StrokeEarly Phase 1NCT04412850
Intravenous Magnesium Sulphate in Acute Ischemic Stroke
A Early Phase 1 study testing Magnesium Sulfate in people with Stroke and Ischemic Stroke, run by Dow University of Health Sciences.
Trial summary
Magnesium has a neuroprotective role so the investigators aim to evaluate the role of intravenous magnesium sulphate in improving the clinical outcomes as assessed by the NIH Stroke Scale (NIHSS) in patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 45 to 95 years
- Conditions the study is for
- Stroke, Ischemic Stroke
- What is being tested?
- Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Aug 2021
- Phase
- Early Phase 1
- 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 45 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a confirmed diagnosis of ischemic stroke on neurological examination and CT scan findings aged between 45 -95 years of age of either gender.
- Adults presenting within a stroke onset of 24 hours.
Who cannot join
- Patients with confirmed diagnosis other than ischemic stroke (evidence of Intracranial bleed or space occupying lesion)
- Subjects with systolic blood pressure less than 90mmHg
- Presence of Bundle Branch block or atrioventricular block.
- Serum Creatinine > 3mg/dl
- Respiratory failure (O2 saturation <90% or Respiratory Rate >24 or <12)
- Pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Intravenous Magnesium Sulphate in Improving Clinical Outcome in Patients Suffering From Acute Ischemic Stroke
Magnesium has a neuroprotective role so the investigators aim to evaluate the role of intravenous magnesium sulphate in improving the clinical outcomes as assessed by the NIH Stroke Scale (NIHSS) in patients with acute ischemic stroke.
- Conditions
- Stroke, Ischemic Stroke
- Being tested
- Magnesium Sulfate
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Magnesium and placebo (Normal Saline) will be prepared as solutions of identical volume and appearance. All patients will be randomized and blind to treatment.
All patients will have pretreatment Electrogram (ECG), serum biochemistry and serum Magnesium levels. Serum Magnesium levels will also be measured at 48 hours. Blood pressure, heart rate, respiratory rate and serious adverse events will be monitored at baseline, 15 minutes, and 12, 24 and 48 hours after infusion. Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form.
Follow-up visits will be conducted by the same investigators, and repeated scores on the NIH Stroke Scale will be obtained at 24 hours, 48 hours post admission and on the day of discharge.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. The regiment chosen for this study is designed to double serum magnesium concentration to twice physiological concentration for therapeutic effects in humans, Serum levels between 4.8mg/dl-6mg/dl are considered to have an optimal neuroprotective effect. Receives: Drug: Magnesium Sulfate |
| placebo group | Placebo comparator | Normal Saline in equal volume as the control group. Receives: Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke.
Measured: 7 days
Secondary outcomes (1)
adverse effects
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Naim, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412850
- Sponsor's protocol ID
- huda01
- Status last verified
- Jun 2020
- First submitted
- 11 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Intravenous Magnesium Sulphate in Improving Clinical Outcome in Patients Suffering From Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04412850
- Acronym / sponsor ID
- huda01
- Conditions
- Stroke, Ischemic Stroke
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 2 Jun 2020 (actual)
- 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.
Magnesium has a neuroprotective role so the investigators aim to evaluate the role of intravenous magnesium sulphate in improving the clinical outcomes as assessed by the NIH Stroke Scale (NIHSS) in patients with acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Drug: Magnesium SulfateMagnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. The regiment chosen for this study is designed to double serum magnesium concentration to twice physiological concentration for therapeutic effects in humans, Serum levels between 4.8mg/dl-6mg/dl are considered to have an optimal neuroprotective effect. |
| placebo group | Placebo comparator | Drug: Magnesium SulfateNormal Saline in equal volume as the control group. |
Who may qualify
- Ages
- 45 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with a confirmed diagnosis of ischemic stroke on neurological examination and CT scan findings aged between 45 -95 years of age of either gender.
- Adults presenting within a stroke onset of 24 hours.
Key exclusion criteria (6 listed)
- Patients with confirmed diagnosis other than ischemic stroke (evidence of Intracranial bleed or space occupying lesion)
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 SulfateMagnesium and placebo (Normal Saline) will be prepared as solutions of identical volume and appearance. All patients will be randomized and blind to treatment. All patients will have pretreatment Electrogram (ECG), serum biochemistry and serum Magnesium levels. Serum Magnesium levels will also be measured at 48 hours. Blood pressure, heart rate, respiratory rate and serious adverse events will be monitored at baseline, 15 minutes, and 12, 24 and 48 hours after infusion. Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form. Follow-up visits will be conducted by the same investigators, and repeated scores on the NIH Stroke Scale will be obtained at 24 hours, 48 hours post admission and on the day of discharge. | Drug | Control group, placebo group |
Primary outcome
Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke.
Time frame: 7 days
1 secondary outcome
adverse effects
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Magnesium Sulfate in people with Stroke and Ischemic Stroke, run by Dow University of Health Sciences.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huda Naim, MBBS (03333656270, huda_naim@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement In Clinical Outcome As Measured By The improvement in NIH Stroke Scale After Infusion Of Magnesium Sulphate In Patients Suffering From Acute Ischemic Stroke. (time frame: 7 days). 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 2 Jun 2020.