Incidence and predictors for post-stroke epilepsy. A prospective controlled trial. The Akershus stroke study

The aim of the study was to assess the incidence and identify predictors for post-stroke epilepsy (PSE), in particular the possible influence of treatment in a stroke unit (SU). Patients with PSE were identified between 4 weeks and 1 year after the stroke. Different parameters were studied as possible predictors. Twelve patients (2.5%) developed PSE during 12 months. Four of the patients (33%) were treated in an SU and eight of the patients (67%) were treated in general medical wards (GMWs) (P=0.50). Mean age in those with PSE was 75 and 76 in those without (P=0.57). Four out of 363 patients (1.1%) with minor stroke [Scandinavian Stroke Scale (SSS)-score >30] developed PSE. Seven out of 104 patients (6.3%) with severe stroke developed PSE (P=0.004). In the multivariate analysis SSS-score scores below 30 was a significant predictor for incidence of PSE (odds ratio=6.1, P=0.003). At 12 months the incidence of PSE was 2.5%. SSS-score below 30 was a significant predictor for PSE, whilst age and treatment in SU versus GMW were not.     

Headache in patients with epilepsy: a prospective incidence study

High prevalence of headache has been reported in patients with refractory epilepsy in cross-sectional surveys based on retrospective recall. We conducted a prospective study to document the incidence of headache over a 3-month observation period in a cohort of 227 adult patients with less refractory epilepsy. The mean seizure frequency was 2.46 per month. Fifty (22%) patients reported to have had at least one headache episode, 45 (19.8%) had interictal headache, 11 (4.8%) had periictal headache, and 5 (2.2%) had both interictal and periictal headache. Forty-nine percent of the patients with headache took over-the-counter analgesics as acute treatment. The headache was rated to have made very severe or substantial impact on their lives by 34% of patients. A formal headache diagnosis was not made in any of the patients prior to the survey. Although the incidence of headache in epilepsy patients appeared to be low, it was underdiagnosed and associated with substantial negative impact.     

Autism and epilepsy: a retrospective follow-up study

So-called "idiopathic" autism, which exhibited no major complications before diagnosis is well-known as one of the risk factors for epilepsy. This retrospective follow-up study aimed to clarify the characteristics of epilepsy in the autism; onset of seizure, seizure types, EEG findings and epilepsy outcome and the differences as a group between the autism with epilepsy and those without epilepsy. One hundred thirty individuals with autistic disorder or atypical autism diagnosed in childhood were followed up over 10 years and were evaluated almost every year up to 18-35 years of age. Their medical records related to perinatal conditions, IQ, social maturity scores and several factors of epilepsy were reviewed in October 2005. Thirty-three of the follow-up group (25%) exhibited epileptic seizures. The onset of epilepsy was distributed from 8 to 26 years of age. Two types of seizure were observed; partial seizure with secondarily generalized seizure and generalized seizure. Twenty of the epileptics (61%) showed the partial seizure. Although 18% of the non-epileptic group exhibited epileptic discharges on EEG, 68% of the epileptic group revealed epileptiform EEG findings before the onset of epilepsy. No differences were observed concerning the sex ratio, autistic disorder/atypical autism and past history of febrile seizures between the epileptic and non-epileptic groups. Lower IQ, lower social maturity score and higher frequency of prescribed psychotropics were observed in the epileptic group compared to the non-epileptics. Idiopathic autism was confirmed as the high risk factor for epilepsy. Epileptiform EEG findings predict subsequent onset of epileptic seizures in adolescence. Epilepsy is one of negative factors on cognitive, adaptive and behavioral/emotional outcomes for individuals with autism.     

Quality of life after extratemporal epilepsy surgery: a prospective clinical study

PURPOSE: The purpose of this prospective clinical study was to assess quality of life (QOL) and impact of seizure status on QOL in patients with extratemporal epilepsy after surgery. PATIENTS AND METHODS: Twenty-three consecutive patients who had been operated due to extratemporal epilepsy were included in this study. Quality of Life Inventory in Epilepsy-10 (QOLIE-10) questionnaire was completed by all patients before 6 months and 2 years after surgery. Results obtained from short- and long-term follow-up were compared to baseline. Furthermore, patients who were seizure-free since surgery and those who had seizure were also compared in terms of outcome in QOL after surgery. RESULTS: All patients showed significantly improved QOL in both short- and long-term follow-ups compared to preoperative status regardless of seizure status (p<0.001). Seizure-free patients showed better QOL than those of patients who continued to have seizure during postoperative period. Furthermore, improved QOL was correlated with seizure status and shorter duration of epilepsy (p=0.001). CONCLUSION: Our findings showed that improved QOL is related to postoperative seizure status. However, future clinical studies including larger population of patients with extratemporal epilepsy are required to elucidate the role of other factors.     

