carbamates has been researched along with Abdominal Epilepsy in 47 studies
| Excerpt | Relevance | Reference |
|---|---|---|
| "The purpose of this study was to evaluate the efficacy and safety of adjunctive retigabine/ezogabine (RTG/EZG) therapy in Asian adults with partial-onset seizures." | 9.22 | Efficacy and safety of retigabine/ezogabine as adjunctive therapy in adult Asian patients with drug-resistant partial-onset seizures: A randomized, placebo-controlled Phase III study. ( Kwan, P; Lim, KS; Lotay, N; White, R, 2016) |
| " Adults with partial-onset seizures must have been taking either carbamazepine/oxcarbazepine (CBZ/OXC), lamotrigine (LTG), levetiracetam (LEV), or valproic acid (VPA)." | 9.20 | Efficacy and safety of ezogabine/retigabine as adjunctive therapy to specified single antiepileptic medications in an open-label study of adults with partial-onset seizures. ( Brandt, C; Daniluk, J; DeRossett, S; Edwards, S; Lerche, H; Lotay, N, 2015) |
| "The purpose of this study was to evaluate the efficacy and safety of adjunctive retigabine/ezogabine (RTG/EZG) therapy in Asian adults with partial-onset seizures." | 5.22 | Efficacy and safety of retigabine/ezogabine as adjunctive therapy in adult Asian patients with drug-resistant partial-onset seizures: A randomized, placebo-controlled Phase III study. ( Kwan, P; Lim, KS; Lotay, N; White, R, 2016) |
| " Adults with partial-onset seizures must have been taking either carbamazepine/oxcarbazepine (CBZ/OXC), lamotrigine (LTG), levetiracetam (LEV), or valproic acid (VPA)." | 5.20 | Efficacy and safety of ezogabine/retigabine as adjunctive therapy to specified single antiepileptic medications in an open-label study of adults with partial-onset seizures. ( Brandt, C; Daniluk, J; DeRossett, S; Edwards, S; Lerche, H; Lotay, N, 2015) |
| " The slopes of the exposure-response relationship for probability of dizziness and abnormal coordination were similar to that for efficacy, whereas the slopes for dysarthria, somnolence, tremor, and blurred vision were shallower, indicating that the probability of these events occurring was less affected than the probability of efficacy by increases in retigabine/ezogabine AUC0-τ." | 5.17 | Efficacy and tolerability exposure-response relationship of retigabine (ezogabine) immediate-release tablets in patients with partial-onset seizures. ( Berry, NS; Crean, CS; Reeve, R; Tompson, DJ, 2013) |
| "Adult patients with uncontrolled focal seizures taking 1 to 3 concomitant ASMs were randomized to receive adjunctive cenobamate or placebo (double-blind studies C013 and C017) or cenobamate (open-label study C021)." | 3.11 | Onset of efficacy and adverse events during Cenobamate titration period. ( Ben-Menachem, E; Brandt, C; García Morales, I; Rosenfeld, WE; Santamarina, E; Serratosa, JM; Steinhoff, BJ, 2022) |
| "Management of drug resistant epilepsy (DRE) represents a challenge to the treating clinician." | 3.01 | Cenobamate in refractory epilepsy: Overview of treatment options and practical considerations. ( Ben-Menachem, E; Kälviäinen, R; Lattanzi, S; Nashef, L; Schmitz, B; Vonck, K, 2023) |
| " Safety assessments included adverse event (AE) monitoring, clinical laboratory evaluations, electrocardiograms, and physical and neurologic examinations." | 2.79 | A novel design for a dose finding, safety, and drug interaction study of an antiepileptic drug (retigabine) in early clinical development. ( Biton, V; DeRossett, S; Nohria, V; Partiot, A; Porter, RJ; Rosenfeld, WE; Sachdeo, R; Tompson, D, 2014) |
| " Discontinuation rates due to treatment-emergent adverse events (TEAEs) were numerically higher in the fast- (10/23) and medium- (7/22) titration groups than in the slow-titration group (3/23) but statistical significance was achieved only for the high-titration group compared with the low-titration group (p=0." | 2.78 | Safety and tolerability of different titration rates of retigabine (ezogabine) in patients with partial-onset seizures. ( Biton, V; Brodie, MJ; Derossett, SE; Gil-Nagel, A; Nohria, V, 2013) |
| " Dizziness was the most common treatment-emergent adverse event, with a higher incidence (≥ 5% difference) in the combined carisbamate group (31%) than placebo (9%); the incidence was higher with carisbamate 1,200 mg (32%, n = 58) than with carisbamate 800 mg (30%, n = 53)." | 2.76 | A randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of adjunctive carisbamate treatment in patients with partial-onset seizures. ( Ben-Menachem, E; Eerdekens, M; Halford, JJ; Kwan, P; Ness, S; Novak, G; Schmitt, J, 2011) |
| " Treatment discontinuations due to adverse events (AEs) were more likely with EZG (RTG) than with placebo (placebo, 8%; 600 mg, 17%, 900 mg, 26%)." | 2.75 | Efficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsy. ( Brodie, MJ; Elger, C; Gil-Nagel, A; Hall, S; Lerche, H; Mansbach, H; Nohria, V; Shin, P, 2010) |
| " Cenobamate demonstrated significant efficacy at a dosage between 100 and 400 mg per day." | 2.66 | Cenobamate for the treatment of focal epilepsies. ( Bauer, S; Mann, C; Rosenow, F; Strzelczyk, A; Willems, LM, 2020) |
| "This manuscript summarizes the pharmacokinetic and biopharmaceutical properties of retigabine collated from published and unpublished in vitro and clinical phase I-III studies in healthy volunteers or patients with partial-onset seizures." | 2.49 | Clinical pharmacokinetics of retigabine/ezogabine. ( Crean, CS; Tompson, DJ, 2013) |
| " Consequently, the adverse event (AE) profile of RTG/EZG includes a potential risk of effects on the urinary system." | 2.48 | The urinary safety profile and secondary renal effects of retigabine (ezogabine): a first-in-class antiepileptic drug that targets KCNQ (K(v)7) potassium channels. ( Brickel, N; DeRossett, S; Gandhi, P; Hammond, J; VanLandingham, K, 2012) |
