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Article ; Online: Call for the use of the ILAE terminology for seizures and epilepsies by health care professionals and regulatory agencies to benefit patients and caregivers.

Auvin, Stéphane / Arzimanoglou, Alexis / Brambilla, Isabella / French, Jacqueline / Knupp, Kelly G / Lagae, Lieven / Perucca, Emilio / Trinka, Eugen / Dlugos, Dennis

Epilepsia

2024 Volume 65, Issue 2, Page(s) 283–286

Abstract: The International League Against Epilepsy (ILAE) introduced a classification for seizure types in 2017 and updated the classification for epilepsy syndromes in 2022. These classifications aim to improve communication among healthcare professionals and ... ...

Abstract	The International League Against Epilepsy (ILAE) introduced a classification for seizure types in 2017 and updated the classification for epilepsy syndromes in 2022. These classifications aim to improve communication among healthcare professionals and help patients better describe their condition. So far, regulatory agencies have used different terminology. This paper stresses the crucial need for consistently adopting ILAE terminology in both regulatory processes and clinical practice. It highlights how language plays a significant role in healthcare communication and how standardized terminology can enhance patient comprehension. The ongoing review of guidelines by regulatory bodies offers a timely opportunity. Aligning regulatory terminologies holds the potential to facilitate discussions on future drug development and harmonize practices across diverse regions, ultimately fostering improved care and research outcomes in epilepsy treatment.
MeSH term(s)	Humans ; Caregivers ; Epilepsy/diagnosis ; Seizures/diagnosis ; Epileptic Syndromes ; Forecasting
Language	English
Publishing date	2024-01-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	216382-2
ISSN	1528-1167 ; 0013-9580
ISSN (online)	1528-1167
ISSN	0013-9580
DOI	10.1111/epi.17868
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Zs.A 517: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Pitfalls of using video-EEG for a trial endpoint in children aged <4 years with focal seizures.

Bozorg, Ali / Beller, Cynthia / Jensen, Lori / Arzimanoglou, Alexis / Chiron, Catherine / Dlugos, Dennis / Gaitanis, John / Wheless, James W / McClung, Carrie

Annals of clinical and translational neurology

2024 Volume 11, Issue 3, Page(s) 780–790

Abstract: Objective: Double-blind, randomized, and placebo-controlled trial SP0967 (NCT02477839/2013-000717-20) did not demonstrate superior efficacy of lacosamide versus placebo in patients aged ≥1 month to <4 years with uncontrolled focal seizures, per ≤72 h ... ...

Abstract	Objective: Double-blind, randomized, and placebo-controlled trial SP0967 (NCT02477839/2013-000717-20) did not demonstrate superior efficacy of lacosamide versus placebo in patients aged ≥1 month to <4 years with uncontrolled focal seizures, per ≤72 h video-electroencephalogram (video-EEG)-based primary endpoints (reduction in average daily frequency of focal seizures at end-of-maintenance [EOM] versus end-of-baseline [EOB], patients with ≥50% response). This was unexpected because randomized controlled trial SP0969 (NCT01921205) showed efficacy of lacosamide in patients aged ≥4 to <17 years with uncontrolled focal seizures. SP0969's primary endpoint was based on seizure diary instead of video-EEG, an issue with the latter being inter-reader variability. We evaluated inter-reader agreement in video-EEG interpretation in SP0967, which to our knowledge, are the first such data for very young children with focal seizures from a placebo-controlled trial. Methods: Local investigator and central reader agreement in video-EEG interpretation was analyzed post hoc. Results: Analysis included 105 EOB and 98 EOM video-EEGs. Local investigators and central reader showed poor agreement based on ≥2 focal seizures at EOB (Kappa = 0.01), and fair agreement based on ≥2 focal seizures at EOM (Kappa = 0.23). Local investigator and central reader seizure count interpretations varied substantially, particularly for focal seizures, but also primary generalized and unclassified epileptic seizures, at both timepoints. Interpretation: High inter-reader variability and low inter-reader reliability of the interpretation of seizure types and counts prevent confident conclusion regarding the lack of efficacy of lacosamide in this population. We recommend studies in very young children do not employ video-EEGs exclusively for accurate study inclusion or as an efficacy measure.
MeSH term(s)	Child ; Humans ; Child, Preschool ; Lacosamide/therapeutic use ; Anticonvulsants ; Epilepsies, Partial/diagnosis ; Epilepsies, Partial/drug therapy ; Reproducibility of Results ; Treatment Outcome ; Seizures/diagnosis ; Seizures/drug therapy ; Seizures/chemically induced ; Electroencephalography
Chemical Substances	Lacosamide (563KS2PQY5) ; Anticonvulsants
Language	English
Publishing date	2024-02-06
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	2740696-9
ISSN	2328-9503 ; 2328-9503
ISSN (online)	2328-9503
ISSN	2328-9503
DOI	10.1002/acn3.51999
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Article ; Online: Safety of Diazepam Nasal Spray in Children and Adolescents With Epilepsy: Results From a Long-Term Phase 3 Safety Study.

