valproic acid has been researched along with Adverse Drug Event in 58 studies
Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.
valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem.
| Excerpt | Relevance | Reference |
|---|---|---|
| "To evaluate the efficacy and tolerability of the treatment with valproic acid (VPA) in patients with status epilepticus (SE) or acute repetitive seizures (ARS) comparing it with phenytoin (PHT) treatment." | 9.13 | Treatment of status epilepticus and acute repetitive seizures with i.v. valproic acid vs phenytoin. ( Dabby, R; Gilad, R; Izkovitz, N; Lampl, Y; Rapoport, A; Sadeh, M; Weller, B, 2008) |
| "This study was aimed at identifying genetic and non-genetic risk factors for valproic acid (VPA)-induced hyperammonaemia in Chinese paediatric patients with epilepsy." | 7.88 | Risk Factors for Valproic Acid-induced Hyperammonaemia in Chinese Paediatric Patients with Epilepsy. ( Li, X; Zhang, T; Zhao, L; Zhu, X, 2018) |
| "Primary outcome was seizure cessation for 1h, and secondary outcomes were 24h seizure remission, in-hospital death, and severe adverse events (SAE)." | 6.84 | Comparison of lacosamide versus sodium valproate in status epilepticus: A pilot study. ( Dubey, D; Kalita, J; Misra, UK, 2017) |
| "Valproic acid (VPA) is a short-chain fatty acid widely prescribed in the treatment of seizure disorders and epilepsy syndromes, although its therapeutic value may be undermined by its toxicity." | 5.91 | Quantitative systems pharmacology Model to characterize valproic acid-induced hyperammonemia and the effect of L-carnitine supplementation. ( Fagiolino, P; Ibarra, M; Maldonado, C; Schiavo, A; Trocóniz, IF; Vázquez, M, 2023) |
| "Lithium carbonate was not associated with an increased risk of Parkinson-like events, but was related to these events in patients taking sodium valproate." | 5.72 | Relationship between lithium carbonate and the risk of Parkinson-like events in patients with bipolar disorders: A multivariate analysis using the Japanese adverse drug event report database. ( Nabekura, T; Uwai, Y, 2022) |
| "Phospholipid-valproic acid (DP-VPA)is a prodrug for treating epilepsy." | 5.69 | Population pharmacokinetics and exposure-safety of lipophilic conjugates prodrug DP-VPA in healthy Chinese subjects for dose regime exploring. ( Cao, G; Chen, Y; Fan, Y; Guo, B; Hu, J; Li, X; Li, Y; Liu, X; Wang, Y; Wu, H; Wu, J; Wu, X; Xu, X; Yu, J; Yu, P; Zhan, H; Zhang, J, 2023) |
| "To evaluate the efficacy and tolerability of the treatment with valproic acid (VPA) in patients with status epilepticus (SE) or acute repetitive seizures (ARS) comparing it with phenytoin (PHT) treatment." | 5.13 | Treatment of status epilepticus and acute repetitive seizures with i.v. valproic acid vs phenytoin. ( Dabby, R; Gilad, R; Izkovitz, N; Lampl, Y; Rapoport, A; Sadeh, M; Weller, B, 2008) |
| " The treatment of choice for CAE with absence seizures only is ethosuximide." | 5.01 | A Practical Guide to Treatment of Childhood Absence Epilepsy. ( Kessler, SK; McGinnis, E, 2019) |
| "Valproic acid is an effective first line drug for the treatment of epilepsy." | 4.90 | Valproic acid and fatalities in children: a review of individual case safety reports in VigiBase. ( Choonara, I; Edwards, IR; Star, K, 2014) |
| " Exanthema as especially clinically relevant adverse drug event was rightly chosen for carbamazepine by 18 (8%) and for lamotrigine by 12 (5%) participants." | 4.02 | Knowledge of epilepsy among German pharmacists. ( Bertsche, A; Bertsche, T; Herziger, B; Jeschke, S; Müller, RM; Neininger, MP, 2021) |
| "This study was aimed at identifying genetic and non-genetic risk factors for valproic acid (VPA)-induced hyperammonaemia in Chinese paediatric patients with epilepsy." | 3.88 | Risk Factors for Valproic Acid-induced Hyperammonaemia in Chinese Paediatric Patients with Epilepsy. ( Li, X; Zhang, T; Zhao, L; Zhu, X, 2018) |
| " VPM would require a closer dosing schedule and a 20% reduction in dosage when switching to valproate." | 3.01 | Valproate, divalproex, valpromide: Are the differences in indications justified? ( Besson, VC; Blaise, N; Bloch, V; Chouchana, M; Delage, C; Etain, B; Hagenimana, M; Palayer, M; Smati, J, 2023) |
| "Beta-blockers are effective for migraine attack prophylaxis but are associated with dizziness and fatigue and are contraindicated in patients with certain co-morbidities, including asthma, congestive heart failure, and abnormal cardiac rhythms." | 3.01 | Non-CGRP Antagonist/Non-Triptan Options for Migraine Disease Treatment: Clinical Considerations. ( Ahmadzadeh, S; Bocklud, BE; Corley, SC; Granier, MA; Ingram, EE; Kaye, AD; Neuchat, EE; Shekoohi, S, 2023) |
