| 1. |
- Baumgartner, T., et al.
(författare)
-
A survey of the European Reference Network EpiCARE on clinical practice for selected rare epilepsies
- 2021
-
Ingår i: Epilepsia Open. - : Wiley. - 2470-9239. ; 6:1, s. 160-170
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: Clinical care of rare and complex epilepsies is challenging, because evidence-based treatment guidelines are scarce, the experience of many physicians is limited, and interdisciplinary treatment of comorbidities is required. The pathomechanisms of rare epilepsies are, however, increasingly understood, which potentially fosters novel targeted therapies. The objectives of our survey were to obtain an overview of the clinical practice in European tertiary epilepsy centers treating patients with 5 arbitrarily selected rare epilepsies and to get an estimate of potentially available patients for future studies. Methods: Members of the European Reference Network for rare and complex epilepsies (EpiCARE) were invited to participate in a web-based survey on clinical practice of patients with Dravet syndrome, tuberous sclerosis complex (TSC), autoimmune encephalitis, and progressive myoclonic epilepsies including Unverricht Lundborg and Unverricht-like diseases. A consensus-based questionnaire was generated for each disease. Results: Twenty-six of 30 invited epilepsy centers participated. Cohorts were present in most responding centers for TSC (87%), Dravet syndrome (85%), and autoimmune encephalitis (71%). Patients with TSC and Dravet syndrome represented the largest cohorts in these centers. The antiseizure drug treatments were rather consistent across the centers especially with regard to Dravet syndrome, infantile spasms in TSC, and Unverricht Lundborg / Unverricht-like disease. Available, widely used targeted therapies included everolimus in TSC and immunosuppressive therapies in autoimmune encephalitis. Screening for comorbidities was routinely done, but specific treatment protocols were lacking in most centers. Significance: The survey summarizes the current clinical practice for selected rare epilepsies in tertiary European epilepsy centers and demonstrates consistency as well as heterogeneity in the treatment, underscoring the need for controlled trials and recommendations. The survey also provides estimates for potential participants of clinical trials recruited via EpiCARE, emphasizing the great potential of Reference Networks for future studies to evaluate new targeted therapies and to identify novel biomarkers. © 2020 The Authors. Epilepsia Open published by Wiley Periodicals LLC on behalf of International League Against Epilepsy
|
|
| 2. |
- Ben-Menachem, Elinor, 1945, et al.
(författare)
-
Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial
- 2021
-
Ingår i: Epilepsia Open. - : Wiley. - 2470-9239. ; 6:3
-
Tidskriftsartikel (refereegranskat)abstract
- The primary objective of this trial (SP1042; NCT02582866) was to assess long-term safety and tolerability of lacosamide monotherapy (200-600 mg/day) in adults with focal (partial-onset) seizures or generalized tonic-clonic seizures (without clear focal origin). This Phase III, long-term, open-label, multicenter, follow-up trial enrolled patients with epilepsy who were taking lacosamide in, and completed, the previous double-blind trial (SP0994; NCT01465997). Primary safety outcomes were treatment-emergent adverse events (TEAEs), discontinuations due to TEAEs, and serious TEAEs. One hundred and six patients were enrolled and received lacosamide: 84 (79.2%) completed the trial and 22 (20.8%) discontinued. The median duration of exposure was 854.0 days, with a median modal dose of 200 mg/day. Ninety-six (90.6%), 64 (60.4%), and 44 (41.5%) patients had >= 12, >= 24, and >= 36 months of lacosamide exposure, respectively. At least one TEAE was reported by 61 (57.5%) patients. The most common (>= 4%) TEAEs were headache (10 [9.4%]), nasopharyngitis (eight [7.5%]), and back pain (five [4.7%]). One (0.9%) patient discontinued due to a TEAE (sudden unexpected death in epilepsy; not considered drug-related), 14 (13.2%) patients reported serious TEAEs, and seven (6.6%) patients reported TEAEs that were considered drug-related. Overall, long-term lacosamide monotherapy was generally well tolerated up to 600 mg/day, with no new safety signals identified.
|
|
| 3. |
|
|
| 4. |
|
|
| 5. |
- Ibinda, Fredrick, et al.
