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INFORMATION FOR

Clinical Outcome Research

Patient-oriented epilepsy research at Yale has led to major advances in the diagnosis and treatment of epilepsy. Yale was one of the first centers in the world to perform epilepsy neurosurgery and remains at the forefront in developing innovative brain imaging methods, deep brain stimulation, other neurosurgical techniques, medication trials, and additional novel approaches. Ongoing projects are listed below:

REALIZE (CVL-865) - reported to be a non-sedating benzodiazepine

PI: Dr. Hamada Altalib, DO, MPH, FAES

This is a multi-center, randomized, active-treatment, open-label extension of CVL-865 as adjunctive therapy in adults with drug-resistant focal onset seizures. Patients with focal seizures for at least two years and a failure of two or more anti-seizure medications are eligible to participate in this study, which will last for 25 weeks with up to seven visits.

HUMAN EPILEPSY PROJECT 3: NEW-ONSET GENERALIZED EPILEPSY

PI: Dr. Hamada Altalib, DO, MPH, FAES

This is a study coordinated and funded by the Epilepsy Foundation through New York University, which aims to characterize the long-term natural history of patients who have been newly diagnosed with idiopathic generalized epilepsy. This study involves yearly visits and monthly check-ins, along with a daily electronic diary to track seizure frequency.

NORSE: (New-Onset Refractory Status Epilepticus)

PI: Dr. Lawrence Hirsch, MD

The purpose of this study is to understand the cause of NORSE and create a biorepository of laboratory and biomarker assessments of blood and tissue. This study will continue for two years, including visits at three, six, 12, and 24 months post-discharge.

MEDTRONIC DEEP BRAIN STIMULATION THERAPY POST-APPROVAL STUDY

PI: Dr. David King-Stephens, FAAN(Neurology), FAES, MD

Deep brain stimulation (DBS) is a surgical treatment for patients with epilepsy, and the purpose of this post-approval study is to further evaluate the long-term safety and effectiveness of Medtronic DBS therapy for epilepsy on seizure reduction in newly implanted patients through three years of follow-up.

RAISE (Randomized in Status Epilepticus)

PI: Dr. Lawrence Hirsch, MD

This study is sponsored by Marinus Pharmaceuicals and is a double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of intravenous ganaxolone in status epilepticus (SE). This study involves approximately two days of treatment and follow-ups for the next four weeks. The primary objective is to establish efficacy and safety of IV ganaxolone for the treatment of SE after failure of first-line benzodiazepines and two second-line IV AEDs.