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Sponsored by: |
Relox Medical, LLC |
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Information provided by: | Relox Medical, LLC |
ClinicalTrials.gov Identifier: | NCT00933868 |
The purpose of this study is to evaluate the effect of six intravenous (IV) infusions of magnesium chloride versus placebo in patients who have residual muscle weakness from a stroke that occurred three months to four years ago.
Condition | Intervention | Phase |
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Stroke |
Drug: Magnesium Chloride Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Magnesium Chloride Infusions Versus Placebo Administered Concomitantly With 100% Oxygen Given to Patients Who Have Residual Muscle Weakness From a Stroke That Occurred Three Months to Four Years Ago |
Estimated Enrollment: | 88 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Magnesium infusion in patients breathing 100% oxygen: Experimental
Patients will be given six infusions over three weeks. Each infusion will last between 4 and 10 minutes. They will then return to clinic in 1,2 and 3 months for the same tests (but no infusions will be given).
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Drug: Magnesium Chloride
An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
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Placebo infusion: Placebo Comparator
The patients will receive six placebo infusions after which they will return to clinic at one, two and three months. At the conclusion of the trial those patients who received placebo may elect to receive the active treatment in another (open label) trial that will begin shortly after this one concludes.
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Drug: Placebo
A saline placebo will be given as an infusion (six infusions over a three week period) in a double blind manner with the active test agent
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The hypothesis being tested is that these six treatments will improve muscle weakness and lead to an improvement in functioning/activities of daily living as measured by the 100-point Barthel index, three months after their last treatment versus their baseline measure, and that the mean difference between the treatment and placebo groups of patients will be at least three points in this index.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mark Roffman, PhD | 201-650-8073 | markroffmanphd@gmail.com |
Contact: Bert Spilker, PhD, MD | 301-718-5150 | bspilker@comcast.net |
United States, Michigan | |
Born Preventive Healthcare Clinic, PC | Recruiting |
Grand Rapids, Michigan, United States, 49512 | |
Contact: Tammy Born, DO 616-656-3700 | |
Principal Investigator: Tammy Born, DO | |
United States, New York | |
Schachter Center for Complementary Medicine | Recruiting |
Suffern, New York, United States, 10901 | |
Contact: Michael Schachter, MD 845-368-4700 office@mbschachter.com | |
Principal Investigator: Michael Schacter, MD | |
United States, Ohio | |
Comprehensive Heart Care Inc. | Recruiting |
Toledo, Ohio, United States, 43606 | |
Contact: James Roberts, MD 419-531-4235 chctoledo@sbcglobal.net | |
Principal Investigator: James Roberts, MD |
Principal Investigator: | Bert Spilker, PhD, MD | President, Bert Spilker & Associates, LLC |
Responsible Party: | Relox Medical, LLC ( Robert Brown ) |
Study ID Numbers: | RM-R001 |
Study First Received: | June 30, 2009 |
Last Updated: | July 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00933868 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Any type of stroke that was three months to four years ago |
Cerebral Infarction Asthenia Stroke Vascular Diseases Brain Ischemia Central Nervous System Diseases |
Ischemia Brain Infarction Brain Diseases Infarction Muscle Weakness Cerebrovascular Disorders |
Cerebral Infarction Nervous System Diseases Stroke Vascular Diseases Brain Ischemia |
Central Nervous System Diseases Cardiovascular Diseases Brain Infarction Brain Diseases Cerebrovascular Disorders |