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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00401310
Recruitment Status : Terminated (Termination date was 20-Oct-2008. Subjects were monitored during the post treatment 90 day follow-up period (per protocol) resulting in LPLV 19-Jan-2009.)
First Posted : November 20, 2006
Last Update Posted : July 22, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Middle Cerebral Artery Stroke Drug: Comparator: Placebo Drug: Comparator: MK0724 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
Placebo Comparator: 1
Drug: Comparator: Placebo
Placebo IV infusions 1hr/daily over 7 days.

Experimental: 2
Drug: Comparator: MK0724
MK0724 8 mg/kg/hr 1 hr/daily over 7 days.

Primary Outcome Measures :
  1. Action Research Arm Test score [ Time Frame: At 90 days ]

Secondary Outcome Measures :
  1. Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index. [ Time Frame: At 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00401310

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00401310     History of Changes
Other Study ID Numbers: 0724-018
First Posted: November 20, 2006    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
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Infarction, Middle Cerebral Artery
Trauma, Nervous System
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Wounds and Injuries