search
Back to results

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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Middle Cerebral Artery Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 17, 2006
    Last Updated
    July 21, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    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)

    We'll reach out to this number within 24 hrs