| " In the network meta-analysis, RTG was not found to be different from the other AEDs for responder rate (maintenance period), seizure freedom (maintenance period and double-blind period), withdrawals due to adverse events, and incidences of ataxia, dizziness, fatigue and nausea." | 2.48 | The efficacy and safety of retigabine and other adjunctive treatments for refractory partial epilepsy: a systematic review and indirect comparison. ( Cooper, J; Duffy, S; Glanville, J; Hugel, P; Lane, PW; Martyn-St James, M; McCool, R, 2012) |
| "Ezogabine is a newly approved anticonvulsant for adjunctive therapy in partial-onset seizures in adults with a novel mechanism of action, activating low-threshold voltage-gated potassium channels." | 2.48 | Ezogabine (retigabine) and its role in the treatment of partial-onset seizures: a review. ( Splinter, MY, 2012) |
| " Careful monitoring of drug interactions and adverse reactions is necessary." | 2.48 | Ezogabine: an evaluation of its efficacy and safety as adjunctive therapy for partial-onset seizures in adults. ( Welty, TE; Yamada, M, 2012) |
| "Ezogabine (retigabine) is a novel antiepileptic agent which primarily acts to stabilize neuronal potassium-gated ion channels." | 2.46 | Ezogabine: a novel antiepileptic as adjunctive therapy for partial onset seizures. ( Owen, RT, 2010) |
| "We measured seizure reduction, median reduction in seizure frequency, median dose, responder rate, and treatment-emergent adverse events." | 1.72 | Adjunctive use of cenobamate for pediatric refractory focal-onset epilepsy: A single-center retrospective study. ( Karkare, S; Kothare, SV; Shah, YD; Varughese, RT, 2022) |
| "Focal-onset or partial seizures are localized to a specific brain area or areas of the cerebral hemisphere." | 1.56 | Cenobamate for the treatment of focal epilepsy. ( Dhir, A, 2020) |
| "Retigabine reduced seizure frequency or severity for 24." | 1.43 | Adjunctive retigabine in refractory focal epilepsy: Postmarketing experience at four tertiary epilepsy care centers in Germany. ( Elger, CE; Graf, W; Hamer, HM; Kasper, B; Kull, A; Kurth, C; Nass, RD; Rosenow, F; Steinhoff, BJ; Strzelczyk, A; Surges, R, 2016) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 1 (2.13) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 4 (8.51) | 29.6817 |
| 2010's | 28 (59.57) | 24.3611 |
| 2020's | 14 (29.79) | 2.80 |
| Authors | Studies |
|---|---|
| Steinhoff, BJ | 4 |
| Rosenfeld, WE | 4 |
| Serratosa, JM | 2 |
| Brandt, C | 3 |
| Klein, P | 1 |
| Toledo, M | 1 |
| Krauss, GL | 1 |
| Lu, C | 1 |
| Zheng, J | 1 |
| Cao, Y | 1 |
| Bresnahan, R | 1 |
| Martin-McGill, KJ | 1 |
| Varughese, RT | 1 |
| Shah, YD | 1 |
| Karkare, S | 1 |
| Kothare, SV | 1 |
| Ben-Menachem, E | 3 |
| García Morales, I | 1 |
| Santamarina, E | 1 |
| Makridis, KL | 1 |
| Kaindl, AM | 1 |
| Schmitz, B | 1 |
| Lattanzi, S | 2 |
| Vonck, K | 1 |
| Kälviäinen, R | 2 |
| Nashef, L | 1 |
| Keam, SJ | 1 |
| Aschenbrenner, DS | 1 |
| Dhir, A | 1 |
| Buckley, CT | 1 |
| Waters, OR | 1 |
| DeMaagd, G | 1 |
| Strzelczyk, A | 2 |
| Mann, C | 1 |
| Willems, LM | 1 |
| Rosenow, F | 2 |
| Bauer, S | 1 |
| Mula, M | 1 |
| Roberti, R | 1 |
| De Caro, C | 1 |
| Iannone, LF | 1 |
| Zaccara, G | 1 |
| Russo, E | 1 |
| Holko, P | 1 |
| Kawalec, P | 1 |
| Tompson, DJ | 2 |
| Crean, CS | 2 |
| Reeve, R | 1 |
| Berry, NS | 1 |
| Biton, V | 2 |
| Gil-Nagel, A | 4 |
| Brodie, MJ | 4 |
| Derossett, SE | 2 |
| Nohria, V | 5 |
| Sachdeo, R | 2 |
| Partiot, A | 2 |
| Tompson, D | 1 |
| DeRossett, S | 3 |
| Porter, RJ | 3 |
| Mangubat, EZ | 1 |
| Kellogg, RG | 1 |
| Harris, TJ | 1 |
| Rossi, MA | 1 |
| Lerche, H | 2 |
| Daniluk, J | 1 |
| Lotay, N | 2 |
| Edwards, S | 1 |
| Nass, RD | 1 |
| Kurth, C | 1 |
| Kull, A | 1 |
| Graf, W | 1 |
| Kasper, B | 1 |
| Hamer, HM | 1 |
| Elger, CE | 1 |
| Surges, R | 1 |
| Lim, KS | 1 |
| White, R | 2 |
| Kwan, P | 3 |
| Faught, E | 1 |
| Holmes, GL | 1 |
| Novak, G | 3 |
| Neto, W | 1 |
| Greenspan, A | 2 |
| Schmitt, J | 3 |
| Yuen, E | 2 |
| Reines, S | 1 |
| Haas, M | 2 |
| Sperling, MR | 1 |
| Cramer, JA | 1 |
| Halford, JJ | 2 |
| Cook, T | 1 |
| Elger, C | 1 |
| Hall, S | 3 |
| Shin, P | 2 |
| Mansbach, H | 2 |
| Owen, RT | 1 |
| Ness, S | 1 |
| Eerdekens, M | 1 |
| French, JA | 1 |
| Abou-Khalil, BW | 1 |
| Leroy, RF | 1 |
| Yacubian, EM | 1 |
| Stafstrom, CE | 1 |
| Grippon, S | 1 |
| Kirkpatrick, P | 1 |
| Brickel, N | 1 |
| Gandhi, P | 1 |
| VanLandingham, K | 2 |
| Hammond, J | 1 |
| Burdette, DE | 1 |
| Hall, ST | 1 |
| Shaikh, S | 1 |
| Rheims, S | 1 |
| Ryvlin, P | 1 |
| Hecht, B | 1 |
| Leroy, R | 1 |
| Cyr, T | 1 |
| Castiglia, M | 1 |
| Twomey, C | 1 |
| Martyn-St James, M | 1 |
| Glanville, J | 1 |
| McCool, R | 1 |
| Duffy, S | 1 |
| Cooper, J | 1 |
| Hugel, P | 1 |
| Lane, PW | 1 |
| Splinter, MY | 1 |
| Yamada, M | 1 |
| Welty, TE | 1 |
| Craig, D | 1 |
| Rice, S | 1 |
| Paton, F | 1 |
| Fox, D | 1 |
| Woolacott, N | 1 |
| Kristian, B | 1 |
| Wachtmeister, K | 1 |
| Stefan, F | 1 |
| Forsgren, L | 1 |
| Plosker, GL | 1 |
| Scott, LJ | 1 |
| Alves, WM | 1 |
| Straub, H | 1 |
| Köhling, R | 1 |
| Höhling, J | 1 |
| Rundfeldt, C | 1 |
| Tuxhorn, I | 1 |
| Ebner, A | 1 |
| Wolf, P | 1 |
| Pannek, H | 1 |
| Speckmann, E | 1 |
| Jannasch, R | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures.[NCT00740623] | Phase 3 | 547 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
| [NCT00228969] | Phase 2 | 0 participants | Interventional | 2005-02-28 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Partial Onset Seizures Followed by an Open-Label Extension Study.[NCT00425282] | Phase 3 | 566 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
| Epilepsy Phase III Trial[NCT00433667] | Phase 3 | 563 participants (Actual) | Interventional | 2006-11-30 | Completed | ||
| Effect of Melatonin on Seizure Outcome, Neuronal Damage and Quality of Life in Patients With Generalized Epilepsy: A Randomized, add-on Placebo-controlled Clinical Trial[NCT03590197] | Phase 4 | 104 participants (Actual) | Interventional | 2018-08-06 | Completed | ||
| Clinical Validation Study of the Simplified Seizure Classification Algorithm[NCT03796520] | 240 participants (Actual) | Observational | 2019-06-02 | Completed | |||
| A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects With Refractory Partial Seizures (Protocol 333369-EPY-2003 [Double-blind] and Protocol 333369-EPY-200[NCT00210522] | Phase 2 | 421 participants (Actual) | Interventional | 2005-05-31 | Completed | ||
| Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study - Determine Efficacy and Safety of Two Doses of Retigabine (900 Mg/Day and 600 Mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Se[NCT00235755] | Phase 3 | 539 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Retigabine (1200 mg/Day) Used as Adjunctive Therapy in Refractory Epilepsy Patients With Partial-Onset Seizures[NCT00232596] | Phase 3 | 306 participants (Actual) | Interventional | 2005-09-30 | Completed | ||
| Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy[NCT01587339] | 6,498 participants (Actual) | Observational | 2010-09-30 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00235755)
Timeframe: Week 16/end of treatment phase
| Intervention | scores on a scale (Mean) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | 3.2 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 2.9 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 2.9 |
PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00235755)
Timeframe: Week 16/end of treatment phase
| Intervention | scores on a scale (Mean) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | 3.3 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 2.9 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 3.0 |
28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 5 through Week 16
| Intervention | Percent change in seizure frequency (Median) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | -17.4 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | -35.3 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | -44.3 |
28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative valu es indicate a reduction in seizure frequency. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), DB Phase (Week 1 through Week 16)
| Intervention | percent change in seizure frequency (Median) |
|---|---|
| Placebo - Double Blind (DB) Phase (Titration Plus Maintenance) | -15.9 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | -39.9 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | -27.9 |
A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | percentage of days (Median) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | 77.8 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 79.5 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 82.1 |
A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the Maintenance Phase divided by the number of days in the Maintenance Phase x 100%. (NCT00235755)
Timeframe: Week 5 through Week 16
| Intervention | percentage of days (Median) |
|---|---|
| Placebo - DB Phase (Titration Plus Maintenance) | 78.1 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 81.6 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 84.5 |
Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 16 minus the value at Baseline. (NCT00235755)
Timeframe: Baseline (Week -7 through 0), Weeks 8 and 16
| Intervention | milliliters (Median) | |
|---|---|---|
| Week 8, n=143, 134, 121 | Week 16, n=141, 131, 115 | |
| Placebo: Maintenance Phase | 0 | 0 |
| Retigabine 200 mg TID: Maintenance Phase | 0 | 0 |
| Retigabine 300 mg TID: Maintenance Phase | 0 | 0 |
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period. (NCT00235755)
Timeframe: Week 5 through Week 16
| Intervention | participants (Number) | |
|---|---|---|
| Responders | Non-responders | |
| Placebo - DB Phase (Titration Plus Maintenance) | 31 | 133 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance | 61 | 97 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 70 | 79 |
New seizure types included those seizures which were not reported by any participant at Baseline. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 16
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Partial seizures without motor signs | Partial evolving to secondarily generalized | Partial seizures with motor signs | Tonic-clonic seizures | Flurries | Tonic seizures | Complex partial seizures | Unclassified seizures | |
| Placebo - DB Phase (Titration Plus Maintenance) | 9 | 6 | 5 | 0 | 3 | 3 | 1 | 0 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 8 | 5 | 6 | 0 | 2 | 0 | 4 | 1 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 12 | 9 | 3 | 3 | 1 | 1 | 4 | 0 |
Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 5 through Week 16
| Intervention | participants (Number) | ||
|---|---|---|---|
| 0% to 25% increase | >=25% increase | >0% reduction | |
| Placebo - DB Phase (Titration Plus Maintenance) | 28 | 22 | 114 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 14 | 23 | 121 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 11 | 19 | 119 |
A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| Dysuria | Urinary retention | Polyuria | Urinary hesitation | Haematuria | |
| Placebo - DB Phase (Titration Plus Maintenance) | 0 | 0 | 4 | 3 | 2 |
| Placebo - Transition Phase | 0 | 0 | 0 | 3 | 1 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 3 | 1 | 1 | 6 | 5 |
| Retigabine 200 mg TID - Transition Phase | 0 | 0 | 0 | 1 | 0 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 4 | 4 | 2 | 1 | 2 |
| Retigabine 300 mg TID - Transition Phase | 0 | 0 | 0 | 0 | 1 |
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | participants (Number) | |
|---|---|---|
| Responders | Non-responders | |
