Quelling of Excitotoxicity in Acute Stroke With Ketamine

NCT03223220 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LMNRF-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke, Neuroprotection, Ketamine

Outcome Measures

Primary Outcomes (1)

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

  An improvement of 2 in mRS score will be considered favorable outcome.

  On day 1 and at 90 days

Secondary Outcomes (8)

• Barthel's index

  On day 1, and at 90 days

• NIH stroke scale score

  On day 1, day 4 or discharge whichever is earlier, and at 90 days

• Depression score using the PHQ9 questionnaire

  On day 1, and day 4 or discharge whichever is earlier.

• Infarct volumes

  On day 1, and day 4 or discharge whichever is earlier

• All cause mortality

  90 days

Study Arms (2)

Study Drug

EXPERIMENTAL

Will receive Ketamine infusion, and Midazolam (Versed).

Drug: Ketamine; Drug: Midazolam injection

Placebo

PLACEBO COMPARATOR

Will receive Normal saline infusion and Midazolam (Versed).

Other: Normal Saline; Drug: Midazolam injection

Interventions

Ketamine DRUG

IV infusion

Study Drug

Normal Saline OTHER

IV infusion

Placebo

Midazolam injection DRUG

Injection

Also known as: Versed

Placebo; Study Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• Lower Merion Neurology Research Foundation: lead

Study Sites (1)

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Ketamine; Saline Solution; Midazolam

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Sudhir Aggarwal, MD, PhD

CONTACT

4844132572; saggarwal@lowermerionneurology.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist and Medical Director

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 21, 2017
• Study Start: July 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)