(författare)
-
Magnitude and factors associated with nonadherence to antiepileptic drug treatment in Africa : a cross-sectional multisite study
- 2017
-
Ingår i: Epilepsia Open. - : John Wiley & Sons. - 2470-9239. ; 2:2, s. 226-235
-
Tidskriftsartikel (refereegranskat)abstract
- Objectives: The epilepsy treatment gap is large in low- and middle-income countries, but the reasons behind nonadherence to treatment with antiepileptic drugs (AEDs) across African countries remain unclear. We investigated the extent to which AEDs are not taken and associated factors in people with active convulsive epilepsy (ACE) identified in cross-sectional studies conducted in five African countries.Methods: We approached 2,192 people with a confirmed diagnosis of ACE for consent to give blood voluntarily. Participants were asked if they were taking AEDs, and plasma drug concentrations were measured using a fluorescence polarization immunoassay analyzer. Information about possible risk factors was collected using questionnaire-based clinical interviews. We determined factors associated with nonadherence to AED treatment in children and adults, as measured by detectable and optimal levels, using multilevel logistic regression.Results: In 1,303 samples assayed (43.7% were children), AEDs were detected in 482, but only 287 had optimal levels. Of the 1,303 samples, 532 (40.8%) were from people who had reported they were on AEDs. The overall prevalence of nonadherence to treatment was 63.1% (95% confidence interval [CI] 60.5–65.6%) as measured by detectable AED levels and 79.1% (95% CI 73.3–84.3%) as measured by optimal AED levels; self-reported nonadherence was 65.1% (95% CI 45.0–79.5%). Nonadherence was significantly (p < 0.001) more common among the children than among adults for optimal and detectable levels of AEDs, as was the self-reported nonadherence. In children, lack of previous hospitalization and learning difficulties were independently associated with nonadherence to treatment. In adults, history of delivery at home, absence of burn marks, and not seeking traditional medicine were independently associated with the nonadherence to AED treatment.Significance: Only about 20% of people with epilepsy benefit fully from antiepileptic drugs in sub-Saharan Africa, according to optimum AEDs levels. Children taking AEDs should be supervised to promote compliance.
|
|
| 6. |
|
|
| 7. |
- Karlsson Lind, Linnéa, et al.
(författare)
-
Valproic acid utilization among girls and women in Stockholm : Impact of regulatory restrictions
- 2018
-
Ingår i: Epilepsia open. - : Wiley-Blackwell Publishing Inc.. - 2470-9239. ; 3:3, s. 357-363
-
Tidskriftsartikel (refereegranskat)abstract
- Objective: In November 2014, the European Medicines Agency (EMA) strengthened restrictions on the use of valproic acid in girls and women of childbearing potential. The objective of this study was to determine whether there has been a change in initiations of valproic acid treatment to females after the regulatory restrictions and to assess if such changes differed between indications (epilepsy and psychiatric disorder).Methods: An interrupted time-series analysis was conducted using all initiations of valproic acid in Stockholm, Sweden. from January 2011 to June 2017. Female and male patients aged 0-45 years with a recorded diagnosis of epilepsy and/or a psychiatric disorder were compared.Results: Before the EMA warning, a decline in trend of valproic acid initiations was seen in patients with epilepsy. After the warning, a significant decrease of valproic acid initiations was seen in women with a psychiatric disorder, but not in women with epilepsy.Significance: The regulatory warning appeared to have significantly influenced valproic acid initiations in women of childbearing age with a psychiatric disorder. No effect was seen in women with epilepsy, probably because the decline had started long before.
|
|
| 8. |
- Koepp, M. J., et al.
(författare)
-
Antiepileptogenesis after stroke-trials and tribulations: Methodological challenges and recruitment results of a Phase II study with eslicarbazepine acetate
- 2023
-
Ingår i: Epilepsia Open. - : Wiley. - 2470-9239. ; 8:3, s. 1190-1201
-
Tidskriftsartikel (refereegranskat)abstract
- There is currently no evidence to support the use of antiseizure medications to prevent unprovoked seizures following stroke. Experimental animal models suggested a potential antiepileptogenic effect for eslicarbazepine acetate (ESL), and a Phase II, multicenter, randomized, double-blind, placebo-controlled study was designed to test this hypothesis and assess whether ESL treatment for 1 month can prevent unprovoked seizures following stroke. We outline the design and status of this antiepileptogenesis study, and discuss the challenges encountered in its execution to date. Patients at high risk of developing unprovoked seizures after acute intracerebral hemorrhage or acute ischemic stroke were randomized to receive ESL 800 mg/d or placebo, initiated within 120 hours after primary stroke occurrence. Treatment continued until Day 30, then tapered off. Patients could receive all necessary therapies for stroke treatment according to clinical practice guidelines and standard of care, and are being followed up for 18 months. The primary efficacy endpoint is the occurrence of a first unprovoked seizure within 6 months after randomization ("failure rate"). Secondary efficacy assessments include the occurrence of a first unprovoked seizure during 12 months after randomization and during the entire study; functional outcomes (Barthel Index original 10-item version; National Institutes of Health Stroke Scale); post-stroke depression (Patient Health Questionnaire-9; PHQ-9); and overall survival. Safety assessments include the evaluation of treatment-emergent adverse events; laboratory parameters; vital signs; electrocardiogram; suicidal ideation and behavior (PHQ-9 question 9). The protocol aimed to randomize approximately 200 patients (1:1), recruited from 21 sites in seven European countries and Israel. Despite the challenges encountered, particularly during the COVID-19 pandemic, the study progressed and included a remarkable number of patients, with 129 screened and 125 randomized. Recruitment was stopped after 30 months, the first patient entered in May 2019, and the study is ongoing and following up on patients according to the Clinical Trial Protocol.