Tarquinio, Daniel / Dlugos, Dennis / Wheless, James W / Desai, Jay / Carrazana, Enrique / Rabinowicz, Adrian L

Pediatric neurology

2022 Volume 132, Page(s) 50–55

Abstract: Background: To evaluate safety and tolerability of long-term treatment with diazepam nasal spray (Valtoco) for seizure clusters in patients aged six to 17 years.: Methods: The study enrolled patients aged six to 65 years with frequent seizure ... ...

Abstract	Background: To evaluate safety and tolerability of long-term treatment with diazepam nasal spray (Valtoco) for seizure clusters in patients aged six to 17 years. Methods: The study enrolled patients aged six to 65 years with frequent seizure clusters. Age- and weight-based doses of diazepam nasal spray were administered; second doses were permitted if needed. Safety assessments included treatment-emergent adverse events (TEAEs). Results: Of 163 treated patients, 45 (27.6%) were aged six to 11 years and 33 (20.2%) were aged 12 to 17 years. Mean doses per month were 2.1 in the 6 to 11 subgroup and 2.4 in the 12 to 17 subgroup. Of 1634 seizure clusters in pediatric patients, 186 (11.4%) required a second dose of diazepam nasal spray within 24 hours of the first dose. Similar proportions of TEAEs and serious TEAEs were reported in 6 to 11 (91.1%, 40.0%) and 12 to 17 subgroups (81.8%, 30.3%), respectively. No serious TEAEs were considered treatment related, and no patients discontinued because of TEAEs. Treatment-related TEAEs were more frequent in the 12 to 17 subgroup; only epistaxis and somnolence occurred in two or more patients overall. TEAE rates were similar across subgroups that received concomitant clobazam (90.0%), received prior diazepam rectal gel (90.9%), and were administered less than two versus greater than or equal to two doses per month (87.2% for both) of diazepam nasal spray. Most survey respondents (88%) were satisfied or very satisfied with treatment. Conclusions: In this long-term safety analysis in pediatric patients with seizure clusters, repeated doses of diazepam nasal spray demonstrated a safety profile consistent across subgroups. These data support the dosing guidelines for diazepam nasal spray according to age and weight for pediatric patients.
MeSH term(s)	Administration, Intranasal ; Adolescent ; Adult ; Aged ; Anticonvulsants/therapeutic use ; Child ; Diazepam/adverse effects ; Double-Blind Method ; Epilepsy/drug therapy ; Epilepsy, Generalized/drug therapy ; Female ; Humans ; Male ; Middle Aged ; Nasal Sprays ; Seizures/drug therapy ; Treatment Outcome
Chemical Substances	Anticonvulsants ; Nasal Sprays ; Diazepam (Q3JTX2Q7TU)
Language	English
Publishing date	2022-04-28
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639164-3
ISSN	1873-5150 ; 0887-8994
ISSN (online)	1873-5150
ISSN	0887-8994
DOI	10.1016/j.pediatrneurol.2022.04.011
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Zs.A 2260: Show issues

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Article ; Online: Skeletal muscle architecture and aging: A comparison of ultrasound techniques and an assessment of intrarater reliability.