脑磁图定位顽固性癫痫手术治疗51例临床分析

目的　探讨脑磁图在顽固性癫痫术前评估的价值。方法　术前对 5 1例顽固性癫痫患者行脑磁图、磁共振及视频脑电检查 ,结合术中皮层脑电图分别进行选择性海马杏仁核切除术、标准前颞叶切除术及致痫灶切除术等手术 ;并用脑磁图定位神经导航下手术切除致痫灶 2例 ,神经导航下海马杏仁核切除 2例。结果　术后发作完全停止的占 76 5 % ,发作减少 >75 %的占 11 8% ,发作减少>5 0 %的占 5 8% ,发作减少不足 5 0 %的占 5 8% ;脑磁图与视频脑电及皮层脑电图的定位符合率分别为 82 %和 96 % ;脑磁图对内侧颞叶癫痫的定位敏感性较差 ;脑磁图定位导航手术可在切除致痫灶的同时保护脑的重要结构。结论　脑磁图是一项灵敏的无创性癫痫灶定位方法 ,是癫痫外科术前评估中的一项技术突破     

Sleep profile and Polysomnography in patients with drug-resistant temporal lobe epilepsy (TLE) due to hippocampal sclerosis (HS) and the effect of epilepsy surgery on sleep-a prospective cohort study

ObjectivesWe analyzed changes in sleep profile and architecture of patients with drug-resistant TLE-HS using three validated sleep questionnaires- Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), NIMHANS Comprehensive Sleep Disorders, and polysomnography (PSG). We studied the effect of epilepsy surgery in a subset of patients.MethodsIn this prospective observational cohort study, sleep profile of 40 patients with drug-resistant TLE-HS was compared to 40 healthy matched controls. Sleep architecture of 22 patients was studied by overnight PSG and compared to 22 matched controls. Sleep profile was reassessed in 20 patients after a minimum period of three months after epilepsy surgery.ResultsThe mean PSQI was higher among patients compared to controls(P=0.0004) while mean ESS showed no difference. NCSDQ showed fewer patients feeling refreshed after a night's sleep compared to controls (p=0.006). PSG revealed a higher time in bed (p=0.0001), longer total sleep time (p=0.006) and more time spent in NREM stage 1 (p=0.001) and stage 2 (p=0.005) while spending less time in stage 3 (p=0.039) among TLE patients. Sleep efficiency was worse in patients on ≥3 ASMs compared to those on 2 ASMs (p-0.044). There was no change in mean ESS (p=0.48) or PSQI (p=0.105) after surgery.ConclusionsPatients with drug-resistant TLE-HS have an altered sleep profile and architecture. Patients on ≥3 ASMs have a lower sleep efficiency. Reassessment at short intervals after epilepsy surgery did not reveal significant changes in sleep profile.     

Incidence of fractures among epilepsy patients: a population-based retrospective cohort study in the General Practice Research Database

PURPOSE: To compare the incidence of various fractures in a cohort of patients with epilepsy with a reference cohort of patients not having epilepsy. METHODS: Patients were included in the epilepsy cohort if they had at least one diagnosis of epilepsy in their medical history and had sufficient evidence of "active" epilepsy (use of antiepileptic drugs, diagnoses) after the practice was included in the General Practice Research Database (GPRD). Two reference patients were sampled for each patient with epilepsy from the same practice. Primary outcome was the occurrence of any fracture during follow-up. Poisson regression analysis was used to estimate incidence density ratios (IDRs). RESULTS: The study population comprised 40,485 and 80,970 patients in the epilepsy and reference cohorts, respectively. The median duration of follow-up was approximately 3 years. The overall incidence rate in the epilepsy cohort was 241.9 per 10,000 person-years. This rate was about twice as high as that in reference cohort: age- and sex-adjusted IDR, 1.89 (95% CI, 1.81-1.98). When comparing IDRs among the different groups of fractures, the highest relative-risk estimate was found for hip and femur fractures (adjusted IDR, 2.79; 95% CI, 2.41-3.24). IDRs were consistently elevated across age and sex groups and across fracture subtypes. CONCLUSIONS: The overall risk of fractures was nearly twice as high among patients with epilepsy compared with the general population. The relative fracture risk was highest for hip and femur. Further study is necessary to elucidate whether this elevated risk is due to the disease, the use of antiepileptic drugs, or both.     

