|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00415519 |
|
Date of registration:
|
22/12/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III
|
|
Scientific title:
|
An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner |
|
Date of first enrolment:
|
December 2006 |
|
Target sample size:
|
25 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00415519 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Koji Abe, professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Graduate School of Medicine and Dentistry, Okayama University |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
20 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Amyotrophic Lateral Sclerosis (ALS)
|
|
Intervention(s)
|
|
Drug: Placebo of MCI-186
|
|
Drug: MCI-186
|
|
Primary Outcome(s)
|
|
Revised ALS functional rating scale (ALSFRS-R) scores
[Time Frame: 24 weeks]
|
|
Secondary Outcome(s)
|
|
Period until death or a certain state (i.e., inability to walk alone, failure of arm function, tracheostomy, respirator installation, tubal feeding replenishment), %FVC, etc.
[Time Frame: 24 weeks]
|
|
Adverse events, adverse drug reactions, laboratory test and sensory examinations
[Time Frame: 24 weeks]
|
|
Secondary ID(s)
|
|
MCI186-18
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|