EPILEPSY RESEARCH

RISE 2 (23-1919)

• Investigator: Naveed Chaudhry, MD
• Purpose: to see the effectiveness and safety of an investigational new drug as a possible treatment for focal seizures for patients who are taking Anti-Seizure Medications (ASMs) and still experience seizures.
• Intervention: 25 mg investigational drug (33% chance), 50 mg investigational drug (33% chance), or placebo (33% chance).
• Timeline: Screening and Observational Phase: 8 weeks with 1 screening visit (in-person visit to the study site), Double-Blind Phase: 12 weeks with 5 study visits, and Follow-Up Phase: 2 weeks after the last day you take BHV-7000/placebo with 1 study visit.
• ClinicalTrials.gov Identifier: NCT06132893
• Key Eligibility Criteria:
  • Age: 18-75 years of age at time of consent
  • Diagnosis: Focal Onset Epilepsy at least 1 year prior to screening visit
  • Ability to keep accurate seizure diaries and miss no more than 4 entries
    

X-TOLE2 (23-0395)

• Investigator: Nitish Harid, MD
• Purpose: to determine if XEN1101 can reduce Focal-Onset Seizure frequency and if it is safe to use.
• Intervention: XEN1101 (66% chance) or placebo (33% chance).
• Timeline: Screening/Baseline Period (up to 9.5 weeks), Double-blind Study Treatment Period (up to 12 weeks), and Post-Study Treatment Follow‑Up Period (up to 8 weeks).  Once you complete the Double-blind Study Treatment Period, you may be eligible to participate in the Open-label Extension (OLE) Study.
• ClinicalTrials.gov Identifier: NCT05614063
• Key Eligibility Criteria:
  • Age: ≥18
  • Diagnosis: Focal Epilepsy for ≥2 years
  • Weight: BMI ≤40 kg/m2 at Visit 1
    

NAUTILUS (22-0838)

• Investigator: Naveed Chaudhry, MD
• Purpose: to find out if thalamic stimulation with NeuroPace RNS® System is safe and effective (works well) as an additional treatment in reducing the frequency of primarily generalized seizures in individuals 12 years of age or older with drug resistant Idiopathic Generalized Epilepsy (IGE).
• Intervention: NeuroPace RNS® System implantation (50% chance) or sham implantation (50% chance).
• Timeline: up to 14 in person visits over up to 2 years.
• ClinicalTrials.gov Identifier: NCT05147571
• Key Eligibility Criteria:
  • Age: 12+ years old
  • Diagnosis: Idiopathic Generalized Epilepsy (IGE)
  • Failed treatment with 2+ antiseizure medications
  • Able to maintain daily electronic diary

X-ACKT (23-0396)

• Investigator: Naveed Chaudhry, MD
• Purpose: to determine if XEN1101 can reduce Primary Generalized Tonic-Clonic Seizure (PGTCS) frequency and if it is safe to use.
• Intervention: XEN1101 (50% chance) or placebo (50% chance).
• Timeline: Screening/Baseline Period (up to 9.5 weeks), Double-blind Study Treatment Period (up to 12 weeks), and Post-Study Treatment Follow‑Up Period (up to 8 weeks).  Once you complete the Double-blind Study Treatment Period, you may be eligible to participate in the Open-label Extension (OLE) Study.
• ClinicalTrials.gov Identifier: NCT05667142
  
• Key Eligibility Criteria:
  • Age: ≥18
  • Diagnosis: probable or possible Primary Generalized Tonic-Clonic Seizure (PGTCS) (with or without other subtypes of generalized seizures) in the setting of generalized epilepsy for ≥2 years
  • Weight: BMI ≤40 kg/m2 at Visit 1
    

NEURONA (21-3486)

• Investigator: Lesley Kaye, MD
• Purpose: to evaluate the safety and efficacy of a surgical cell therapy called NRTX-1001 in participants with drug resistant Mesial Temporal Lobe Epilepsy (MTLE). Additionally, to see if NRTX-1001 can reduce number of seizures.
• Intervention: there are two different stages of this study, described below.  If eligible, you would participate in one of the stages.
  • NRTX-1001
  • NRTX-1001 (66% chance) or sham surgery (33% chance)
• Timeline: 13 visits over 24 months, then long-term follow up for 13 years (for both stages).
• ClinicalTrials.gov Identifier:  NCT05135091
• Key Eligibility Criteria:
  • Age: 18-65 years old
  • Diagnosis: Mesial Temporal Lobe Epilepsy (MTLE), seizure frequency average 2 or more per 28 day period in the previous 6 months
  • Has failed to achieve seizure control despite trials of at least 2 anti-seizure drugs