Seizure occurrence during ovulatory and anovulatory cycles in patients with temporal lobe epilepsy: a prospective study

We investigated the influence of ovulatory and anovulatory menstrual cycles on seizure occurrence in female patients with complex partial seizures. We prospectively documented seizures in relation to menstrual cycles (defined by measurement of basal body temperature and progesterone serum concentrations) in 39 female patients. One hundred and thirty-two cycles of 35 patients entered final analysis. Only eight patients had anovulatory cycles, in 18 patients all cycles were ovulatory. In the remaining nine patients anovulatory as well as ovulatory cycles were documented. In ovulatory cycles the mean frequency of seizures during the days of menstruation was significantly higher as compared to the periovulatory or the luteal phase of the cycles. During anovulatory cycles seizure frequency was significantly lower during menstruation than in the remaining days of the cycles. Since progesterone is known to exhibit anticonvulsant effects, seizure occurrence during menstruation seems to be related to ovulatory cycles, possibly due to the premenstrual decrease of progesterone. Therapeutic recommendations for the treatment of seizures related to the menstrual cycle (catamenial seizures) include the administration of hormones, as progesterone (recommended especially for women with catamenial epilepsy who have a documented inadequate luteal phase) or the suppression of the menstrual hormonal cycle by synthetic gonadotropin releasing hormone analogs.     

Bidirectional relation between schizophrenia and epilepsy: a population-based retrospective cohort study

Purpose: Schizophrenia and epilepsy may share a mutual susceptibility. This study examined the bidirectional relation between the two disorders. Methods: We used claims data obtained from the Taiwan National Health Insurance database to conduct retrospective cohort analyses. Analysis 1 compared 5,195 patients with incident schizophrenia diagnosed in 1999–2008 with 20,776 controls without the disease randomly selected during the same period, frequency matched with sex and age. Analysis 2 comprised a similar method to compare 11,527 patients with newly diagnosed epilepsy with 46,032 randomly selected sex‐ and age‐matched controls. At the end of 2008, analysis 1 measured the incidence and risk of developing epilepsy and analysis 2 measured the incidence and risk of developing schizophrenia. Key Findings: In analysis 1, the incidence of epilepsy was higher in the schizophrenia cohort than in the nonschizophrenia cohort (6.99 vs. 1.19 per 1,000 person‐years) with an adjusted hazard ratio (aHR) of 5.88 [95% confidence interval (CI) 4.71–7.36] for schizophrenia patients. In analysis 2, the incidence of schizophrenia was higher in the epilepsy cohort than in the nonepilepsy comparison cohort (3.53 vs. 0.46 per 1,000 person‐years) with an aHR of 7.65 (95% CI 6.04–9.69) for epilepsy patients. The effect of schizophrenia on subsequent epilepsy was greater for women, but the association between epilepsy and elevated incidence of schizophrenia was more pronounced in men. Significance: We found a strong bidirectional relation between schizophrenia and epilepsy. These two conditions may share common causes. Further studies on the mechanism are required.     

Consequences of antiepileptic drug withdrawal: a randomized, double-blind study (Akershus Study)

OBJECTIVE: Despite side effects associated with the use of antiepileptic drugs (AEDs), withdrawal of AEDs remains controversial, even after prolonged seizure freedom. The main objective of this study was to assess the effects of AED withdrawal on cognitive functions, seizure relapse, health-related quality of life (HRQOL), and EEG results. Additionally, potential predictors for freedom from seizures after AED withdrawal were studied. METHODS: Patients, seizure-free for more than 2 years on AED monotherapy, were recruited for a controlled, prospective, randomized, double-blinded withdrawal study lasting for 12 months, or until seizure relapse. Patients were randomized to AED withdrawal (n = 79) and nonwithdrawal (n = 81) groups. The examination program included clinical neurological examinations, neuropsychological testing, EEG-recordings, cerebral MRI, and assessments of HRQOL. Follow-up data on seizure relapse were also collected beyond the 12-month study period (median 47 months). RESULTS: Seizure relapse at 12 months occurred in 15% of the withdrawal group and 7% of the nonwithdrawal group (RR 2.46; 95% CI: 0.85-7.08; p = 0.095). After withdrawal, seizure relapse rates were 27% after a median of 41 months off medication. A normal result to all 15 neuropsychological tests increased significantly from 11% to 28% postwithdrawal. We found no significant effects of withdrawal on quality of life and EEG. Predictors for remaining seizure-free after AED-withdrawal over 1 year were normal neurological examination and use of carbamazepine prior to withdrawal. CONCLUSION: Seizure-free epilepsy patients on AED monotherapy who taper their medication may improve neuropsychological performance with a relative risk of seizure relapse of 2.46, compared to those continuing therapy.     

