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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Middle Cerebral Artery Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

Placebo IV infusions 1hr/daily over 7 days.

2

MK0724

Group Type EXPERIMENTAL

Comparator: MK0724

Intervention Type DRUG

MK0724 8 mg/kg/hr 1 hr/daily over 7 days.

Interventions

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Comparator: Placebo

Placebo IV infusions 1hr/daily over 7 days.

Intervention Type DRUG

Comparator: MK0724

MK0724 8 mg/kg/hr 1 hr/daily over 7 days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No