|
|
| 9. |
|
|
| 10. |
|
|
| 11. |
- Lisovska, K., et al.
(författare)
-
An online tool for information to women with epilepsy and therapeutic drug monitoring in pregnancy: Design and pilot study
- 2021
-
Ingår i: Epilepsia Open. - : Wiley. - 2470-9239. ; 6:2, s. 339-344
-
Tidskriftsartikel (refereegranskat)abstract
- Objective Information to women with epilepsy on pregnancy-related antiseizure medication (ASM) issues and reliable tools for therapeutic drug monitoring (TDM) are important aspects of epilepsy care. We aimed to develop and test an online tool for patient education on pregnancy-related issues and communication with epilepsy nurses during pregnancy for women with epilepsy. Methods An existing national platform for online communication (1177.se) was used, and an online tool was developed by two epilepsy nurses, two neurologists, and an IT technician. The tool was launched as a complement to standard care, and patients deciding to use it were invited to participate in a survey of user experiences and knowledge questions. Results The online tool consists of two modules: one for patient education and one for TDM during pregnancy. The latter module allows scheduling of automatic reminders of blood tests that are sent to patients at set intervals. The epilepsy nurse can communicate results and suggested dose changes in the tool. A total of 48 women answered the survey: 28 had been invited to use the information module and 20 to use the TDM module. Patient experiences were generally good, and most users of the TDM module would prefer an online means of communication in future pregnancies. For epilepsy nurses, the tool provided good overview of patients currently pregnant and administrative advantages compared with traditional means of communication. Significance Online patient education and communication about TDM during pregnancy are feasible and can be a valuable part of future digitalization efforts in epilepsy care.
|
|
| 12. |
|
|
| 13. |
- Reilly, Colin, et al.
(författare)
-
Child and parental sleep in young children with epilepsy: A population-based case-control study.
- 2018
-
Ingår i: Epilepsia open. - : Wiley. - 2470-9239. ; 3:3, s. 383-391
-
Tidskriftsartikel (refereegranskat)abstract
- To determine the prevalence of parent-reported sleep problems in young children with epilepsy and their parents, and to compare findings with those in a non-epilepsy-related neurodisability (neurodevelopmental/neurological difficulties) group.Parents of young children (1-7years) with epilepsy (n=48 [91% ascertainment]) completed the Child Sleep Habits Questionnaire (CSHQ). Parents (mothers and fathers) also completed the Pittsburgh Sleep Quality Index (PSQI) and the Iowa Fatigue Scale (IFS) in relation to their own functioning. The responses of parents of children with epilepsy were compared with parents of developmental-, age-, and gender-matched children with nonepilepsy-related neurodisability (n=48).There was not a significant difference in the proportion of children with epilepsy and the children with neurodisability scoring in the at-risk range on the CSHQ (81% vs. 71% respectively) (p=0.232). 62% of mothers and 44% of fathers of children with epilepsy had 'poor quality sleep' on the PSQI; there was not a significant difference between mothers of children with epilepsy and those of children with neurodisability (p=0.526) or IFS (p=0.245) total scores. However, mothers of children with epilepsy had significantly more difficulties on the productivity subscale of the IFS (p=0.004). There were no significant differences between fathers' scores on either measure. In the epilepsy group, child behavioral problems (p=0.001) were independently associated with child sleep difficulties and maternal mental health problems were associated with parental sleep difficulties (p=0.04) and fatigue (p=0.018).Young children with epilepsy and their parents have a high rate of sleep difficulties. There is a need to develop effective interventions for this population, taking into consideration of the role of child behavioral problems and parental mental health difficulties.
|
|
| 14. |
|
|
| 15. |
- Schmitz, Bettina, et al.
