Tiagabine and brivaracetam combination rewire epileptic activity in kainic acid-induced temporal lobe epilepsy model: Multimodal analysis of EEG spectra, behavior and neuroinflammatory modulation.

Clinical practice guidelines for the administration of third-generation anti-seizure medications.

Brivaracetam (BRV) is a novel third-generation antiseizure medication characterized by its high-affinity selective binding to synaptic vesicle protein 2A (SV2A). Its pharmacokinetic profile is marked by linear and dose-proportional metabolism, low protein binding, and a low risk of drug-drug interactions, eliminating the need for dosage adjustment in cases of renal impairment. Clinical studies have confirmed its efficacy and acceptable tolerability as an adjunctive therapy for children with epilepsy. Although existing data support BRV as a valuable therapeutic option, its optimal dosing strategies and specific indications in the pediatric population warrant further investigation. This review provides a comprehensive evaluation of BRV to guide evidence-based management of pediatric epilepsy.

Epilepsy is a long‐lasting neurological condition often associated with cognitive and behavioral comorbidities, such as anxiety, depression, and memory deficits. This study examined the therapeutic effect of topiramate (TPM) and brivaracetam (BRV), both separately and combined, using pentylenetetrazole‐kindled mice. Seizure severity was visually observed during the kindling process. After that, mice underwent a series of behavioral tests to evaluate anxiety, depression, and memory performance. Subsequently, neurochemical analyses were performed to assess cholinergic activity and oxidative stress markers. The TPM + BRV group showed significantly attenuated seizure progression during all PTZ doses (p < 0.001), with an 88.4% reduction in seizure scores compared to monotherapies. PTZ‐kindled mice showed marked behavioral impairments and biochemical imbalances, including elevated oxidative stress and acetylcholinesterase activity. While monotherapy with BRV or TPM displayed partial improvements, combined therapy provided significantly greater effects, enhancing central explorations (152% and 259.6%), sociability (195.2%), memory retention (508.4% for discrimination index and 463.9% for aversive awareness), and reducing depressive‐like behaviors (52.7%–73.7%). Biochemically, the combined treatment restored antioxidant enzyme levels (SOD, CAT, and GPx) by 45%–70% and significantly lowered MDA levels (70.7%) and restored SOD activity (220.9%). These findings suggest that low‐dose rational polytherapy with TPM and BRV may enhance seizure control and ameliorate associated neuropsychiatric and oxidative imbalance.

Evidence directly comparing newer antiseizure medications (ASMs) is limited but crucial for guiding treatment decisions. This study compared the real-world effectiveness and tolerability of brivaracetam (BRV), lacosamide (LCM) and perampanel (PER) as add-on therapy in adults with epilepsy, applying a causal-inference extension of the COMPARE study. The aim of this approach was to overcome the limitations of standard multivariable analyses, better approximate causal effects, and reinforce the credibility of the results. Data were retrospectively collected in the Italian multicentre COMPARE study. To emulate a randomized setting, we estimated multinomial propensity scores and applied stabilized inverse probability weights. The primary analysis used a log-logistic accelerated failure time model to estimate time-to-treatment discontinuation, adjusting for adverse events (AEs), clinical response and follow-up duration. Secondary analyses evaluated changes in total and concomitant drug load and tolerability over time. Among the 850 subjects included in this analysis (259, 240 and 351 receiving LCM, BRV and PER, respectively; 53.4% female; median age 43years), the estimated probability of 12-month retention was highest for LCM (86.1%), followed by BRV (79.1%) and PER (75.4%). Long-term trends suggested convergence of PER and LCM retention, whereas BRV discontinuation remained higher. In the adjusted analyses, BRV and PER were associated with shorter time-to-treatment discontinuation than LCM, but this negative effect decreased over time, while the beneficial effect of clinical response strengthened. Total drug load increased across all groups but remained lowest for LCM; concomitant ASM load decreased, particularly among responders. AEs were mostly mild, with dizziness, irritability and somnolence the most common AEs. AE rates were initially higher for PER and BRV, but differences diminished over time. Treatment discontinuation in epilepsy emerges as a dynamic process shaped by both tolerability and clinical response. Early persistence was higher for LCM, whereas long-term retention was improved for BRV and PER. These results support a personalized approach to ASM selection that integrates early tolerability with sustained effectiveness.