| "Primary outcome was seizure cessation for 1h, and secondary outcomes were 24h seizure remission, in-hospital death, and severe adverse events (SAE)." | 2.84 | Comparison of lacosamide versus sodium valproate in status epilepticus: A pilot study. ( Dubey, D; Kalita, J; Misra, UK, 2017) |
| "Valproic acid (VPA) has demonstrated potential as a therapeutic candidate for spinal muscular atrophy (SMA) in vitro and in vivo." | 2.75 | SMA CARNI-VAL trial part I: double-blind, randomized, placebo-controlled trial of L-carnitine and valproic acid in spinal muscular atrophy. ( Acsadi, G; Bromberg, MB; Chan, GM; Crawford, TO; D'Anjou, G; Elsheik, B; Kissel, JT; Krosschell, KJ; LaSalle, B; Maczulski, JA; Prior, TW; Reyna, SP; Schroth, MK; Scott, CB; Simard, LR; Sorenson, SL; Swoboda, KJ, 2010) |
| " In conclusion, the combination studied is safe and has significant clinical activity." | 2.73 | Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome. ( Cortes, J; Estey, EH; Estrov, Z; Faderl, S; Garcia-Manero, G; Giles, F; Issa, JP; Kantarjian, HM; Ouzounian, S; Pierce, S; Quezada, A; Ravandi, F; Soriano, AO; Wierda, WG; Yang, H, 2007) |
| "Their efficacy in bipolar depression has not always been confirmed in more recent and methodologically more reliable studies." | 2.47 | [Lithium and anticonvulsants in bipolar depression]. ( Llorca, PM; Nourry, A; Samalin, L, 2011) |
| "Epilepsy is characterized by repeated seizure activity." | 1.91 | Impact of ( Kesavan, R; Kumar, RR; Narayan, SK; Ramakrishnan, K; Shewade, D; Venkatraman, S, 2023) |
| "We related seizure control to VPA doses through uni- and multivariate statistical analyses." | 1.91 | Minimum effective sodium valproate dose in genetic generalized epilepsies. ( Bittar Guaranha, MS; Duarte, JTC; Guilhoto, LM; Hackbart, BA; Marques, VD; Peixoto-Santos, JE; Yacubian, EMT, 2023) |
| "Valproic acid (VPA) is a short-chain fatty acid widely prescribed in the treatment of seizure disorders and epilepsy syndromes, although its therapeutic value may be undermined by its toxicity." | 1.91 | Quantitative systems pharmacology Model to characterize valproic acid-induced hyperammonemia and the effect of L-carnitine supplementation. ( Fagiolino, P; Ibarra, M; Maldonado, C; Schiavo, A; Trocóniz, IF; Vázquez, M, 2023) |
| "Lithium carbonate was not associated with an increased risk of Parkinson-like events, but was related to these events in patients taking sodium valproate." | 1.72 | Relationship between lithium carbonate and the risk of Parkinson-like events in patients with bipolar disorders: A multivariate analysis using the Japanese adverse drug event report database. ( Nabekura, T; Uwai, Y, 2022) |
| " We investigated potential transgenerational adverse effects of valproate." | 1.72 | Transgenerational adverse effects of valproate? A patient report from 90 affected families. ( Bewley, S; Braillon, A; Hill, C; MacLennan, AH; Martin, M, 2022) |
| "Tremor is frequently observed in patients with epilepsy (PWE), which is generally attributed to the side-effect of antiepileptic drugs (AEDs) particularly valproate (VPA) with largely unknown mechanisms." | 1.51 | The clinical characteristics and related factors of tremor in patients with epilepsy. ( Chen, J; Jiang, X; Lu, L; Xiao, Y; Xiong, W; Zhang, Y; Zhou, D, 2019) |
| "Levetiracetam was independently associated with anger/aggression, nervousness/agitation, upset stomach, depression, and sleep disturbance; lamotrigine with nervousness/agitation, upset stomach, and difficulty concentrating; and valproic acid with upset stomach and shaky hands." | 1.43 | Specific adverse effects of antiepileptic drugs--A true-to-life monotherapy study. ( Fidzinski, P; Gaus, V; Holtkamp, M; Kowski, AB; Losch, F; Weissinger, F, 2016) |
| "Pulmonary fibrosis is the major limiting factor for the use of bleomycin." | 1.43 | Amelioration of bleomycin-induced lung fibrosis in rats by valproic acid and butyrate: Role of nuclear factor kappa-B, proinflammatory cytokines and oxidative stress. ( Elmaaboud, MAA; Kabel, AM; Omar, MS, 2016) |
| " When the results of CYP2C9 genotyping and CYP2C9 expression were combined, the patients' VPA-metabolizing capacity was predicted, and VPA dosing was adjusted to the patients' CYP2C9-status." | 1.42 | Clinical significance of CYP2C9-status guided valproic acid therapy in children. ( Bűdi, T; Garami, M; Háfra, E; Kiss, Á; Monostory, K; Nagy, A; Szever, Z; Tapodi, A; Temesvári, M; Tóth, K, 2015) |
