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Pediatric Epilepsy Program

Golisano Children's Hospital / Pediatric Epilepsy Program / Research & Clinical Trials

 

Research & 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 an ethical way.
We are looking for patients for the studies listed below.

Epilepsy Clinical Trials at URMC

  • 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 12 to 17 years old 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 immediately relieve your symptoms). Alprazolam is approved by the FDA in pill form (Xanax) for anxiety and other conditions. Dr. Berman is a sub-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. Find more information about the study.
  • VALTOCO for Epilepsy (An Open-label, Single-dose, Pharmacokinetics Study of Valtoco with Open-label Safety Period in Pediatric Subjects with Epilepsy. Protocol Number: DIAZ.001.08)

    We are looking for patients between 2 to 5 years old who have been diagnosed with epilepsy for a VALTOCO (diazepam) trial. VALTOCO is being tested as a rescue medication (a medicine intended to immediately relieve your symptoms). VALTOCO is approved by the FDA for patients over 6 years old. Dr. Hughes is the Principal Investigator on this study. Find more information about the study.
  • New Medication NBI-921352 for Epilepsy (A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE) Protocol Number: NBI-921352-DEE2012)

    We are looking for patients between 2 to 21 years old who have been diagnosed with epilepsy caused by a specific genetic mutation (in the SCN8A gene) for a new medication trial. Patients are given either a new medication that targets specific sodium channels or a placebo (drug with no active ingredient that will not have any effect). Dr. Hughes is the Principal Investigator on this study. Find more information about the 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 will be looking for patients 9 years and older who have been diagnosed with focal epilepsy for a trial with a new external device that stimulates your scalp. Dr. Berman is a sub-Investigator on the study.

More Information

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.