What side effects are associated with this type of intervention?

Intravenous ketamine, an NMDA receptor antagonist studied for reducing neuroexcitotoxicity in stroke, is associated with side effects such as increased blood pressure, dizziness, dissociation, delirium, nausea, and vomiting. Other NMDA receptor antagonists, like dextromethorphan, can cause lightheadedness, drowsiness, decreased coordination, and unsteady gait. Broadly, stroke treatments may also involve anticoagulants and thrombolytics, which carry risks of bleeding and hemorrhage.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, primarily focusing on thrombolytic agents like tissue plasminogen activator (tPA) for ischemic stroke, which helps dissolve blood clots. Other treatments include antiplatelet drugs such as aspirin and anticoagulants like warfarin to prevent further clotting. While ketamine, an NMDA receptor antagonist, is being studied for its potential neuroprotective effects in reducing neuroexcitotoxicity in stroke, it has not yet received FDA approval for this indication. Current research is exploring its efficacy and safety in this context.

What other types of research exist?

GV150526, a glycine site antagonist at the NMDA receptor, is a promising novel alternative to intravenous ketamine for reducing neuroexcitotoxicity in stroke patients.

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NMDA Receptor Antagonist

Ketamine for Stroke (QUEST-KETA Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Lower Merion Neurology Research Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pre-stroke modified Rankin scale of 0-2

Be older than 18 years old

Must not have

Pre-stroke modified Rankin scale of 3 or above

Eligibility to receive IV Alteplase or intra-arterial thrombectomy/embolectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on day 1 and at 90 days

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial is testing if giving ketamine can help protect the brains of stroke patients by calming overactive nerve cells.

Who is the study for?

This trial is for adults over 18 with acute ischemic stroke within the last 24 hours, confirmed by MRI. They must have been relatively independent before the stroke (modified Rankin scale of 0-2) and agree to participate. It's not for those with brain hemorrhage, pregnancy, known ketamine allergy, eligibility for certain other stroke treatments, psychiatric illness, seizure at symptom onset or severe uncontrolled high blood pressure.

What is being tested?

The study tests if intravenous ketamine can protect the brain after an acute ischemic stroke by reducing harmful overactivity of nerve cells. Participants will receive either ketamine or placebo (normal saline), and some may get a sedative (midazolam injection) as part of this phase II trial.

What are the potential side effects?

Ketamine might cause side effects like hallucinations, confusion, elevated blood pressure, nausea or vomiting. Midazolam could lead to drowsiness or breathing difficulties. The severity and occurrence vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was independent in daily activities before my stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I needed help with my daily activities before my stroke.

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I am eligible for clot-dissolving medication or a procedure to remove clots.

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My blood pressure is very high despite taking medication.

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I had a brain bleed when first diagnosed.

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I had a seizure when my symptoms first started.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on day 1 and at 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on day 1 and at 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 1 and at 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in weighted modified Rankin scale score between day 1 and 90 will be assessed.

Secondary study objectives

Barthel's index

Deterioration in neurologic status

Infarct volumes

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Study DrugExperimental Treatment2 Interventions

Will receive Ketamine infusion, and Midazolam (Versed).

Group II: PlaceboPlacebo Group2 Interventions

Will receive Normal saline infusion and Midazolam (Versed).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

FDA approved

Midazolam

FDA approved

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke often aim to reduce neuroexcitotoxicity, which is a harmful process where excessive glutamate causes overactivation of NMDA receptors, leading to neuronal damage. Intravenous ketamine, an NMDA receptor antagonist, works by blocking these receptors, thereby reducing excitotoxicity and providing neuroprotection. This is crucial for stroke patients as it helps to minimize brain damage and improve functional recovery. Other treatments may include thrombolytics to dissolve blood clots, antiplatelet agents to prevent further clotting, and neuroprotective agents to safeguard brain cells. Together, these treatments aim to restore blood flow, protect neurons, and enhance recovery, ultimately improving outcomes for stroke patients.

Long-term functional recovery and compensation after cerebral ischemia in rats.