Browsing by Author "Rocamora, Rodrigo"
Now showing 1 - 2 of 2
Results Per Page
Sort Options
- Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension studyPublication . Trinka, Eugen; Rocamora, Rodrigo; Chaves, João; Moreira, Joana; Ikedo, Fábio; Soares‐da‐Silva, Patrício; Estol, Conrado; Newton, Mark; Carne, Ross; Kowacs, Pedro; Petrova, Dorina; Syankov, Dimitar; Maslarov, Dimitar; Stanev, Slavi; Lasso, Jorge; Bašić, Silvio; Bar, Michal; Vyskočilová, Dana; Pazdera, Ladislav; Haldre, Sulev; Kaarina Kälviäinen, Reetta; Peltola, Jukka; Georges Maillard, Louis; Deckert‐Schmitz, Maria; Springub, Joachim; Barcs, Gábor; Ménes, Andrea; Tóth, Marianna; Giallonardo, Anna Teresa; Paganini, Marco; Asmane, Santa; Logina, Lnara; Meilute Lescinskiene, Loreta; Cruz, Ana; Umeres, Hugo; Czapiński, Piotr; Trzebińska‐Frydrychowska, Ewa; Sales, Francisco; Falup‐Pecurariu, Cristian Gavril; Silviu Manescu, Emilian; Roceanu, Adina‐Maria; Odinak, Miroslav; Tretyakova, Evgeniya; Volkova, Larisa; Lebedeva, Anna; Lipatova, Liudmila; Bogdanov, Enver; Vladimirovna Polezhaeva, Tatiana; Gebauer‐Bukurov, Ksenija; Jovanovic‐Mihajlovic, Natalija; Milovanovic, Maja; Spasic, Mirjana; Lipovský, L'Ubomír; Perichtová, Magdaléna; Chamilová, Jana; Balaguer, Ernest; Ugarte, Antonio; Dubenko, Andriy; Kharchuk, Sergii; Moroz, Svitlana; Shkrobot, Svitlana; Mar'yenko, Lidiya; Litovchenko, Tetyana; Cock, HannahObjective: To assess the efficacy, safety, and tolerability of eslicarbazepine acetate (ESL) monotherapy during long-term treatment. Methods: An open-label extension (OLE) study was conducted in adults completing a phase 3, randomized, double-blind, noninferiority trial, during which they had received monotherapy with either once-daily ESL or twice-daily controlled-release carbamazepine (CBZ-CR) for newly diagnosed focal epilepsy. In the OLE study, all patients received ESL (800-1600 mg/d) for 2 years. Primary efficacy outcome was retention time (from baseline of the OLE study). Secondary efficacy assessments included seizure freedom rate (no seizures during the OLE study) and responder rate (≥50% seizure frequency reduction from baseline of double-blind trial). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs). Results: Of 206 randomized patients, 96 who received ESL in the double-blind trial (ESL/ESL) and 88 who received CBZ-CR in the double-blind trial (CBZ-CR/ESL) were treated with ESL monotherapy (89.3% overall). Treatment retention time was similar between groups, with low probability of ESL withdrawal overall (<0.07 at any time). After 24 months, the probability of ESL withdrawal was 0.0638 (95% confidence interval [CI] = 0.0292-0.1366) in the ESL/ESL group and 0.0472 (95% CI = 0.0180-0.1210) in the CBZ-CR/ESL group. Seizure freedom rates were 90.6% (ESL/ESL) and 80.7% (CBZ-CR/ESL; P = .0531). Responder rates remained >80% in both groups throughout the study. Incidence of serious TEAEs was similar between groups (7.3% vs 5.7%; 0% vs 1.1% possibly related), as were the incidences of TEAEs considered at least possibly related to treatment (17.7% vs 18.2%) and TEAEs leading to discontinuation (3.1% vs 4.5%). The types of TEAEs were generally consistent with the known safety profile of ESL. Significance: ESL monotherapy was efficacious and generally well tolerated over the long term, including in patients who transitioned from CBZ-CR monotherapy. No new safety concerns emerged.
- A survey of the European Reference Network EpiCARE on clinical practice for selected rare epilepsiesPublication . Baumgartner, Tobias; Carreño, Mar; Rocamora, Rodrigo; Bisulli, Francesca; Boni, Antonella; Brázdil, Milan; Horak, Ondrej; Craiu, Dana; Pereira, Cristina; Guerrini, Renzo; San Antonio‐Arce, Victoria; Schulze‐Bonhage, Andreas; Zuberi, Sameer M.; Hallböök, Tove; Kalviainen, Reetta; Lagae, Lieven; Nguyen, Sylvie; Quintas, Sofia; Franco, Ana; Cross, J. Helen; Walker, Matthew; Arzimanoglou, Alexis; Rheims, Sylvain; Granata, Tiziana; Canafoglia, Laura; Johannessen Landmark, Cecilie; Sen, Arjune; Rattihalli, Rohini; Nabbout, Rima; Tartara, Elena; Santos, Manuela; Pereira Rangel Pinho, Rui Jorge; Krsek, Pavel; Marusic, Petr; Specchio, Nicola; Braun, Kees P. J.; Smeyers, Patricia; Villanueva, Vicente; Kotulska, Katarzyna; Surges, RainerObjective: 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.