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NMDA Receptor Antagonist

IV Ketamine for Epilepsy

Phase 2

Recruiting

Led By Madeline Fields, MD

Research Sponsored by Madeline Fields

Eligibility Criteria Checklist

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

Must have

Established diagnosis of Drug Resistant Epilepsy (DRE) i.e. failed two or more appropriately chosen anti-seizure medications (ASMs)

Adults (18 years or older)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post infusion

Awards & highlights

Study Summary

This trial will study whether subanesthetic doses of ketamine can effectively treat drug resistant seizures in outpatients.

Who is the study for?

This trial is for adults with drug-resistant epilepsy, having more than four seizures per month. They must have a stable use of seizure devices and anti-seizure medications for specific periods before the study starts. Excluded are pregnant or breastfeeding women, those at risk of suicide or homicide, with unstable illnesses, under 18 years old, substance misuse history within two years, certain cardiovascular conditions, immobility issues or recent severe seizures.Check my eligibility

What is being tested?

The trial tests if low doses of IV Ketamine can help control seizures in outpatients with epilepsy that doesn't respond to standard drugs. It's exploring whether this approach used in hospitals for continuous seizures can be effective when patients aren't hospitalized.See study design

What are the potential side effects?

While not specified here, common side effects of subanesthetic ketamine may include confusion, hallucinations, changes in blood pressure and heart rate, dizziness and nausea. Long-term effects are unclear since it's usually used short-term.

Eligibility Criteria

Inclusion Criteria

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

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My epilepsy hasn't improved after trying two different medications.

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I am 18 years old or older.

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I experience more than 4 seizures of any type per month.

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My epilepsy device settings have been stable for at least 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with seizure reduction

Seizure frequency

Secondary outcome measures

General Anxiety Disorder 7-item questionnaire (GAD-7)

Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score

Quality of Life in Epilepsy (QOLIE-10)

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504

Lightheadedness with low blood pressure

Pump Malfunction

PTSD

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine

Trial Design

1Treatment groups

Experimental Treatment

Group I: IV Ketamine HydrochlorideExperimental Treatment1 Intervention

dose 0.5mg/kg of IV Ketamine Hydrochloride over 40 min

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Madeline FieldsLead Sponsor

Madeline Fields, MDPrincipal InvestigatorIcahn School of Medicine

Lara Marcuse, MDPrincipal InvestigatorIcahn School of Medicine

Media Library

Ketamine Hydrochloride (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05019885 — Phase 2

Epilepsy Research Study Groups: IV Ketamine Hydrochloride

Epilepsy Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT05019885 — Phase 2

Ketamine Hydrochloride (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05019885 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor actively recruiting participants?

"The data from clinicaltrials.gov indicates that enrollment is still open for this investigation which was first uploaded on August 26th 2022 and then updated the same day."

Answered by AI

What is the total enrollment number for this clinical experiment?

"Affirmative. According to the information on clinicaltrials.gov, this scientific investigation is currently enrolling participants. The study was initially posted on August 26th 2022 and since then has been updated; it aims to recruit 15 patients from a single site."

Answered by AI

Could you elaborate on the potential risks posed by Ketamine Hydrochloride?

"Based on our team's assessment, Ketamine Hydrochloride is considered a 2 out of 3 in terms of safety due to evidence suggesting it may be safe but no clinical data supporting its efficacy."

Answered by AI