The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.

Condition	Treatment or Intervention	Phase
Cerebrovascular Accident	Drug: magnesium sulfate	Phase III

Further Study Details: 

Expected Total Enrollment:  1298

Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.

Currently, rt-PA is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.

The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.

Ages Eligible for Study:  40 Years   -   95 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Suspected stroke identified by the Los Angeles Prehospital Stroke Screen
• Age 40-95, inclusive
• Last known well time within 2 hours of treatment initiation
• Deficit present for >/= 15 minutes

Exclusion Criteria:

• Coma
• Rapidly improving neurologic deficit
• Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
• SBP < 90 or > 220
• Known severe renal dysfunction (on dialysis or known chronic creatinine > 3.0)
• Severe respiratory distress (O2 sat < 90% or respiratory rate < 12 or >/= 24)
• Known second or third degree heart block with no pacemaker in place
• Major head trauma in the last 24 hours
• Recent stroke within prior 30 days
• Patient unable to give informed consent and no available legally authorized representative to provide informed consent

Jeffrey Saver, M.D.      310-794-6379 

California
      The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza, Los Angeles,  California,  90095,  United States; Recruiting

Study chairs or principal investigators

Jeffrey Saver, M.D.,  Principal Investigator,  University of California, Los Angeles   
Sidney Starkman, M.D.,  UCLA Stroke Center, co-Principal Investigator   
Chelsea Kidwell, M.D.,  UCLA Stroke Center, co-Principal Investigator   
Marc Eckstein, M.D.,  Los Angeles City Emergency Medical Service, co-Principal Investigator   

Study ID Numbers:  R01NS44364
Record last reviewed:  January 2005
Last Updated:  January 12, 2005
Record first received:  April 23, 2003
ClinicalTrials.gov Identifier:  NCT00059332
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08