Clinical Trial: Perampanel

Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome.   ClinicalTrials.gov 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

Location:
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)

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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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