The efficacy of switching intravenous to oral brivaracetam following status epilepticus: A real-world, multicenter Sicilian study.

This study conducts a cost-effectiveness analysis of brivaracetam (BRV) compared to other 3rd-generation antiseizure medications (AEDs) for the treatment of pharmacoresistant focal-onset seizures in Jordan. A Markov model was constructed over a 2-years’ time horizon for a hypothetical cohort of focal-onset seizures patients. A cycle of 3-months was adopted in our economic evaluation (total cycles of 8 cycles). Four health states were defined: seizure free, partial responders (≥50% reduction in seizure frequency), non-responders, and discontinuation. In addition to BRV, 3 treatment comparators were included in this economic evaluation: eslicarbazepine (ESL), lacosamide (LCM), and perampanel (PER). Clinical data were retired from a previously published network meta-analysis of 65 randomized controlled trials. Cost inputs were obtained from the Jordan Food and Drug Administration and local healthcare providers. Incremental Cost-Effectiveness Ratio (ICER) was calculated using the percentage of complete response (CR) in the denominator. Probabilistic sensitivity analysis was conducted to assess the robustness of the study findings. BRV was associated with the highest gains in CR over all AEDs included in this economic evaluation. The 2-year cost of ESL is JOD 4139; LCM is JOD 3078; PER is JOD 5541; BRV is JOD 3925. The incremental gain in CR with BRV was higher by 29.0%, 30.9%, and 26.4% compared to ESL, LCM, and PER, respectively. Despite these higher gains in CR with BRV versus all other AEDs in this economic evaluation, it was associated with lower cost when compared to ESL and PER at saving ICER of -JOD 737 per 1% CR achieved and -JOD 6113 per 1% CR achieved, respectively. However, BRV was associated with the ICER of JOD 2744 per 1% of CR achieved compared with LCM. These estimates were confirmed by the probabilistic sensitivity analysis. Compared to ESL and PER, BRV was associated with cost-savings. Compared to LCM, the BRV was cost-effective at the World Health Organization recommended willingness-to-pay threshold of 3× of Jordanian gross domestic product per capita.

BackgroundThere are increasing incidence of psychiatric side effects associated with the use of anti-epileptics. Prospective observational studies on the effectiveness and safety of levetiracetam (LEV) and brivaracetam (BRV), along with the haematological abnormalities of both treatments, in seizure patients in an Indian population are lacking. Therefore, we aimed to compare the effectiveness and safety of LEV and BRV in seizure patients and evaluated behavioural and non-behavioural side effects, as well as outcomes when switching between LEV and BRV.MethodsA prospective observational study was conducted in newly diagnosed as well as previously diagnosed patients (n = 115) with epilepsy aged ≥ 5 years of age receiving LEV (n = 66) or BRV (n = 49). Baseline data were collected during the initiation of the study and were compared to the data obtained at the end of the study. A seizure severity questionnaire was used to assess the severity of seizures, and a brief psychiatric rating scale, Hamilton anxiety rating scale, and pediatric epilepsy side effects questionnaire were used to assess the behavioural and non-behavioural side effects.ResultsAt baseline, adults taking LEV showed higher rates of behavioral adverse events (BAEs) compared to those on BRV. During follow-up, the most common behavioural adverse event reported in both treatment groups (LEV and BRV) was depression. The most frequently reported non-behavioural side effect in patients taking BRV was drowsiness. Patients who switched from LEV to BRV due to psychiatric side effects showed positive results with BRV (n = 5).ConclusionsIn summary, the study found that BRV is a safe alternative, with fewer and less severe side effects compared to LEV. While LEV showed slightly higher efficacy and a lower probability of drowsiness, BRV proved more tolerable for patients experiencing LEV-induced side effects. Switching from LEV to BRV decreased the psychiatric side effects.Supplementary InformationThe online version contains supplementary material available at 10.1186/s42494-025-00229-z.