(författare)
-
Cenobamate in refractory epilepsy: Overview of treatment options and practical considerations
- 2023
-
Ingår i: Epilepsia Open. - 2470-9239. ; 8:4, s. 1241-1255
-
Tidskriftsartikel (refereegranskat)abstract
- Management of drug resistant epilepsy (DRE) represents a challenge to the treating clinician. This manuscript addresses DRE and provides an overview of treatment options, medical, surgical, and dietary. It addresses treatment strategies in polytherapy, then focuses on the role cenobamate (CNB) may play in reducing the burden of DRE while providing practical advice for its introduction. CNB is a recently approved, third generation, anti-seizure medication (ASM), a tetrazole-derived carbamate, thought to have a dual mechanism of action, through its effect on sodium channels as well as on GABAA receptors at a non-benzodiazepine site. CNB, having a long half-life, is an effective add-on ASM in refractory focal epilepsy with a higher response rate and a higher seizure-freedom rate than is usually seen in regulatory clinical trials. Experience post-licensing, though still limited, supports the findings of clinical trials and is encouraging. Its spectrum of action in relation to generalized epilepsies and seizures remains to be established, and there are no data on its efficacy in monotherapy. At the time of writing, CNB has been prescribed for some 50 000 individuals with DRE and focal epilepsy. A larger number is needed to fully establish its safety profile. It should at all times be introduced slowly to minimize the risk of serious allergic drug reactions. It has clinically meaningful interactions which must be anticipated and managed to maximize tolerability and likelihood of successful treatment. Despite the above, it may well prove to be of major benefit in the treatment of many patients with drug resistant epilepsy.
|
|
| 16. |
- Smith Malm, Christofer, et al.
(författare)
-
Survey of an online system for information to women with epilepsy of childbearing age and management during pregnancy: A 3-year evaluation
- 2024
-
Ingår i: EPILEPSIA OPEN. - 2470-9239.
-
Tidskriftsartikel (refereegranskat)abstract
- ObjectiveWe developed an online tool for women with epilepsy consisting of two modules: one with information on pregnancy-related issues (information module) and one for reminders about blood test and communication about dose changes (pregnancy module). Our aim was to assess perceived value, user-friendliness and improvement of patient knowledge in users.MethodsThe system was launched in 2019 and patients invited by epilepsy nurses were asked to participate in a survey 1 month after the invitation for the information module, and 1 month postnatally for the pregnancy module.ResultsBy November 2022, the system had been used by 96 individuals out of 100 invited in the pregnancy module, in a total of 114 pregnancies. One hundred and eleven women had been invited to the information module, and 70 of these accessed it. The survey received 96 answers (44 information, 52 pregnancy). User-friendliness was rated as good or very good by a little over half of the users; 55% in the information module and 52% in the pregnancy module. Among pregnant women, 83% found the TDM part useful and most would prefer a similar system in future pregnancies. Sixty-four percent of users of the information module and 48% of the pregnancy module found that the system had increased their knowledge. Two knowledge questions were answered correctly by a significantly higher proportion of those that had accessed the online information.SignificanceThere was great demand for online communication during pregnancy and our experiences of implementation can hopefully assist digitalization of epilepsy care elsewhere. Online information also seems to increase knowledge about pregnancy-related issues, but our invitation-only method of inclusion was not effective for widespread dissemination. Patient-initiated access with optional epilepsy-team contact if questions arise could be an alternative.Plain Language SummaryWe have performed a survey of users of a new Internet-based tool for information to women of childbearing age and communication about dose changes during pregnancy. Users were overall satisfied with the tool and answered some knowledge questions more accurately after accessing the information.
|
|
| 17. |
|
|
| 18. |
- Zelano, Johan, 1981
(författare)
-
Recurrence risk after a first remote symptomatic seizure in adults: Epilepsy or not?
