RNS® System LTT Study

Completed · Phase 4

Conditions studied: Epilepsy

In brief

The RNS® System LTT study is designed to assess the ongoing safety and to evaluate the long-term efficacy of the RNS® System as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures that are refractory to two or more antiepileptic medications. Candidates will continue to receive their epilepsy medications while participating in the trial.

Key facts

Study ID

NCT00572195

Run by

NeuroPace

People needed

230

Starts

2006-04-01

Expected to finish

2018-05-01

Last updated by the study team

2019-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has completed either the RNS® System Pivotal or Feasibility study
• Subject has an implanted RNS® System
• Subject has elected to continue to receive responsive neurostimulation therapy after completion of the RNS® System Pivotal or Feasibility study
• Subject is able to attend scheduled appointments for the RNS® System LTT study

You may not qualify if…

• Subject has active psychiatric or medical illness that makes it inadvisable for the subject to continue to receive responsive neurostimulation therapy with the RNS® System
• Subject has been diagnosed with psychogenic or non-epileptic seizures, or primarily generalized seizures during the RNS® System Pivotal or Feasibility study
• Subject has been noncompliant with scheduled appointments during the RNS® System Pivotal or Feasibility study
• Subject has been noncompliant with maintaining seizure diaries during the RNS® System Pivotal or Feasibility study
• Informed consent cannot be obtained from subject or caregiver

Where it is running

• 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 Regents 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
• Louisiana State University Epilepsy Center of Excellence — New Orleans, Louisiana, 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
• Weill Medical College of Cornell University — New York, New York, 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

Full record on ClinicalTrials.gov

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