D'Lugos, Andrew C / Skotak, Nathan J / Faris, Jacquelyn J / Thomas, Nicholas T / Mazo, Corey E / Dickinson, Jonathan J / Moore, Jessy G / Jorgensen, Theresa M / Dickinson, Jared M

Clinical physiology and functional imaging

2024

Abstract: Objective: To assess intrarater reliability of ultrasound-determined measurements of skeletal muscle characteristics across different measurement outcomes, imaging techniques, and age groups.: Methods: 2D ultrasound images (B-mode) of the quadriceps ... ...

Abstract	Objective: To assess intrarater reliability of ultrasound-determined measurements of skeletal muscle characteristics across different measurement outcomes, imaging techniques, and age groups. Methods: 2D ultrasound images (B-mode) of the quadriceps were obtained from young (26 ± 4 year, n = 8 M, 8 F) and older (70 ± 7 year, n = 7 M, 5 F) adults on two occasions, separated by 6 ± 3 days. With participants in both standing and supine postures, images were collected from five anatomical sites along the anterior (two sites) and lateral (three sites) compartments of the thigh corresponding to 56%, 39%, and 22% (lateral only) of femur length. Images were analysed for muscle thickness, pennation angle, and echogenicity. Intraclass correlation coefficients (ICC) were used to assess reliability. Results: Muscle thickness values were higher (p < 0.05) on images collected in the stand versus supine posture only for muscles of the anterior compartment, independent of age. Echogenicity values were higher (p < 0.05) in the vastus intermedius on images collected in the supine versus stand posture only in older adults. Pennation angle values were not impacted by imaging posture (p > 0.05). ICC values for thickness, echogenicity, and pennation angle were generally higher for analyses conducted on images collected in the supine versus stand posture. Imaging posture generated a greater difference in ICC values in the lateral versus anterior muscles and in older versus younger participants. Conclusion: Our findings suggest that participant posture during imaging impacts the absolute values and intrarater reliability of ultrasound-determined muscle characteristics in a muscle-specific fashion, and this effect is greater in older compared to younger individuals.
Language	English
Publishing date	2024-04-14
Publishing country	England
Document type	Journal Article
ZDB-ID	2071203-0
ISSN	1475-097X ; 1475-0961
ISSN (online)	1475-097X
ISSN	1475-0961
DOI	10.1111/cpf.12882
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Zs.A 1650: Show issues

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Article ; Online: Effects of indulgent food snacking, with and without exercise training, on body weight, fat mass, and cardiometabolic risk markers in overweight and obese men.

Tucker, Wesley J / Jarrett, Catherine L / D'Lugos, Andrew C / Angadi, Siddhartha S / Gaesser, Glenn A

Physiological reports

2021 Volume 9, Issue 22, Page(s) e15118

Abstract: We hypothesized that exercise training would prevent gains in body weight and body fat, and worsening of cardiometabolic risk markers, during a 4-week period of indulgent food snacking in overweight/obese men. Twenty-eight physically inactive men (ages ... ...

Abstract	We hypothesized that exercise training would prevent gains in body weight and body fat, and worsening of cardiometabolic risk markers, during a 4-week period of indulgent food snacking in overweight/obese men. Twenty-eight physically inactive men (ages 19-47 yr) with body mass index (BMI) ≥25 kg/m
MeSH term(s)	Adipose Tissue ; Adult ; Blood Glucose/metabolism ; Blood Pressure ; Body Weight ; Cardiometabolic Risk Factors ; Exercise ; Exercise Therapy/methods ; High-Intensity Interval Training/methods ; Humans ; Insulin/blood ; Lipids/blood ; Male ; Middle Aged ; Obesity/metabolism ; Obesity/physiopathology ; Obesity/therapy ; Overweight ; Oxygen Consumption/physiology ; Sedentary Behavior ; Snacks ; Vasodilation/physiology ; Young Adult
Chemical Substances	Blood Glucose ; Insulin ; Lipids
Language	English
Publishing date	2021-11-24
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2724325-4
ISSN	2051-817X ; 2051-817X
ISSN (online)	2051-817X
ISSN	2051-817X
DOI	10.14814/phy2.15118
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Article ; Online: Proposal for an updated seizure classification framework in clinical trials.

