Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00424463
First received: January 17, 2007
Last updated: February 27, 2013
Last verified: February 2013

January 17, 2007
February 27, 2013
January 2007
May 2009   (final data collection date for primary outcome measure)
Revised ALS functional rating scale (ALSFRS-R) scores [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Revised ALS functional rating scale (ALSFRS-R) scores, 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.
Complete list of historical versions of study NCT00424463 on ClinicalTrials.gov Archive Site
  • 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: 36 weeks ] [ Designated as safety issue: No ]
  • Adverse events, adverse drug reactions, laboratory test and sensory examinations. [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • Adverse events, adverse drug reactions, laboratory test and sensory
  • Examinations.
Not Provided
Not Provided
 
Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)
An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)

This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis (ALS)
  • Drug: MCI-186
    Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days ) - observation (14 days) cycle is repeated eight times.
    Other Names:
    • Edaravone
    • Radicut
  • Drug: Placebo of MCI-186
    Two ampoules of placebo injection are intravenously administered once a day for 10 days during 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated eight times.
  • Experimental: 1
    Intervention: Drug: MCI-186
  • Placebo Comparator: 2
    Intervention: Drug: Placebo of MCI-186
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who ware completed drug administration without discontinuation in the preceding confirmatory study NCT00330681.

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.
  • Patients whose creatinine clearance is 50mL/min or less at the time of completion of drug administration in the study NCT00330681.
  • Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant, and patients who can not agree to contraception.
  • Patients who are participating in other clinical trials except the study NCT00330681.
  • In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00424463
MCI186-17
No
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Study Chair: Koji Abe, professor Graduate School of Medicine and Dentistry, Okayama University
Mitsubishi Tanabe Pharma Corporation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP