Epilepsy Research: Novel treatments are being investigated at the Northeast Regional Epilepsy Group offices - Feature article
The Northeast Regional Epilepsy Group (NEREG) is currently conducting research on a new drug called TAK935 in their Hackensack, New Jersey offices. The Principal Investigator (PI) of the study at NEREG is Dr. Marcelo Lancman who is also the Medical Director of the program.
The drug being tested in this study is called TAK-935 and is being tested to treat people who have developmental and/or epileptic encephalopathies. Encephalopathy is a general term that basically means "brain disease, damage, or malfunction."
Ovid Therapeutics Inc. is the company sponsoring this study. This is a biopharmaceutical company committed to developing medicines for rare neurological diseases.
The U.S. Food and Drug Administration (FDA) just recently granted orphan drug designation to TAK-935/OV935 for the treatment of Dravet syndrome. Dravet syndrome is "a rare, catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent and/or prolonged seizures" (for more information, visit: https://www.dravetfoundation.org/what-is-dravet-syndrome/). If you are wondering what an "orphan drug" is, it is a medication/drug that is developed to treat a rare medical condition which is, in itself, referred to as an orphan disease. The orphan drug designation allows for speedier drug development for rare diseases for which there are no current treatments available.
This current study of TAK935 plans to look at safety, tolerability (the degree to which overt adverse effects of a drug can be tolerated by a patient), and pharmacokinetics (the movement of drug into, through, and out of the body--how long it takes to absorb, distribute, metabolize, and excrete) of people who take TAK-935.
We sat down to ask Munazza Malik, Northeast Regional Epilepsy Group Research Coordinator, a few questions about this study.
Who can be a subject in this study and how might it help?
If someone has a diagnosis of a developmental and/or epileptic encephalopathy within first 2 years of life, this person would be a likely candidate. To better understand if a patient can participate, the investigators will also collect specific information about seizure frequency and number of anti-epileptic drugs that are being taken at the start of the study. All participants in this study will be adults (18 years to 65 years old) and can be of either gender. There also needs to be a legally acceptable representative to sign consent forms.
In addition, there are reasons why a patient might not be considered a candidate for this particular study. Among others, being started on a ketogenic diet or having a vagal nerve stimulator implanted within 6 months before the screening and settings have been changed within 1 month of the screening visit and/or if these are anticipated to change during the study. Other reasons for not being able to participate include: having been admitted to a hospital for treatment of status epilepticus within 6 months of the screening visit, intermittent use of Benzodiazepines as a rescue medication more than 3 times per week, history of drug abuse, and history of suicidal behavior or ideation at the screening visit.
What does being part of this study require from the patient?
The patient would be expected to attend a total of seven office visits, as well as participate in one phone visit after a week and one last in-clinic follow up after 4 weeks. The visits fall on the 11th day from the previous visit. Several tests would be run including safety labs, testing for hepatitis B and C panel and an HIV screening blood test.
Active participation is required in that a seizure diary must be kept by the patient or caregiver in which daily seizures are recorded for the investigators to examine throughout the duration of the study.
Does the patient get reimbursed for participating?
Yes, the patient receives $50 per visit. Additionally, if their commute is long, extra reimbursement for travel and food would also be provided.
How long will the study last typically?
Once patient completes his/her seven visits within 24 weeks, the study is complete for that person.
Thanks so much for explaining this to us. If someone wanted to contact you for more information about participating, how would they go about doing this?
They would be able to reach me by calling 201-343-6676 and asking for Munazza Malik, research coordinator or they can always email me at mmalik@epilepsygroup.com. To check the many open clinical trials we are running and to verify if you or someone you know might be a good candidate for a particular research project, check here: http://epilepsygroup.com/info23-70/open-clinical-studies.htm