ObjectiveLevetiracetam (LEV) has been widely used as an antiseizure medication (ASM), but is associated with psychiatric and behavioral adverse effects (PBAEs). Brivaracetam (BRV) has demonstrated better psychiatric tolerability, albeit at a higher cost. This study aimed to evaluate the cost‐effectiveness of initiating BRV versus LEV therapy with a subsequent switch to BRV in the event of PBAEs across the US, Australia, and Japan.MethodsWe developed a decision tree model with a 10‐year time horizon comparing two strategies across the US, Australia, and Japan: initial BRV therapy versus initial LEV therapy with a switch to BRV upon the occurrence of PBAEs. We utilized clinical trial data and regional cost estimates to conduct base‐case and probabilistic sensitivity analyses.ResultsThe results of the base‐case analyses indicated that initial BRV therapy was cost‐effective only in Australia. The results of the sensitivity analyses revealed that the probability of initial BRV being cost‐effective was 0% in the US, 49.6% in Japan, and 99.99% in Australia. In Japan, when the risk of LEV‐induced PBAEs was assumed to be 24%, the probability that initial BRV therapy would be cost‐effective rose to 70%, supporting the potential utility of an initial BRV strategy in high‐risk populations. By contrast, in the US, the risk of PBAEs needed to exceed 76% to achieve a comparable cost‐effectiveness probability.SignificanceWhile the initial BRV strategy consistently demonstrated cost‐effectiveness in Australia, it failed to do so in Japan and the US. However, Japan presents a unique opportunity where BRV can be used cost‐effectively when combined with pre‐assessments of LEV‐induced risk for PBAEs.Plain Language SummaryBRV causes fewer PBAEs than LEV, but costs more, creating a clinical dilemma. A cost‐effectiveness analysis comparing BRV versus LEV as initial monotherapy with a focus on PBAEs was conducted across the US, Australia, and Japan. The results indicated that compared with LEV, BRV is cost‐effective in Australia, but not in the US. In Japan, BRV is cost‐effective as initial treatment only for patients at high risk for LEV‐induced PBAEs.

Brivaracetam (BRV) and levetiracetam (LEV) are antiseizure medications (ASMs); UCB-J is a PET tracer targeting synaptic vesicle protein 2A (SV2A); UCB7361 is closely related to padsevonil, an experimental anticonvulsant; while UCB1244283 acts as an allosteric modulator for BRV and LEV binding but not for these other ligands. The SV2A-BRV-UCB1244283 structure reveals how UCB1244283 allosterically enhances BRV binding by occupying an allosteric site near the primary binding site, preventing BRV dissociation. This allosteric site, formed by hydrophobic and uncharged residues, is an uncharacterized small-molecule binding site in SV2A. Structural analysis and mutagenesis demonstrate that an allosteric network between the primary and allosteric sites governs high-affinity ASM binding. Our studies suggest that UCB1244283 selectively binds SV2A over SV2B and SV2C, with specific mutations disrupting binding. Structures of SV2A-UCB-J and SV2A-UCB7361 show that UCB1244283 binding is only possible when the primary site ligand does not overlap with the allosteric site, and that repositioning of Ser601, Thr605, and Leu655 is critical for allosteric ligand binding. Structural comparison of multiple SV2A complexes reveals that primary site occupancy shapes the conformation of the lumenal half of the transmembrane domain, influencing how UCB1244283 binds via a connected network that differentially stabilizes TM1 in either an open or closed conformation and repositions key allosteric and primary site residues. These insights provide a foundation for developing therapeutics targeting the allosteric site and modulating SV2A function.

ObjectiveTo evaluate the effectiveness and safety of brivaracetam (BRV) as an add‐on therapy in patients with focal onset seizures who did not achieve seizure freedom with antiseizure medication (ASM) monotherapy in routine clinical practice.MethodsThis was a retrospective, observational, multicenter study conducted across 17 neurology centers in Spain. We evaluated adult patients with focal onset epilepsy who had inadequate seizure control after at least 3 months of ASM monotherapy and were treated with dual therapy, combining BRV with their previous ASM, with the intention of maintaining this treatment for at least 6 months. Data were collected from medical records on seizure frequency, ASM doses, and adverse events (AEs), taking into account the end of this 6‐month period of dual therapy. The primary efficacy outcomes were the proportion of patients achieving ≥50% reduction in seizure frequency and those achieving seizure freedom. Safety outcomes included the incidence of treatment‐related AEs.ResultsA total of 195 patients (mean age: 43.2 years; 52.3% male; mean disease duration: 11.5 years) were included in the study. The main location of epilepsy was identified (53.8%) as the frontal lobe (27.7%). The mean number of seizures during the last 3 months of ASM monotherapy was 12.1 (SD 39.5), which decreased to 6.4 (SD 21.2) after 6 months of BRV add‐on therapy. A ≥ 50% reduction in seizure frequency was achieved by 90.8% of patients, while 49.7% reached seizure freedom. The most common AEs were related to the central nervous system, reported by 22.1% of patients, with a treatment discontinuation rate due to AEs of 12.8%.SignificanceBRV as an add‐on therapy is effective in reducing seizure frequency and is well‐tolerated in patients with focal onset seizures. This study supports the use of BRV as an add‐on option in patients who do not achieve adequate seizure control with ASM monotherapy.Plain Language SummaryThis study evaluated how effective and safe brivaracetam (BRV) is when added to another medication for patients with focal onset seizures. The results showed that adding BRV helped many patients reduce the number of seizures, and some patients stopped having seizures completely. Side effects were generally mild.

Epilepsy is one of those primary illnesses that affect the brain, and the population is estimated to be around 50 million people. Objective: To evaluate the efficacy and safety of adjunctive Brivaracetam therapy in adult patients with epilepsy. Methods: This observational, non-interventional, single-center study assessed the use of adjunctive Brivaracetam (BRV) in patients aged ≥16 years over six months (October 2023–March 2024). Eligible participants had stable antiepileptic drug (AED) regimens for at least one month before BRV initiation. Demographic data, seizure type, frequency, and intensity were documented at baseline, 3 months, and 6 months. The primary endpoint was the change in seizure frequency. Secondary outcomes included ≥50% seizure reduction, seizure freedom, and adverse events. Data were analyzed using SPSS version 23.0. Results: A total of 168 patients (mean age: 25.1 ± 12.9 years) received adjunctive BRV therapy. Partial seizures and comorbid depression were the most common indications for BRV use. Mean seizure frequency decreased from 5.26 ± 0.29 at baseline to 2.41 ± 0.24 at 3 months. All patients achieved seizure freedom by 6 months. Reported adverse effects were generally mild: somnolence 12 (7%), headache 10 (6%), and dizziness 9 (5%). Conclusions: Adjunctive BRV therapy demonstrated significant efficacy in reducing seizure frequency and achieving seizure freedom, with a favourable safety profile. These findings support BRV as a promising treatment option for patients with epilepsy unresponsive to conventional AEDs.

