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About
This study is being conducted to demonstrate that perampanel given as adjunctive anti-epileptic treatment is superior to placebo in reducing the number of drop seizures in participants with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS).
Full description
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study of perampanel as adjunctive therapy in participants with inadequately controlled seizures associated with LGS. The study will consist of 3 phases: Prerandomization (4 to 8 weeks), Randomization (18 weeks), and an Extension A (52 weeks). An additional Extension B with open-label treatment will be available for optional participation to participants who reside in Japan and in countries where an expanded access program (EAP) cannot be implemented or has not yet been implemented.
Enrollment
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Volunteers
Inclusion criteria
Participants must have a diagnosis of LGS as evidenced by:
Participants must be at least 2 years old at the time of consent/assent
Participants must have been <11 years old at the onset of LGS
Participants must have experienced an average of at least 2 drop seizures per week in the 4-week Baseline Period preceding randomization
Participants must have been receiving 1 to 4 concomitant antiepileptic drugs (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). Use of cannabidiol (CBD) products is allowed and is counted as one of the 4 maximum allowed concomitant AEDs. CBD dose and product must have remained stable for at least 30 days before Visit 1 and is to remain the same throughout the course of the Core Study
In the investigator's opinion, parents or caregivers must be able to keep accurate seizure diaries
Body weight at least 8 kilogram (kg)
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
101 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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