Steriade, Claude / Sperling, Michael R / DiVentura, Bree / Lozano, Meryl / Shellhaas, Renée A / Kessler, Sudha Kilaru / Dlugos, Dennis / French, Jacqueline

Epilepsia

2022 Volume 63, Issue 3, Page(s) 565–572

Abstract: The International League Against Epilepsy (ILAE) seizure classification scheme has been periodically updated to improve its reliability and applicability to clinicians and researchers alike. Here, members of the Epilepsy Study Consortium propose a ... ...

Abstract	The International League Against Epilepsy (ILAE) seizure classification scheme has been periodically updated to improve its reliability and applicability to clinicians and researchers alike. Here, members of the Epilepsy Study Consortium propose a pragmatic seizure classification, based on the ILAE scheme, designed for use in clinical trials with a focus on outcome measures that have high reliability, broad interpretability across stakeholders, and clinical relevance in the context of the development of novel antiseizure medications. Controversies around the current ILAE classification scheme are discussed in the context of clinical trials, and pragmatic simplifications to the existing scheme are proposed, for intended use by investigators, industry sponsors, and regulatory agencies.
MeSH term(s)	Clinical Trials as Topic ; Epilepsy/diagnosis ; Epilepsy/drug therapy ; Humans ; Outcome Assessment, Health Care ; Reproducibility of Results ; Research Personnel ; Seizures/diagnosis ; Seizures/drug therapy
Language	English
Publishing date	2022-01-07
Publishing country	United States
Document type	Journal Article
ZDB-ID	216382-2
ISSN	1528-1167 ; 0013-9580
ISSN (online)	1528-1167
ISSN	0013-9580
DOI	10.1111/epi.17120
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Article ; Online: Antiseizure Medication Withdrawal in Seizure-Free Patients: Practice Advisory Update Summary: Report of the AAN Guideline Subcommittee.

Gloss, David / Pargeon, Kimberly / Pack, Alison / Varma, Jay / French, Jacqueline A / Tolchin, Benjamin / Dlugos, Dennis J / Mikati, Mohamad A / Harden, Cynthia

Neurology

2021 Volume 97, Issue 23, Page(s) 1072–1081

Abstract: Objective: To update a 1996 American Academy of Neurology practice parameter.: Methods: The authors systematically reviewed literature published from January 1991 to March 2020.: Results: The long-term (24-60 months) risk of seizure recurrence is ... ...

Abstract	Objective: To update a 1996 American Academy of Neurology practice parameter. Methods: The authors systematically reviewed literature published from January 1991 to March 2020. Results: The long-term (24-60 months) risk of seizure recurrence is possibly higher among adults who have been seizure-free for 2 years and taper antiseizure medications (ASMs) vs those who do not taper ASMs (15% vs 7% per the 1 Class I article addressing this issue). In pediatric patients, there is probably no significant difference in seizure recurrence between those who begin tapering ASMs after 2 years vs 4 years of seizure freedom, and there is insufficient evidence of significant difference in risk of seizure recurrence between those who taper ASMs after 18 months of seizure freedom and those tapering after 24 months. There is insufficient evidence that the rate of seizure recurrence with ASM withdrawal following epilepsy surgery after 1 year of seizure freedom vs after 4 years is not significantly different than maintaining patients on ASMs. An epileptiform EEG in pediatric patients increases the risk of seizure recurrence. ASM withdrawal possibly does not increase the risk of status epilepticus in adults. In seizure-free adults, ASM weaning possibly does not change quality of life. Withdrawal of ASMs at 25% every 10 days to 2 weeks is probably not significantly different from withdrawal at 25% every 2 months in children who are seizure-free in more than 4 years of follow-up. Recommendations: Fourteen recommendations were developed.
MeSH term(s)	Adult ; Anticonvulsants/adverse effects ; Child ; Epilepsy/chemically induced ; Epilepsy/drug therapy ; Humans ; Quality of Life ; Recurrence ; Seizures/chemically induced ; Seizures/drug therapy
Chemical Substances	Anticonvulsants
Language	English
Publishing date	2021-12-06
Publishing country	United States
Document type	Journal Article ; Practice Guideline ; Research Support, Non-U.S. Gov't
ZDB-ID	207147-2
ISSN	1526-632X ; 0028-3878
ISSN (online)	1526-632X
ISSN	0028-3878
DOI	10.1212/WNL.0000000000012944
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Article ; Online: A quality improvement initiative to improve folic acid supplementation counseling for adolescent females with epilepsy.