Aim and objectives Focal seizures impact a significant portion of the pediatric population. The efficacy and safety of current antiseizure medications (ASMs) remain subjects of ongoing debate, prompting the evaluation of newer, safer drugs. Brivaracetam (BRV), a novel ASM, has yet to be fully compared to established first-line ASMs, particularly in pediatric patients. Thus, this study was planned to compare the efficacy, safety, and tolerability of oxcarbazepine (OXC) and BRVin children with focal epilepsy. Materials and methods Pediatric patients with focal seizures, aged four to 14 years, were prospectively enrolled in this comparative study after informed parental consent. Patients with seizures due to metabolic abnormalities or concomitant chronic systemic illnesses were excluded. A complete history-taking, physical examination, anthropometry, and relevant investigations (includingelectroencephalogram and neuroimaging) were done in all cases. Participants were randomized to receive either OXC or BRVand followed for up to six months. Participants were followed monthly forcompliance, anthropometric measurements, seizure recurrence, and any clinical adverse effects. Seizure-free outcome at six months was the primary outcome. Treatment-emergent adverse events (TEAEs) were recorded and analyzed statistically as secondary outcomes. Results Of the327 participants,292 completed the study (OXC: 144; BRV: 148). Seizure-free outcome rates at three and six months were 83.3% (120/144) and 65.3% (94/144) in the OXC group, and 77.7% (115/148) and 73.0% (108/148) in the BRV group, respectively, with no statistically significant difference between the groups. Both medications were well tolerated. Somnolence, behavioral abnormalities, and headache were the most common adverse effects. However, the OXC group had a significantly higher incidence of hyponatremia and weight gain compared to the BRV group. Conclusion No significant difference in seizure-free outcome rates or overall adverse effects between the groups was seen, indicating that BRV is comparable to OXC in treating pediatric focal epilepsy and can be used in cases where OXC is non-tolerated or has adverse effects.

This trial evaluated long-term safety, tolerability, and maintenance of efficacy of adjunctive brivaracetam (BRV) in Japanese and Chinese patients aged ≥ 16years with focal-onset seizures (FOS). Interim analysis of data from EP0085 (NCT03250377), a long-term follow-up trial of adjunctive BRV 50-200mg/day in Japanese and Chinese patients. Post hoc analyses assessed efficacy for 12- and 24-month completers and BRV retention. At data cutoff (June 1, 2023), 207 patients had enrolled; of these, 157 (75.8%) were ongoing and 50 (24.2%) had discontinued. Overall, 137 patients were 12-month completers and 63 were 24-month completers. Mean age was 36.7years and 107 (51.7%) patients were female (100 [48.3%] male). Mean duration of epilepsy was 17.16years. At data cutoff, total duration of BRV exposure was 378.5 patient-years. Mean duration of BRV exposure was 667.8days (median 427.0days), with a median modal dose of 200.0mg/day (range 25.0-200.0mg/day). Kaplan-Meier-estimated BRV retention rates at 12, 24, and 36months were 85%, 76%, and 68%, respectively. Treatment-emergent adverse events (TEAEs) were reported by 184 (88.9%) patients, drug-related TEAEs by 60 (29.0%), serious TEAEs by 29 (14.0%), and 8 (3.9%) discontinued as a result of TEAEs. Median FOS frequency/28days decreased from 7.59 during baseline to 4.11 during the evaluation period. For the overall evaluation period, 12-month, and 24-month completers, median percentage reductions from baseline in FOS frequency/28days were 42.4%, 44.0%, and 38.9%, respectively, and 50% responder rates were 46.4%, 46.7%, and 38.1%. Based on this interim and post hoc analysis, long-term adjunctive BRV was well tolerated and efficacious in Japanese and Chinese patients with FOS. The efficacy response was maintained over time in those completing 12 and 24months of trial participation. Overall, 68% of patients remained on BRV treatment for 3years. ClinicalTrials.gov NCT03250377. Graphical abstract available for this article.

