Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke

NCT00933868 | Completed Phase 2

• 1 other identifier: RM-R001
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

A stroke that occurred three months to four years ago

Outcome Measures

Primary Outcomes (1)

• Barthel Index

  Infusions are given over 3 weeks and subjects are followed-up at 1, 2 and 3 month intervals after the infusions

Secondary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Magnesium infusion in patients breathing 100% oxygen

EXPERIMENTAL

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

Placebo infusion

PLACEBO COMPARATOR

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

Interventions

Magnesium Chloride DRUG

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

Magnesium infusion 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

Placebo infusion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Relox Medical, LLC: lead

Study Sites (3)

Born Preventive Healthcare Clinic, PC

Grand Rapids, Michigan, 49512, United States

Location

Schachter Center for Complementary Medicine

Suffern, New York, 10901, United States

Location

Comprehensive Heart Care Inc.

Toledo, Ohio, 43606, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Magnesium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Magnesium Compounds

Study Officials

• Bert Spilker, PhD, MD

  President, Bert Spilker & Associates, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Principal Investigator

Study Record Dates

• First Submitted: June 30, 2009
• First Posted: July 7, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 25, 2012

Record last verified: 2010-09

Locations

US (3)