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

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415519
• Other study ID #: MCI186-18
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2006
• Last updated: November 20, 2017
• Start date: December 2006
• Est. completion date: July 2008

Study information

• Verified date: November 2017
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• MCI-186
Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
• Placebo of MCI-186
Two ampoules of Placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

References & Publications (1)

WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 18 STUDY GROUP. Exploratory double-blind, parallel-group, placebo-controlled study of edaravone (MCI-186) in amyotrophic lateral sclerosis (Japan ALS severity classification: Grade 3, requiring assist — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks	No primary endpoint was used, because various exploratory analyses were performed.; 0=worst; 48=best	baseline and 24 weeks
Primary	Death or a Specified State of Disease Progression	No primary endpoint was used, because various exploratory analyses were performed.; 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.	24 weeks
Primary	Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks	No primary endpoint was used, because various exploratory analyses were performed.	baseline and 24 weeks
Primary	Percentage of Participants With Adverse Events	No primary endpoint was used, because various exploratory analyses were performed.	24 weeks
Primary	Percentage of Participants With Adverse Drug Reactions	No primary endpoint was used, because various exploratory analyses were performed.	24 weeks
Primary	The Percentage of Participants With an Abnormal Change in Laboratory Tests That Occurred in More Than Two Patients	No primary endpoint was used, because various exploratory analyses were performed.	24 weeks
Primary	Percentage of Participants With Abnormal Changes in Sensory Examinations	No primary endpoint was used, because various exploratory analyses were performed.	24 weeks