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

Launched by MADELINE FIELDS · Aug 24, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring the use of low doses of a medication called ketamine to help patients with drug-resistant epilepsy, which means their seizures haven't improved despite trying multiple other treatments. Ketamine is commonly used as an anesthetic and has recently shown promise in treating severe depression when given at lower doses. The researchers want to see if giving ketamine through an IV can reduce the number of seizures in outpatients who continue to experience frequent seizures despite taking anti-seizure medications.

To be eligible for this study, participants must be adults aged 18 or older who have been diagnosed with drug-resistant epilepsy. They should have experienced at least four seizures each month despite being on one or more stable anti-seizure medications for the past three months. Importantly, individuals with certain medical conditions or those who are pregnant or breastfeeding cannot participate. If you join the trial, you can expect to receive ketamine treatment in a safe outpatient setting, and the researchers will closely monitor your response to the medication. This study aims to find a new way to help patients manage their epilepsy more effectively.

Gender

ALL

Eligibility criteria

• Inclusion 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 devices is not allowed during the study.
• • Exclusion Criteria
• • 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.)