StrokePhase 2/3NCT00933868
Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke
A Phase 2/3 study testing Magnesium Chloride in people with Stroke, run by Relox Medical, LLC at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Magnesium Chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2009to Jul 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Born Preventive Healthcare Clinic, PC
Grand Rapids, Michigan, 49512
Schachter Center for Complementary Medicine
Suffern, New York, 10901
Comprehensive Heart Care Inc.
Toledo, Ohio, 43606
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Magnesium Chloride, Placebo
- Keywords
- A stroke that occurred three months to four years ago
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium ChlorideDrug
An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Infusions are given over 3 weeks and subjects are followed-up at 1, 2, and 3 months after the infusions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Relox Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Bert Spilker, Relox Medical, LLC
- Investigators
- Bert Spilker, PhD, MD, Principal investigator, President, Bert Spilker & Associates, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933868
- Sponsor's protocol ID
- RM-R001
- Status last verified
- Sep 2010
- First submitted
- 30 Jun 2009
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00933868
- Acronym / sponsor ID
- RM-R001
- Conditions
- Stroke
- Keywords
- A stroke that occurred three months to four years ago
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Relox Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium infusion in patients breathing 100% oxygen | Experimental | Drug: Magnesium ChloridePatients 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). |
| Placebo infusion | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium ChlorideAn infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen | Drug | Magnesium infusion in patients breathing 100% oxygen |
| PlaceboA 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 | Drug | Placebo infusion |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bert Spilker, PhD, MD principal investigator
President, Bert Spilker & Associates, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnesium Chloride in people with Stroke, run by Relox Medical, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2012.