Clinical Trial: YKP3089 (Cenobamate)

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

Location:
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)

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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

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Lacosamide Clinical Trial

A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy – Protocol SP0982.

ClinicalTrials.gov Identifier: NCT02408523

Inclusion Criteria:
•    Idiopathic generalized epilepsy (IGE) – primary generalized tonic-clonic seizures (PGTCS)
•    Age ≥4 years
•    ≥ 3 PGTCS during the 16-week Combined Baseline (12-week Historical Baseline plus 4-week Prospective Baseline)
•    No imaging evidence of a lesion likely to be associated with partial-onset seizures
•    Stable dose regimen of 1 – 2 non-benzodiazepine marketed anti-epileptic drugs (AEDs) OR 1 – 3 AEDs (with at least 1 AED identified as a benzodiazepine) for at least 28 days prior to Visit 1 with or without additional concurrent stable vagus nerve stimulation (VNS)
•    An electroencephalogram (EEG) report consistent with IGE (eg, generalized ≥ 3Hz epileptiform discharges and a normal EEG background)
Exclusion Criteria:
•    History of partial onset seizures or EEG findings indicating partial onset seizures
•    Symptomatic generalized epilepsy, e.g. Lennox-Gastaut Syndrome
•    Lifetime history of suicide attempt, or suicidal ideation in past 6 months
•    Use of felbamate or vigabatrin within last 6 months
•    Subject is on a ketogenic diet

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

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