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Neuroprotective Agent

Neuroprotective Agents for Ischemic Stroke

Phase 1
Recruiting
Led By Thomas W Link, MD, MS
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Angiography must reveal a thromboembolism which is completely occluding flow within the intracranial portion of the internal carotid artery, the M1 or proximal M2 portions of the middle cerebral artery
Participants must meet criteria for intra-arterial thrombectomy as determined and documented by the Stroke Neurology and Interventional Neuroradiology attending physicians at Northshore University Hospital
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of treatment
Awards & highlights

Study Summary

This trial is testing whether it is safe to give patients a cocktail of neuroprotective drugs immediately after they have a stroke, in order to try to improve long-term outcomes.

Who is the study for?
This trial is for adults aged 18-90 with acute ischemic stroke due to large vessel occlusion, who are eligible for intra-arterial thrombectomy. Excluded are pregnant or lactating women, those with certain heart conditions, renal insufficiency, severe liver issues, systemic lupus erythematosus, idiopathic intracranial hypertension, prior therapeutic anticoagulation or known allergies to contrast dye or trial drugs.Check my eligibility
What is being tested?
The study tests the safety and feasibility of delivering a mix of neuroprotective agents (cold saline, minocycline and magnesium sulfate) directly into the artery immediately after mechanical clot removal in stroke patients. It's an early-phase trial focusing on targeted therapy to damaged brain areas.See study design
What are the potential side effects?
Potential side effects may include reactions related to cold infusion such as shivering or discomfort at injection site; allergic responses; possible impact on kidney function from magnesium sulfate; and typical drug-related risks like nausea associated with minocycline.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My brain scan shows a complete blockage in a major brain artery.
Select...
I am eligible for a clot removal procedure as confirmed by specialists.
Select...
I have been diagnosed with a stroke caused by a blocked large blood vessel, confirmed by the Stroke Neurology team.
Select...
I am between 18 and 90 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intracranial hemorrhage
Presence of serious adverse event
Secondary outcome measures
Functional outcome
Infarct volume

Side effects data

From 2017 Phase 2 trial • 22 Patients • NCT01746043
20%
Peripheral Neuropathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Armodafinil+Minocycline
Minocycline
Armodafinil

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intra-arterial neuroprotective substancesExperimental Treatment1 Intervention
Cold saline, minocycline, and magnesium sulfate to be infused intra-arterially immediately after thrombectomy via the internal carotid artery. A dose escalation design will be used, as described above in "Study Description."

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,909 Total Patients Enrolled
1 Trials studying Ischemic Stroke
53 Patients Enrolled for Ischemic Stroke
Thomas W Link, MD, MSPrincipal InvestigatorNorthwell Health

Media Library

Intra-arterial cold saline, minocycline, and magnesium (Neuroprotective Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05032781 — Phase 1
Ischemic Stroke Research Study Groups: Intra-arterial neuroprotective substances
Ischemic Stroke Clinical Trial 2023: Intra-arterial cold saline, minocycline, and magnesium Highlights & Side Effects. Trial Name: NCT05032781 — Phase 1
Intra-arterial cold saline, minocycline, and magnesium (Neuroprotective Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05032781 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Jun 2024