IntroductionEpilepsy poses significant management challenges, particularly in patients with refractory epilepsy where conventional antiseizure medications (ASMs) are ineffective. Cenobamate (CNB), a recently approved third-generation ASM, has shown unprecedented efficacy as an adjunctive therapy in clinic-based practice. However, to date, its use by office-based neurologists in Germany remains relatively limited. One reason for this is its perceived complexity and false perception as a medication of last resort. This study focuses on the logistics of German care pathways, CNB titration, and ASM combinations in a first cohort of office-based outpatients. It also gives a glimpse into which ASMs are being used in the office-based setting in comparison to population and clinic-based data sources.MethodsThe cohort comprised 55 patients from two office-based outpatient practices (Niedergelassene) in Berlin (n = 25) and Hamburg (n = 30). All patients had a history of refractory epilepsy despite optimal treatment with existing ASMs. Patients were initiated on CNB from the month of approval (June 2021) to March 2023. Data on prior ASM usage were collated alongside clinical data, which included seizure frequency and drug load reduction outcomes to March 2025.ResultsPrior to CNB initiation, patients at both office-based practices had similar levels of 1–2 concurrent ASMs (Berlin 80%; Hamburg 77%). The most common ASMs were voltage-gated sodium channel blockers (VGSC), Levetiracetam (LEV)/Brivaracetam (BRV) synaptic vesicle protein 2A (SV2A) inhibitors, and Perampanel (PER). CNB titration was configured into a quarterly office-based outpatient schedule. All patients had seizure reductions in-line with published and real-world evidence, and were compliant.Discussion and conclusionCNB is a valuable adjunctive therapy suitable for refractory epilepsy outpatients attending office-based neurologists. A slow titration schedule helped mitigate most side effects. Despite differences to clinic-based practice, in office-based outpatient practice CNB can be broadly used. It can be prescribed to patients on conventional therapy who are still having seizures and have failed two or more other ASMs. By reporting experiences of CNB titration, seizure, and drug load reduction outcomes in office-based neurology, this study will give German office-based outpatient neurologists evidence to support both CNB and other third-generation ASM use in their practice.

The planned study demonstrates the validation of the developed simple, precise, and robust stability-indicating assay method by high-pressure liquid chromatography and the identification and characterization of Brivaracetam (BRV) degradants by High-Performance Liquid Chromatography-Tandem Mass Spectrometry. The drug was exposed to a few stressors i.e. acidic, basic, oxidative, thermal, and UV light to study the stability-indicating behavior of the planned method and observed sufficient degradation in the acidic stressor. All separations were done on Hi-Q SiliC-18 (I250 x 4.6mm, 5µm particle size) by isocratic elution flow at 1ml/min. Detection was set at 210nm. All obtained results indicate that the present method is helpful in the quality control (QC) laboratory to the day-to-day investigation of (BRV) for the assay and degradation products. HPLC method development and validation have been done per the current ICH guidelines. The m/z value obtained in LC-MS analysis of the degradant was used to study further fragmentation patterns, structural elucidation of the degradant, and its pathway.

IntroductionSubjects with intellectual disability are usually excluded from clinical trials and there is limited evidence-based guidance for the choice of antiseizure medications in this vulnerable population. The study explored the effectiveness of brivaracetam (BRV) in people with epilepsy and intellectual disability.MethodsBRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST) was a 12-month retrospective, multicenter study including adults prescribed adjunctive BRV. Main outcomes included the rates of seizure‐freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The occurrence of adverse events (AEs) was also considered. Analyses by the presence and severity of intellectual disability were performed.ResultsSubjects with intellectual disability were 253 (24.6%) out of 1029 participants. The 12-month rates of seizure freedom were 18.4% and 10.3% in participants without and with intellectual disability, respectively; the corresponding values for seizure response were 40.0% and 28.9%. Intellectual disability was not an independent predictor of seizure outcomes. The rates of treatment discontinuation were 25.8% and 26.4% in participants without and with intellectual disability. respectively. There were no statistically significant differences in the rates of any AEs, somnolence, nervousness/agitation, and aggressiveness by the presence and degree of intellectual disability.ConclusionBrivaracetam can be a suitable treatment option and offer opportunities for clinical improvement in subjects with intellectual disability and uncontrolled seizures.

