Clinical Trial: Perampanel

Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome. Identifier: NCT02834793

Inclusion Criteria:
•    Participants must have a diagnosis of Lennox-Gastaut Syndrome (LGS) as evidenced by:
•    more than one type of generalized seizure, including drop seizures (atonic, tonic, or myoclonic) for at least 6 months before Visit 1;
•    an EEG reporting diagnostic criteria for LGS at some point in their history (abnormal background activity accompanied by slow, spike, and wave pattern <2.5 Hz).
•    At least 2 years old at the time of consent.
•    Have been <11 years old at the onset of LGS.
•    At least 2 drop seizures per week in the 4-week Baseline Period preceding randomization.
•    Receiving 1 to 3 concomitant AEDs at a stable dose for at least 30 days before Visit 1 (vagal nerve stimulation (VNS) and ketogenic diet do not count as AEDs).

Exclusion Criteria:
•    Presence of progressive neurological disease
•    Presence of drop seizure clusters where individual seizures cannot be reliably counted (seizure clusters are defined as ≥2 drop seizures with <5 minutes between any 2 consecutive seizures)
•    Prior treatment with perampanel with discontinuation due to safety issues (related to perampanel)
•    Prior treatment with perampanel must have been discontinued at least 30 days before Visit 1
•    Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the participant’s safety or study conduct
•    Scheduled for epilepsy-related surgery or any other form of surgery during the projected course of the study
•    Ketogenic diet and VNS, unless stable and ongoing, for at least 30 days before Visit 1

David Vossler, MD and Carole Burton RN, Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057. Phone 1 425-251-1720

(Posted 10/06/16)


Clinical Trial: YKP3089 (Cenobamate)

An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 (cenobamate) as Adjunctive Therapy in Subjects With Partial Onset Seizures. Identifier: NCT NCT02535091

Inclusion Criteria:
•    Ages 18-70 years
•    Partial-onset seizures and require additional AED therapy despite having been treated with at least one AED within approximately the last 2 years.
•    Currently on stable antiepileptic treatment regimen:
•    Subject must have been receiving stable doses of 1 to 3 AEDs for at least 3 weeks prior to Visit 2
•    Vagus nerve stimulator (VNS) will not be counted as an AED, but parameters must remain stable for > 4 weeks prior to baseline. The VNS must have been implanted at least 5 months prior to Visit 1.

Exclusion Criteria:
•    History of any serious drug-induced hypersensitivity reaction (including but not limited to Stevens Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms) or any drug-related rash requiring hospitalization.
•    History of any drug-induced rash or hypersensitivity reaction.
•    History of a first degree relative with a serious cutaneous drug-induced adverse reaction.
•    Subjects taking phenytoin must not be taking phenobarbital or primidone; subjects taking phenobarbital must not be taking phenytoin or primidone

David Vossler, MD, Krista Kawaguchi, MD & Carole Burton RN, Rainier Clinical Research Center, Inc. Renton, Washington, United States, 98057. Phone 1 425-251-1720
(Posted 10/04/16)


WSNS MOC Statement

Washington State Neurological Society in conjunction with the American Medical Association calls for the elimination of mandatory exams for Maintenance of Certification. We also oppose any requirements for MOC that have no demonstrable benefit to patient care. In conjunction with Washington State Medical Association, WSNS supports alternative pathways to board recertification and Maintenance of Certification (ie. National Board of Physicians and Surgeons).

The government of the State of Oklahoma has enacted legislation prohibiting the use of MOC for licensure, reimbursement, employment or admitting privileges. The WSNS supports similar legislation for the State of Washington.

Adopted Oct. 1, 2016