Ensayos clínicos

Inclusion Criteria:

• Participants ≥ 18 years of age.
• Participants with Drug Resistance Epilepsy as defined by the ILAE5.
• Participants undergoing bilateral implantation of DBS leads into the anterior nucleus of the thalamus.
• Adequate organ function as assessed by the following laboratory values within 3 weeks prior to admission to the study:
  • Serum creatinine and urea < 2 times the upper limit of normal;
  • ALT, AST and alkaline phosphatase < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL;
  • Prothrombin time ≤ 1.5 times upper limit of normal;
  • INR and PTT ≤ 1.5 times the upper limit of normal;
  • Hemoglobin ≥ 9 g/dL;
  • Platelets ≥ 100 x 10^9/L;
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L.
• Patient or legal guardian is able to fully understand and provide written and verbal consent for the protocol.
• Patient is a candidate for ANT DBS based on the following criteria established by the American Society for Stereotactic and Functional Neurosurgeons:
  • Confirmed diagnosis of epilepsy by an epileptologist with focal-onset seizures, with or without generalization;
  • Failure to adequately control seizures after two (or more) appropriate and adequately-dosed anti-seizure medications;
  • Either partial-onset seizures with a localized onset in a region not amenable to resection or following failed resective surgery or focal-onset seizures with distributed or unclear onset zone.

Exclusion Criteria:

• Patients who have undergone a prior intracranial procedure for epilepsy.
• Patients with an intracranial tumor.
• Confirmed pregnancy.
• History of cancer not in remission for at least 5 years.
• History of diabetes, chronic renal failure, or other significant underlying medical or immunosuppressive conditions.
• History of drug or alcohol abuse.
• Subjects allergic to any component of the investigational product.
• Subjects > 75 years of age.
• Cognitively impaired adults.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/21/23. Questions regarding updates should be directed to the study team contact.