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1 ICNC-0262 Evaluation of efficacy, safety and workload of inpatient and outpatient initiation of the Ketogenic Diet in children (0-18 y) with refractory epilepsy IntroductionKetogenic Diet (KD) treatment requires close multidisciplinary monitoring and most children are hospitalized during KD initiation. Outpatient diet initiation is not routinely done. MethodThis retrospective observational cohort study evaluated efficacy, safety and workload of our ketoteam in the first three months after KD initiation. We compared patients whose KD was electively initiated in a hospital setting with patients whose KD was initiated in an outpatient setting, according to an intentionto-treat analysis.efficacy is defined as >50% seizure reduction and change in number of anti-epileptic drugs (AED s).safety is defined as number of hospitalization days, emergency department visits, type and number of complications. Workload is defined as number of consultations.resultsat baseline, of 135 patients, 87 were in the outpatient group and 48 in the inpatient group.at 3 months; seizure reduction (outpatient group: 58.3% vs inpatient group 50%, p=0.842), and AED s change (outpatient group: vs inpatient group -0.19, p 0.846) was not significantly different. Patients in outpatient group had less days (p= 0.037) in hospital, less visits to emergency department (p= 0.035) and no significant differenes in incidence and type of complications (p=0.316). There was no difference in number of consultations of our ketoteam between the outpatient and inpatient group. ConclusionAfter 3 months of KD treatment, outpatient initiation seems to be as safe and effective, and with no difference in respect to workload as inpatient initiation. The decision making should always be approached individually, as outpatient diet initiation is more patient- and family-friendly. Elles van der Louw*(1);Tessa Wesstein(1);Florianne Vehmeijer(1);Raakhee Desadien(1);Coriene Catsman-Berrevoets(1);Rinze Neuteboom(1);
2 ICNC-0204 Introduction: Efficacy and safety of Lacosamide in children The use of lacosamide as an anti-epileptic drug in children has been increasing over recent years in the UK. Large data specifically on childhood cohorts are currently limited in literature. Methods: A retrospective analysis of lacosamide use across four tertiary paediatric neurology units in the UK was carried out. Case notes of all children under 18 years commenced on lacosamide prior to 2015 were analysed in the study. Results: 61 children were included, with a male to female ratio of 36:25. The mean age of commencing lacosamide was 12.5 years (age range 1-17). Data on safety and side effect profile were obtained from all patients and lacosamide was tolerated without side effects in 73.7% of our patients. In the remaining, dizziness and somnolence were the most commonly reported side effects. Only 5 patients discontinued lacosamide due to its side effect, and no child had life-threatening events secondary to lacosamide. In terms of efficacy, documentation in case notes limited analysis to 54 patients. Out of this group, 53.7% had a seizure reduction of >50% at 6 months. 3 children obtained seizure freedom at 6 months and at last follow-up (average 19.2 months). At this stage, 6.56% of our total cohort moved to lacosamide monotherapy. Overall, 29.51% discontinued lacosamide due to lack of efficacy. Conclusion: Lacosamide was safely tolerated in most of our patients without any major side effects. More than half had desirable seizure reductions. Although mainly recommended for focal epilepsy, some patients had an improvement in their generalised seizures. Dipak Ram*(1); Laura Calder(1); Nina Swiderska(2); Albert Lim(3); Seetha Rajendran(4); Anand Iyer(4); Helen Basu(2); Rob Forsyth(3); Jeen Tan(1) (1)Department of Paediatric Neurology, Royal Manchester Children's Hospital, Manchester, UK ; (2) Department of Paediatric Neurology, Royal Preston Hospital, Preston, UK; (3)Department of Paediatric Neurology, Great North Children's Hospital, Newcastle, UK ; (4) Department of Paediatric Neurology, Alder Hey Children's Hospital, Liverpool, UK;
3 ICNC-0225 Addition of Pyridoxine to prednisolone in the treatment of infantile spasms: A randomized controlled trial Objectives: This study aimed to test the hypothesis that the addition of pyridoxine to oral prednisolone may be more efficacious than prednisolone alone for spasm resolution at 14-days in children with infantile spasms. Methods: This was a randomized, open-label-trial conducted at a tertiary-level-hospital from November-2012 to March Children aged 3-months to 3-years presenting with infantile spasms in clusters (at least 1 cluster/day) with hypsarrhythmia or its variants on EEG were enrolled. The study participants were randomized to receive either oral prednisolone (4 mg/kg/day) alone or 30 mg/kg/day of pyridoxine with oral prednisolone. The primary outcome measure was the proportion of children who achieved spasm freedom for 48-h at day-14 after treatment initiation as per parental reports in both the groups. The adverse effects were also monitored. The study was registered with the clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT ). Results: Sixty-two children were randomized into the two groups with comparable baseline characteristics. The proportion of children with spasm cessation on day-14 was similar in the two groups (39% vs. 37%, p = 0.98). The adverse effects were comparable in both the groups. Conclusions: The combination of pyridoxine with oral prednisolone was not found to be beneficial therapy as compared to prednisolone alone. Suvasini Sharma*(1); Satinder Aneja(1); Puneet Jain(1); Vedavathi Kunnanayaka(1); Anju Seth(1) Lady Hardinge Medical College, New Delhi, India(1)