Molisani, Sara E / Parikh, Darshana / DiGiovine, Marissa / Dlugos, Dennis / Fitzgerald, Mark P / Fried, Lawrence / Helbig, Ingo / Kessler, Sudha Kilaru / McDonnell, Pamela Pojomovsky / Melamed, Susan / Prelack, Marisa S / Sharif, Uzma / Tefft, Sarah / Tencer, Jaclyn / Witzman, Stephanie / Shaw, Kathy / Abend, Nicholas S

Epilepsia

2023 Volume 64, Issue 10, Page(s) 2818–2826

Abstract: Objective: We designed a quality improvement (QI) project to improve rates of documented folic acid supplementation counseling for adolescent females with epilepsy, consistent with a quality measure from the American Academy of Neurology and American ... ...

Abstract	Objective: We designed a quality improvement (QI) project to improve rates of documented folic acid supplementation counseling for adolescent females with epilepsy, consistent with a quality measure from the American Academy of Neurology and American Epilepsy Society. Our SMART aim was to increase the percentage of visits at which folic acid counseling was addressed from our baseline rate of 23% to 50% by July 1, 2020. Methods: This initiative was conducted in female patients ≥12 years old with epilepsy who were prescribed daily antiseizure medication and were seen by the 13 providers in our Neurology QI Program. Using provider interviews, we undertook a root cause analysis of low counseling rates and identified the following main factors: insufficient time during clinic visit to counsel, lack of provider knowledge, and forgetting to counsel. Countermeasures were designed to address these main root causes and were implemented through iterative plan-do-study-act (PDSA) cycles. Interventions included provider education and features within the electronic health record, which were introduced sequentially, culminating in the creation of a best practice advisory (BPA). We performed biweekly chart reviews of visits for applicable patients to establish baseline performance rate and track progress over time. We used a statistical process control p-chart to analyze the outcome measure of documented counseling. As a balancing measure, clinicians were surveyed using the Technology Adoption Model survey to assess acceptance of the BPA. Results: From September 2019 to August 2022, the QI team improved rates of documented folic acid counseling from 23% to 73% through several PDSA cycles. This level of performance has been sustained over time. The most successful and sustainable intervention was the BPA. Provider acceptance of the BPA was overall positive. Significance: We successfully used QI methodology to improve and sustain our rates of documented folic acid supplementation counseling for adolescent females with epilepsy.
Language	English
Publishing date	2023-08-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	216382-2
ISSN	1528-1167 ; 0013-9580
ISSN (online)	1528-1167
ISSN	0013-9580
DOI	10.1111/epi.17723
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Zs.A 517: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Considerations for determining the efficacy of new antiseizure medications in children age 1 month to younger than 2 years.

French, Jacqueline A / Cleary, Elena / Dlugos, Dennis / Farfel, Gail / Farrell, Kathleen / Gidal, Barry / Grzeskowiak, Caitlin L / Gurrell, Rachel / Harden, Cynthia / Stalvey, Tracy J / Tsai, Julia / Wirrell, Elaine C / Blum, David / Fountain, Nathan

Epilepsia

2022 Volume 63, Issue 10, Page(s) 2664–2670

Abstract: Objectives: Drug treatment for children with epilepsy should, ideally, be governed by evidence from adequate and well-controlled clinical studies. However, these studies are difficult to conduct, and so direct evidence supporting the informed use of ... ...