- 2021
-
Ingår i: Epilepsia Open. - : Wiley. - 2470-9239. ; 6:4, s. 634-644
-
Tidskriftsartikel (refereegranskat)abstract
- The ILAE practical definition of epilepsy has a one seizure possibility to diagnose epilepsy after a first seizure if the recurrence risk is very high. The recurrence risk after a first seizure in brain disorders (first remote seizure) is often high, but varies with etiology, so more specific information is needed for clinical practice. This review describes etiology-specific recurrence risks in adults with a first remote seizure in stroke, traumatic brain injury, infections, dementia, multiple sclerosis, and tumors. Most studies are short, single center, and retrospective. Inclusion criteria, outcome ascertainment, and results vary. Few patient categories are clearly above the epilepsy threshold of recurrence risk, and there are surprisingly little data for important etiologies like brain infections. Beside stroke, severe TBI could have a sufficiently high recurrence risk for early epilepsy diagnosis, but more studies are needed, preferably prospective ones. The literature is uninformative regarding which seizures qualify as remote. The clinical implication of the low level of available evidence is that for other etiologies than stroke, seizure recurrence remains the most appropriate indicator of epilepsy for most patients with a first remote seizure. Nonetheless, there are worrying indications of a diagnostic drift, which puts patients with a preexisting brain disorder at risk of misdiagnosis. Although there are drawbacks to an intermediate term like "possible epilepsy," it could perhaps be useful in cases when the recurrence risk is high, but epilepsy criteria are not definitely met after a first remote seizure.
|
|
| 19. |
- Zelano, Johan, 1981, et al.
(författare)
-
Report of the ILAE SUDEP Task Force on national recommendations and practices around the world regarding the use of wearable seizure detection devices: A global survey
- 2023
-
Ingår i: Epilepsia Open. - 2470-9239. ; 8:4, s. 1271-1278
-
Tidskriftsartikel (refereegranskat)abstract
- Wearable seizure detection devices have the potential to address unmet needs of people with epilepsy. A recently published evidence-based international guideline recommends using such devices for safety indications in patients with tonic-clonic seizures (TCS). Our objective was to map existing guidelines and clinical practices at national level. We conducted a survey of the International League Against Epilepsy (ILAE) chapters regarding national recommendations and practical circumstances for prescribing seizure detection devices, and another survey of physicians in the ILAE constituency anywhere in the world, concerning their views and practices regarding recommendations for and prescription of such devices. Fifty-eight ILAE chapters (response rate 48%) and 157 physicians completed the surveys. More than two-thirds of responding countries do not have standards on wearables for seizure detection, although they indicated availability of such devices. The most often recognized indications were safety and objective seizure quantification. In nearly half of countries, devices are purchased by patients or caregivers, and either lack a uniform reimbursement scheme (41%) or patients pay the full cost for the device (48%). Tonic-clonic seizure frequency, nocturnal seizures, and previous injuries were the main factors that influenced the surveyed physicians to recommend wearable seizure detection devices. Our results document the need to implement international clinical practice guidelines at national level and to consider these when deciding upon reimbursement of seizure detection devices.
|
|
| 20. |
- Zelano, Johan, 1981, et al.
(författare)
-
The provision of epilepsy care across Europe 2017: A 17-year follow-up survey.
- 2019
-
Ingår i: Epilepsia open. - : Wiley. - 2470-9239. ; 4:1, s. 144-152
-
Tidskriftsartikel (refereegranskat)abstract
- To assess the resources available in the provision of epilepsy care across Europe and the developments since the International League Against Epilepsy (ILAE) survey published in 2003 (data collected in 2000).An updated online version of the European Epilepsy Services Inventory was distributed to all European chapters of the ILAE (N=47) and responses were obtained from 33 chapters (response rate 70%). To assess trends and allow comparisons with the survey published in 2003, the responding countries were divided into 4 groups (Western, Central, Southern, and Eastern). Responses from European Union (EU) member states are reported as a subgroup (N=23), since the current survey is a part of the EU-funded European Study on the Burden and Care of Epilepsy (ESBACE, www.esbace.eu).The total number of physicians involved in epilepsy care had increased since 2000, with the largest increase seen for neurologists. The gap between the best- and the least-provided areas with regard to the competence of the providers had diminished. However, the density of comprehensive multidisciplinary epilepsy teams had not changed to any greater degree. The main problems reported by the chapters were to a large extent the same as in 2000 and included lack of specialists and specialist care, lack or underuse of epilepsy surgery, and problems regarding financing and resource allocation. Several chapters also highlighted problems with healthcare structure and organization.Although there have been some improvements concerning the availability of care for people with epilepsy in Europe over the last 17years, there are still a number of problem areas with little improvement or where there are important regional differences.
|
|
