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NCT05019885 · ClinicalTrials.gov registry record · Phase 2

The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

A Phase 2 study of Drug Resistant Epilepsy and Refractory Epilepsy, sponsored by Madeline Fields.

Recruiting
Registry status
Phase 2
Development phase
8
Enrollment target
1
Study location

NCT05019885: Recruiting Phase 2 study of Drug Resistant Epilepsy and Refractory Epilepsy, sponsored by Madeline Fields.

NCT05019885 is a Phase 2 study of Drug Resistant Epilepsy and Refractory Epilepsy that is actively recruiting participants, run by Madeline Fields. The registered enrollment target is 8 participants, below the 35-participant average among 6 other Drug Resistant Epilepsy trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05019885, a Phase 2 study of Drug Resistant Epilepsy and Refractory Epilepsy, is actively recruiting participants, sponsored by Madeline Fields.

RECRUITING
Registry status
Phase 2
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

Ketamine is a medication that came into clinical practice in the 1960's. Ketamine is used as an anesthetic and to provide pain relief. Recently, Ketamine was approved to treat drug resistant depression using subanesthetic doses. In the hospital setting, intravenous anesthetic dosages are used to treat unrelenting seizures known as status epilepticus in comatose patients. Ketamine in subanesthetic doses has not been tried as a treatment for medication resistant seizures in the outpatient setting. This study would like to examine the effectiveness of subanesthetic ketamine in outpatients who suffer from drug resistant epilepsy.

Primary Outcome

50% seizure reduction during the 2 week period of active treatment

Interventions

  • DRUG Ketamine Hydrochloride

Study Locations (1)

New York

  • Mount Sinai Hospital - New York

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2022-08-26
Est. Completion 2026-03
Phase Phase 2
Madeline Fields

1 total trials

What NCT05019885 shows while recruiting

NCT05019885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 35-participant average among 6 other Drug Resistant Epilepsy trials with a reported enrollment target (77% lower).

The record links to 3 conditions, with Drug Resistant Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Ketamine Hydrochloride is the first listed.

NCT05019885 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT05019885 about?

NCT05019885 is a clinical study titled "The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy". Ketamine is a medication that came into clinical practice in the 1960's. Ketamine is used as an anesthetic and to provide pain relief. Recently, Ketamine was approved to treat drug resistant depression using subanesthetic doses. In the hospital setting, intravenous anesthetic dosages are used to tre...

What is the current status of trial NCT05019885?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2022-08-26. Estimated completion is 2026-03.

What conditions does trial NCT05019885 study?

This clinical trial studies the following conditions: Drug Resistant Epilepsy, Refractory Epilepsy, Medically Refractory Epilepsy.

What interventions are being tested in trial NCT05019885?

The interventions under investigation include: Ketamine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT05019885?

This trial is sponsored by Madeline Fields, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05019885 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05019885, the US trial registry maintained by the National Library of Medicine. NCT05019885 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.