Clinical trial NCT00933868: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stroke
Keywords: A stroke that occurred three months to four years ago
Lead sponsor: Relox Medical, LLC
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Barthel Index
timeFrame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions
Secondary outcomes:
measure: Improvement in muscle strength and function
timeFrame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions
measure: Change in the Mini-mental status examination
timeFrame: Infusions are given over 3 weeks and subjects are followed up at 1,2, and 3 months after the infusions
measure: Change in balance, coordination, range of motion
timeFrame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 months after the infusions
measure: Incidence of adverse events and changes in vital signs
timeFrame: Infusions are given over 3 weeks and subjects are followed-up at 1, 2, and 3 months after the infusions
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Born Preventive Healthcare Clinic, PC
state: Michigan
city: Suffern
country: United States
facility: Schachter Center for Complementary Medicine
state: New York
city: Toledo
country: United States
facility: Comprehensive Heart Care Inc.
state: Ohio
Study officials:
affiliation: President, Bert Spilker & Associates, LLC
name: Bert Spilker, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: