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: February 27, 2013
Last verified: February 2013

January 13, 2009
February 27, 2013
February 2009
November 2010   (final data collection date for primary outcome measure)
Adverse event, Adverse drug Reaction [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00821821 on ClinicalTrials.gov Archive Site
  • Plasma MCI-186 pharmacokinetics [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
  • mRS, NIHSS, Barthel Index [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke
A Phase IIa, Multi-centre, Randomised, Double-blind, Placebo Controlled, Clinical Study Investigating the Safety, Tolerability and Pharmacokinetics of MCI-186 in Subjects With Acute Ischemic Stroke

The objectives of this study are to assess the safety, tolerability and local tolerance, and to investigate the plasma levels and terminal elimination half life of MCI-186, and to review the routine clinical and neurological assessments data of MCI-186 in subjects with acute ischemic stroke.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Ischemic Stroke (AIS)
  • Drug: MCI-186
    Cohort 1: ca.1000 mg/throughout study, Cohort 2: ca.2000 mg/throughout study
    Other Name: edaravone
  • Drug: Placebo
    Cohort 1 and Cohort 2: matching volume of active formulation
  • Experimental: 1 MCI-186
    Intervention: Drug: MCI-186
  • Placebo Comparator: 2 Placebo
    Intervention: Drug: Placebo
Kaste M, Murayama S, Ford GA, Dippel DW, Walters MR, Tatlisumak T; MCI-186 study group. Safety, tolerability and pharmacokinetics of MCI-186 in patients with acute ischemic stroke: new formulation and dosing regimen. Cerebrovasc Dis. 2013;36(3):196-204. doi: 10.1159/000353680. Epub 2013 Oct 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Full functional independence prior to the present stroke (as evidenced by a pre-morbid modified Rankin Scale score of 0-2
  • Clinical diagnosis of acute stroke with CT scan ruling out intracranial hemorrhage
  • Onset of symptoms within 1-24 hours of commencement of infusion of study drug
  • Measurable deficit on NIHSS (as evidenced by a score of 3-15)
  • Full consciousness (i.e. the score for NIHSS item 1a=0)
  • Written valid informed consent is obtained from the subject or his/her next of kin or legal representative if the subject is fully conscious (i.e. the score for NIHSS item 1a = 0) but unable to read and/or sign the ICF, in accordance with National legislation and local IRB requirements

Exclusion Criteria:

  • Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition
  • Subjects with severe illness with life expectancy less than 6 months
  • Body weight in excess of 120 kg
  • Subjects who have received rTPA or other thrombolytics (e.g. urokinase, streptokinase, reteplase, tenecteplase) within the previous 24 hours
  • Likelihood of forbidden concomitant therapy such as vascular surgery, coronary artery bypass graft (CABG), valve replacement, or carotid endarterectomy (CEA)
  • Evidence of cerebral herniation
  • Subjects with confounding neurological diseases such as dementia
  • Subjects with CADASIL, Moya Moya, or carotid dissection
  • Subjects who have experienced a stroke within the previous 3 months (Note: subjects who have recently experienced a TIA, but whose premorbid mRS prior to their stroke is 0-2, will be allowed to enter the study)
  • Evidence from admission imaging tests of infarction involving >1/3 of MCA territory, or entire ACA territory involvement, or internal carotid artery (ICA) occlusions without coexisting separate occlusion of the middle cerebral artery (because of the difficulty distinguishing between chronic and acute ICA lesions in such subjects)
  • Pathology other than cerebral infarction on any admission imaging tests (e.g. ICH or SAH, AV malformation, cerebral aneurysm, or cerebral neoplasm)
  • Current or previous known excessive alcohol use or dependence
  • Current known illicit drug use or dependence
  • Participation in a previous clinical study within 30 days
  • Subjects unlikely to be able and willing to attend all study follow-up visits
  • Any other conditions which in the opinion of the investigator deem the subject ineligible for inclusion
  • Females who are pregnant or intend to become pregnant or subjects (male and female) who do not agree to use effective contraception for 3 months after end of treatment
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Netherlands,   United Kingdom
 
NCT00821821
MCI-186-E04
Yes
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Study Chair: Professor Information at Mitsubishi Pharma Europe
Mitsubishi Tanabe Pharma Corporation
February 2013

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