The Efficacy and Safety of MK0724 IV for Improvement of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke (0724-018)
Primary Purpose
Middle Cerebral Artery Stroke
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: Placebo
Comparator: MK0724
Sponsored by
About this trial
This is an interventional treatment trial for Middle Cerebral Artery Stroke
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Placebo
MK0724
Outcomes
Primary Outcome Measures
Action Research Arm Test score
Secondary Outcome Measures
Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index.
Full Information
NCT ID
NCT00401310
First Posted
November 17, 2006
Last Updated
July 21, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00401310
Brief Title
The Efficacy and Safety of MK0724 IV for Improvement of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke (0724-018)
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 Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
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.
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Middle Cerebral Artery Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
MK0724
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
Placebo IV infusions 1hr/daily over 7 days.
Intervention Type
Drug
Intervention Name(s)
Comparator: MK0724
Intervention Description
MK0724 8 mg/kg/hr 1 hr/daily over 7 days.
Primary Outcome Measure Information:
Title
Action Research Arm Test score
Time Frame
At 90 days
Secondary Outcome Measure Information:
Title
Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index.
Time Frame
At 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of MK0724 IV for Improvement of Neurological Damage and Recovery From Middle Cerebral Artery Ischemic Stroke (0724-018)
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