Regional differences and secular trends in the incidence of epilepsy in Finland: a nationwide 23-year registry study

Purpose: Regional variations and temporal trends in the incidence of new‐onset epilepsy are clinically important and may offer clues on how to prevent epilepsy. Methods: We examined regional differences and secular trends in the incidence of new‐onset epilepsy in the Finnish population based on the nationwide full‐refundable antiepileptic drug registry and the population registry in the years 1986–2008. Key Findings: The overall incidence of epilepsy was significantly higher in eastern Finland than in middle [risk ratio (RR) 1.08 (95% confidence interval, CI 1.05–1.12)), p < 0.0001] and western Finland [RR 1.32 (1.30–1.35), p < 0.0001] but it was declining from 1986 to 2008 in all regions [RR 0.83 (0.81–0.84), p < 0.0001]. The mean annual decline was 0.6%. Although the incidence of epilepsy was falling from 1986 to 2008 in childhood [annual decline 1.9%, RR 0.80 (0.75–0.86), p < 0.0001] and in middle age [annual decline 0.8%, RR 0.88 (0.84–0.93), p < 0.0001], it increased significantly in the elderly (age 65 years or older) in all of Finland [annual increase 3.5%, RR 1.25 (1.18–1.33), p < 0.0001], and particularly in east versus west Finland [RR 1.48 (1.42–1.55), p < 0.0001]. As a result, starting with the year 2000, the incidence rate of epilepsy was higher in the elderly than in children for all of Finland. Significance: In view of the falling incidence of epilepsy in childhood and middle‐age in all of Finland from 1986 to 2008, the significant increase in the incidence of epilepsy in the elderly is of concern. The regional increase of epilepsy may offer clues for allocating resources and, possibly, population epileptogenesis between west and east Finland and for strategies to prevent epilepsy in the elderly.     

Newly diagnosed single unprovoked seizures and epilepsy in Stockholm, Sweden: First report from the Stockholm Incidence Registry of Epilepsy (SIRE)

Purpose:   To describe and report initial findings of a system for prospective identification and follow-up of patients with newly diagnosed single unprovoked seizures and epilepsy in Stockholm, Sweden, the Stockholm Incidence Registry of Epilepsy (SIRE).
Methods:   From September 2001 through August 2004, a surveillance system has been in use to identify incident cases of first unprovoked seizures (neonatal seizures excluded) and epilepsy among residents of Northern Stockholm, an urban area with approximately 998,500 inhabitants. Potential cases are identified through multiple mechanisms: Network of health care professionals, medical record screening in specific hospital units, including outpatient clinics, emergency room services, and review of requests for electroencephalography (EEG) examination. Potential cases are classified 6 months after the index seizure based on review of medical records.
Results:   After screening approximately 10,500 EEG requests and 3,300 medical records, 1,015 persons met the criteria for newly diagnosed unprovoked seizures (430 single seizures; 585 epilepsy). The crude incidence for first unprovoked seizures and epilepsy was 33.9/100,000 person years, (the same adjusted to the European Standard Million), highest the first year of life (77.1/100,000) and in the elderly. No cause could be identified in 62.4%.
Conclusions:   We have established a sustainable system for prospective identification of new onset epilepsy cases in Stockholm. Despite a possible under-ascertainment, the registry provides a useful starting point for follow-up studies.     

