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Sponsors and Collaborators: |
University of California, Los Angeles National Institute of Neurological Disorders and Stroke (NINDS) |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00059332 |
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 | Intervention | Phase |
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Cerebrovascular Accident |
Drug: magnesium sulfate Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Field Administration of Stroke Therapy-Magnesium Trial: A Randomized, Double-Blind, Placebo Controlled Trial of Neuroprotective Magnesium Sulfate Therapy for Acute Stroke Initiated Within 2 Hours of Onset by Paramedics in the Field |
Estimated Enrollment: | 1298 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: magnesium sulfate
Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes or matched placebo, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours or matched placebo.
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B: Placebo Comparator |
Drug: placebo
an inactive substance
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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 to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffrey Saver, M.D. | 310-794-6379 |
United States, California | |
The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Jeffrey Saver, M.D. 310-794-6379 | |
Principal Investigator: Jeffrey Saver, M.D. |
Principal Investigator: | Jeffrey Saver, M.D. | University of California, Los Angeles |
Investigator: | Sidney Starkman, M.D. | UCLA Stroke Center, co-Principal Investigator |
Investigator: | Chelsea Kidwell, M.D. | UCLA Stroke Center, co-Principal Investigator |
Investigator: | Marc Eckstein, M.D. | Los Angeles City Emergency Medical Service, co-Principal Investigator |
Investigator: | Samuel Stratton, MD | Los Angeles Emergency Medical Services Agency, co-Principal Investigator |
Responsible Party: | Geffen School of Medicine at UCLA ( Jeffrey Saver, MD, Professor of Neurology and Director of the UCLA Stroke Center ) |
Study ID Numbers: | R01NS44364 |
Study First Received: | April 23, 2003 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00059332 |
Health Authority: | United States: Food and Drug Administration |
stroke brain attack magnesium sulfate |
neuroprotection prehospital care emergency medical services |
Cerebral Infarction Magnesium Sulfate Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Calcium, Dietary Emergencies Brain Ischemia Brain Infarction Infarction |
Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Calcium Channel Blockers Anesthetics Central Nervous System Depressants Reproductive Control Agents Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators |
Tocolytic Agents Sensory System Agents Therapeutic Uses Cardiovascular Diseases Analgesics Peripheral Nervous System Agents Anti-Arrhythmia Agents Central Nervous System Agents Anticonvulsants |