Efficacy and safety of adjunctive perampanel in adolescent patients with epilepsy: Post hoc analysis of six randomized studies

Publication date: March 2020Source: Epilepsy &Behavior, Volume 104, Part AAuthor(s): J. Eric Piña-Garza, William Rosenfeld, Kazunori Saeki, Vicente Villanueva, Harumi Yoshinaga, Anna Patten, Betsy Williams, Manoj MalhotraAbstractObjectiveThis post hoc analysis of six randomized, double-blind, Phase II and III studies evaluated efficacy and safety of adjunctive perampanel (2–12 mg/day) in adolescent patients (aged ≥ 12 to ≤ 17 years) with uncontrolled partial-onset seizures, with or without secondarily generalized (SG) seizures, or primary generalized tonic–clonic (PGTC) seizures.MethodsAdolescent patients from Studies 304 (NCT00699972), 305 (NCT00699582), 306 (NCT00700310), 335 (NCT01618695), 235 (NCT01161524), and 332 (NCT01393743) were included. Efficacy assessments (split by seizure type) included median percent change in seizure frequency per 28 days from baseline and seizure-freedom rates. Safety assessments (all seizure types combined) included monitoring of treatment-emergent adverse events (TEAEs).ResultsThe Safety Analysis Set included 372 adolescent patients (placebo, n = 114; perampanel, n = 258); the Full Analysis Set included 346 patients with partial-onset seizures (placebo, n = 103; perampanel, n = 243), of whom 125 experienced SG seizures during baseline (placebo, n = 37; perampanel, n = 88), and 22 with PGTC seizures (placebo, n = 9; perampanel, n = 13). Compared with placebo, peramp...
Source: Epilepsy and Behavior - Category: Neurology Source Type: research

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tra M Abstract OBJECTIVE: This post hoc analysis of six randomized, double-blind, Phase II and III studies evaluated efficacy and safety of adjunctive perampanel (2-12 mg/day) in adolescent patients (aged ≥12 to ≤17 years) with uncontrolled partial-onset seizures, with or without secondarily generalized (SG) seizures, or primary generalized tonic-clonic (PGTC) seizures. METHODS: Adolescent patients from Studies 304 (NCT00699972), 305 (NCT00699582), 306 (NCT00700310), 335 (NCT01618695), 235 (NCT01161524), and 332 (NCT01393743) were included. Efficacy assessments (split by seizure type) included media...
Source: Epilepsy and Behaviour - Category: Neurology Authors: Tags: Epilepsy Behav Source Type: research
CONCLUSIONS: This review provides very low-certainty evidence of no treatment difference between norethisterone and placebo, and moderate- to low-certainty evidence of no treatment difference between progesterone and placebo for catamenial epilepsy. However, as all the included studies were underpowered, important clinical effects cannot be ruled out.Our review highlighted an overall deficiency in the literature base on the effectiveness of a wide range of other hormonal and non-hormonal interventions currently being used in practice, particularly for those patients who do not have regular menses. Further clinical trials a...
Source: Cochrane Database of Systematic Reviews - Category: General Medicine Authors: Tags: Cochrane Database Syst Rev Source Type: research
ConclusionsIn this open-label trial, the 52-week retention rate was not significantly different between LEV and TPM. However, LEV was associated with a substantially higher seizure freedom rate and a more favorable safety profile than TPM in this population of Korean patients with focal seizures.
Source: Epilepsy and Behavior - Category: Neurology Source Type: research
CONCLUSIONS: In this open-label trial, the 52-week retention rate was not significantly different between LEV and TPM. However, LEV was associated with a substantially higher seizure freedom rate and a more favorable safety profile than TPM in this population of Korean patients with focal seizures. PMID: 31195326 [PubMed - as supplied by publisher]
Source: Epilepsy and Behaviour - Category: Neurology Authors: Tags: Epilepsy Behav Source Type: research
ConclusiontVNS is safe and well tolerated at the doses tested in research studies to date.
