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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01492686
• Date of registration: 11/12/2011
• Prospective Registration: No
• Primary sponsor: Mitsubishi Tanabe Pharma Corporation
• Public title: Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis
• Scientific title: Efficacy and Safety Study of MCI-186 for Treatment of the Patients With Amyotrophic Lateral Sclerosis (ALS) 2
• Date of first enrolment: December 2011
• Target sample size: 137
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01492686
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis (ALS)

Intervention(s)

Drug: MCI-186 in open label phase

Drug: MCI-186

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks [Time Frame: baseline and 24 weeks]

Secondary Outcome(s)

Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks [Time Frame: baseline and 24 weeks]

Percentage of Participants With Adverse Drug Reactions [Time Frame: 24 weeks]

Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks [Time Frame: baseline and 24 weeks]

Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks [Time Frame: baseline and 24 weeks]

Percentage of Participants With Abnormal Values in Sensory Examinations [Time Frame: baseline and 24 weeks]

Number of Participants With Death or a Specified State of Disease Progression [Time Frame: 24 weeks]

Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0) [Time Frame: 24 weeks]

Percentage of Participants With Adverse Events [Time Frame: 24 weeks]

Secondary ID(s)

MCI186-19

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01492686