Monday, November 7, 2005
seven. His seizures are characterized by head version to the right followed by the secondarily generalized tonic clonic seizures. [nterictal EEG spike focus was localized in the left frontal region, however, MRI showed post-traumatic lesionsin the left parietal and tempo ral area. Intracranial recording confirmed the seizure onset left prefrontal area. Surgical disconnection of epileptogenic area eliminated the seizures for 1 year. Conclusion: Epilepsy surgery with subdural grid electrode evaluation is effective for the treatment of post-traumatic epilepsy. The epileptogenic focus may be located away form the lesions shovat by the imaging studies. 0043 Levetixaeetaln in Refractory Epflepw: 2 ~ years of experience AI-Jishi, A. Sabnaniya Medical Complex
A Retrospective analysis of twenty patients (eleven males and nine females) from Bahrain with Refractory Epilepsy seen between September 2002 and March 2005. Age ranged between 18-45 years. These patients were put on Levetiracetam(LEV) as add-on therapy. Duration of Epilepsy was 4-30 years. There were 6 generalized epilepsies and 14 partial with or without secondary generalization. There were 16 symptomatic or cryptogenic epilepsies and 4 idiopathic epilepsies. Average of 4 drugs were tried before addition of LEV and 2 concomitant drugs after the addition of LEV. Results: No benefit in 3 patients (15%), < 50% seizures reduction in 3 patients (15%), > 50',/0 seizures reduction in 14 patients (70%) and 100% control in 2 patients (10%). Side Elleels: Were minor and occurred in 40% of patients and one withdrew LEV for fear of pregnancy. Conclusion: LEV proved to be highly effective and safe in majority of Refractory Epilepsy. 0044 Levetixaeetam: Relative Bioavailability and Bioequivalence of 10% Oral Solution (750 mg) and 750 mg Tablets
Coupez, R ~, Straetemans, R ~, Sehgal, G ~, Stoclds, A ~, Lu, Z ~.
~UCB S.A. Pharma Sector, Chemin du Yoriest, Braine l'Alleu& Belgium; 2UCB Pharma Inc., Smyrna, Georgia, USA Purpose: Levetiracetam (LEV) is widely used as adjunctive treatment for partial-onset seizures. The availability o f a LEV oral solution formulation would provide an additional treatment option for patients with difficulty swallowing tablets. This study evaluated the bioequivalence of 10% LEV oral solution compared to 750 mg oral tablet and characterised its pharmacokinetics. Methods: A phase I single-centre, randomised, open-label, two-way crossover, single-dose study was conducted. Each of 24 healthy subjects received a single oral 750 mg dose of the randomised LEV formulation (7.5 mL 10% solution or 750 mg table 0 on Day 1 and a single oral dose of the alternate fommlation on Day 8. Serial blood samples were collected from 0 to 36 hours after each dosing for determination of plasma LEV concentrations. Pharmacokinetic parameters were calculated and bioeqnivalence of the two formulations evaluated. Results: The mean LEV plasma concentration time curves and pharmacokinetic parameters were essentially identical for the oral 10% solution and 750 mg tablet and consistent with previously reported LEV pharmacokinetics. 90% confidence limits of the geometric mean ratio of the two formulations for area under the plasma concentration-time curve from time 0 to infinity, area under the plasma concentration-rime curve from time 0 to last measurable time point, and maximum plasma concentration were within the 80% to 125',/o range, demonstrating bioequivalence of the two formulations. Both formulations were well tolerated.
Poster Abstracts Contusions: The LEV 10% oral solution is a bioequivalent, well tolerated alternative to the tablet formulation in patients who have difficulty swallowing.
0045 Early Posit-Stroke Seizures Treated with Levefiracetam Daniele O ~, Didato G ~, Fierro B ~, Vind G 2, Tata M R 3, Natal~ E 2.
1Department of N. O.O.P., University of Palermo, Palermo, Italy; 2Department of Neurosciences, Ospedale Civico, ARNAS, Palermo, Italy; 3Department of Neurosciences, University of Napoli, Napoli, Italy Purpose: In the elderly, ischaemic or haemorrhagic stroke is one of the most common causes of seizures or epilepsy. Early post-stroke seizures (ES) occur immediately after, or witlffn 15 days of the stroke (up to 80"/0 of patients wiffiin 48 hours), and are regarded as a risk factor for seizure recurrence. According to most authors ES are easy to control, requiring only antiepileptie drug (AED) monotherapy. We evaluated the effect of Leveriracetam (LEV), a new AED with a pharmacokinetic profile close to ideal, as monotherapy in the treatment of ES. Methods: 54 patients with ES were included in the study. 34 patients (20 male, 14 female); mean age 73 years received LEV (29 with ischaemic, 5 with haemorrhagic stroke) and 20 (all with ischaemic stroke) were controls. Focal seizures occurred in 13 patients (11 with ischaemic and 2 with haemorrhagic stroke); in 10 patients, lesions were located in cortical regions and in 8 a secondary generalisation occurred. Generalised seizures occurred in 21 patients (18 with ischaemic and 3 with haemor,-hagic stroke). LEV was administered at doses of 1500-3000 mg/daily with low titration, for a 6-monffi period and a follow-up to-date of 12 months. Results: Seizure recurrence was observed in only 2 (5.8%) of the 34 LEV-treated patients whereas they recurred in 3 (115%) of the 20 controls. Only 3 (18.8"/o) patients complained o f mild somnolence. Conclusions: On the basis of tiffs study, LEV should be considered as a useful and safe drug in the treatment of ES.
0046 Levetiracetam in the Treatment of Idiopathic Generalised Seizures NatalS, E*, Fierro, B2, Didato, G 2, Brighina, F 2, Tata, M 3, Daniele, 0 2.
1Department of Neuroseiences, Ospedale Civico, ARNAS, Palermo, Italy; 2Department of N.O.O.P., University of Palermo, Palermo, Italy; :Department of Neuroseienees, University of Napoli, Napoli, Italy Purpose: Levetiracetam (LEV) is approved as add-on therapy in patients wiffi refractory partial onset seizures. Increasing evidence suggest its efficacy in primary generalised seizures. We evaluated the efficacy of LEV as both add-on and monoffierapy in patients wiffi primary generalised epilepsies. Methods: Nineteen (19) patients (111 male, 8 female); mean age 23 (range 9-32) years with generalised epilepsies were included in the study: 4 Absence, 8 Juvenile Myoclonic Epilepsy (JME) and 7 Generalised Tonic-Clonic ( G T Q seizures. At study entry antiepileptic drug (AED) therapy included VPA (11), VPA + LTG (4), VPA + PB (1), PB (2), and LTG (1), and all patients were still experiendng monthly seizures. Patients received LEV 1500-4000 mg/daily initially as add-on therapy, and are gradually being converted to LEV monotherapy (lover a 3 month period). Maximum follow-up to date (the study is still ongoing) is 18 months. Results: All 19 patients improved both clinically and electroencephalographically after LEV initiation with a _>50% seizure frequency reduction. Currently, 3 JME and 2 GTC patients have received LEV monotherapy for 12 months, all 5 (100%) patients are seizure-free since 6-12 months. Of the remaining 14 patients still receiving LEV add-on therapy 9 (165"/o) achieved seizure freedom for 6-12 months and 5 (35%) had a 50-75"/0 seizure frequency reduction. Only 3 patients experienced mild somnolence, not requiring LEV discontinuation.