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NCT Number: NCT00933868

Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Born Preventive Healthcare Clinic, PC, Grand Rapids, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium Chloride

Drug

An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen

Placebo

Drug

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 outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Relox Medical, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 7, 2009
Registry last updated
May 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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