Phase 3
N=109
SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00101933 ↗Enrolled (actual)
109
Serious AEs
7.3%
Results posted
Jan 2013
Primary outcome: Primary: Primary Analysis: Change in Seizure Rate — -40.4; -14.5 Percentage change from baseline — p=0.0017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Medtronic DBS Therapy for epilepsy (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedtronicNeuro
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Analysis: Change in Seizure Rate |
-40.4; -14.5 | 0.0017 sig |
| PRIMARY Alternative Primary Analysis: Change in Seizure Rate |
-35.0; -21.1 | 0.0387 sig |
| SECONDARY Adverse Events Experienced With the Medtronic DBS System |
110; 10; 23; 8; 6; 7 | — |
| SECONDARY Incidence of Sudden Unexplained Death in Epilepsy (SUDEP) |
2 | — |
| SECONDARY Seizure Responder Rate |
16; 14 | 0.830 |
| SECONDARY Change in Percentage of Days Seizure-free |
15.3; 8.8 | 0.105 |
| SECONDARY Percentage Change in the Maximum Length of Seizure-free Intervals |
35.0; 24.0 | 0.498 |
| SECONDARY Proportion of Treatment Failures |
0; 0 | 1.0 |
Summary
The purpose of this research is to study the safety and effectiveness of bilateral stimulation of the anterior nucleus of the thalamus as adjunctive therapy for reducing the frequency of seizures in adults diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to antiepileptic medications.
Eligibility Criteria
Relevant Inclusion and Exclusion Criteria are listed below.
Inclusion Criteria
- Partial-onset seizures with or without secondary generalization. The final determination shall be made by the Investigator based on a clinical description of the seizures and previous diagnostic testing that includes, at a minimum, video/clinical EEG that captured at least one ictal event.
- Anticipated average of 6 or more partial-onset seizures (with or without secondary generalized seizures) per month during the Baseline Phase, with no more than 30 days between seizures during the Baseline Phase.
- Refractory to antiepileptic drugs (AEDs). Patients will be considered refractory if they have failed at least three AEDs due to lack of efficacy.
- Receiving one to four currently marketed AEDs
- Be between 18 and 65 years of age at the time of lead implant
Exclusion Criteria
- Multilobar (>3 different lobes) anatomic areas of seizure onset
- Symptomatic generalized epilepsy
- Previous diagnosis of psychogenic/non-epileptic seizures
- Presence of implanted electrical stimulation medical device anywhere in the body (e.g., cardiac pacemakers, spinal cord stimulator) or any metallic implants in the head (e.g., aneurysm clip, cochlear implant). Vagal nerve stimulators are allowed if the device has been turned off for at least 30 days prior to the Baseline Week -12 visit and the patient agrees to have the generator explanted prior to or at the time of the Kinetra Neurostimulator implant.
Data sourced from ClinicalTrials.gov (NCT00101933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.