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Not yet recruiting NCT03223220

Quelling of Excitotoxicity in Acute Stroke With Ketamine

Phase II / Phase III Interventional Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ketamine, Normal Saline, Midazolam injection.
Who it may be relevant to
Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The investigators plan to undertake a phase II study to investigate the efficacy and side effects of intravenous ketamine to reduce neuroexcitotoxicity, and thus provide neuroprotection in patients diagnosed with acute ischemic stroke.

Detailed description

After obtaining informed consent, patients enrolled in the 'study drug' arm of the trial will receive Ketamine (1 mg/ml solution prepared in normal saline) infusion at a rate of 20 mg/h for a period of 24 hours. The infusion will start at a rate of 5 mg/h, and then gradually tapered up during the first 3 hours by 5 mg an hour. Similarly, the infusion rate will be gradually tapered down at a rate of 5 mg/h during the last 3 hours of infusion. The patients randomized to the 'placebo arm' of the trial will receive normal saline infusion at the same rates. In order to prevent the psychogenic adverse effects associated with Ketamine, the patients will be administered Midazolam at a dose of 1 mg IV every 4 hours. Midazolam will also be administered at the same rate to the patients randomized to the placebo arm. Blood Ketamine levels will be measured before starting the treatment, and daily while the infusion is on. While receiving treatment, the patients will be admitted to the telemetry floor in the hospital, on a monitored bed.

Interventions

  • Drug Ketamine
    IV infusion
  • Other Normal Saline
    IV infusion
  • Drug Midazolam injection
    Injection

Primary outcome measures

  • Change in weighted modified Rankin scale score between day 1 and 90 will be assessed. [Time frame: On day 1 and at 90 days]
Secondary outcome measures (8)
  • Barthel's index [Time frame: On day 1, and at 90 days]
  • NIH stroke scale score [Time frame: On day 1, day 4 or discharge whichever is earlier, and at 90 days]
  • Depression score using the PHQ9 questionnaire [Time frame: On day 1, and day 4 or discharge whichever is earlier.]
  • Infarct volumes [Time frame: On day 1, and day 4 or discharge whichever is earlier]
  • All cause mortality [Time frame: 90 days]
  • Stroke-related mortality [Time frame: 90 days]
  • Symptomatic intracranial hemorrhage [Time frame: Day 4 or discharge whichever is earlier]
  • Deterioration in neurologic status [Time frame: Up to day 4 or discharge whichever is earlier]

Eligibility criteria

Inclusion criteria

  • All patients who are 18 years or older, presenting or admitted to the study site with acute ischemic stroke, up to 24 hours since their last known well time
  • An MRI evidence of acute ischemic infarct on the diffusion-weighted imaging with ADC correlate
  • Pre-stroke modified Rankin scale of 0-2
  • Patient should be willing to participate in the study by providing a written consent himself/herself or through a proxy.

Exclusion criteria

  • Eligibility to receive IV Alteplase or intra-arterial thrombectomy/embolectomy
  • Longer than 24 hours since last known well time
  • Pre-stroke modified Rankin scale of 3 or above.
  • Pregnant or lactating females
  • Pre-existing psychiatric illness
  • Intracranial hemorrhage of any type at presentation
  • Seizure at onset of symptoms
  • Sustained uncontrolled hypertension defined as Systolic Blood pressure greater than 185 mmHg or Diastolic Blood Pressure greater than 110 mmHg, despite administration of antihypertensive medications
  • Known hypersensitivity or adverse reaction to prior administration of Ketamine
  • Inability/refusal to provide consent by the patient or through a proxy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Lankenau Medical Center — Wynnewood

Publications

  • Vekhova KA, Namiot ED, Jonsson J, Schioth HB. Ketamine and Esketamine in Clinical Trials: FDA-Approved and Emerging Indications, Trial Trends With Putative Mechanistic Explanations. Clin Pharmacol Ther. 2025 Feb;117(2):374-386. doi: 10.1002/cpt.3478. Epub 2024 Oct 20. PMID 39428602

Identifiers

NCT: NCT03223220 · LMNRF-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