NCT00401310

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

November 17, 2006

Last Update Submit

July 21, 2015

Conditions

Middle Cerebral Artery Stroke

Outcome Measures

Primary Outcomes (1)

  • Action Research Arm Test score

    At 90 days

Secondary Outcomes (1)

  • Scores on the Stroke Arm Strength question, modified Rankin, and Barthel Index.

    At 90 days

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo

2

EXPERIMENTAL

MK0724

Drug: Comparator: MK0724

Interventions

Comparator: PlaceboDRUG

Placebo IV infusions 1hr/daily over 7 days.

1
Comparator: MK0724DRUG

MK0724 8 mg/kg/hr 1 hr/daily over 7 days.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs of age inclusive
  • Patient is able to receive IV infusion 8-36 hours after stroke onset
  • Baseline NIHSS of 6-18 inclusive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebral InfarctionBrain InfarctionBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesStrokeVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

July 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

July 22, 2015

Record last verified: 2015-07