Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492686
• Other study ID #: MCI186-19
• Status: Completed
• Phase: Phase 3
• Start date: December 2011
• Est. completion date: October 2014

Study information

• Verified date: June 2018
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients whose conditions are defined as "definite ALS"or "probable ALS"diagnostic criteria El Escorial and revised 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 2 years after the onset of ALS.

• Patients whose progress of the condition during 12 weeks before administration meet other requirements.

Exclusion Criteria:

• 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.

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). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
• Placebo
Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
• MCI-186 in open label phase
All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (2)

WRITING GROUP ON BEHALF OF THE EDARAVONE (MCI-186) ALS 19 STUDY GROUP. Open-label 24-week extension study of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017 Oct;18(sup1):55-63. doi: 10.1080/216784 — View Citation

Writing Group; Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017 Jul;16(7):505-512. doi: 10.1016/ — 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	0=worst; 48=best	baseline and 24 weeks
Secondary	Number of Participants With Death or a Specified State of Disease Progression	Any of "death, disability of independent ambulation, loss of upper limbs function, tracheotomy, use of respirator, use of tube feeding and loss of useful speech" was defined as an event.	24 weeks
Secondary	Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks		baseline and 24 weeks
Secondary	Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks	The Modified Norris Scale is a measure of movement disorder for patients with ALS. 0=worst; 102=best	baseline and 24 weeks
Secondary	Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks	The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, Activities of daily living (ADL) and independence, eating and drinking, communication, and emotional reactions. 200=worst; 40=best	baseline and 24 weeks
Secondary	Percentage of Participants With Adverse Events		24 weeks
Secondary	Percentage of Participants With Adverse Drug Reactions		24 weeks
Secondary	Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0)		24 weeks
Secondary	Percentage of Participants With Abnormal Values in Sensory Examinations		baseline and 24 weeks