Education

Multicenter Observational Studies

The Human Epilepsy Project (HEP)1

The Human Epilepsy Project (HEP)1 is a large, 10-year prospective study designed to identify biomarkers that predict epilepsy progression, treatment response, and outcomes in people with recently diagnosed focal epilepsy. HEP1 is a partnership among 33 international academic centers, foundations, and industries. HEP1 researchers have collected blood samples and high-resolution MRI and electroencephalogram (EEG) data from more than 400 people with epilepsy who track their seizures in a digital diary. Each person is followed for three to six years. HEP1 also collects information on memory, mood, and drug adverse effects over time, which allows investigators to determine whether there is any progressive disturbance in these areas that are so important to quality of life.

Another aim of the project is the creation of an open data repository of clinical information and biologic samples that allows researchers to determine how all of these elements are related. Data gathered so far reveal important insights into the likelihood of mood problems, the association between specific abnormalities in brain imaging and treatment resistance, and the likelihood of response to different medications.

The UM Epilepsy Center is one of 27 academic centers participating in HEP, and Dr. Andres Kanner leads the HEP Comorbidity Team that studies whether some participants with epilepsy develop depression or anxiety, and what can predict and cure these developments.

HEP is funded by the Epilepsy Study Consortium, a nonprofit collaboration if foundations and investigators interested in the improvement of epilepsy patients' lives. HEP has the potential to provide new insights into the biological basis of epilepsy, which will advance our efforts to discover effective treatments and cures for these important disorders.

Human Epilepsy Project 2 Study

The Human Epilepsy Project 2 study will follow 200 people with medication-resistant focal epilepsy (with seizures that occur at least 4 times per month) over two years to measure changes in their seizure frequency, treatments used, adverse events experienced, presence of co-morbidities like depression and anxiety, healthcare costs, and quality of life. Blood samples will also be collected in order to look for biomarkers of epilepsy severity and treatment response.

Participants can join the HEP2 study at any one of nine recruiting study centers, including the University of Miami. These study centers were selected because they are epilepsy centers with track records of conducting high-quality research

Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)

Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) is a NIH-sponsored multi-center prospective observational study with 20 sites across the United States that enrolled 565 participants. The overall goal of this study is to establish the relationship between anti-epileptic drug (AED) exposure and outcomes in the mother and child as well as to describe and explain the variability in AED exposure and response. This investigation provides a unique cohort of exposed and unexposed children who have been followed prospectively starting in pregnancy with detailed data collection, including the first study to directly assess AED exposure by blood levels during pregnancy.

MONEAD has also collected data on the effects of breastfeeding while taking AEDs which includes blood levels in the child that directly delineate their exposure. In addition, the children are undergoing detailed neuropsychological testing from the age of 2 to 6 years old. The results will provide clear indications of AED risks to the immature brain for the presently most commonly used AEDs, and provide sentinel data on less commonly used AEDs to direct future studies. 

UM Comprehensive Epilepsy Center Clinical Trials Program

Industry Sponsored Clinical Trials

Stereotactic Laser Ablation in Temporal Lobe Epilepsy (SLATE)

This is a multicenter trial which is investigating the safety and efficacy of a new neurosurgical technique, laser ablation procedure for drug-resistant focal epilepsy of mesial temporal origin secondary to mesial temporal sclerosis. This trial is sponsored by the Medtronic Company, which manufacturers the equipment to perform the procedure and which is seeking an indication by the Food and Drug Administration for this procedure for the treatment of mesial temporal lobe epilepsy (MTLE). 

Antiepileptic Drug Trials

The University of Miami Comprehensive Epilepsy Center has been participating in clinical drug trials sponsored by various pharmaceutical companies for more than 40 years. Many of the medications that are available in the market today, began as drug trials that were conducted with University of Miami patients

 Participation in a clinical trial offers patients the possibility of access to new antiepileptic medications before they come to market. Our clinicians are committed to conducting clinical research that benefits both adults and adolescents who have epilepsy or seizure disorders.

Led by Kamil Detyniecki, MD, clinical trials director, patients at the UM Comprehensive Epilepsy Center have taken part in several multicenter protocols for treating both focal and generalized epilepsy.

Patients are screened for eligibility according to each trial’s criteria by their physicians, along with research coordinators, including Reina Malcolm, MD and Kristen Ramirez. Once enrolled in a clinical trial, participants receive regular evaluation by the research staff to assess the safety and efficacy of the drug or treatment under study.

Below, find clinical trials that are currently recruiting:

• A study to Evaluate the Safety and Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal Onset Epilepsy.
• A study to Evaluate the Efficacy and Safety of Padsevonil as adjunctive treatment of focal onset seizures in adult subjects with drug-resistant epilepsy.
• A Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Trial of CVL-865 as Adjunctive Therapy in Adults with Drug-resistant Focal Seizures.