Efficacy and safety of topiramate in refractory epilepsy: a long-term prospective trial

The effects of topiramate in 15 patients with drug refractory partial epilepsy or Lennox-Gastaut syndrome were assessed in an open, add-on prospective study. After a follow-up of 14–21 months, six patients are still on topiramate (mean dosage 583 mg/day, range 400–800 mg/day), and nine have discontinued treatment because of adverse events (n=6), inefficacy (n=2) or poor compliance (n=1). Nine patients (69%) continued to have a 50% reduction in seizure frequency during the last two months of treatment, and one has been seizure-free for the last 19 months. The most common adverse events were somnolence, weight loss, mental slowing, fatigue, ataxia and irritability. Most of these events were reversible, but withdrawal of treatment was required in six cases as a result of ataxia (two patients), somnolence, metabolic acidosis, irritability or psychotic symptoms (one patient each). It is concluded that topiramate is a valuable agent for the long-term management of refractory epilepsy.

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Sommario Gli effetti di topiramato utilizzato in aggiunta alla terapia preesistente sono stati valutati nell'ambito di uno studio prospettico in aperto in 15 pazienti farmacoresistenti affetti da epilessia parziale o sindrome Lennox-Gastaut. Dopo un follow-up di 14–21 mesi, 6 pazienti sono tuttora in trattamento (posologia media di topiramato 583 mg/die, range 400–800 mg/die), mentre 9 hanno sospeso il farmaco a causa di eventi avversi (n=6), inefficacia (n=2) o scarsa compliance (n=1). Nove pazienti (69%) continuavano a presentare una riduzione di almeno il 50% della frequenza delle crisi durante gli ultimi 2 mesi di trattamento e un paziente è libero da crisi da 19 mesi. Gli eventi avversi più frequenti erano costituiti da sonnolenza, calo ponderale, rallentamento mentale, astenia, atassia e irritabilità. La maggior parte di questi eventi è risultata reversibile, ma in 6 pazienti si è resa necessaria la sospensione del trattamento a causa di atassia (2 casi), sonnolenza, acidosi metabolica, irritabilità e sintomi psicotici (1 caso ciascuno). Sulla base di questi dati, il topiramato può essere ritenuto un utile presidio nel trattamento a lungo termine dell'epilessia farmacoresistente.

     

Incidence of epilepsy in extremely low-birthweight infants (<1,000 g): A population study of central and southern Sardinia

Purpose:   With the development of intensive care, the survival of extremely low-birthweight (ELBW) infants (<1,000 g) has greatly improved. The aim of our study was to report the incidence of epilepsy after a follow-up of >7 years in a population of ELBW children, born in central and southern Sardinia between 1991 and 2000.
Methods:   We analyzed data of 104 children. All infants had had serial cranial ultrasound echography (CUE) in the neonatal period and some also had magnetic resonance imaging (MRI). At last follow-up we evaluated the occurrence of epilepsy through a review of clinical charts and a structured telephone interview.
Results:   In 11 (10.6%) of 104 of children we observed febrile seizures (FS). Epilepsy occurred in 9 (8.6%) of 104 ELBW children, and in these patients a frequent positive family history for epilepsy and/or FS was present. In four epilepsy patients CUE was highly pathologic, showing intraventricular hemorrhage (IVH) of grade IV and in two mildly abnormal (IVH of grade I–II). In three additional children with normal neonatal ultrasound scan, a later magnetic resonance imaging (MRI) study revealed lesions related to neonatal insult.
Discussion:   In our ELBW population, epilepsy had an incidence clearly superior to that expected in infancy (8.6% vs. 0.6–0.8% ) . A frequent positive familiar history for epilepsy and/or FS suggests that a genetic predisposition may also play a role. Subjects with highly abnormal CUE are a subgroup with high risk for seizures; however, epilepsy can occur even with normal CUE.     

Learning disability: occurrence and long-term consequences in childhood-onset epilepsy

This study analyzed the occurrence of learning disability (LD) in adults with childhood-onset epilepsy and the impact of LD on medical and social outcome. Any LD occurred in 76%: in 57% of mentally normal (IQ > 85), in 67% of mentally near-normal (IQ = 71–85), and, self-evidently, in all mentally retarded (IQ < 71) adults. Half of the patients (51%) with LD had mental retardation. In multivariate analysis, mental retardation and subsequent LD were predicted by occurrence of cerebral palsy (odds ratio [OR] = 3.83; 95% confidence interval [CI] = 1.77–8.28, P = 0.0006), onset of epilepsy before the age of 6 years (OR = 3.63, 95% CI = 1.57–8.42, P = 0.0026), and poor early effect of drug therapy (OR = 2.78, 95% CI = 1.43–5.39, P = 0.0025). Among mentally normal or near-normal subjects, a symptomatic etiology of epilepsy was the only predictor (OR = 7.72, 95% CI = 3.02–19.76). The degree of LD significantly affected medical, social, and educational long-term outcomes.     

