Research

Providence VA Medical Center: Neuroimaging Biomarker for Seizures

Brief Summary
This multi-site study will examine patients with epilepsy (ES) following head injury [i.e., posttraumatic epilepsy (PTE)] and posttraumatic psychogenic Non-epileptic seizures (PNES) and will compare them to patients with traumatic brain injury (TBI) who do not have seizures using functional neuroimaging.

Inclusion Criteria
Inclusion criteria for PNES, ES and TBI (w/o PNES or ES) participants:

• Individuals with history of documented TBI (any severity).
• Males and Females ages 18-60 years.
• Women of child bearing potential, if currently using appropriate contraception.

Inclusion criteria of PNES and ES participants:

• Diagnosed by video/EEG with lone PNES or by EEG with lone ES.
• Patients must have at least 1 PNES or 1 ES during the year prior to enrollment.

Sponsor
Providence VA Medical Center

Contacts

• W. Curt LaFrance, Jr., MD, MPH
  P: 401-273-7100 ext 2441   |  E: william_lafrance_jr@brown.edu
• Krista Tocco, BA
  P: 401-273-7100 ext 6229   |  Krista.Tocco@va.gov

Yale: New Onset Refractory Status Epilepticus (NORSE)/Febrile Infection-Related Epilepsy Syndrome (FIRES) Open Biorepository

Inclusion Criteria

• At least 2 years old
• Status epilepticus (SE) refractory to first and second line therapy
• No etiology found in the first 24 hours (if known cause we can use as a control case)

Exclusion Criteria

• Major ongoing acute or subacute medical issues (e.g., organ failure, active cancer, etc.)

Patient Commitment & Support

• 2 years total enrollment
• Follow-up at 3-6, 12, 24, and 60 months post discharge (can be done remotely)
• Bio-specimen collection
• No direct benefit to patients
• This is an observational study only, with no effect on clinical treatment

Contact

• Margaret Gopaul, PhD., MSCP: Margaret.gopaul@yale.edu or norse@yale.edu

Yale: Randomized Therapy in Status Epilepticus (RAISE): IV ganaxolone vs placebo

Inclusion Criteria

• 12 years or older, nonconvulsive status epilepticus; body mass index over 40kg.
• At least 6 minutes of cumulative seizure activity over a 30-min period within an hour before drug initiation, AND at least some seizure activity during the 30 mins immediately prior to drug initiation. 
• Failed 2 or more antiseizure treatments: Either a benzodiazepine and at least 1 second line IV antiseizure medication or 2 or more second-line IV antiseizure medications.
• Must be at Yale-New Haven Hospital at the time of administration of the study drug.

Exclusion Criteria

• Life expectancy less than 24 hours.
• Anoxic brain injury or an uncorrected, rapidly reversible metabolic condition.
• Super-refractory status epilepticus: Participants who have received high dose IV anesthetics during the current episode of status epilepticus for more than 18 hours.
• Not a candidate for IV anesthesia.

Patient Commitment & Support

• Maximum duration of approximately 4 weeks.

Contacts

• Margaret Gopaul, PhD., MSCP: Margaret.gopaul@yale.edu

Yale: Human Epilepsy Project (HEP-3)

Inclusion Criteria

• All cohorts: Age 13 or older at enrollment; age 6 or older at time of seizure onset.
• Cohort 1: Diagnosed with idiopathic generalized epilepsy within the prior year.
  • 1 seizure in 6 months prior to treatment; antiseizure medication less than 1 year.
• Cohort 2: Established idiopathic generalized epilepsy and responsive to treatment.
  • 2 years-controlled seizures; 1 or more antiseizure medication(s).
• Cohort 3: Established treatment-resistant idiopathic generalized epilepsy.
  • Started treatment 2 years prior; 1 or more antiseizure medication(s)

Exclusion Criteria

• Focal epilepsy; generalized/focal epilepsy mixed syndromes; progressive neurological disorder; epileptic or developmental encephalopathy; major co-morbidities.

Patient Commitment & Support

• 2 years total enrollment.
• Screening visit, 12 and 24 months (cohort 1 only); monthly phone follow-up.
• Bio-specimen, seizure diary collection, EEG, and MRI (optional) records.
• Participants will receive up to $450 compensation:
  • $150 after the baseline visit and 12 months (all cohorts).
  • $150 after month 24 (cohort 1 only).

Contacts

• Margaret Gopaul, PhD., MSCP: Margaret.gopaul@yale.edu

Yale: Drug-Resistant focal Onset Seizures (REALIZE) 

Inclusion Criteria

• 18-75; Focal onset seizures for at least 2 years; 4+ seizures in previous 4 weeks.
• Failed 2 or more antiseizure medications; Currently on 1-3 antiseizure medications.
• Body mass index of 17.5 to 40.0 kg/m2 and total body weight greater than 50 kg. )

Exclusion Criteria

• Genetic (formerly known as idiopathic) generalized epilepsy or combined generalized and focal epilepsy types.
• Only focal aware seizures w/o motor component.
• Seizures past 12 months-high frequency (e.g., repetitive seizures, cluster seizures).
• Psychogenic nonepileptic seizure within one year.
• Status epilepticus within 5 years.
• More than 3 background antiseizure medications.
• Benzodiazepine chronically or as a rescue medication for > 4 days. on average over 28 days

Patient Commitment & Support

•  A maximum of 25 weeks, which includes:
  • 8-week screening period.
  • 10- or 13-week treatment period.
  • 4-week follow-up period.

Contacts

• Margaret Gopaul, PhD., MSCP: Margaret.gopaul@yale.edu

Yale: Staccato: Double-Blind Outpatient Study (Efficacy and Safety of Staccato Alprazolam)

Inclusion Criteria

• Age 12 or older. 
• 4 or more prolonged seizures in the past 6 months, 2 of which must have occurred within the past 3 months.
• Must have a study caregiver 18 years or older at the Screening Visit; caregiver(s) should be able:
  • To provides daily care and have a significant personal relationship with the patient.
  • To recognize and observe the patient’s seizures.

Exclusion Criteria

• Atrial fibrillation; mitral stenosis; asthma; chronic pulmonary disorder.

Patient Commitment & Support

• Maximum of approximately 19 weeks (including the screening period, follow-up, and early termination visit).
• Compensation: 
  • $150 for each patient on-site study visit (completed) and unscheduled study visits.
  • $100 patient kit exchange visits (completed).
  • $52 patient and caregiver travel to on-site visits.

Contacts

• Margaret Gopaul, PhD., MSCP: Margaret.gopaul@yale.edu

Yale: Staccato: Open-label Outpatient Study (Safety and Tolerability of Staccato Alprazolam)

Inclusion Criteria

•  Age 12 or older.
• Participant must have completed participation in EP0162 (double-blind study).
• Must have a study caregiver 18 years or older at the Screening Visit; caregiver(s) should be able:
  • To provides daily care and have a significant personal relationship with the patient.
  • To recognize and observe the patient’s seizures.

Exclusion Criteria

• Atrial fibrillation; mitral stenosis; asthma; chronic pulmonary disorder.

Patient Commitment & Support

• Screening/Baseline assessments no more than 6 weeks; Treatment Period: approximately 0 to 4 years
• Compensation:
  •  $150 for each patient on-site study visit (completed).
  • $100 patient kit exchange visits (completed).
  • $52 patient and caregiver travel to on-site visits

Contacts

• Margaret Gopaul, PhD., MSCP: Margaret.gopaul@yale.edu