| Placebo - DB Phase (Titration Plus Maintenance) | 31 | 148 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 57 | 124 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 70 | 108 |
Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | participants (Number) | |
|---|---|---|
| Seizure-free | Not seizure-free | |
| Placebo - DB Phase (Titration Plus Maintenance) | 2 | 174 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 0 | 179 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 7 | 168 |
Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase. (NCT00235755)
Timeframe: Week 5 through Week 16
| Intervention | participants (Number) | |
|---|---|---|
| Seizure-free | Not seizure-free | |
| Placebo - DB Phase (Titration Plus Maintenance) | 2 | 162 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 5 | 153 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 7 | 142 |
Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses. (NCT00235755)
Timeframe: Week 1 through Week 16
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Protenuria | Hyperlipidemia | Hypercholesterolemia | Hematuria | |
| Placebo - DB Phase (Titration Plus Maintenance) | 3 | 3 | 2 | 2 |
| Placebo - Transition Phase | 0 | 0 | 0 | 1 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 2 | 0 | 4 | 5 |
| Retigabine 200 mg TID - Transition Phase | 1 | 0 | 0 | 0 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 0 | 0 | 1 | 2 |
| Retigabine 300 mg TID - Transition Phase | 0 | 0 | 1 | 1 |
The number of participants with recorded weight gain of >=7% over their baseline weight was measured. (NCT00235755)
Timeframe: Weeks 2 and 4 of Titration Phase and Weeks 6, 8, 12, and 16 of Maintenance Phase
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Week 2, n=174, 180, 175 | Week 4, n=169, 172, 167 | Week 6, n=169, 165, 152 | Week 8, n=161, 160, 149 | Week 12, n=159, 151, 144 | Week 16, n=153, 139, 132 | |
| Placebo - DB Phase (Titration Plus Maintenance) | 0 | 0 | 1 | 1 | 6 | 4 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 3 | 7 | 8 | 9 | 15 | 13 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 3 | 8 | 7 | 7 | 13 | 12 |
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the category 0-10% increase category. (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 16
| Intervention | participants (Number) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reduction: 90% to 100% | Reduction: 80% to <90% | Reduction: 70% to <80% | Reduction: 60% to <70% | Reduction: 50% to <60% | Reduction: 40% to <50% | Reduction: 30% to <40% | Reduction: 20% to <30% | Reduction: 10% to <20% | Reduction: >0% to <10% | Increase: 0% to 10% | Increase: >10% to 20% | Increase: >20% to 30% | Increase: >30% | |
| Placebo - DB Phase (Titration Plus Maintenance) | 3 | 4 | 8 | 7 | 9 | 9 | 15 | 24 | 18 | 16 | 20 | 13 | 8 | 25 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 5 | 8 | 11 | 14 | 19 | 13 | 16 | 16 | 18 | 13 | 11 | 9 | 3 | 25 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 11 | 14 | 7 | 21 | 17 | 17 | 21 | 9 | 10 | 8 | 11 | 7 | 1 | 24 |
"Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data are included in the No reduction category." (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 16
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| 75% to 100% reduction | 50% to <75% reduction | 25% to <50% reduction | >0 to <25% reduction | No reduction | |
| Placebo - DB Phase (Titration Plus Maintenance) | 12 | 19 | 39 | 43 | 66 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 16 | 41 | 38 | 38 | 48 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 27 | 43 | 41 | 24 | 43 |
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint). (NCT00235755)
Timeframe: Baseline (Week -7 through Week 0), Week 5 through Week 16
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| >75% reduction | 50% to 75% reduction | >0 to <50% reduction | No reduction | |
| Placebo - DB Phase (Titration Plus Maintenance) | 11 | 20 | 83 | 50 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 27 | 34 | 60 | 37 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 30 | 40 | 49 | 30 |
The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores. (NCT00235755)
Timeframe: End of Baseline (Week 0), Weeks 4, 8, and 16
| Intervention | scores on a scale (Mean) | |||
|---|---|---|---|---|
| Baseline, n=165, 173, 166 | Week 4 (Titration Phase), n=155, 155, 149) | Week 8 (Maintenance Phase), n=141, 146, 127 | Week 16 (Maintenance Phase), n=143, 133, 123 | |
| Placebo - DB Phase (Titration Plus Maintenance) | 53.3 | 55.4 | 55.3 | 54.7 |
| Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance) | 56.0 | 57.3 | 59.6 | 59.1 |
| Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance) | 52.1 | 52.7 | 52.7 | 53.2 |
Clinical Global Impression of Improvement (CGI-I) is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the treatment. Scores on the scale are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00232596)
Timeframe: Week 18/end of treatment phase
| Intervention | scores on a scale (Mean) |
|---|---|
| Placebo - Maintenance Phase | 3.2 |
| Retigabine - Maintenance Phase | 2.7 |
PGI is a participant-rated scale of improvement that was administered at the end of the Maintenance Phase in order to assess the participant's impression of his or her own improvement. PGI assessments were scored using a 7-point scale: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. (NCT00232596)
Timeframe: Week 18/end of treatment phase
| Intervention | scores on a scale (Mean) |
|---|---|
| Placebo - Maintenance Phase | 2.9 |
| Retigabine - Maintenance Phase | 2.9 |
28-day total partial seizure frequency in the BL period = (No. of total partial seizures reported in the BL period divided by the No. of days of available total partial seizure data in the BL period) x 28 days. 28-day total partial seizure frequency in the Maintenance Phase = (No. of total partial seizures reported in the Maintenance Phase divided by the No. of days of available total partial seizure data in the same phase) x 28 days. Percent change = (value in the Maintenance Phase minus value at BL divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency. (NCT00232596)