| "Weight gain was found to be lower in the elderly for antipsychotic drugs, in particular for olanzapine." | 1.39 | Age and adverse drug reactions from psychopharmacological treatment: data from the AMSP drug surveillance programme in Switzerland. ( Baumann, P; Greil, W; Grohmann, R; Häberle, A; Schuhmann, T, 2013) |
| "Phospholipidosis (PLD) is a lysosomal storage disorder induced by compounds, notably cationic amphiphilic drugs, which although reversible interferes with cellular phospholipids." | 1.38 | In silico assay for assessing phospholipidosis potential of small druglike molecules: training, validation, and refinement using several data sets. ( Atzpodien, EA; Csato, M; Doessegger, L; Fischer, H; Lenz, B; Schmitt, G; Singer, T, 2012) |
| " We proposed a systematic classification scheme using FDA-approved drug labeling to assess the DILI potential of drugs, which yielded a benchmark dataset with 287 drugs representing a wide range of therapeutic categories and daily dosage amounts." | 1.37 | FDA-approved drug labeling for the study of drug-induced liver injury. ( Chen, M; Fang, H; Liu, Z; Shi, Q; Tong, W; Vijay, V, 2011) |
| "Numerous xenobiotics are toxic to human and animal cells by interacting with their metabolism, but the precise metabolic step affected and the biochemical mechanism behind such a toxicity often remain unknown." | 1.37 | Protocols and applications of cellular metabolomics in safety studies using precision-cut tissue slices and carbon 13 NMR. ( Baverel, G; Duplany, A; El Hage, M; Faiz, H; Ferrier, B; Gauthier, C; Martin, G; Renault, S, 2011) |
| "A 32-year-old comatose woman was admitted to the ICU at our hospital; she suffered from hypotension, respiratory depression, hypoglycaemia, sinus bradycardia, hyperammonaemia, metabolic acidosis, and her core body temperature was 33." | 1.35 | Severe valproic acid intoxication: case study on the unbound fraction and the applicability of extracorporeal elimination. ( Meulenbelt, J; Sikma, MA; van den Broek, MP; Ververs, TF, 2009) |
| "As pharmacokinetic drug interactions frequently cause adverse events, it is important that the relevant information is given in package inserts (PIs)." | 1.34 | Adverse events caused by drug interactions involving glucuronoconjugates of zidovudine, valproic acid and lamotrigine, and analysis of how such potential events are discussed in package inserts of Japan, UK and USA. ( Hasegawa, R; Hirata-Koizumi, M; Miyake, S; Saito, M, 2007) |
| "Post-ERCP pancreatitis was defined as abdominal pain and/or vomiting associated with amylase/lipase plasma levels equal to or greater than twice the upper normal value." | 1.32 | Are drugs a risk factor of post-ERCP pancreatitis? ( Bauret, P; Berthier, E; Blanc, F; Blayac, JP; Fabbro-Peray, P; Hanslik, B; Hillaire-Buys, D; Larrey, D; Melki, M; Pageaux, GP; Perney, P; Roques, V, 2003) |
| "5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects." | 1.32 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. ( Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 6 (10.34) | 18.7374 |
| 1990's | 3 (5.17) | 18.2507 |
| 2000's | 13 (22.41) | 29.6817 |
| 2010's | 24 (41.38) | 24.3611 |
| 2020's | 12 (20.69) | 2.80 |
| Authors | Studies |
|---|---|
| Matthews, EJ | 1 |
| Kruhlak, NL | 1 |
| Weaver, JL | 1 |
| Benz, RD | 1 |
| Contrera, JF | 1 |
| Pedersen, JM | 1 |
| Matsson, P | 1 |
| Bergström, CA | 1 |
| Norinder, U | 1 |
| Hoogstraate, J | 1 |
| Artursson, P | 1 |
| Chen, M | 1 |
| Vijay, V | 1 |
| Shi, Q | 2 |
| Liu, Z | 2 |
| Fang, H | 2 |
| Tong, W | 2 |
| Dawson, S | 1 |
| Stahl, S | 1 |
| Paul, N | 1 |
| Barber, J | 1 |
| Kenna, JG | 1 |
| Fischer, H | 1 |
| Atzpodien, EA | 1 |
| Csato, M | 1 |
| Doessegger, L | 1 |
| Lenz, B | 1 |
| Schmitt, G | 1 |
| Singer, T | 1 |
| Ding, D | 1 |
| Kelly, R | 1 |
| Sakatis, MZ | 1 |
| Reese, MJ | 1 |
| Harrell, AW | 1 |
| Taylor, MA | 1 |
| Baines, IA | 1 |
| Chen, L | 1 |
| Bloomer, JC | 1 |
| Yang, EY | 1 |
| Ellens, HM | 1 |
| Ambroso, JL | 1 |
| Lovatt, CA | 1 |
| Ayrton, AD | 1 |
| Clarke, SE | 1 |
| Martin, M | 1 |
| Hill, C | 1 |
| Bewley, S | 1 |
| MacLennan, AH | 1 |
| Braillon, A | 1 |
| Wartman, C | 1 |
| VandenBerg, A | 1 |
| Uwai, Y | 1 |
| Nabekura, T | 1 |
| Delage, C | 2 |
| Palayer, M | 2 |
| Etain, B | 2 |
| Hagenimana, M | 2 |
| Blaise, N | 2 |
| Smati, J | 2 |
| Chouchana, M | 2 |
| Bloch, V | 2 |
| Besson, VC | 2 |
| Schiavo, A | 1 |
| Maldonado, C | 1 |
| Vázquez, M | 1 |
| Fagiolino, P | 1 |
| Trocóniz, IF | 1 |
| Ibarra, M | 1 |
| Marques, VD | 1 |
| Hackbart, BA | 1 |
| Guilhoto, LM | 1 |
| Duarte, JTC | 1 |
| Peixoto-Santos, JE | 1 |
| Yacubian, EMT | 1 |
| Bittar Guaranha, MS | 1 |
| Li, Y | 1 |
| Zhan, H | 1 |
| Wu, J | 1 |
| Yu, J | 1 |
