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

Middle Cerebral Artery Stroke Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00401310
• Other study ID #: 0724-018
• Secondary ID: 2006_559
• Status: Terminated
• Phase: Phase 2
• First received: November 17, 2006
• Last updated: July 21, 2015
• Start date: July 2007
• Est. completion date: January 2009

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction, Middle Cerebral Artery
• Middle Cerebral Artery Stroke
• Stroke
• Trauma, Nervous System

Intervention

Drug:
• Comparator: Placebo
Placebo IV infusions 1hr/daily over 7 days.
• Comparator: MK0724
MK0724 8 mg/kg/hr 1 hr/daily over 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Action Research Arm Test score		At 90 days	No
Secondary	Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index.		At 90 days	No