The Research Institute at St. Joseph's Regional Medical Center strives to improve our patient's quality of life, advance science, and develop better standards of care.
The Neuroscience Institute at St. Joseph's Regional Medical Center is currently enrolling patients in the following studies:
Title - OV - 1012 "Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Clobazam
(0.25, 0.5 and 1.0 mg/kg/day) in Patients with Lennox-Gastaut Syndrome"
Background and Purpose of the Study
The study involves a drug called clobazam. This drug is approved in over 100 countries for the treatment of anxiety and/or add-on treatment of epilepsy. Clobazam is an investigational drug, which means it has not been approved by the United State Food and Drug Administration (FDA), which needs to see studies of the drug before they will let it be sold in the US. Clobazam is being studied as a possible add-on treatment for people with Lennox-Gastaut Syndrome (LGS). Lennox-Gastaut Syndrome is a form of childhood epilepsy. People with LGS have "drop seizures". A drop seizure occurs when a person falls, slumps in a chair, hits their head and sometimes may get hurt.
Principle Investigator (PI): Dipak Pandya, MD
Eligibility Criteria:
- Patients must be between the ages of 2 and 60
- Patient must have been
- Patient must have LGS
- Patient must be on at least 1 antiepileptic drug (AED)
- Parent or caregiver must be able to keep an accurate seizure diary
For additional information, please contact Millicent Ferguson at 973.754.2406.
Title - OV- 1004: "Safety and Efficacy of Clobazam in Subjects with Lennox-Gastaut Syndrome".
This is a roll over from OV-1012. Patients that completed the OV-1012 study may be eligible to participate in this protocol.
Principle Investigator (PI): Dipak Pandya, MD
For additional information, please contact Millicent Ferguson at 973.754.2406.
Title - SEPRACOR "Double-Blind, Randomized, Historical Control Study of the Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects with Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs".
Background and Purpose of the Study
This research study tests the effectiveness of an experimental drug called eslicarbazepine acetate. "Experimental" means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA).
The purpose of this research study is to see if eslicarbazepine acetate works in people with partial epilepsy (having seizures that affect only part of the brain) and if it is safe. Eslicarbazepine acetate is a new medicine being tested as a monotherapy (single medication) for people with partial epilepsy not well controlled by other antiepileptic drugs (AEDs). You will be given two medicines (lorazepam and diazepam) to use if the study medicine does not control your seizures.
This study will involve about 160 subjects at about 50 different centers in the United States and Canada.
The study will take place over up to 29 weeks and will include about 10 office visits to the study doctor. You may have more than 10 visits if you need extra visits to check your health.
Principle Investigator (PI): Dipak Pandya, MD
Eligibility Criteria:
- Patient must have diagnosis of Partial Epilepsy
- Patient must be between the ages of 16 and 70
For additional information, please contact Millicent Ferguson at 973.754.2406.
If you are interested in participating in a Neurology Study, please contact:
Millicent Ferguson, Clinical Trial Coordinator, at 973.754.2406.
For all other research related inquiries, please contact:
Lindsey Meade, Manager of Research, at 973.754.2416.