| Cao, G | 1 |
| Wu, X | 1 |
| Guo, B | 1 |
| Liu, X | 1 |
| Fan, Y | 1 |
| Hu, J | 1 |
| Li, X | 2 |
| Wu, H | 1 |
| Wang, Y | 1 |
| Chen, Y | 1 |
| Xu, X | 1 |
| Yu, P | 1 |
| Zhang, J | 1 |
| Ingram, EE | 1 |
| Bocklud, BE | 1 |
| Corley, SC | 1 |
| Granier, MA | 1 |
| Neuchat, EE | 1 |
| Ahmadzadeh, S | 1 |
| Shekoohi, S | 1 |
| Kaye, AD | 1 |
| Ramakrishnan, K | 1 |
| Kesavan, R | 1 |
| Venkatraman, S | 1 |
| Narayan, SK | 1 |
| Kumar, RR | 1 |
| Shewade, D | 1 |
| Kumar, S | 1 |
| Sarangi, SC | 1 |
| Tripathi, M | 1 |
| Gupta, YK | 1 |
| Choi, SA | 1 |
| Kim, H | 1 |
| Kim, S | 1 |
| Yoo, S | 1 |
| Yi, S | 1 |
| Jeon, Y | 1 |
| Hwang, H | 1 |
| Kim, KJ | 1 |
| Müller, RM | 1 |
| Herziger, B | 1 |
| Jeschke, S | 1 |
| Neininger, MP | 1 |
| Bertsche, T | 1 |
| Bertsche, A | 1 |
| Misra, UK | 1 |
| Dubey, D | 1 |
| Kalita, J | 1 |
| Meijboom, RW | 1 |
| Grootens, KP | 1 |
| Gillinder, L | 1 |
| Lehn, A | 1 |
| Brown, H | 1 |
| Dionisio, S | 1 |
| Zhu, X | 1 |
| Zhang, T | 1 |
| Zhao, L | 1 |
| Koristkova, B | 1 |
| Grundmann, M | 1 |
| Brozmanova, H | 1 |
| Kacirova, I | 1 |
| Kessler, SK | 1 |
| McGinnis, E | 1 |
| Xiao, Y | 1 |
| Xiong, W | 1 |
| Lu, L | 1 |
| Chen, J | 1 |
| Zhang, Y | 1 |
| Jiang, X | 1 |
| Zhou, D | 1 |
| Greil, W | 1 |
| Häberle, A | 1 |
| Schuhmann, T | 1 |
| Grohmann, R | 1 |
| Baumann, P | 1 |
| Vella, T | 1 |
| Mifsud, J | 1 |
| Star, K | 1 |
| Edwards, IR | 1 |
| Choonara, I | 2 |
| Bűdi, T | 1 |
| Tóth, K | 1 |
| Nagy, A | 1 |
| Szever, Z | 1 |
| Kiss, Á | 1 |
| Temesvári, M | 1 |
| Háfra, E | 1 |
| Garami, M | 1 |
| Tapodi, A | 1 |
| Monostory, K | 1 |
| Birur, B | 1 |
| Fargason, RE | 1 |
| Moore, N | 1 |
| Kowski, AB | 1 |
| Weissinger, F | 1 |
| Gaus, V | 1 |
| Fidzinski, P | 1 |
| Losch, F | 1 |
| Holtkamp, M | 1 |
| Kabel, AM | 1 |
| Omar, MS | 1 |
| Elmaaboud, MAA | 1 |
| Churchwell, MD | 1 |
| Pasko, DA | 1 |
| Smoyer, WE | 1 |
| Mueller, BA | 1 |
| Gilad, R | 1 |
| Izkovitz, N | 1 |
| Dabby, R | 1 |
| Rapoport, A | 1 |
| Sadeh, M | 1 |
| Weller, B | 1 |
| Lampl, Y | 1 |
| van den Broek, MP | 1 |
| Sikma, MA | 1 |
| Ververs, TF | 1 |
| Meulenbelt, J | 1 |
| de Leon, J | 1 |
| Kiesel, JL | 1 |
| Fleming, MW | 1 |
| Strobl, B | 1 |
| Waszkielewicz, A | 1 |
| Szkaradek, N | 1 |
| Pękala, E | 1 |
| Galzarano, F | 1 |
| Marona, H | 1 |
| Swoboda, KJ | 1 |
| Scott, CB | 1 |
| Crawford, TO | 1 |
| Simard, LR | 1 |
| Reyna, SP | 1 |
| Krosschell, KJ | 1 |
| Acsadi, G | 1 |
| Elsheik, B | 1 |
| Schroth, MK | 1 |
| D'Anjou, G | 1 |
| LaSalle, B | 1 |
| Prior, TW | 1 |
| Sorenson, SL | 1 |
| Maczulski, JA | 1 |
| Bromberg, MB | 1 |
| Chan, GM | 1 |
| Kissel, JT | 1 |
| Baverel, G | 1 |
| Renault, S | 1 |
| Faiz, H | 1 |
| El Hage, M | 1 |
| Gauthier, C | 1 |
| Duplany, A | 1 |
| Ferrier, B | 1 |
| Martin, G | 1 |
| Samalin, L | 1 |
| Nourry, A | 1 |
| Llorca, PM | 1 |
| Prohaska, ES | 1 |
| Muzyk, AJ | 1 |
| Rivelli, SK | 1 |
| Clarkson, A | 1 |
| Johannessen, CU | 1 |
| Johannessen, SI | 1 |
| Perney, P | 1 |
| Berthier, E | 1 |
| Pageaux, GP | 1 |
| Hillaire-Buys, D | 1 |
| Roques, V | 1 |
| Fabbro-Peray, P | 1 |
| Melki, M | 1 |
| Hanslik, B | 1 |
| Bauret, P | 1 |
| Larrey, D | 1 |
| Blayac, JP | 1 |
| Blanc, F | 1 |
| Hirata-Koizumi, M | 1 |
| Saito, M | 1 |
| Miyake, S | 1 |
| Hasegawa, R | 1 |
| Soriano, AO | 1 |
| Yang, H | 1 |
| Faderl, S | 1 |
| Estrov, Z | 1 |
| Giles, F | 1 |
| Ravandi, F | 1 |
| Cortes, J | 1 |
| Wierda, WG | 1 |
| Ouzounian, S | 1 |
| Quezada, A | 1 |
| Pierce, S | 1 |
| Estey, EH | 1 |
| Issa, JP | 1 |
| Kantarjian, HM | 1 |
| Garcia-Manero, G | 1 |
| Jinjuvadia, K | 1 |
| Kwan, W | 1 |
| Fontana, RJ | 1 |
| Kozu, T | 1 |
| McQueen, EG | 1 |
| Vereczkey, L | 1 |
| Park, BK | 1 |
| Pirmohamed, M | 1 |
| Kitteringham, NR | 1 |
| Beach, JE | 1 |
| Faich, GA | 1 |
| Bormel, FG | 1 |
| Sasinowski, FJ | 1 |
| Wardell, WM | 1 |
| Tsianco, MC | 1 |
| Anavekar, SN | 1 |
| Davis, HT | 1 |
| Dobrilla, G | 2 |
| Felder, M | 2 |
| Chilovi, F | 2 |
| Lauterburg, BH | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Multi-center Phase II Trial of Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy (SMA CARNI-VAL Trial)[NCT00227266] | Phase 2 | 94 participants (Actual) | Interventional | 2005-09-30 | Completed | ||
| Phase 0 Clinical Trial With Valproic Acid as a Chemopreventive Agent in Patients With Head and Neck Squamous Cell Carcinoma Previously Treated[NCT02608736] | Early Phase 1 | 42 participants (Actual) | Interventional | 2015-12-31 | Completed | ||
| Phase II Study of the Combination of 5-azacytidine With Valproic Acid and All-trans Retinoic Acid in Patients With High Risk Myelodysplastic Syndrome and Acute Myelogenous Leukemia[NCT00326170] | Phase 2 | 34 participants (Actual) | Interventional | 2005-07-31 | Completed | ||