Abstract	Objectives: Drug treatment for children with epilepsy should, ideally, be governed by evidence from adequate and well-controlled clinical studies. However, these studies are difficult to conduct, and so direct evidence supporting the informed use of specific drugs is often lacking. The Research Roundtable for Epilepsy (RRE) met in 2020 to align on an approach to therapy development for focal seizures in children age 1 month <2 years of age. Methods: The RRE reviewed the regulatory landscape, epidemiology, seizure semiology, antiseizure medicine pharmacology, and safety issues applicable to this population. Results: After reviewing evidence, the conclusion was that pediatric efficacy trials would be impracticable to conduct but a waiver of the regulatory requirement to conduct any study would lead to an absence of information to guide dosing in a critical population. Review of available data and discussion of RRE attendees led to the conclusion that the requirements for extrapolation of efficacy from older children down to infants from age 1 month to <2 years old appeared to be met. After the RRE, the US Food and Drug Administration (FDA) approved brivaracetam for use in children with focal epilepsy above the age of 1 month in August 2021 and lacosamide in October 2021, both based on the principle of extrapolation from data in older children. Significance: These recommendations should result in more rapid accessibility of antiseizure medications for infants.
MeSH term(s)	Adolescent ; Anticonvulsants/therapeutic use ; Child ; Epilepsies, Partial/drug therapy ; Epilepsy/drug therapy ; Humans ; Infant ; Lacosamide/therapeutic use ; Seizures/drug therapy
Chemical Substances	Anticonvulsants ; Lacosamide (563KS2PQY5)
Language	English
Publishing date	2022-08-12
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	216382-2
ISSN	1528-1167 ; 0013-9580
ISSN (online)	1528-1167
ISSN	0013-9580
DOI	10.1111/epi.17366
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Article: The early identification of candidates for epilepsy surgery.

Dlugos, D J

Archives of neurology

2001 Volume 58, Issue 10, Page(s) 1543–1546

Abstract: The effectiveness of resective surgery for the treatment of carefully selected patients with medically intractable, localization-related epilepsy is clear. Seizure-free rates following temporal lobectomy are consistently 65% to 70% in adults and 68% to ... ...

Abstract	The effectiveness of resective surgery for the treatment of carefully selected patients with medically intractable, localization-related epilepsy is clear. Seizure-free rates following temporal lobectomy are consistently 65% to 70% in adults and 68% to 78% in children. Extratemporal resections less commonly lead to a seizure-free outcome, although one recent childhood series reported a seizure-free rate of 62% following extratemporal epilepsy surgery. With both temporal and extratemporal resections, additional patients have a reduction in seizures following surgery but are not completely seizure free. The identification of favorable surgical candidates has been the subject of extensive research, and many investigators have examined predictors of outcome following epilepsy surgery. However, the early identification of the potential epilepsy surgery candidate and the optimal timing of surgery have only occasionally been addressed in the literature. This issue is methodologically challenging to study since studies require large numbers of patients with new-onset partial epilepsy who are followed over time. The purpose of this article is to review the current ability for early prediction of medical intractability in patients with surgically remediable epilepsy. Emphasis will be placed on the early prediction of intractable temporal lobe epilepsy in children and adolescents, since temporal lobectomy remains the prototype epilepsy surgery, and early surgery may improve psychosocial outcome in younger patients.
MeSH term(s)	Child ; Epilepsy/surgery ; Humans ; Magnetic Resonance Imaging ; Models, Neurological ; Predictive Value of Tests ; Sensitivity and Specificity ; Syndrome ; Treatment Outcome
Language	English
Publishing date	2001-10
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	80049-1
ISSN	1538-3687 ; 0003-9942
ISSN (online)	1538-3687
ISSN	0003-9942
DOI	10.1001/archneur.58.10.1543
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