Acute Ischemic StrokePhase 2/3QUEST-KETANCT03223220
Quelling of Excitotoxicity in Acute Stroke With Ketamine
A Phase 2/3 study testing Ketamine, Normal Saline and Midazolam injection in people with Acute Ischemic Stroke, run by Lower Merion Neurology Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Ketamine, Normal Saline and Midazolam injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 31 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Sudhir Aggarwal, MD, PhD, 484-413-2572, saggarwal@lowermerionneurology.com
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Ketamine, Normal Saline, Midazolam injection
- Keywords
- Stroke, Neuroprotection, Ketamine
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
IV infusion
Normal SalineOther
IV infusion
Midazolam injectionDrug
Also called Versed
Injection
| Study group | Role | What they receive |
|---|---|---|
| Study Drug | Experimental | Will receive Ketamine infusion, and Midazolam (Versed). Receives: Drug: Ketamine; Drug: Midazolam injection |
| Placebo | Placebo comparator | Will receive Normal saline infusion and Midazolam (Versed). Receives: Other: Normal Saline; Drug: Midazolam injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On day 1 and at 90 days
Secondary outcomes (8)
Barthel's index
An improvement of 10 or more points in Barthel's index will be considered a favorable outcome.
Measured: On day 1, and at 90 days
NIH stroke scale score
Measured: On day 1, day 4 or discharge whichever is earlier, and at 90 days
Depression score using the PHQ9 questionnaire
Measured: On day 1, and day 4 or discharge whichever is earlier.
Infarct volumes
Measured from the DWI-MRI and/or CT images
Measured: On day 1, and day 4 or discharge whichever is earlier
All cause mortality
Measured: 90 days
Stroke-related mortality
Measured: 90 days
Symptomatic intracranial hemorrhage
Measured: Day 4 or discharge whichever is earlier
Deterioration in neurologic status
Increase of 4 or more points in the NIH stroke scale
Measured: Up to day 4 or discharge whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lower Merion Neurology Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudhir Aggarwal MD, PhD,, Lower Merion Neurology Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223220
- Sponsor's protocol ID
- LMNRF-001
- Acronym
- QUEST-KETA
- Status last verified
- Dec 2023
- First submitted
- 14 Jul 2017
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39428602
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quelling of Excitotoxicity in Acute Stroke With Ketamine
- ClinicalTrials.gov ID
- NCT03223220
- Acronym / sponsor ID
- QUEST-KETA / LMNRF-001
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Neuroprotection, Ketamine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Lower Merion Neurology Research FoundationUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Drug | Experimental | Drug: Ketamine, Drug: Midazolam injectionWill receive Ketamine infusion, and Midazolam (Versed). |
| Placebo | Placebo comparator | Other: Normal Saline, Drug: Midazolam injectionWill receive Normal saline infusion and Midazolam (Versed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineIV infusion | Drug | Study Drug |
| Normal SalineIV infusion | Other | Placebo |
| Midazolam injectionAlso: VersedInjection | Drug | Placebo, Study Drug |
Primary outcome
Change in weighted modified Rankin scale score between day 1 and 90 will be assessed.
Time frame: On day 1 and at 90 days
An improvement of 2 in mRS score will be considered favorable outcome.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 39428602Vekhova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine, Normal Saline and Midazolam injection in people with Acute Ischemic Stroke, run by Lower Merion Neurology Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sudhir Aggarwal, MD, PhD (4844132572, saggarwal@lowermerionneurology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weighted modified Rankin scale score between day 1 and 90 will be assessed. (time frame: On day 1 and at 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03223220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.