4 ICNC-0220 Low-dose Add-on Fenfluramine in Dravet Syndrome: Effect on seizure control, sleep quality, and quality of Life in a prospective open-label study. Introduction Dravet syndrome (DS) is a severe, drug-resistant epilepsy syndrome in which many patients do not achieve satisfactory seizure control. Fenfluramine (FFA) was previously shown to have antiepileptic activity in 12 DS patients1. MethodsEight new DS patients between ages 1 and 21 years enrolled in the study. Seizure frequency was captured via a diary beginning 3 months prior to starting FFA. All major motor seizures were counted. FFA was added to the AED regimen up to a maximum of 20mg daily. Effectiveness and side effects were assessed at each visit. Results Patient median age at inclusion was 11.9yr with a median follow-up duration of 1.5yr (range, yr). Median seizure frequency was 8.7/mo before FFA treatment and was 1.7/mo during FFA treatment, representing a median decrease of 71.5% (range %) Six patients (75%) demonstrated 50% reduction in seizure frequency during FFA. At the most recent visit, mean sleep quality for patients and parents was 8.3/10 and 7.6/10, respectively (10=very good), mean QOL scores were 7.4/10 and 7.1/10 respectively (10=very good). No cardiac side effects were found. Treatment-emergent adverse events included somnolence (n=6, 75%), diminished appetite (n=4, 50%), mood changes (n=2, 25%), and obtundation status (n=2, 25%).Conclusion Low-dose add-on FFA in this new cohort of DS patients improved major motor seizure control. At the most recent visit sleep quality and QOL were good for both patients and parents. FFA was generally well tolerated and no cardiovascular side effects were seen. 1. Ceulemans B, Boel M, Leyssens K, et al. Successful use of fenfluramine as an add-on treatment for Dravet syndrome. Epilepsia 2012;53: Schoonjans*, A.S.(1)*;Paelinck, B.(2);Marchau, F.(3);Gunning, B.(4);Galer, B.(5);Gammaitoni, A.(5);Lagae, L.(6);Ceulemans, B.(1); (1)Antwerp University Hospital, Department of Neurology - Pediatric Neurology, University of Antwerp, Belgium;(2)Antwerp University Hospital, Department of Cardiology, University of Antwerp, Belgium;(3)Antwerp University Hospital, Department of Pediatric Cardiology, University of Antwerp, Belgium;(4)Epilepsy Center SEIN, Zwolle, The Netherlands;(5)Zogenix Inc., CA, U.S.A.;(6)University Hospitals Gasthuisberg- Leuven, Department of Development and Regeneration- Section Paediatric Neurology,, Belgium;
5 ICNC-0151 Efficacy of cannabidiol in refractory epilepsy in children and adolescents prospective open label F/U registry of 45 patients Objective: The aim of the study is to evaluate the efficacy of cannabidiol in the treatment of refractory epilepsy in children and adolescents. Methods: We conducted a prospective open-label follow-up on patients treated with oil extracted from Cannabis with CBD/THC ratio of 20:1. The exact dosing of CBD and THC were tested by certified laboratories. Patients with F/U period of less than 4 months who are still treated were excluded. CBD dose was increased according to response and adverse reactions. Results: Forty five patients with different types of epilepsies and etiologies were recruited in a single pediatric epilepsy outpatient clinic. The patients' age range is between 1 to 20 years. 12/45 patients has normal intelligence. The patients were followed for a period of 4-24 months. Fourteen patients failed AEDs prior to treatment and fifteen failed 5-10 AEDs each. Many of the patients tried also other treatments prior to cannabidiol including VNS (16), KTG (15) and epilepsy surgery (3). Response to CBD-THC oil treatment was calculated according to parents' reports at clinic visits. Twelve patients dropped from the trial due to either lack of response or adverse reactions. Of the 45 patients, 14 had no response to the treatment, 6 had less than 50% seizures' reduction, 14 (31%) had 50-75% reduction, 7 (15%) had 75-99% reduction and 4 (9%) were seizure free. Conclusions: The results suggest that in cases of refractory epilepsy the use of cannabidiol resulted in a significant reduction of seizure frequency in about 20% of the patients and therefore should be considered as an additional treatment option. Uri Kramer(1); Shay Menascu*(1); Aviva Fattal-Valevski(1) Pediatric Neurology Unit, Tel Aviv, Sourasky, Medical Center, Tel Aviv University, Israel(1)
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