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
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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:


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 ]

Enrollment: 81
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
Drug: Magnesium Chloride
An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
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.
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
Born Preventive Healthcare Clinic, PC
Grand Rapids, Michigan, United States, 49512
United States, New York
Schachter Center for Complementary Medicine
Suffern, New York, United States, 10901
United States, Ohio
Comprehensive Heart Care Inc.
Toledo, Ohio, United States, 43606
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: Bert Spilker, Lead Principal Investigator, Relox Medical, LLC
ClinicalTrials.gov Identifier: NCT00933868     History of Changes
Other Study ID Numbers: RM-R001
Study First Received: June 30, 2009
Last Updated: May 23, 2012
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 October 02, 2014