Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bert Spilker, Relox Medical, LLC
ClinicalTrials.gov Identifier:
NCT00933868
First received: June 30, 2009
Last updated: May 23, 2012
Last verified: September 2010

June 30, 2009
May 23, 2012
April 2009
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00933868 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke
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

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Drug: Magnesium Chloride
    An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
  • 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
  • Experimental: Magnesium infusion in patients breathing 100% oxygen
    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).
    Intervention: Drug: Magnesium Chloride
  • Placebo Comparator: Placebo infusion
    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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
July 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Any traumatic brain injury or other brain injury apart from stroke
  2. Renal insufficiency or renal failure
  3. Any medical or physical condition that would interfere with the measurements to be conducted
  4. Any physical therapy in a facility outside their home within three days of screening
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00933868
RM-R001
No
Bert Spilker, Relox Medical, LLC
Relox Medical, LLC
Not Provided
Principal Investigator: Bert Spilker, PhD, MD President, Bert Spilker & Associates, LLC
Relox Medical, LLC
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP