The Efficacy and Safety of MK0724 IV for Improvement of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke (0724-018)

A Phase IIa Randomized, Double-Blind, Parallel-Groups, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of MK0724 Intravenous Infusion on the Amelioration of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke

The safety and efficacy of MK0724 will be assessed in patients with acute middle cerebral artery stroke using the Action Reach Arm Test (ARAT). This test allows measurement of a specific functional deficit and subsequent recovery correlating with the specific area of stroke in the brain.

Study Overview

• Status: Terminated
• Conditions: Middle Cerebral Artery Stroke
• Intervention / Treatment: Drug: Comparator: Placebo; Drug: Comparator: MK0724

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-80 yrs of age inclusive
• Patient is able to receive IV infusion 8-36 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Placebo	Drug: Comparator: Placebo; Placebo IV infusions 1hr/daily over 7 days.
Experimental: 2; MK0724	Drug: Comparator: MK0724; MK0724 8 mg/kg/hr 1 hr/daily over 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Action Research Arm Test score	At 90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index.	At 90 days

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: November 17, 2006
• First Submitted That Met QC Criteria: November 17, 2006
• First Posted (Estimate): November 20, 2006

Study Record Updates

• Last Update Posted (Estimate): July 22, 2015
• Last Update Submitted That Met QC Criteria: July 21, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Brain Ischemia; Infarction; Brain Infarction; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebral Infarction; Stroke; Ischemic Stroke; Infarction, Middle Cerebral Artery; Trauma, Nervous System
• Other Study ID Numbers: 0724-018; 2006_559