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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)(TERMINATED)

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.)
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00401310
First received: November 17, 2006
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Merck:

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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401310

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00401310     History of Changes
Other Study ID Numbers: 2006_559, MK0724-018
Study First Received: November 17, 2006
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013