Source: Brain Stimulation - Category: Neurology Source Type: research
Common violet (Viola odorata L., Violaceae) has shown various medical applications. Current study aimed to compile a review over chemical composition and medicinal properties of this plant in modern phytotherapy and its related multipotential products from traditional Persian medicine (TPM). Medicinal applications of V. odorata and respective products were derived from credible pharmaceutical textbooks of TPM (10th–18th century AD). In parallel, electronic databases including PubMed, Scopus, and ScienceDirect were explored for targeted purposes. Management of cough, fever, common cold, headache, insomnia, epilep...
Source: Phytotherapy Research - Category: Biochemistry Authors: Tags: Review Source Type: research
Conclusions:Efficacy and safety outcomes for the ‘true ESL monotherapy’ patient subgroup (no AEDs added back during the OLE) were favorable and generally consistent with those for the total OLE population, although with fewer SAEs and discontinuations due to TEAEs.Study Supported by: Sunovion Pharmaceuticals Inc.Disclosure: Dr. Chung has received personal compensation for activities with UCB Pharma, Eisai, Lundbeck, Upsher-Smith, and Sunovion. Dr. Chung has received research support from Lundbeck, UCB Pharma, Upsher-Smith, and SK Life Sciences. Dr. Sinha has received personal compensation for activities with Mo...
Source: Neurology - Category: Neurology Authors: Tags: Epilepsy and Clinical Neurophysiology: Therapeutics I Source Type: research
Conclusions:This post hoc analysis indicated that lacosamide monotherapy was efficacious and generally well tolerated in patients with newly-diagnosed epilepsy and psychiatric comorbidities.Study Supported by: UCB PharmaDisclosure: Dr. Schmitz received personal compensation for activities with UCB Pharma, Desitin Pharma, and Eisai as a speaker. Dr. Schmitz received research support from UCB Pharma. Dr. Newton has nothing to disclose. Dr. Dimova has received personal compensation for activities with UCB Pharma as an employee. Dr. Dimova holds stock and/or stock options in UCB Pharma. Dr. Zhang has received personal compensa...
Source: Neurology - Category: Neurology Authors: Tags: Epilepsy and Clinical Neurophysiology: Clinical Epilepsy IV Source Type: research
Summary ObjectivesTo report pooled safety/tolerability and seizure outcome data from adults with uncontrolled partial‐onset (focal) seizures (POS) receiving adjunctive brivaracetam (BRV) during phase IIb/III and long‐term follow‐up (LTFU) studies. MethodsSeizure outcome data were pooled from phase IIb (NCT00175929 and NCT00175825), III/IIIb (NCT00490035, NCT00464269, NCT00504881, and NCT01261325) and associated LTFU studies (NCT00175916, NCT00150800, and NCT01339559). Safety/tolerability data were pooled from these studies plus NCT01405508, NCT01653262, and NCT01728077 (LTFU). Patients received placebo (during core s...
Source: Epilepsia - Category: Neurology Authors: Tags: Full ‐Length Original Research Source Type: research
Summary ObjectivesTo report pooled safety/tolerability and seizure outcome data from adults with uncontrolled partial‐onset (focal) seizures (POS) receiving adjunctive brivaracetam (BRV) during phase IIb/III and long‐term follow‐up (LTFU) studies. MethodsSeizure outcome data were pooled from phase IIb (NCT00175929 and NCT00175825), III/IIIb (NCT00490035, NCT00464269, NCT00504881, and NCT01261325) and associated LTFU studies (NCT00175916, NCT00150800, and NCT01339559). Safety/tolerability data were pooled from these studies plus NCT01405508, NCT01653262, and NCT01728077 (LTFU). Patients received placebo (during core s...
Source: Epilepsia - Category: Neurology Authors: Tags: Full ‐Length Original Research Source Type: research
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