Ongoing Clinical Trials
Epilepsy Research at URMC
The University of Rochester Medical Center is a research institution. We participate in research that helps our patients and improves our knowledge. Doctors and staff in our adult and pediatric epilepsy areas are committed to participation in clinical trials.
What are Clinical Trials?
Clinical trials are research studies that are highly regulated (carefully controlled) by independent groups (not associated with the clinical trial) to make sure that research is done in a safe and ethical way.
We are looking for patients for the studies listed below.
Epilepsy Clinical Trials at URMC
RAISE – Randomized Therapy in Status Epilepticus (A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous Ganaxolone in Status Epilepticus Protocol Number: 1042-SE-3003)
We are looking for patients 18 years and older who have been admitted to the hospital with status epilepticus (SE)(seizures that cannot be stopped even with rescue medication). Ganaxolone is being tested as an added medication to the current standard treatment. You can pre-consent for the study if you are at risk for SE. Dr. Trenton Tollefson is the Principal Investigator on this study.
REALIZE - (A Randomized, Double-blind, Placebo-controlled Trial of CVL-865 as Adjunctive Therapy in Adults with Drug-Resistant Focal Onset Seizures. Protocol Number: CVL-865-SZ-001)
We are looking for patients 18 to 75 years old with focal onset epilepsy and have 4 or more seizures a month for a study of a new medication taken with your current anti-seizure medications. Patients are given either CVL-865 or a placebo (drug with no active ingredient that will not have any effect). Dr. Trenton Tollefson is the Principal Investigator on this study.
StarStim: New External Device for Refractory Focal Epilepsy (A Multicenter, Randomized, Double-Blinded, Parallel-Group Study of the Safety and Therapeutic Measures of Transcranial Cathodal Direct Current Stimulation (TDCS) in Patients with Refractory Focal Epilepsy. Protocol Number NE001)
We are looking for patients 9 years and older who have been diagnosed with focal epilepsy for a trial with a new external device that stimulates the brain from outside your scalp. Dr. Trenton Tollefson is the Principal Investigator on this study.
SYCAMORE - (A Phase 2 Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of REC-994 in the Treatment of Symptomatic Cerebral Cavernous Malformation. Protocol Number: REC-994-201)
We are looking for patients 18 years and older who have been diagnosed with cerebral cavernous malformation (CCM) and are experiencing symptoms such as headaches or seizures. We are testing an experimental medication, REC-994. Patients are given 200 mg, 400 mg, or a placebo (drug with no active ingredient that will not have any effect). Dr. Michel Berg is the Principal Investigator on the study.
STARS: Staccato alprazolam for Focal or Generalized Seizures (A Phase 3, Double-blind, Randomized, Placebo-Controlled, Multicenter, Outpatient, Parallel-Group Study to Assess the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older with Stereotypical Prolonged Seizures. Protocol Number EP0162)
We will be looking for patients between 18 years and older who have been diagnosed with focal or generalized seizures for the Staccato alprazolam trial. Alprazolam is being tested as a rescue medication (a medicine intended to quickly stop repetitive or prolonged seizures). Alprazolam is approved by the FDA in pill form (Xanax) for anxiety and other conditions. Dr. Thomas Wychowski is the Principal Investigator on this study.
TRUST-TSC: Treating Uncontrolled Seizures in Tuberous Sclerosis Complex (A Phase 3, Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Adults with Tuberous Sclerosis Complex (TSC)-related Epilepsy. Protocol 1042-TSC-3001)
We will be looking for patients between 1 to 65 years old who have been diagnosed with tuberous sclerosis complex and have 8 seizures or more a month. Patients are given either Ganaxolone or a placebo (drug with no active ingredient that will not have any effect). Dr. Inna Hughes is the Principal Investigator on this study.
All studies are listed on www.clinicaltrials.gov
If you are a patient and are interested in learning about our research studies, or if you are a CRO or Sponsor and you wish to speak with someone about URMC becoming a site, please email: URMCEpilepsyStudies@URMC.Rochester.edu