Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00821821
First received: January 13, 2009
Last updated: April 7, 2014
Last verified: April 2014
Results First Received: January 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Ischemic Stroke (AIS)
Interventions: Drug: MCI-186
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MCI-186 Cohort1 Edaravone: circa 1000 mg / 72-hour infusion
MCI-186 Cohort2 Edaravone: circa 2000 mg / 72-hour infusion
Placebo Group

Cohort1:circa 1000mg / 72-hour infusion matching placebo

Cohort2:circa 2000mg / 72-hour infusion matching placebo


Participant Flow:   Overall Study
    MCI-186 Cohort1     MCI-186 Cohort2     Placebo Group  
STARTED     12     13     11  
COMPLETED     12     13     11  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MCI-186 Cohort1 Edaravone: circa 1000 mg / 72-hour infusion
MCI-186 Cohort2 Edaravone: circa 2000 mg / 72-hour infusion
Placebo Group

Cohort1:circa 1000mg / 72-hour infusion matching placebo

Cohort2:circa 2000mg / 72-hour infusion matching placebo

Total Total of all reporting groups

Baseline Measures
    MCI-186 Cohort1     MCI-186 Cohort2     Placebo Group     Total  
Number of Participants  
[units: participants]
  12     13     11     36  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     5     9     2     16  
>=65 years     7     4     9     20  
Gender  
[units: participants]
       
Female     2     4     3     9  
Male     10     9     8     27  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants That Experienced Adverse Events   [ Time Frame: 87days ]

2.  Secondary:   Plasma MCI-186 Pharmacokinetics   [ Time Frame: 72 hours ]

3.  Secondary:   mRS, NIHSS, Barthel Index   [ Time Frame: throughout study ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp


Publications of Results:

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00821821     History of Changes
Other Study ID Numbers: MCI-186-E04
Study First Received: January 13, 2009
Results First Received: January 5, 2014
Last Updated: April 7, 2014
Health Authority: Finland: Finnish Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency