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

This study has been 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.)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: November 17, 2006
Last updated: July 21, 2015
Last verified: July 2015
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 Intervention Phase
Middle Cerebral Artery Stroke
Drug: Comparator: Placebo
Drug: Comparator: MK0724
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Action Research Arm Test score [ Time Frame: At 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index. [ Time Frame: At 90 days ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: July 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00401310

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00401310     History of Changes
Other Study ID Numbers: 0724-018  2006_559 
Study First Received: November 17, 2006
Last Updated: July 21, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Infarction, Middle Cerebral Artery
Trauma, Nervous System
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebral Arterial Diseases
Cerebral Infarction
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases
Wounds and Injuries processed this record on May 30, 2016