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Clinical trials faces 2010
- 1. New Therapies and News from Clinical Trials Jacqueline A French MD NYU Epilepsy Center
- 4. How Common is Drug Resistant Epilepsy? Long-Term Follow-Up of Mixed Population (N=525) * *Epilepsy Unit, Glasgow, Scotland 1984-1997 Kwan P, Brodie MJ. N Engl J Med 342:314, 2000 Seizure-free 63% (n=333) Uncontrolled 37% (n=192)
- 5. Resistance vs Syndrome Semah F et al. Neurology 51:1256, 1998 45% 35% 82% 27% % of Seizure-Free Patients n 33 337 445 294 Global disturbance Genetic Known Cause Unknown cause Generalized Focal 0 20 40 60 80 100 Difficult to control Easy to control
- 6. Seizure Control vs Lesion Location / Etiology Post-stroke Vascular Tumor Normal Head Cortical Isolated Dual malformation MRI trauma dysgenesis hippocampal pathology* sclerosis *HS + another lesion Semah F et al. Neurology 51:1256, 1998 0 20 40 60 80 100 0 20 40 60 80 100 % of Seizure-Free Patients 54% 50% 46% 42% 30% 24% 11% 3% n 26 57 50 268 50 81 224 38 Difficult to control Easy to control
- 10. SINCE 1998 2000 0 5 10 20 Zonisamide Felbamate Gabapentin Topiramate Oxcarbazepine Tiagabine Levetiracetam Pregabalin Calendar Year Number of Licensed Antiepileptic Drugs Lamotrigine 1990 2010 Lacosamide Rufinamide
- 17. Brivaracetam Adverse Events PBO BRV5 BRV20 BRV50 Patients (N) 54 50 52 52 Permanent study drug discontinuation 2 (3.7) 3 (6.0) 1 (1.9) 0 Patients with ≥1 AE, n (%) 29 (53.7) 26 (52.0) 29 (55.8) 28 (53.8) Total AEs 59 50 72 56 AEs reported in ≥ 5% patients Headache Somnolence Influenza Dizziness Neutropenia Fatigue 4 (7.4) 4 (7.4) 4 (7.4) 3 (5.6) 1 (1.9) 2 (3.7) 4 (8.0) 1 (2.0) 4 (8.0) 1 (2.0) 4 (8.0) 0 2 (3.8) 3 (5.8) 0 0 2 (3.8) 2 (3.8) 1 (1.9) 3 (5.8) 1 (1.9) 4 (7.7) 0 3 (5.8)
- 19. Double-Blind Placebo-Controlled Add-on Trial of Eslicarbazerpine (ESL) in Refractory Partial Epilepsy: 50% Responder Rates (n=143) 28% 41% % Patients 54%* Placebo ESL ESL 1200 mg/d 1200 mg/d o.i.d b.i.d. (* P=0.008 vs PL) Bialer et al., Epilepsy Res 2007;73:1-52.
- 21. Patients with > 50% Seizure Reduction in Overall Treatment Period (Titration + Maintenance) Intent-to-treat Study 302 Study 301 *p<0.005 **p<0.001 % Patients 179 181 178 152 153 Placebo 600 900 Placebo 1200 RTG RTG
- 22. Most Common Adverse Events ( > 10% Incidence) % Patients Placebo (N=331) RTG 600 (N=181) RTG 900 (N=178) RTG 1200 (N=153) Dizziness 10 17 26 40 Somnolence 13 14 26 31 Fatigue 5 17 15 16 Confusion 1 2 5 14 Dysarthria 1 5 2 12 Headache 16 11 17 12 Ataxia / gait disturbance 2 3 5 12 Urinary tract infection 5 1 2 12 Tremor 3 2 9 11 Vision blurred 2 <1 5 11 Nausea 5 6 7 10
- 27. Comparative Efficacy of IN MDZ vs IV DZP Lahat E, et al. BMJ . 2000;321:83-86. Dose = 0.3 mg/kg Dose = 0.2 mg/kg N=47 children with febrile seizures (>10 min) 3.5 min 5 min 6.1 min 8 min Main outcome measures: Time from arrival at hospital to drug administration & time to seizure cessation Observation period = 60 minutes
- 30. Devices under study Medtronic, “Sante” Trial NeuroPace “RNS” Trial
- 32. Stimulating Electrode, 4 contacts Electrode (4 contacts )
- 33. Results of stimulation (sham)
- 35. Seizure frequency changes 2 years after randomization
- 43. RNS with Leads
- 44. RNS
- 45. Anthony Murro, M.D. Medical College of Georgia
Notes de l'éditeur
- Further studies to see if effect is due to transneural transport may be needed In a study by Hussain, et al in the Biological and Synthetic Membranes, 1989, IN administration in humans of lipophilic propranolol resulted in blood levels similar to those observed following IV administration (60 ng/ml)
- Objective: To compare the safety and efficacy of midazolam given intranasally with diazepam given intravenously in the treatment of children with prolonged febrile seizures. Design: Prospective randomized study. Setting: Pediatric emergency department in a general hospital. Subjects: 47 children aged six months to five years with prolonged febrile seizure (at least 10 minutes) during a 12 month period. Interventions: Intranasal midazolam (0.2 mg/kg) and intravenous diazepam (0.3 mg/kg). Main outcome measures: Time from arrival at hospital to starting treatment and cessation of seizures. Results: Intranasal midazolam and intravenous diazepam were equally effective. Overall, 23 of 26 seizures were controlled with midazolam and 24 out of 26 with diazepam. The mean time from arrival at hospital to starting treatment was significantly shorter in the midazolam group (3.5 (SD 1.8) minutes, 95% confidence interval 3.3 to 3.7) than the diazepam group (5.5 (2.0), 5.3 to 5.7). The mean time to control of seizures was significantly sooner (6.1 (3.6), 6.3 to 6.7) in the midazolam group than the diazepam group (8.0 (0.5), 7.9 to 8.3). No significant side effects were observed in either group. Conclusion: Seizures were controlled more quickly with intravenous diazepam than with intranasal midazolam, although midazolam was as safe and effective as diazepam. The overall time to cessation of seizures after arrival at hospital was faster with intranasal midazolam than with intravenous diazepam. The intranasal route can possibly be used not only in medical centers but in general practice and, with appropriate instructions, by families of children with recurrent febrile seizures at home.
- Greg: These 3 slides are from the ANTs patients. The first 2 show that focal discharges on the EEG can be seen focally on biopolar recordings from the ANTs electrodes (they are shown at a different gain in referential and bipolar montages. The last slide shows a delay from the right frontal to left frontal regions (across the callosum) to the ANTs: I.e. frontal regions to thalamus in this patient with a right frontal focus with rapid spread. The ANTs stimulator stopped her falls. This slide supports a proposed functional disruption of conduction from the frontal to more central regions, which might be responsible for the therapeutic effect (the stim. Was off the entire time these recordings were obtained).