Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933868
• Other study ID #: RM-R001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 30, 2009
• Last updated: May 23, 2012
• Start date: April 2009
• Est. completion date: July 2010

Study information

• Verified date: September 2010
• Source: Relox Medical, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Magnesium Chloride
An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
• 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

Locations

Country	Name	City	State
United States	Born Preventive Healthcare Clinic, PC	Grand Rapids	Michigan
United States	Schachter Center for Complementary Medicine	Suffern	New York
United States	Comprehensive Heart Care Inc.	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Relox Medical, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel Index		Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions	No
Secondary	Improvement in muscle strength and function		Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions	No
Secondary	Change in the Mini-mental status examination		Infusions are given over 3 weeks and subjects are followed up at 1,2, and 3 months after the infusions	No
Secondary	Change in balance, coordination, range of motion		Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 months after the infusions	No
Secondary	Incidence of adverse events and changes in vital signs		Infusions are given over 3 weeks and subjects are followed-up at 1, 2, and 3 months after the infusions	Yes