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Tests treatment safety and results for Drug Resistant Epilepsy
Official title The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
ClinicalTrials.gov ID: NCT05019885
What this study is testing
What is Ketamine Hydrochloride?
Ketamine Hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for drug resistant epilepsy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Ketamine is a medication that came into clinical practice in the 1960's. Ketamine is used as an anesthetic and to provide pain relief.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Patients \<18 years of age
- Pregnant women
- Women that are breast feeding
- Patients who had \>21 days of seizure freedom in the last year.
- Patients with a history of status epilepticus within 3 months of screening
- Patients with a history of alcoholism of drug misuse within the last 2 years
See the full eligibility criteria
- 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...
- Patients \<18 years of age
- Pregnant women
- Women that are breast feeding
- Patients who had \>21 days of seizure freedom in the last year.
- Patients with a history of status epilepticus within 3 months of screening
- Patients with a history of alcoholism of drug misuse within the last 2 years
- Unstable medical illness
- Serious or imminent suicidal or homicidal risk
- Patients with cardiovascular disease
- Patients with schizophrenia
- Patients with history of aneurysm or aortic dissection, arteriovenous malformation and intracerebral hemorrhage
- Patients that are immobile i.e. wheel chair bound, bed ridden individuals
- Patients on psychostimulants (amphetamines, methylphenidate etc.) and Monoamine oxidase inhibitors (selegiline, isocarboxazid, phenelzine etc.)
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.