Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke - Full Text View

Sponsor:	Relox Medical, LLC
Information provided by:	Relox Medical, LLC
ClinicalTrials.gov Identifier:	NCT00933868

Purpose

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
Stroke	Drug: Magnesium Chloride Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Placebo Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Chlorides Magnesium Magnesium Chloride

U.S. FDA Resources

Further study details as provided by Relox Medical, LLC:

Primary Outcome Measures:

Barthel Index [ Time Frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in muscle strength and function [ Time Frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions ] [ Designated as safety issue: No ]
Change in the Mini-mental status examination [ Time Frame: Infusions are given over 3 weeks and subjects are followed up at 1,2, and 3 months after the infusions ] [ Designated as safety issue: No ]
Change in balance, coordination, range of motion [ Time Frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 months after the infusions ] [ Designated as safety issue: No ]
Incidence of adverse events and changes in vital signs [ Time Frame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2, and 3 months after the infusions ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	88
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	Drug: Magnesium Chloride An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
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.	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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects of either sex above 18 years of age
Documented history of stroke 3 months to four years ago
Subjects may have had two or more strokes
Must have residual muscle weakness with a 25% or greater difference in strength between the right and left sides of the body
Must be assessed as a 2 or 3 on the Modified Rankin Scale
Must have a Barthel score at or below 85

Exclusion Criteria:

Any traumatic brain injury or other brain injury apart from stroke
Renal insufficiency or renal failure
Any medical or physical condition that would interfere with the measurements to be conducted
Any physical therapy in a facility outside their home within three days of screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933868

Contacts

Contact: Mark Roffman, PhD	201-650-8073	markroffmanphd@gmail.com
Contact: Bert Spilker, PhD, MD	301-718-5150	bspilker@comcast.net

Locations

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

Sponsors and Collaborators

Relox Medical, LLC

Investigators

Principal Investigator:

Bert Spilker, PhD, MD

President, Bert Spilker & Associates, LLC

More Information

No publications provided

Responsible Party:	Relox Medical, LLC ( Bert Spilker )
ClinicalTrials.gov Identifier:	NCT00933868 History of Changes
Other Study ID Numbers:	RM-R001
Study First Received:	June 30, 2009
Last Updated:	February 17, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Relox Medical, LLC:

A stroke that occurred three months to four years ago

Additional relevant MeSH terms:

Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 31, 2010