Interview with Biohaven Medical Director on RISE A Clinical Trial For Epilepsy

RISE: A Clinical Trial For Epilepsy

I recently had the opportunity to speak with Jason Lerner, MD, Medical Director Research and Development at Biohaven, a board-certified pediatric neurologist and epileptologist about his role and about RISE: A Clinical Trial For Epilepsy.

Background on Dr. Lerner

Before joining Biohaven in the spring of 2022, Dr. Lerner was a Clinical Professor at the University of California, Los Angeles. At UCLA Dr. Lerner was also the Associate Child Neurology Division Chief and the Director of the Adolescent Epilepsy Center at UCLA. During his tenure he held many leadership positions including Director of the Pediatric Neurophysiology Lab and Director of the Child Neurology Residency Program and contributed to numerous clinical trials.

Dr. Lerner has published more than 35 peer-reviewed articles and book chapters in leading journals such as Epilepsia, Neurology and the Journal of Clinical Neurophysiology. In his current role at Biohaven, Dr. Lerner is a Medical Director and clinical lead of the BHV-7000 development program in epilepsy. Dr. Lerner was trained at New Jersey Medical School in 2000, completed a residency in Pediatrics at the Penn State Health, Milton S. Hershey Medical Center, residency in Child Neurology at the Albert Einstein College of Medicine, Montefiore Medical Center, and fellowship in Pediatric Clinical Neurophysiology at UCLA.

Living Well With Epilepsy:Could you share a little about your role at Biohaven?

Jason Lerner: I am a pediatric epileptologist and after 16 years in an academic clinical practice at UCLA I left two and a half years ago to join Biohaven as the Medical Lead for the BHV7000 Epilepsy program. In that position I worked with our team as well as key opinion leaders in epilepsy to develop the protocols for our ongoing studies. Now with the studies ongoing I am working with our Medical Monitoring team to monitor how the study is running and patient safety.

A Strong Connection to Epilepsy

LWWE: Would you mind sharing your connection to the epilepsy community?

JL: It was neuroscience that led me to medical school and after exploring various specialties I found that pediatric neurology was what I wanted to work in. I met my wife, Kelli, who has epilepsy, at the end of medical school. Listening to her stories and struggles living with epilepsy was a significant influence on my decision to specialize in epilepsy. Kelli also led a teen support group when we were in NYC and listening to their stories and struggles showed me the great need in this community.

LWWE: As spouse of someone with epilepsy how does that inform your work?

JL: As a spouse of someone with epilepsy I can see many different sides of epilepsy, including as a caregiver, not only from the physician standpoint. I think that has really helped me see things like comorbidities and ASM adverse effects and what is important to the epilepsy community as a whole.

A Focus on Quality of Life

LWWE: How does your background as a pediatric neurologist inform your work?
JL: My patients that really showed me the importance of quality of life and how epilepsy as well as the treatments can cause problems and have a great impact on quality of life.

RISE A Focal Refractory Epilepsy Study

LWWE: Tell us about the RISE Clinical Trial and what makes it unique

JL: BHV7000 is a new potassium channel activator that we are testing in focal epilepsy, generalized epilepsy, depression, and bipolar disorder.  The potassium channel helps regulate the excitability of a cell and activating it may inhibit seizures from starting and evolving.  Currently there are no potassium channel activators available in the market so this would be a unique mechanism.  The RISE trial is the name of the focal trials.

An Epilepsy Clinical Trial

LWWE: Who is eligible for RISE?

JL: People between 18 and 75 years old who have a diagnosis of focal seizures and are continuing to have seizures despite treatment may be eligible for the study.

LWWE: Why should someone participate in RISE?

JL: Anyone who has focal (complex partial) seizures and continues to have seizures despite treatment should at least consider a clinical trial.  While we are actively studying BHV7000, it is not available for doctors to prescribe.  Joining a trial is a way to try a medication earlier than waiting for it to be approved.

LWWE: What is the best way to learn more about RISE?

JL: The website below provides a lot of information about the study and there is a link to a questionnaire to see if you could be a candidate. The patient will be contacted by a representative who can provide more information and help find the closest participating site. We encourage everyone to speak with their personal physicians to see if they may be a good candidate for the study.  If their physician is not part of the study, he/she may also be able to refer the patient to a center participating in the study.

What to Expect in a Clinical Trial

LWWE: What can people expect if they participate in RISE?
JL: The study consists of a period during which the seizures will be observed followed by a time that you would be taking a dose of BHV7000 or a placebo. This is the double-blind phase during which the patient, physician and company running the study do now know which dose or placebo the patient is being given. After this phase people completing the study will have the opportunity to go into a long-term study during which they will be given a dose of the medication which will be known by the patient and the physician.

LWWE: Biohaven seems to do things differently. Would you mind sharing your perspective on that?

JL: Here at Biohaven we know that days matter to patients when they are suffering from a disease or disorder and our goal is to find the best treatments possible, study them and run trials to show how well they work and how safe they are as safely and quickly as possible

Dr. Lerner thank you so much for taking the time to speak with Living Well With Epilepsy in this way. For more information on the RISE Clinical Trial click the button below: