Middle cerebral artery ischemic stroke MedDRA version: 9.1 Level: LLT Classification code 10055221 Term: Ischemic stroke
Conditions
Interventions
Product Code: MK-0724
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: MK-0724
Concentration unit: mg milligram(s)
Concentration type: equal
Con
Sponsors
Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age 18-80, inclusive, not pregnant ? Must be randomized into the study and begin receiving the first infusion of blinded study medication between 8 hours to 36 hours after the initial onset of stroke symptoms ? Stroke is ischemic in origin, middle cerebral artery territory ? No significant neglect (score 60 min. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Stroke in 3 months preceding index stroke ? Baseline imaging ASPECTS = 3 ? Treatment with thrombolytic therapies: tPA, urokinase, streptokinase, intra-arterial t-PA or devices for reperfusion, thromboectomy ? Evidence of a non-ischemic mechanism, subarachnoid hemorrhage, or intracerebral and/or intraventricular hemorrhage, clinically significant cerebral edema ? Reduced level of consciousness (= 2 on NIHSS question 1a) ? Dense hemiplegia (NIHSS question 5 = 4 and question 6 = 4) ? Pre-stroke Modified Rankin score of =2 ? Rapidly improving neurological signs and symptoms ? Premorbid history suggestive of cognitive impairment, dementia, aphasia, unable to carry out ADL independently ? Previous disorder that would confound interpretation of the neurological scales ? Severe coexisting or terminal systemic disease (including HIV/AIDS) or explicit comfort care status ? History of Malignancy = 5 years ? Body weight of >125 kg ? Pregnancy or lactation ? Serum creatinine > 2mg/dL. ALTor AST = 150% of the ULN with concomitant bilirubin > 2 mg/dL and/or ascites ? Decompensate CHF ? ECG: QTc>480 ms or ventricular arrhythmias or a Mobitz Type 1 or greater AV block ? Participation in previous Ono-2506 study or other investigational study within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy MK-0724 8 mg/kg/hr x 1 hr daily for 7 days to placebo in patients with middle cerebral artery ischemic stroke using the Day 90 Action Research Arm Test (ARAT) scores. ;Secondary Objective: To compare the efficacy MK-0724 8 mg/kg/hr x 1 hr daily for 7 days to placebo in patients with middle cerebral artery ischemic stroke using (1) the Day 90 Stroke Arm Strength score, (2) the Day 90 modified Rankin Scale (mRS), and (3) the Day 90 Barthel Index (BI) score.;Primary end point(s): The primary end point is the Day 90 Action Research Arm Test (ARAT) score for patients treated with MK-0724 8 mg/kg/hr x 1 hr daily for seven days as compared to those treated with placebo. | — |
Countries
Austria, Hungary
Outcome results
None listed