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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 2

Conditions: Middle Cerebral Artery Stroke

Treatments: Drug: Comparator: MK0724; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401310

2006_559

0724-018

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo

2

Experimental group

Description:

MK0724

Treatment:

Drug: Comparator: MK0724