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)
