Back to resultsMagnesium Chloride Versus Placebo in Patients Who Have Had a Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Magnesium Chloride
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring A stroke that occurred three months to four years ago
Eligibility 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
Sites / Locations
- Born Preventive Healthcare Clinic, PC
- Schachter Center for Complementary Medicine
- Comprehensive Heart Care Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Magnesium infusion in patients breathing 100% oxygen
Placebo infusion
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Barthel Index
Secondary Outcome Measures
Improvement in muscle strength and function
Change in the Mini-mental status examination
Change in balance, coordination, range of motion
Incidence of adverse events and changes in vital signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00933868
Brief Title
Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Relox Medical, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
A stroke that occurred three months to four years ago
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnesium infusion in patients breathing 100% oxygen
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo infusion
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Magnesium Chloride
Intervention Description
An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bert Spilker, PhD, MD
Organizational Affiliation
President, Bert Spilker & Associates, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Born Preventive Healthcare Clinic, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49512
Country
United States
Facility Name
Schachter Center for Complementary Medicine
City
Suffern
State/Province
New York
ZIP/Postal Code
10901
Country
United States
Facility Name
Comprehensive Heart Care Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
12. IPD Sharing Statement
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Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke
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