Timeframe: Baseline (Week -7 through Week 0), Week 7 through Week 18
| Intervention | percent change in seizure frequency (Median) |
|---|---|
| Placebo - Maintenance Phase | -18.9 |
| Retigabine - Maintenance Phase | -54.5 |
28-day total PS (PSs [also called focal seizures] are seizures limited to a specific area of the brain) frequency in the BL period = (Number [No.] of total PSs reported in the BL period divided by the No. of days of available total PS data in the BL period) x 28 days. 28-day total PS frequency in the DB period = (No. of total PSs reported in the DB period divided by the No. of days of available total PS data in the DB period) x 28 days. Percent change = ([value in the DB period minus value at BL] divided by the BL value) x 100%. Negative values indicate a reduction in seizure frequency. (NCT00232596)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 18
| Intervention | percent change in seizure frequency (Median) |
|---|---|
| Placebo - DB Phase (Titration + Maintenance) | -17.5 |
| Retigabine - DB Phase (Titration + Maintenance) | -44.3 |
A seizure-free day was a day without any seizures. For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in DB period x 100%. (NCT00232596)
Timeframe: Week 1 through Week 18
| Intervention | percentage of days (Median) |
|---|---|
| Placebo - DB Phase (Titration + Maintenance) | 77.3 |
| Retigabine DB Phase (Titration + Maintenance) | 84.1 |
A seizure-free day was a day without any seizures. The percentage of seizure-free days was calculated as the total number of days without seizures in the DB period divided by the number of days in the DB period x 100%. (NCT00232596)
Timeframe: Week 7 through Week 18
| Intervention | percentage of days (Median) |
|---|---|
| Placebo - Maintenance Phase | 78.2 |
| Retigabine - Maintenance Phase | 86.9 |
Post-void residual (PVR) urine refers to the amount of urine remaining in the bladder after normal urination. To investigate the possible effects of retigabine on bladder function, all participants underwent post-void residual bladder ultrasound at Baseline and during the Maintenance Phase. The PVR bladder ultrasound was performed by a urologist, a qualified ultrasound technician, or a qualified study nurse who was certified to do PVR bladder ultrasound. Change from Baseline in PVR residual volume was calculated as the values at Week 10 and Week 18 minus the value at Baseline. (NCT00232596)
Timeframe: Baseline (Week -7 through Week 0), Weeks 10 and 18
| Intervention | milliliters (Median) | |
|---|---|---|
| Week 10, n=111, 100 | Week 18, n=95, 76 | |
| Placebo - DB Phase (Titration and Maintenance) | -1.0 | -3.0 |
| Retigabine - DB Phase (Titration and Maintenance) | 0.0 | 0.0 |
New seizure types included those seizures which were not reported by any participant at Baseline. (NCT00232596)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 18
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| No new seizure type | Partial seizures without motor signs | Partial evolving to secondarily generalized | Complex partial seizures | Partial seizures with motor signs | Flurries | Tonic-clonic seizures | Atonic seizures | |
| Placebo - DB Phase (Titration + Maintenance) | 33 | 12 | 7 | 5 | 11 | 3 | 0 | 1 |
| Retigabine DB Phase (Titration + Maintenance) | 42 | 17 | 12 | 11 | 7 | 1 | 1 | 0 |
Participants who experienced an exacerbation from Baseline in the 28-day total partial seizure frequency were categorized as having a 0-25% or a >25% increase (EMEA endpoint). The number of participants experiencing a >0% reduction from Baseline in the 28-day total partial seizure frequency are also presented. (NCT00232596)
Timeframe: Baseline (Week -7 through Week 0), Week 7 through Week 18
| Intervention | participants (Number) | ||
|---|---|---|---|
| 0% to 25% increase | >=25% increase | >0% reduction | |
| Placebo - Maintenance Phase | 20 | 21 | 96 |
| Retigabine - Maintenance Phase | 4 | 16 | 99 |
A summary of the adverse events classified as renal or urinary disorders and in which at least 2% (rounded to an integer) of participants in any treatment arm reported during the study is presented. (NCT00232596)
Timeframe: Week 1 through Week 24
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Urinary hesitation | Dysuria | Chromaturia | Polyuria | Nephrolithiasis | Hematuria | Urinary retention | |
| Placebo - DB Phase (Titration and Maintenance) | 1 | 2 | 0 | 1 | 0 | 1 | 2 |
| Placebo (DB Phase) and Retigabine (Transition Phase) | 2 | 2 | 0 | 0 | 0 | 2 | 2 |
| Retigabine - DB Phase (Titration and Maintenance) | 9 | 8 | 7 | 4 | 4 | 2 | 1 |
| Retigabine (DB Phase) and Retigabine (Transition Phase) | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the DB Phase as compared to the Baseline period. Participants without any post-baseline data were considered non-responders. (NCT00232596)
Timeframe: Week 1 through Week 18
| Intervention | participants (Number) | |
|---|---|---|
| Responders | Non-responders | |
| Placebo - DB Phase (Titration + Maintenance) | 27 | 125 |
| Retigabine - DB Phase (Titration + Maintenance) | 68 | 85 |
Responders were participants with at least a 50% reduction in the 28-day total partial seizure frequency in the Maintenance Phase as compared to the Baseline period. (NCT00232596)
Timeframe: Week 7 through Week 18
| Intervention | participants (Number) | |
|---|---|---|
| Responders | Non-responders | |
| Placebo - Maintenance Phase | 31 | 106 |
| Retigabine - Maintenance Phase | 66 | 53 |
Participants were considered to be seizure-free if they had not reported any seizures during the DB treatment period (Weeks 1-18). For a participant to be seizure free during the DB Phase, the participant had to be seizure free both Week 7 to Week 18 and Week 1 to Week 6. A participant could be seizure free Week 7 to Week 18 (during the Maintenance Phase), but not seizure free Week 1 to Week 6. Hence, there are fewer participants being reported as seizure free from Week 1 to Week 18 than from Week 7 to Week 18. (NCT00232596)
Timeframe: Week 1 through Week 18
| Intervention | participants (Number) | |
|---|---|---|
| Seizure free | Not seizure free | |
| Placebo - DB Phase (Titration + Maintenance) | 0 | 150 |
| Retigabine DB Phase (Titration + Maintenance) | 3 | 148 |
Participants were considered to be seizure-free if they had not reported any seizures during the Maintenance Phase. (NCT00232596)
Timeframe: Week 7 through Week 18
| Intervention | participants (Number) | |
|---|---|---|
| Seizure free | Not seizure free | |
| Placebo - Maintenance Phase | 2 | 135 |
| Retigabine - Maintenance Phase | 9 | 110 |
Clinically important changes in laboratory values were to be reported as an adverse event if they met one of the following criteria: (1) intervention required; (2) change in dose of study drug required; (3) other treatment/therapy required; (4) association with other diagnoses. (NCT00232596)
Timeframe: Week 1 through Week 24
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Urine analysis abnormal | Bacteria urine | Hematology test abnormal | Urinary sediment present | |
| Placebo - DB Phase (Titration and Maintenance) | 3 | 1 | 0 | 1 |
| Placebo (DB Phase) and Retigabine (Transition Phase) | 3 | 0 | 0 | 0 |
| Retigabine - DB Phase (Titration and Maintenance) | 4 | 1 | 1 | 0 |
| Retigabine (DB Phase) and Retigabine (Transition Phase) | 2 | 2 | 2 | 2 |
The number of participants with recorded weight gain of >=7% over their baseline weight was measured. (NCT00232596)
Timeframe: Weeks 2, 4, 6 of Titration Phase and Weeks 7, 8, 10, 14, and 18 of Maintenance Phase
| Intervention | participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Titration Phase, Week 2, n=149, 150 | Titration Phase, Week 4, n=145, 144 | Titration Phase, Week 6, n=146, 129 | Maintenance Phase, Week 7, n=130, 121 | Maintenance Phase, Week 8, n=135, 128 | Maintenance Phase, Week 10, n=136, 119 | Maintenance Phase, Week 14, n=137, 109 | Maintenance Phase, Week 18, n=127, 92 | |
| Placebo - DB Phase (Titration + Maintenance) | 0 | 0 | 1 | 2 | 1 | 3 | 3 | 4 |
| Retigabine DB Phase (Titration + Maintenance) | 5 | 5 | 6 | 9 | 10 | 15 | 18 | 17 |
"Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a reduction of 75-100%, 50-<75%, 25-<50%, or <25%, in addition to having no reduction. This quartile cutting was specified in the study protocol. Participants without any post-baseline data were included in the No reduction category." (NCT00232596)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 18
| Intervention | participants (Number) | ||||
|---|---|---|---|---|---|
| 75% to 100% reduction | 50% to <75% reduction | 25% to <50% reduction | >0 to <25% reduction | No reduction | |
| Placebo - DB Phase (Titration + Maintenance) | 6 | 21 | 37 | 33 | 55 |
| Retigabine DB Phase (Titration + Maintenance) | 27 | 41 | 20 | 26 | 39 |
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized in decile cutting, i.e., reduction categories of 90-100%, 80-<90%, 70-<80%, 60-<70%, 50-<60%, 40-<50%, 30-<40%, 20-<30%, 10-<20%, >0-<10%, and increase categories of 0-10%, >10-20%, >20-30%, >30% (FDA endpoint). Participants without any post-baseline data were included in the 0-10% increase category. (NCT00232596)
Timeframe: Baseline (Week -7 through Week 0), Week 1 through Week 18
| Intervention | participants (Number) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Reduction: 90% to 100% | Reduction: 80% to <90% | Reduction: 70% to <80% | Reduction: 60% to <70% | Reduction: 50% to <60% | Reduction: 40% to <50% | Reduction: 30% to <40% | Reduction: 20% to <30% | Reduction: 10% to <20% | Reduction: >0% to <10% | Increase: 0% to 10% | Increase: >10% to 20% | Increase: >20% to 30% | Increase: >30% | |
| Placebo - DB Phase (Titration + Maintenance) | 0 | 5 | 4 | 7 | 11 | 11 | 13 | 19 | 13 | 14 | 14 | 12 | 4 | 25 |
| Retigabine DB Phase (Titration + Maintenance) | 12 | 11 | 10 | 20 | 15 | 10 | 6 | 12 | 10 | 8 | 10 | 5 | 4 | 20 |
Participants who experienced a reduction from Baseline in the 28-day total partial seizure frequency were categorized as having a >75%, a 50-75%, or a <50% reduction, in addition to having no reduction (EMEA endpoint). (NCT00232596)
Timeframe: Baseline (Week -7 through Week 0), Week 7 through Week 18
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| >75% reduction | 50% to 75% reduction | >0 to <50% reduction | No reduction | |
| Placebo - Maintenance Phase | 13 | 18 | 65 | 41 |
| Retigabine - Maintenance Phase | 37 | 29 | 33 | 20 |
The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, overall QOL. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are first converted to 0-100 point scores; higher converted scores always reflect better QOL. The overall score is derived by weighting and then summing the 7 domain scores. (NCT00232596)
Timeframe: End of Baseline (Week 0), Weeks 6, 10, and 18
| Intervention | scores on a scale (Mean) | |||
|---|---|---|---|---|
| Baseline (Week -7 through Week 0), n=139, 137 | Week 6 (Titration Phase), n=127, 108 | Week 10 (Maintenance Phase), n=121, 102 | Week 18 (Maintenance Phase), n=116, 85 | |
| Placebo - DB Phase (Titration + Maintenance) | 52.6 | 55.2 | 57.9 | 57.3 |
| Retigabine DB Phase (Titration + Maintenance) | 55.6 | 55.7 | 56.2 | 53.8 |
20 reviews available for carbamates and Abdominal Epilepsy
| Article | Year |
|---|---|
Practical guidance for the management of adults receiving adjunctive cenobamate for the treatment of focal epilepsy-expert opinion.
