The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMadeline Fields
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patients <18 years of age
Pregnant women
Women that are breast feeding
Patients who had >21 days of seizure freedom in the last year.
Trial design
Design model
Single group
Treatments tested in this trial
Ketamine Hydrochloride
DrugThree times a week (M, W, F) for 2 consecutive weeks.
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: IV Ketamine HydrochlorideExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with seizure reduction
50% seizure reduction during the 2 week period of active treatment
Time frame
2 week during active treatment2
Number of participants with seizure reduction
50% seizure reduction during the 28 days post-infusion.
Time frame
28 days post infusion3
Seizure frequency
Return to pre-ketamine infusion seizure frequency in 3 months
Time frame
3 months post infusionSecondary outcomes
1
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
Time frame
Week 62
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
Time frame
Week 103
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
Time frame
Week 144
Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Score
The Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) is a 6-item questionnaire validated to screen for depression in people with epilepsy. Scores range from 6 - 24, with higher scores indicating more depressive symptoms.
Time frame
Week 18Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Madeline Fields
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
Source ClinicalTrials.gov