| Phase II Randomised Trial of 5-azacitidine Versus 5-azacitidine in Combination With Vorinostat in Patients With Acute Myeloid Leukaemia or High Risk Myelodysplastic Syndromes Ineligible for Intensive Chemotherapy[NCT01617226] | Phase 2 | 260 participants (Actual) | Interventional | 2012-09-30 | Completed | ||
| LabAlert: Enhancing Medication Safety Through Electronic Interventions to Improve Medication Safety[NCT00256386] | 800 participants | Interventional | 2004-01-31 | Completed | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed. (NCT00227266)
Timeframe: 1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)
| Intervention | mV (Mean) | |
|---|---|---|
| Baseline | 6 months | |
| Cohort 1a Sitters Placebo Then Treatment | 2.28 | 2.32 |
| Cohort 1b Sitters Treatment | 2.93 | 2.37 |
| Cohort 2 Standers and Walkers - Treatment | 5.52 | 6.56 |
The maximum Compound Motor Action Potential (CMAP) is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This is done multiple times, the outcome used is the highest peak, or response observed. (NCT00227266)
Timeframe: 1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)
| Intervention | mV (Median) | |
|---|---|---|
| Baseline | 6 months | |
| Cohort 1a Sitters Placebo Then Treatment | 1.91 | 1.44 |
| Cohort 1b Sitters Treatment | 2.2 | 1.8 |
| Cohort 2 Standers and Walkers - Treatment | 5.3 | 5.85 |
The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve. (NCT00227266)
Timeframe: 1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)
| Intervention | mVms (Mean) | |
|---|---|---|
| Baseline | 6 months | |
| Cohort 1a Sitters Placebo Then Treatment | 5.46 | 5.28 |
| Cohort 1b Sitters Treatment | 5.45 | 5.26 |
| Cohort 2 Standers and Walkers - Treatment | 14.85 | 16.26 |
The maximum Compound Motor Action Potential (CMAP) area is a measurement obtained through EMG testing that is associated with disease progression. In this study, we measure the maximum CMAP by stimulating one nerve in the hand and measuring the response of the muscle. This procedure is repeated multiple times. The maximum area is the response that results in the largest area under the response curve. (NCT00227266)
Timeframe: 1 month prior to official enrollment, beginning of study (0 months), 6 months, 12 months (data point not available)
| Intervention | mVms (Median) | |
|---|---|---|
| Baseline | 6 months | |
| Cohort 1a Sitters Placebo Then Treatment | 3.6 | 3.74 |
| Cohort 1b Sitters Treatment | 4.6 | 3.4 |
| Cohort 2 Standers and Walkers - Treatment | 13.65 | 16.85 |
Comparison of Modified Hammersmith Change from baseline to 6 months. Scores range from 0 to 40. A higher score indicates a better outcome. This scale is used to assess gross motor abilities of non-ambulant children with SMA in multiple research trials as well as in clinical settings. (NCT00227266)
Timeframe: 0 months, 6 months
| Intervention | Score (Mean) | ||
|---|---|---|---|
| Baseline visit (0 weeks) | 6 Month visit (V2) | Change from Baseline | |
| Cohort 1a Sitters Placebo Then Treatment | 20.0 | 20.6 | 0.6 |
| Cohort 1b Sitters Treatment | 16.6 | 16.8 | 0.2 |
"Baseline Modified Hammersmith Extend testing. The baseline test is the score they receive during their screening visits. This scale ranges from 0 to 56. A higher score indicates a better outcome.~This scale is used to assess gross motor abilities of children with SMA in multiple research trials as well as in clinical settings." (NCT00227266)
Timeframe: 1 month prior to enrollment, at enrollment (0 months)
| Intervention | Score (Mean) | |
|---|---|---|
| Modified Hammersmith Extend at S1 (-4 weeks) | Modified Hammersmith Extend at S2 (0 weeks) | |
| Cohort 2 Experimental | 47.0 | 48.3 |
Clinical activity of combination defined as: Complete Response (CR), bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/L or more and platelet count of 100x10^9 or more; Complete response without platelets (CRp), a complete response except for a platelet count less than 100x10^9 and transfusion independent; and Bone Marrow (BM) Response, bone marrow blast of 5% or less but without meeting the peripheral blood count criteria for (CR) or (CRp). (NCT00326170)
Timeframe: Up to 12 cycles of treatment (28 day cycles)
| Intervention | Participants (Number) | ||
|---|---|---|---|
| CR | CRp | BM | |
| VPA + 5-aza + ATRA | 12 | 3 | 7 |
12 reviews available for valproic acid and Adverse Drug Event
| Article | Year |
|---|---|
Valproate: Not All Boxed Warnings Are Created Equal.
Topics: Anticonvulsants; Chemical and Drug Induced Liver Injury; Drug Labeling; Drug-Related Side Effects an | 2022 |
Valproate, divalproex, valpromide: Are the differences in indications justified?
Topics: Bipolar Disorder; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Humans; Valproic Acid | 2023 |
Valproate, divalproex, valpromide: Are the differences in indications justified?
Topics: Bipolar Disorder; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Humans; Valproic Acid | 2023 |
Valproate, divalproex, valpromide: Are the differences in indications justified?
Topics: Bipolar Disorder; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Humans; Valproic Acid | 2023 |
Valproate, divalproex, valpromide: Are the differences in indications justified?
Topics: Bipolar Disorder; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Humans; Valproic Acid | 2023 |
Non-CGRP Antagonist/Non-Triptan Options for Migraine Disease Treatment: Clinical Considerations.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Antidepressive Agents; Calcium Channel Blockers; Drug-Relat | 2023 |
Dispensability of Annual Laboratory Follow-Up After More than 2 Years of Valproic Acid Use: A Systematic Review.
Topics: Anticonvulsants; Blood Cell Count; Clinical Enzyme Tests; Clinical Laboratory Techniques; Diagnostic | 2017 |
A Practical Guide to Treatment of Childhood Absence Epilepsy.
Topics: Anticonvulsants; Child; Child, Preschool; Drug-Related Side Effects and Adverse Reactions; Electroen | 2019 |
Interactions between valproic acid and quetiapine/olanzapine in the treatment of bipolar disorder and the role of therapeutic drug monitoring.
Topics: Anticonvulsants; Antipsychotic Agents; Benzodiazepines; Bipolar Disorder; Dibenzothiazepines; Drug I | 2014 |
Valproic acid and fatalities in children: a review of individual case safety reports in VigiBase.
Topics: Adverse Drug Reaction Reporting Systems; Anticonvulsants; Chemical and Drug Induced Liver Injury; Ch | 2014 |
[Lithium and anticonvulsants in bipolar depression].
Topics: Anticonvulsants; Antimanic Agents; Antipsychotic Agents; Bipolar Disorder; Clinical Trials as Topic; | 2011 |
Valproate: past, present, and future.
Topics: Animals; Anticonvulsants; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Epilep | 2003 |
[Drug-induced pancreatitis].
Topics: Anti-Infective Agents; Anti-Inflammatory Agents, Non-Steroidal; Antineoplastic Agents; Azathioprine; | 2007 |
The role of cytochrome P450 enzymes in hepatic and extrahepatic human drug toxicity.
Topics: Abnormalities, Drug-Induced; Acetaminophen; Chemical and Drug Induced Liver Injury; Cytochrome P-450 | 1995 |
[Drug damage to the liver: role of reactive metabolites and pharmacokinetics].
Topics: Acetaminophen; Amiodarone; Chemical and Drug Induced Liver Injury; Drug-Related Side Effects and Adv | 1985 |
5 trials available for valproic acid and Adverse Drug Event
| Article | Year |
|---|---|
Population pharmacokinetics and exposure-safety of lipophilic conjugates prodrug DP-VPA in healthy Chinese subjects for dose regime exploring.
Topics: Drug-Related Side Effects and Adverse Reactions; East Asian People; Epilepsy; Healthy Volunteers; Hu | 2023 |
Comparison of lacosamide versus sodium valproate in status epilepticus: A pilot study.
Topics: Acetamides; Administration, Intravenous; Adolescent; Adult; Aged; Aged, 80 and over; Anticonvulsants | 2017 |
Treatment of status epilepticus and acute repetitive seizures with i.v. valproic acid vs phenytoin.
Topics: Acute Disease; Adult; Aged; Anticonvulsants; Brain; Drug-Related Side Effects and Adverse Reactions; | 2008 |
SMA CARNI-VAL trial part I: double-blind, randomized, placebo-controlled trial of L-carnitine and valproic acid in spinal muscular atrophy.
Topics: Age Factors; Body Composition; Body Mass Index; Body Weight; Bone Density; Carnitine; Child; Child, | 2010 |
Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome.
