Effect of MK-0724 on the Improvement of Neurological Damage and Recovery from Ischemic Stroke
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Status:
This trial has been terminated early due to lack of efficacy in a separate Japan Phase III trial.
Purpose:
To evaluate the efficacy of Arundic acid (MK-0724/Ono-2506) compared to placebo, in improving arm motor outcome in patients with middle cerebral artery territory ischemic stroke.
Interventions:
Arundic acid
An astrocyte modulator that demonstrates a wide therapeutic time window in preclinical experimental stroke models, in multiple species.
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Location(s):
U.S. and Canada
Year Started:
2006
Design:
Randomized, double-blind, placebo-controlled, parallel-groups study.
Inclusion Criteria
MCA stroke with at least one cortical symptom; patient is able to receive IV infusion 8-24 hours after stroke onset; baseline NIHSS of 6-18 inclusive.
Exclusion Criteria
Patient had another stroke within 3 months preceding current stroke; patient's stroke is of origin other than MCA (e.g., non-ischemic, hemorrhage); significant cerebral edema; abnormal liver enzymes and abnormal renal and hepatic functions.
Patient Involvement:
Patients will be randomized to receive 8 mg/kg/hr x 1 hr daily intravenous MK-0724 or placebo initiated 8 to 24 hours post-stroke for 7 days, and will be assessed at 2 weeks, 1, 2, and 3 months.
Primary Outcome:
Action Research Arm Test.
Secondary Outcome:
Stroke Arm Strength test, modified Rankin Scale (mRS), and Barthel Index (BI).
Source of Information:
Presented at the 2007 International Stroke Conference [February 2007].
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Web Links and Publications:
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This information last updated on: 2/1/2009
Reviewed on: 02/01/2009.
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