Prognosis and clinical features of intractable epilepsy: A prospective study

Abstract  Of the epileptic patients who were treated for ≥ 5 years until the end of 1990 and had more than four seizures in 1990, 63 patients had been treated without interruption until the end of 1995. We analyzed their clinical courses from 1990 to 1995 prospectively. More than half the subjects were diagnosed with temporal lobe epilepsy. Twenty cases had presumed etiology, and 32 had neuropsychiatric complications. Of the subjects whose seizures were not controlled with conventional antiepileptic drugs (AED), 11 cases demonstrated significant improvement when new AED; that is, lamotrigine, vigabatrin, clobazam, topiramate, tiagabine or CGP33101 were added. However, 10 patients did not respond to new AED. Presumed etiology, neuropsychiatric complications, multiple epileptic foci in EEG and abnormalities on head CT or MRI were characteristics of the patients whose seizures were resistant to new AED.     

Economic evaluation of epilepsy in Kiremba (Burundi): a case-control study

PURPOSE: Epilepsy is a common disease whose prevalence across Africa is extremely variable (from 5 to 74 per thousand ). Its social and economic consequences in this continent are not well established. The objective of this study was to compare the cost of care of patients with epilepsy with that of controls in the commune of Kiremba in Burundi. METHODS: The survey was carried out in the commune of Kiremba from March 1, 2001, to April 30, 2001. A sample of cases (patients with epilepsy) and controls was taken from the general population. The economic analysis was conducted from the viewpoint of the patient. Data collected were direct medical costs (consultations, admissions to hospital, complementary examinations, treatments) and indirect costs (evaluated from the number of days of family life disrupted). RESULTS: In this study, 1,056 patients were included (352 patients with epilepsy and 704 controls). The total annual cost of patients with epilepsy was US dollars 11.0 against US dollars 7.3 for controls (p = 0.03). The indirect costs represented 75.8% of the total cost. For the people with epilepsy that took antiepileptic treatment (n = 18), the annual average total cost became US dollars 48.4. The number of disrupted days was 10.2 days (SD, 18.7 days) for the treated patients with epilepsy and 2.0 days (SD, 9.0 days) for the untreated ones (p < 0.001). CONCLUSIONS: Epilepsy was responsible for an extra cost: an increased direct cost along with more disruption of family life. This extra cost remained after adjustment for use of health care and antiepileptic treatments. Various measures could be envisioned to reduce the impact of indirect costs.     

Sustained efficacy and long-term safety of oxcarbazepine: one-year open-label extension of a study in refractory partial epilepsy

PURPOSE: To evaluate the long-term efficacy, tolerability, and safety of oxcarbazepine (OXC) in medically refractory partial epilepsy. METHODS: This study is the open-label extension phase that followed a multicenter, randomized, double-blind, dose-response clinical study of OXC monotherapy in patients with medically refractory partial epilepsy. We analyzed the efficacy, tolerability, and safety of OXC during the first 48 weeks of open-label therapy. To evaluate efficacy, we compared the change in seizure frequency throughout the 48 weeks of treatment with OXC with the baseline seizure frequency that preceded the double-blind phase of the core study by an intent-to-treat and completer analysis. Safety and tolerability were evaluated by using an intent-to-treat analysis. RESULTS: Of the 87 patients enrolled in the double-blind study, 76 patients participated in the open-label extension phase. Fifty-five (72%) patients completed 48 weeks of open-label treatment on a median OXC dose of 2,400 mg/day. Based on an intent-to-treat analysis, the median reduction in seizure frequency was 47%(p = 0.0054); the 50 and 75% responder rates were 46.1 and 25.0%, respectively, with 6.6% of patients remaining seizure free. The completer analysis yielded comparable efficacy results. OXC was well tolerated, with 13% of patients exiting because of adverse events. The six most common adverse events, irrespective of their causal relation to OXC, were dizziness, headache, fatigue, diplopia, nausea, and rash. For the most part, these adverse events tended to be transient. CONCLUSIONS: The efficacy of OXC is sustained with good safety and tolerability profiles during long-term treatment of patients with medically refractory partial epilepsy.