Topics: Adult; Anticonvulsants; Carbamates; Chlorophenols; Drug Therapy, Combination; Epilepsies, Partial; E | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Carisbamate add-on therapy for drug-resistant focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Drug Therapy, Combination; Epilepsies, | 2021 |
Real-world experience with cenobamate: A systematic review and meta-analysis.
Topics: Adult; Anticonvulsants; Carbamates; Child; Drug Resistant Epilepsy; Epilepsies, Partial; Humans; Sei | 2023 |
Cenobamate in refractory epilepsy: Overview of treatment options and practical considerations.
Topics: Anticonvulsants; Carbamates; Drug Resistant Epilepsy; Epilepsies, Partial; Humans; Tetrazoles | 2023 |
Cenobamate: First Approval.
Topics: Administration, Oral; Adult; Anticonvulsants; Carbamates; Chlorophenols; Drug Approval; Epilepsies, | 2020 |
Cenobamate for the treatment of focal epilepsies.
Topics: Animals; Anticonvulsants; Carbamates; Chlorophenols; Epilepsies, Partial; Headache; Humans; Randomiz | 2020 |
Pharmacological treatment of focal epilepsy in adults: an evidence based approach.
Topics: Adult; Anticonvulsants; Carbamates; Chlorophenols; Epilepsies, Partial; Humans; Tetrazoles | 2021 |
Cenobamate tablets as a treatment for focal-onset seizures in adults.
Topics: Adult; Animals; Anticonvulsants; Carbamates; Chlorophenols; Epilepsies, Partial; Humans; Randomized | 2021 |
Pharmacology of Cenobamate: Mechanism of Action, Pharmacokinetics, Drug-Drug Interactions and Tolerability.
Topics: Adult; Animals; Anticonvulsants; Biological Availability; Carbamates; Chlorophenols; Dose-Response R | 2021 |
Practical Use of Newer Antiepileptic Drugs as Adjunctive Therapy in Focal Epilepsy.
Topics: Acetamides; Adult; Aged; Animals; Anticonvulsants; Carbamates; Dibenzazepines; Drug Resistant Epilep | 2015 |
Ezogabine: a novel antiepileptic as adjunctive therapy for partial onset seizures.
Topics: Animals; Anticonvulsants; Carbamates; Clinical Trials as Topic; Dose-Response Relationship, Drug; Dr | 2010 |
The urinary safety profile and secondary renal effects of retigabine (ezogabine): a first-in-class antiepileptic drug that targets KCNQ (K(v)7) potassium channels.
Topics: Animals; Anticonvulsants; Carbamates; Epilepsies, Partial; Humans; KCNQ Potassium Channels; Muscle, | 2012 |
Retigabine for partial onset seizures.
Topics: Animals; Anticonvulsants; Carbamates; Disease Models, Animal; Epilepsies, Partial; Humans; Phenylene | 2012 |
[Retigabine. A novel anticonvulsant drug for the adjunctive treatment of partial seizures].
Topics: Animals; Anticonvulsants; Carbamates; Clinical Trials, Phase III as Topic; Epilepsies, Partial; Huma | 2012 |
The efficacy and safety of retigabine and other adjunctive treatments for refractory partial epilepsy: a systematic review and indirect comparison.
Topics: Anticonvulsants; Carbamates; Disorders of Excessive Somnolence; Epilepsies, Partial; Humans; Phenyle | 2012 |
Ezogabine (retigabine) and its role in the treatment of partial-onset seizures: a review.
Topics: Animals; Anticonvulsants; Carbamates; Dose-Response Relationship, Drug; Drug Interactions; Epilepsie | 2012 |
Ezogabine: an evaluation of its efficacy and safety as adjunctive therapy for partial-onset seizures in adults.
Topics: Adult; Animals; Anticonvulsants; Carbamates; Drug Interactions; Epilepsies, Partial; Humans; Phenyle | 2012 |
Retigabine for the adjunctive treatment of adults with partial-onset seizures in epilepsy with and without secondary generalization : a NICE single technology appraisal.
Topics: Adolescent; Adult; Anticonvulsants; Carbamates; Cost-Benefit Analysis; Decision Support Techniques; | 2013 |
Clinical pharmacokinetics of retigabine/ezogabine.
Topics: Age Factors; Aged; Anticonvulsants; Biological Availability; Carbamates; Clinical Trials as Topic; D | 2013 |
[Antiepileptics. 39].
Topics: Acetazolamide; Adrenocorticotropic Hormone; Aminoglutethimide; Anticonvulsants; Barbiturates; Carbam | 1969 |
14 trials available for carbamates and Abdominal Epilepsy
| Article | Year |
|---|---|
Onset of efficacy and adverse events during Cenobamate titration period.
Topics: Adult; Anticonvulsants; Carbamates; Chlorophenols; Drug Therapy, Combination; Epilepsies, Partial; H | 2022 |
Efficacy and tolerability exposure-response relationship of retigabine (ezogabine) immediate-release tablets in patients with partial-onset seizures.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Disorders of Excessive Somnolence; Dizziness; | 2013 |
Safety and tolerability of different titration rates of retigabine (ezogabine) in patients with partial-onset seizures.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dose-Response Relationship, Drug; Double-Blind | 2013 |
A novel design for a dose finding, safety, and drug interaction study of an antiepileptic drug (retigabine) in early clinical development.
