RNS® System Pivotal Study
Completed · Phase 3 · Has a placebo group
Conditions studied: Epilepsy
In brief
The RNS® System Pivotal study is designed to assess safety and demonstrate that the RNS® System is effective as an adjunctive (add-on) therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures from no more than two foci (two areas of the brain) that are refractory (drug-resistant or hard-to-treat) to two or more antiepileptic medications. Patients continue to receive their epilepsy medications while participating in the study.
Key facts
- Study ID
- NCT00264810
- Run by
- NeuroPace
- People needed
- 240
- Starts
- 2005-12-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2013-08-28
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- Mayo Clinic - Arizona — Phoenix, Arizona, United States
- University of Southern California — Los Angeles, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- George Washington University — Washington D.C., District of Columbia, United States
- University of Florida at Gainesville — Gainesville, Florida, United States
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
- Miami Children's Hospital — Miami, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Medical College of Georgia / Georgia Health Sciences University — Augusta, Georgia, United States
- Rush University Medical Center/ Epilepsy Center — Chicago, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- Via Christi Comprehensive Epilepsy Center — Wichita, Kansas, United States
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Mayo Clinic - Rochester — Rochester, Minnesota, United States
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Saint Barnabas Medical Center — Livingston, New Jersey, United States
- Columbia University / Columbia Presbyterian Medical Center — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
- Cleveland Clinic Foundation — Cleveland, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.