IntroductionEfficacy/tolerability of adjunctive brivaracetam (BRV) for focal-onset seizures (FOS) in patients aged ≥ 16 years was established in randomized controlled trials. This study aimed to evaluate the effectiveness of adjunctive BRV in patients (≥ 16 years) with FOS with/without focal to bilateral tonic–clonic seizures in daily clinical practice.MethodsA 12-month, prospective, real-world, noninterventional study in nine European countries (EP0077/NCT02687711). BRV was prescribed per clinical practice and European Summary of Product Characteristics. Eligible patients had never received BRV before inclusion. Treating physicians made the decision to prescribe BRV, independently of study participation. Primary effectiveness outcome: BRV retention rate at 12 months; secondary effectiveness outcomes: 50% responder rate, seizure freedom.ResultsA total of 544 patients received ≥ 1 BRV dose (mean age: 43.6 years; 52.8% female; mean time since diagnosis: 22.7 years). Patients had a mean of 7.3 lifetime antiseizure medications (ASMs) and median of 3.7 FOS/28 days during 3-month retrospective baseline. Median total ASM drug load (including BRV) was 3.0 at BRV initiation (n = 539) and 3.3 at study end (n = 314). At 12 months, 57.7% of 541 patients remained on BRV, 60.4% of 230 were responders (≥ 50% seizure reduction since baseline), and 13.8% of 269 were seizure-free since BRV initiation. Historical levetiracetam use appeared not to impact retention rate (56.6% of 320 and 59.3% of 221 patients with and without historical levetiracetam use, respectively). 36.0% of 544 patients had drug-related treatment-emergent adverse events (TEAEs), mostly (≥ 5% of patients) drug ineffective (11.4%) and seizure (6.3%). The three most common drug-related TEAEs leading to permanent BRV discontinuation (of 544 patients) were drug ineffective (10.1%), seizure (5.1%), and behavior disorder (3.3%).ConclusionsAdjunctive BRV was effective in clinical practice in patients with predominantly difficult-to-treat FOS, as shown by BRV retention rate of 57.7% at 12 months, which is in line with real-world retention rates for other new-generation ASMs.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40120-024-00697-4.

IntroductionThis analysis aimed to evaluate patient-related outcomes for health-related quality of life (HRQoL) and cognitive performance in patients (≥ 16 years) with focal-onset seizures (FOS), with/without focal to bilateral tonic–clonic seizures, after initiating adjunctive brivaracetam (BRV) in routine clinical practice.MethodsA 12-month, prospective, real-world, noninterventional study in nine European countries (EP0077/NCT02687711) was performed. BRV was prescribed per clinical practice and the European Summary of Product Characteristics. The outcomes evaluated were the Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P), the Clinical and the Patient’s Global Impression of Change (CGIC and PGIC, respectively), and EpiTrack®. EpiTrack® scores were categorized into cognitive performance categories (excellent: ≥ 39 points; average: 32–38 points; mildly impaired: 29–31 points; significantly impaired: ≤ 28 points). The change in EpiTrack® score was evaluated [improvement: increase in score of ≥ 4 points; no change: change in score of − 2 to 3 points (inclusive); worsening: change in score of at least − 3 points].ResultsFull Analysis Set: 541 patients. 46.6% of patients reported a clinically meaningful improvement in QOLIE-31-P total score from baseline to 12 months; the mean change in total score was + 6.2 points (N = 103). Per CGIC (N = 142) and PGIC (N = 148), respectively, 69.0% and 62.8% of patients had improved in overall condition at 12 months versus baseline, while 3.5% and 8.1% had worsened. EpiTrack® categories at 12 months versus baseline showed improved cognitive performance [baseline (N = 142): significantly impaired 49.3%, mildly impaired 14.8%, average 33.1%, excellent 2.8%; 12 months (N = 61): significantly impaired 36.1%, mildly impaired 4.9%, average 52.5%, excellent 6.6%]. At 12 months, 67.2% of patients showed no significant change from baseline in EpiTrack® score, 23.0% had improved, and 9.8% had worsened (N = 61).ConclusionIn patients with predominantly difficult-to-treat FOS, BRV add-on was associated with good HRQoL and cognitive functioning. Cognitive functioning remained stable for 12 months after BRV initiation in most patients; nearly one-quarter experienced significant improvements. At 12 months, 46.6% of patients reported clinically meaningful HRQoL improvements, and most showed an improved overall condition.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40120-024-00698-3.

First clinical post-approval, observational study to assess clinical safety and effectiveness of brivaracetam sustained-release formulation in real-life settings of India: BEAM study.