A Phase IIa Randomized, Double-Blind, Parallel-Groups, Placebo-Controlled ClinicalTrial to Study the Efficacy and Safety of MK-0724 Intravenous Infusion on theAmelioration of Neurological Damage and Recovery from Middle Cerebral ArteryIschemic Stroke

• Conditions: Middle cerebral artery ischemic stroke; MedDRA version: 9.1Level: LLTClassification code 10055221Term: Ischemic stroke

• Registration Number: EUCTR2008-002079-28-AT
• Lead Sponsor: Merck Sharp & Dohme GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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 <2 on NIHSS question # 11)
?baseline NIHSS of 6-18 inclusive
?baseline aged adjusted NIHSS (NIHSS + age/5) score of 19-32
?Contralateral arm weakness (a score = 1 NIHSS question # 5)
?Persistent neurological deficit >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

?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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified