RNS System RESPONSE Study (NCT04839601) | Clinical Trial Compass
TerminatedNot Applicable
RNS System RESPONSE Study
Stopped: Inadequate Enrollment
United States9 participantsStarted 2021-10-27
Plain-language summary
To demonstrate that the RNS System is safe and effective as an adjunctive therapy in individuals age 12 through 17 years with medically refractory partial onset epilepsy.
Who can participate
Age range12 Years – 17 Years
SexALL
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Inclusion Criteria:
* Subject has disabling motor simple partial seizures, complex partial seizures, and/or secondarily generalized seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility.
* Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the investigator, by the subject or parent/caregiver.
* Subject had an average of three or more disabling motor simple partial seizures, complex partial seizures and/or secondarily generalized seizures over the two most recent consecutive 30-day periods, with no 30-day period with less than two seizures per subject and/or parent/caregiver report.
* Subject failed treatment with a minimum of two anti-seizure medications (used in appropriate doses) with adequate monitoring of compliance and the effects of treatment, as determined by the investigator.
* Subject has undergone diagnostic testing as part of his/her standard care that has identified no more than two epileptogenic regions.
* Subject is male or a female of childbearing potential using a reliable method of contraception (hormonal, barrier method, surgical or abstention).
* Subject is age 12 or older but will be less than age 18 (has not reached 18th birthday) at the time of implantation with the RNS System.
* Subject is able to maintain an electronic diary alone or with the assistance of a…
Timeframe: The primary effectiveness endpoint is the percent of subjects with a ≥ 50% reduction in seizures at 12 months post-implant compared to the pre-implant baseline.