Acute Ischemic StrokeBrain and nervesDrugPhase 2, Phase 3
What this study is
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.
What's being tested
- Ketamine
Intervention · DRUG
- Normal Saline
Intervention · OTHER
- Midazolam injection
Intervention · DRUG
Injection
Both Ketamine and Normal Saline
IV infusion
Study details
- Sponsor
- Lower Merion Neurology Research Foundation
- Conditions
- Acute Ischemic Stroke
- Enrolling
- 120 people
- Starts
- 2024-07-01
- Est. completion
- 2027-12-31
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openLankenau Medical Center
Wynnewood, Pennsylvania, United States
- Sudhir Aggarwal, MD, PhD · Contact484-413-2572saggarwal@lowermerionneurology.com
Study team
Sponsor
Lower Merion Neurology Research Foundation
Study ID LMNRF-001
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.