PMID- 27221398
OWN - NLM
STAT- MEDLINE
DCOM- 20170616
LR  - 20211204
IS  - 1528-1167 (Electronic)
IS  - 0013-9580 (Linking)
VI  - 57
IP  - 7
DP  - 2016 Jul
TI  - Adjunctive perampanel in adolescents with inadequately controlled partial-onset 
      seizures: A randomized study evaluating behavior, efficacy, and safety.
PG  - 1120-9
LID - 10.1111/epi.13417 [doi]
AB  - OBJECTIVE: The noncompetitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic 
      acid (AMPA) receptor antagonist perampanel was shown in phase III trials to be an 
      effective and well-tolerated adjunctive treatment for partial-onset seizures. In 
      adolescents, it is necessary to characterize cognitive, neuropsychological, and 
      behavioral side effects of antiepileptic drugs (AEDs). The current analysis 
      focuses on behavioral outcomes, efficacy, and safety of perampanel in 
      adolescents. METHODS: Adolescents (12-17 years) on a stable regimen of 1-3 AEDs 
      for partial-onset seizures were randomized (2:1 ratio) to receive up to 12 mg/day 
      perampanel or placebo. Alongside efficacy, cognitive, and neuropsychological 
      assessments, behavioral outcomes were measured with the Child Behavior Checklist 
      (CBCL) before and after a 19-week titration and maintenance phase. RESULTS: Of 
      the randomized patients, 85 received perampanel and 48 received placebo. Median 
      reduction in seizure frequency from baseline was 58.0% for perampanel and 24.0% 
      for placebo (p = 0.079). More patients had seizure frequency reduced by 50% after 
      perampanel (n = 49 [59.0%]) than placebo (n = 17 [37.0%]; p = 0.0144). Changes in 
      behavior were minimal, and there were no differences between groups on competency 
      (p = 0.619) or problems (p = 0.174). A greater proportion of placebo patients 
      were classified in the CBCL "clinical" range for competency at end of treatment, 
      whereas the number in the perampanel group remained unchanged. The overall safety 
      profile was similar to that reported previously for perampanel; most frequently 
      reported adverse events (AEs) were dizziness (26 patients [30.6% vs. 14.6% 
      placebo]), somnolence (13 patients [15.3% vs. 4.2%]), and headache (nine patients 
      [10.6% vs. 14.6%]). Aggression was reported in seven patients receiving 
      perampanel (8.2% vs. 2.1% placebo); two of these were serious AEs, with neither 
      requiring treatment discontinuation. SIGNIFICANCE: Adjunctive perampanel is 
      efficacious and well tolerated in adolescents with partial-onset seizures, and 
      appears to have no clinically important impact on behavior measured using the 
      CBCL.
CI  - Wiley Periodicals, Inc. (c) 2016 International League Against Epilepsy.
FAU - Lagae, Lieven
AU  - Lagae L
AD  - Department of Pediatric Neurology, University Hospitals KU Leuven, Belgium.
FAU - Villanueva, Vicente
AU  - Villanueva V
AD  - University Hospital and Polytechnic La Fe, Valencia, Spain.
FAU - Meador, Kimford J
AU  - Meador KJ
AD  - Department of Neurology & Neurological Sciences, Stanford Comprehensive Epilepsy 
      Center, Stanford University School of Medicine, Stanford, California, U.S.A.
FAU - Bagul, Makarand
AU  - Bagul M
AD  - Eisai Ltd, Hatfield, Hertfordshire, United Kingdom.
FAU - Laurenza, Antonio
AU  - Laurenza A
AD  - Eisai Neuroscience and General Medicine Product Creation Unit, Eisai Inc., 
      Woodcliff Lake, New Jersey, U.S.A.
FAU - Kumar, Dinesh
AU  - Kumar D
AD  - Eisai Neuroscience and General Medicine Product Creation Unit, Eisai Inc., 
      Woodcliff Lake, New Jersey, U.S.A.
FAU - Yang, Haichen
AU  - Yang H
AD  - Eisai Neuroscience and General Medicine Product Creation Unit, Eisai Inc., 
      Woodcliff Lake, New Jersey, U.S.A.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160525
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Anticonvulsants)
RN  - 0 (Nitriles)
RN  - 0 (Pyridones)
RN  - H821664NPK (perampanel)
SB  - IM
MH  - Adolescent
MH  - Anticonvulsants/*therapeutic use
MH  - Child
MH  - Child Behavior/*drug effects
MH  - Cognition/*drug effects
MH  - Double-Blind Method
MH  - Epilepsies, Partial/*drug therapy/psychology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Neuropsychological Tests
MH  - Nitriles
MH  - Outcome Assessment, Health Care
MH  - Pyridones/*therapeutic use
MH  - Statistics as Topic
MH  - Surveys and Questionnaires
MH  - *Treatment Outcome
OTO - NOTNLM
OT  - AMPA-receptor antagonist
OT  - Antiepileptic drugs
OT  - Behavior
OT  - Partial-onset epilepsy
OT  - Perampanel
EDAT- 2016/05/26 06:00
MHDA- 2017/06/18 06:00
CRDT- 2016/05/26 06:00
PHST- 2016/04/22 00:00 [accepted]
PHST- 2016/05/26 06:00 [entrez]
PHST- 2016/05/26 06:00 [pubmed]
PHST- 2017/06/18 06:00 [medline]
AID - 10.1111/epi.13417 [doi]
PST - ppublish
SO  - Epilepsia. 2016 Jul;57(7):1120-9. doi: 10.1111/epi.13417. Epub 2016 May 25.