Topics: Acetylation; Adolescent; Adult; Aged; Aged, 80 and over; Azacitidine; Child; Child, Preschool; DNA M | 2007 |
Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome.
Topics: Acetylation; Adolescent; Adult; Aged; Aged, 80 and over; Azacitidine; Child; Child, Preschool; DNA M | 2007 |
Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome.
Topics: Acetylation; Adolescent; Adult; Aged; Aged, 80 and over; Azacitidine; Child; Child, Preschool; DNA M | 2007 |
Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome.
Topics: Acetylation; Adolescent; Adult; Aged; Aged, 80 and over; Azacitidine; Child; Child, Preschool; DNA M | 2007 |
Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome.
Topics: Acetylation; Adolescent; Adult; Aged; Aged, 80 and over; Azacitidine; Child; Child, Preschool; DNA M | 2007 |
Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome.
Topics: Acetylation; Adolescent; Adult; Aged; Aged, 80 and over; Azacitidine; Child; Child, Preschool; DNA M | 2007 |
Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome.
Topics: Acetylation; Adolescent; Adult; Aged; Aged, 80 and over; Azacitidine; Child; Child, Preschool; DNA M | 2007 |
Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome.
Topics: Acetylation; Adolescent; Adult; Aged; Aged, 80 and over; Azacitidine; Child; Child, Preschool; DNA M | 2007 |
Safety and clinical activity of the combination of 5-azacytidine, valproic acid, and all-trans retinoic acid in acute myeloid leukemia and myelodysplastic syndrome.
Topics: Acetylation; Adolescent; Adult; Aged; Aged, 80 and over; Azacitidine; Child; Child, Preschool; DNA M | 2007 |
41 other studies available for valproic acid and Adverse Drug Event
| Article | Year |
|---|---|
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Topics: Adverse Drug Reaction Reporting Systems; Artificial Intelligence; Computers; Databases, Factual; Dru | 2004 |
Prediction and identification of drug interactions with the human ATP-binding cassette transporter multidrug-resistance associated protein 2 (MRP2; ABCC2).
Topics: Administration, Oral; Animals; Antineoplastic Agents; Antipsychotic Agents; Antiviral Agents; ATP Bi | 2008 |
FDA-approved drug labeling for the study of drug-induced liver injury.
Topics: Animals; Benchmarking; Biomarkers, Pharmacological; Chemical and Drug Induced Liver Injury; Drug Des | 2011 |
In vitro inhibition of the bile salt export pump correlates with risk of cholestatic drug-induced liver injury in humans.
Topics: Animals; ATP Binding Cassette Transporter, Subfamily B, Member 11; ATP-Binding Cassette Transporters | 2012 |
In silico assay for assessing phospholipidosis potential of small druglike molecules: training, validation, and refinement using several data sets.
Topics: Animals; Cattle; Cells, Cultured; Computer Simulation; Cornea; Drug-Related Side Effects and Adverse | 2012 |
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
Topics: Animals; Anti-Infective Agents; Anti-Inflammatory Agents; Chemical and Drug Induced Liver Injury; Da | 2011 |
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
Topics: Chemical and Drug Induced Liver Injury; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 Enzyme | 2012 |
Transgenerational adverse effects of valproate? A patient report from 90 affected families.
Topics: Abnormalities, Drug-Induced; Animals; Anticonvulsants; Cleft Lip; Cleft Palate; Drug-Related Side Ef | 2022 |
Relationship between lithium carbonate and the risk of Parkinson-like events in patients with bipolar disorders: A multivariate analysis using the Japanese adverse drug event report database.
Topics: Antimanic Agents; Bipolar Disorder; Drug-Related Side Effects and Adverse Reactions; Humans; Japan; | 2022 |
Quantitative systems pharmacology Model to characterize valproic acid-induced hyperammonemia and the effect of L-carnitine supplementation.
Topics: Ammonia; Anticonvulsants; Carnitine; Dietary Supplements; Drug Overdose; Drug-Related Side Effects a | 2023 |
Minimum effective sodium valproate dose in genetic generalized epilepsies.
Topics: Anticonvulsants; Drug-Related Side Effects and Adverse Reactions; Epilepsy, Generalized; Humans; Ret | 2023 |
Impact of
Topics: Case-Control Studies; Cytochrome P-450 CYP2C9; Drug-Related Side Effects and Adverse Reactions; Epil | 2023 |
Evaluation of adverse drug reaction profile of antiepileptic drugs in persons with epilepsy: A cross-sectional study.
Topics: Adolescent; Adult; Anticonvulsants; Benzodiazepines; Child; Cross-Sectional Studies; Drug-Related Si | 2020 |
Analysis of antiseizure drug-related adverse reactions from the electronic health record using the common data model.
Topics: Anticonvulsants; Common Data Elements; Drug-Related Side Effects and Adverse Reactions; Electronic H | 2020 |
Knowledge of epilepsy among German pharmacists.
Topics: Anticonvulsants; Carbamazepine; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Humans; L | 2021 |
Treatment outcomes after the introduction of a new seizure management protocol.
Topics: Adult; Anticonvulsants; Clinical Protocols; Drug-Related Side Effects and Adverse Reactions; Emergen | 2018 |
Risk Factors for Valproic Acid-induced Hyperammonaemia in Chinese Paediatric Patients with Epilepsy.
Topics: Age Factors; Ammonia; Anticonvulsants; Aspartate Aminotransferases; Chemical and Drug Induced Liver | 2018 |
Lamotrigine drug interactions in combination therapy and the influence of therapeutic drug monitoring on clinical outcomes in paediatric patients.
Topics: Adolescent; Anticonvulsants; Carbamazepine; Child; Child, Preschool; Czech Republic; Dose-Response R | 2019 |
The clinical characteristics and related factors of tremor in patients with epilepsy.
Topics: Activities of Daily Living; Adult; Anticonvulsants; Case-Control Studies; Drug-Related Side Effects | 2019 |
Age and adverse drug reactions from psychopharmacological treatment: data from the AMSP drug surveillance programme in Switzerland.
Topics: Adolescent; Adult; Adverse Drug Reaction Reporting Systems; Age Factors; Aged; Aged, 80 and over; An | 2013 |
Clinical significance of CYP2C9-status guided valproic acid therapy in children.
Topics: Adolescent; Anticonvulsants; Child; Child, Preschool; Cytochrome P-450 CYP2C9; Drug-Related Side Eff | 2015 |
Delayed-onset of psychopharmacologically induced priapism: A cautionary case report.
Topics: Adult; Antipsychotic Agents; Drug Interactions; Drug Substitution; Drug-Related Side Effects and Adv | 2015 |
Specific adverse effects of antiepileptic drugs--A true-to-life monotherapy study.
Topics: Adult; Aged; Anticonvulsants; Anxiety; Carbamazepine; Depression; Drug-Related Side Effects and Adve | 2016 |
Amelioration of bleomycin-induced lung fibrosis in rats by valproic acid and butyrate: Role of nuclear factor kappa-B, proinflammatory cytokines and oxidative stress.
Topics: Animals; Bleomycin; Butyrates; Cytokines; Drug Synergism; Drug Therapy; Drug Therapy, Combination; D | 2016 |
Enhanced clearance of highly protein-bound drugs by albumin-supplemented dialysate during modeled continuous hemodialysis.
Topics: Albumins; Animals; Carbamazepine; Cattle; Drug-Related Side Effects and Adverse Reactions; Hemodialy | 2009 |
Severe valproic acid intoxication: case study on the unbound fraction and the applicability of extracorporeal elimination.
Topics: Adult; Anticonvulsants; Charcoal; Coma; Drug-Related Side Effects and Adverse Reactions; Female; Gla | 2009 |
Valproic acid toxicity associated with low dose of aspirin and low total valproic acid levels: a case report.
Topics: Aspirin; Dose-Response Relationship, Drug; Drug Interactions; Drug-Related Side Effects and Adverse | 2009 |
The study of the lipophilicity of some aminoalkanol derivatives with anticonvulsant activity.
Topics: Animals; Anticonvulsants; Carbamazepine; Chromatography, Reverse-Phase; Chromatography, Thin Layer; | 2010 |
Protocols and applications of cellular metabolomics in safety studies using precision-cut tissue slices and carbon 13 NMR.
Topics: Adenosine Triphosphate; Animals; Drug-Related Side Effects and Adverse Reactions; Humans; Insulin; K | 2011 |
Levocarnitine-induced hypophosphatemia in a hemodialysis patient with acute valproic acid toxicity.
Topics: Adolescent; Anticonvulsants; Bipolar Disorder; Carnitine; Drug-Related Side Effects and Adverse Reac | 2012 |
Surveillance for fatal suspected adverse drug reactions in the UK.
Topics: Anesthetics; Anti-Bacterial Agents; Anticonvulsants; Antineoplastic Agents; Child; Drug-Related Side | 2002 |
Are drugs a risk factor of post-ERCP pancreatitis?
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Azathioprine; Cholangiopancreatography, Endoscopic Retro | 2003 |
Adverse events caused by drug interactions involving glucuronoconjugates of zidovudine, valproic acid and lamotrigine, and analysis of how such potential events are discussed in package inserts of Japan, UK and USA.
Topics: Area Under Curve; Communication; Disclosure; Drug Combinations; Drug Interactions; Drug Labeling; Dr | 2007 |
Searching for a needle in a haystack: use of ICD-9-CM codes in drug-induced liver injury.
Topics: Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Chemical and Drug Induced Li | 2007 |
New Zealand committee on adverse drug reactions: fifteenth annual report 1980.
Topics: Adult; Aged; Cimetidine; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Infant; Ma | 1981 |
Adverse Drug Reactions Advisory Committee: ADRAC report for 1980.
Topics: Adolescent; Adult; Aged; Agranulocytosis; Australia; Bronchial Spasm; Chemical and Drug Induced Live | 1982 |
Structure activity relationship in toxicology.
Topics: Anticonvulsants; Drug-Related Side Effects and Adverse Reactions; Pharmaceutical Preparations; Pharm | 1995 |
Black box warnings in prescription drug labeling: results of a survey of 206 drugs.
Topics: Angiotensin-Converting Enzyme Inhibitors; Drug Information Services; Drug Labeling; Drug-Related Sid | 1998 |
Postmarketing surveillance of new drugs: II. Case studies.
Topics: Azauridine; Bacteriuria; Contraceptives, Oral; Costs and Cost Analysis; Double-Blind Method; Drug-Re | 1979 |
[Proven relationship between drugs and pancreatitis].
Topics: Asparaginase; Azathioprine; Diuretics; Drug-Related Side Effects and Adverse Reactions; Estrogens; H | 1986 |
[Acute drug-induced pancreatitis].
Topics: Acute Disease; Asparaginase; Azathioprine; Chlorothiazide; Drug-Related Side Effects and Adverse Rea | 1985 |