Ketamine Hydrochloride for Drug Resistant Epilepsy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mount Sinai Hospital, New York, NY
Drug Resistant Epilepsy+3 More
Ketamine Hydrochloride - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication called ketamine might be effective in treating drug resistant epilepsy.

See full description

Eligible Conditions

  • Drug Resistant Epilepsy
  • Medically Refractory Epilepsy
  • Refractory Epilepsy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Drug Resistant Epilepsy

Study Objectives

This trial is evaluating whether Ketamine Hydrochloride will improve 2 primary outcomes and 3 secondary outcomes in patients with Drug Resistant Epilepsy. Measurement will happen over the course of week 18.

28 days post infusion
Number of participants with seizure reduction
3 months post infusion
Seizure frequency
Week 18
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
Quality of Life in Epilepsy (QOLIE-10)
week 18
General Anxiety Disorder 7-item questionnaire (GAD-7)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Drug Resistant Epilepsy

Side Effects for

Ketamine
Lightheadedness with low blood pressure
1%
PTSD
1%
Pump Malfunction
1%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03156504) in the Ketamine ARM group. Side effects include: Lightheadedness with low blood pressure with 1%, PTSD with 1%, Pump Malfunction with 1%.

Trial Design

1 Treatment Group

IV Ketamine Hydrochloride
1 of 1
Experimental Treatment

This trial requires 15 total participants across 1 different treatment group

This trial involves a single treatment. Ketamine Hydrochloride is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

IV Ketamine Hydrochloride
Drug
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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months post infusion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months post infusion for reporting.

Closest Location

Mount Sinai Hospital - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Provision of signed and dated informed consent form
Adults (18 years or older)
Cognitively impaired adults are not excluded (i.e. will be included in the study)
Established diagnosis of Drug Resistant Epilepsy (DRE) i.e. failed two or more appropriately chosen anti-seizure medications (ASMs)
EEG consistent with focal or generalized epilepsy
Patients must have >4 focal aware, focal impaired aware, focal to bilateral tonic clonic or generalized tonic clonic seizures per month.
Patients can be on >/= 1 anti-seizure medication (ASM) at the time of enrollment on stable doses 12 weeks prior to initiation
Patients on Epilepsy devices: Vagal nerve stimulator (VNS), Deep brain stimulator (DBS) or Responsive Nerve Stimulator (RNS) must have remained stable for at least 4 weeks before the screening visit. Adjustment of devices is not allowed during the study.

Patient Q&A Section

What are the latest developments in ketamine hydrochloride for therapeutic use?

"The latest studies show that ketamine in a low-dose protocol has efficacy as a second-line treatment for refractory partial seizures and as an adjunct treatment to topiramate in children." - Anonymous Online Contributor

Unverified Answer

What are common treatments for drug resistant epilepsy?

"There are no effective options for the treatment of drug resistant childhood epilepsy. Treatment is primarily aimed to reduce seizure-related damage and improve quality of life. This article describes the treatment approach that is most commonly used to treat such patients." - Anonymous Online Contributor

Unverified Answer

Can drug resistant epilepsy be cured?

"With appropriate treatment, seizure control is obtained in almost all patients with drug resistant epilepsy, and thus it can not be stated that the disease cannot be cured." - Anonymous Online Contributor

Unverified Answer

What is drug resistant epilepsy?

"Drugs resistant epilepsy is an important and ongoing clinical challenge. Many people that have epilepsy will be unable to obtain the optimum treatment due to adverse effects. New and improved approaches to the treatment of resistant epilepsy are needed and need to be urgently developed." - Anonymous Online Contributor

Unverified Answer

What causes drug resistant epilepsy?

"The drug resistance is caused by the disease itself or by the treatment the patients received. Patients in whom the disease and treatment had not caused the drug resistance exhibited good results with the S/T/T combination strategy compared with the other 2 strategies." - Anonymous Online Contributor

Unverified Answer

What are the signs of drug resistant epilepsy?

"Although seizures generally improve with treatment, they may recur in patients who have responded favorably to the initial medications. Patients need to be closely monitored for treatment failure." - Anonymous Online Contributor

Unverified Answer

How many people get drug resistant epilepsy a year in the United States?

"Approximately 50,000 adults in the United States are diagnosed with drug resistant epilepsy a year. This makes up 2.5% of adult patients, a rate comparable to that in other countries. The incidence of drug resistant epilepsy was significantly higher in adults aged 50 and above." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of ketamine hydrochloride?

"In a recent study, findings demonstrated that ketamine hydrochloride had one of three most common side effects, anxiety or tension, nightmares, and hallucinations or dream-related behaviors. However, the frequency of serious side effects of ketamine hydrochloride was low in this study." - Anonymous Online Contributor

Unverified Answer

What is ketamine hydrochloride?

"Ketamine is usually recognized as one of the most frequently prescribed drugs in anesthesia. A recent epidemiologist survey of 6,000 hospitalized patients in China disclosed the low incidence (0.12%) in our study area. The adverse effects usually observed after the use of ketamine are rare, and ketamine is less associated with the most severe adverse effects than propofol or benzodiazepines. Further studies are needed." - Anonymous Online Contributor

Unverified Answer

Is ketamine hydrochloride typically used in combination with any other treatments?

"The present retrospective survey demonstrated that ketamine in the form of the HCl salt with oral antiepileptic drugs is used in combination in few epilepsy centres. In contrast to reports in the literature, the present data revealed that ketamine is rarely used in combination with benzodiazepines. On the contrary, we found that the majority of centres often use a benzodiazepin/ketamine co-administration strategy." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ketamine hydrochloride?

"In a recent study, findings support that ketamine may be an antidepressant adjuvant in patients with treatment-resistant epilepsy, therefore it may be considered in addition to currently available antidepressant drugs for treatment-resistant depression. These effects may occur not only as a direct effects of ketamine hydrochloride but also as a result of ketamine hydrochloride's interactions with other medications. For this reason, patients should be monitored carefully when taking ketamine hydrochloride and should not stop taking ketamine hydrochloride or take additional ketamine hydrochloride while on other treatments or medications." - Anonymous Online Contributor

Unverified Answer

What does ketamine hydrochloride usually treat?

"The most common side effects of ketamine were sleepiness and dizziness, followed by a reduction in muscle tone (paresis), but these were not severe enough to discontinue use or warrant admission to a medical facility. Patients with a history of panic attacks reported improvement on their anxiety level after this drug treatment. Ketamine was also helpful in the treatment of patients with hyperactive and/or restless legs syndrome. The usefulness of ketamine in treating the restless legs syndrome cannot be established unequivocally. Although ketamine has been demonstrated to produce sedation and amnesia, it is not known whether this occurs as a consequence of its stimulant effects or is an active property of ketamine." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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