Topics: Adolescent; Adult; Anticonvulsants; Carbamates; Drug Administration Schedule; Drug Dosage Calculatio | 2014 |
Efficacy and safety of ezogabine/retigabine as adjunctive therapy to specified single antiepileptic medications in an open-label study of adults with partial-onset seizures.
Topics: Aged; Anticonvulsants; Carbamates; Carbamazepine; Dose-Response Relationship, Drug; Drug Therapy, Co | 2015 |
Efficacy and safety of retigabine/ezogabine as adjunctive therapy in adult Asian patients with drug-resistant partial-onset seizures: A randomized, placebo-controlled Phase III study.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Double-Blind Method; Drug Resistant Epilepsy; | 2016 |
Randomized, controlled, dose-ranging trial of carisbamate for partial-onset seizures.
Topics: Adolescent; Adult; Aged; Alanine Transaminase; Anticonvulsants; Body Weight; Carbamates; Dose-Respon | 2008 |
Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dizziness; Dose-Response Relationship, Drug; D | 2010 |
Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dizziness; Dose-Response Relationship, Drug; D | 2010 |
Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dizziness; Dose-Response Relationship, Drug; D | 2010 |
Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dizziness; Dose-Response Relationship, Drug; D | 2010 |
Efficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Dose-Response Relationship, Drug; Double-Blind Method; Drug Ther | 2010 |
A randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of adjunctive carisbamate treatment in patients with partial-onset seizures.
Topics: Adult; Anticonvulsants; Carbamates; Double-Blind Method; Drug Administration Schedule; Drug Therapy, | 2011 |
Randomized, double-blind, placebo-controlled trial of ezogabine (retigabine) in partial epilepsy.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Dose-Response Relationship, Drug; Double-Blind | 2011 |
Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Double-Blind Method; Endpoint Determination; E | 2012 |
Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Double-Blind Method; Endpoint Determination; E | 2012 |
Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Double-Blind Method; Endpoint Determination; E | 2012 |
Retigabine as adjunctive therapy in adults with partial-onset seizures: integrated analysis of three pivotal controlled trials.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Double-Blind Method; Endpoint Determination; E | 2012 |
Safety and efficacy of ezogabine (retigabine) in adults with refractory partial-onset seizures: Interim results from two ongoing open-label studies.
Topics: Adult; Anticonvulsants; Carbamates; Dizziness; Drug Resistance; Epilepsies, Partial; Fatigue; Female | 2012 |
Randomized, multicenter, dose-ranging trial of retigabine for partial-onset seizures.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Australia; Carbamates; Dose-Response Relationship, Drug; E | 2007 |
13 other studies available for carbamates and Abdominal Epilepsy
| Article | Year |
|---|---|
Adjunctive use of cenobamate for pediatric refractory focal-onset epilepsy: A single-center retrospective study.
Topics: Adolescent; Adult; Anticonvulsants; Carbamates; Child; Chlorophenols; Drug Resistant Epilepsy; Epile | 2022 |
New Treatment for Partial-Onset Seizures in Adults.
Topics: Adult; Anticonvulsants; Carbamates; Chlorophenols; Drug Approval; Epilepsies, Partial; Humans; Tetra | 2020 |
Cenobamate for the treatment of focal epilepsy.
Topics: Adult; Anticonvulsants; Carbamates; Chlorophenols; Epilepsies, Partial; Humans; Seizures; Tetrazoles | 2020 |
Cenobamate: A New Adjunctive Agent for Drug-Resistant Focal Onset Epilepsy.
Topics: Adolescent; Adult; Aged; Animals; Anticonvulsants; Carbamates; Chemotherapy, Adjuvant; Chlorophenols | 2021 |
A comment on Craig et al.: ''Retigabine for the adjunctive treatment of adults with partial-onset seizures in epilepsy with and without secondary generalization: a NICE single technology appraisal''.
Topics: Anticonvulsants; Carbamates; Epilepsies, Partial; Humans; Phenylenediamines | 2013 |
Ezogabine (Potiga) toxicity.
Topics: Adult; Anticonvulsants; Carbamates; Drug Labeling; Epilepsies, Partial; Humans; Phenylenediamines; U | 2013 |
On-demand pulsatile intracerebral delivery of carisbamate with closed-loop direct neurostimulation therapy in an electrically induced self-sustained focal-onset epilepsy rat model.
Topics: Animals; Anticonvulsants; Carbamates; Combined Modality Therapy; Disease Models, Animal; Electric St | 2015 |
Adjunctive retigabine in refractory focal epilepsy: Postmarketing experience at four tertiary epilepsy care centers in Germany.
Topics: Adolescent; Adult; Aged; Anticonvulsants; Carbamates; Child; Death, Sudden, Cardiac; Drug Resistant | 2016 |
Ezogabine (retigabine).
Topics: Animals; Anticonvulsants; Carbamates; Epilepsies, Partial; Humans; Phenylenediamines; Randomized Con | 2011 |
Ezogabine (Potiga) for epilepsy.
Topics: Administration, Oral; Adult; Anticonvulsants; Carbamates; Drug Interactions; Epilepsies, Partial; Hu | 2012 |
Retigabine as add-on treatment of refractory epilepsy--a cost-utility study in a Swedish setting.
Topics: Acetamides; Adult; Anticonvulsants; Carbamates; Cost-Benefit Analysis; Drug Therapy, Combination; Ep | 2013 |
Retigabine: in partial seizures.
Topics: Animals; Anticonvulsants; Carbamates; Epilepsies, Partial; Humans; Phenylenediamines | 2006 |
Effects of retigabine on rhythmic synchronous activity of human neocortical slices.
Topics: Action Potentials; Adolescent; Adult; Anticonvulsants; Bicuculline; Carbamates; Child; Child, Presch | 2001 |