PRIMARY Percentage of Participants With Adverse Events	92.3; 100	—
PRIMARY Percentage of Participants With Adverse Drug Reactions	23.1; 8.3	—
PRIMARY The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients	23.1; 8.3; 0; 0	—
PRIMARY Percentage of Participants With Abnormal Changes in Sensory Examinations	0; 0; 10; 0; 0; 0	—

Summary

The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, 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 who met severity classification III.

Eligibility Criteria

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 cannot take at least one action of eating a meal, excreting, or moving with oneself alone, and need assistance in everyday life.
Patients whose progress of the condition during 12 weeks before administration meet other requirements.

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, sever heart disease, sever 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 been administered other investigational products 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00415519). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.