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Article ; Online: Reduced efficacy and risk of seizure aggravation when cannabidiol is used without clobazam.

Rogawski, Michael A

2019 Volume 103, Issue Pt A, Page(s) 106506

Language	English
Publishing date	2019-09-13
Publishing country	United States
Document type	Editorial
ZDB-ID	2010587-3
ISSN	1525-5069 ; 1525-5050
ISSN (online)	1525-5069
ISSN	1525-5050
DOI	10.1016/j.yebeh.2019.106506
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Article ; Online: A randomized, open-label, two-treatment crossover study to evaluate the effect of food on the pharmacokinetics of diazepam nasal spray in healthy adults.

Rogawski, Michael A / Slatko, Gary

Epilepsia

2022 Volume 64, Issue 2, Page(s) 364–373

Abstract: Objective: The pharmacokinetics of oral diazepam are affected by food, but food-effect studies have not been conducted for diazepam nasal spray because it is believed that most absorption occurs via the nasal mucosa. However, gastrointestinal side ... ...

Abstract	Objective: The pharmacokinetics of oral diazepam are affected by food, but food-effect studies have not been conducted for diazepam nasal spray because it is believed that most absorption occurs via the nasal mucosa. However, gastrointestinal side effects reported with nasal diazepam suggest that at least a portion of the drug may be absorbed enterally and thus subject to food effects. The objective of this study was to evaluate the possible effects of food on the pharmacokinetics of diazepam nasal spray in healthy adults. Methods: This randomized, open-label crossover study compared equal doses of diazepam nasal spray after an overnight fast and after a standardized high-fat, high-calorie breakfast. Each participant served as their own control, and there was a washout period of at least 21 days between treatments. Results: Twenty-four healthy adults enrolled in this study. Two participants withdrew consent, and two had pre-dose diazepam concentrations that exceeded the protocol-defined minimum after the washout period and were excluded from the final analysis population of 20 participants. Under fed conditions, the mean maximum plasma diazepam concentration was decreased by 48% (p < .0001) and the overall diazepam exposure during the first 4 h was reduced by 57% (p < .0001) compared with fasted conditions. The time to maximum plasma concentration was 4.0 h in the fed state compared with 2.0 h in the fasted state (p < .0001). At 2 h post-dose, diazepam concentrations were ≥150 ng/mL for 100% of the participants when in the fasted state and 30% when in the fed state. Significantly more participants experienced adverse events under fasted conditions (83.3%) than under fed conditions (54.5%; p = .0340). Significance: This study in healthy volunteers demonstrated that food significantly decreases and delays the absorption of diazepam dosed via nasal spray. Patients using diazepam nasal spray after eating may obtain diazepam concentrations that are below those needed for seizure control.
MeSH term(s)	Humans ; Adult ; Nasal Sprays ; Cross-Over Studies ; Diazepam ; Biological Availability ; Seizures ; Area Under Curve ; Administration, Oral
Chemical Substances	Nasal Sprays ; Diazepam (Q3JTX2Q7TU)
Language	English
Publishing date	2022-12-21
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	216382-2
ISSN	1528-1167 ; 0013-9580
ISSN (online)	1528-1167
ISSN	0013-9580
DOI	10.1111/epi.17459
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Zs.A 517: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Mechanisms of action of currently used antiseizure drugs.

Sills, Graeme J / Rogawski, Michael A

Neuropharmacology

2020 Volume 168, Page(s) 107966

Abstract: Antiseizure drugs (ASDs) prevent the occurrence of seizures; there is no evidence that they have disease-modifying properties. In the more than 160 years that orally administered ASDs have been available for epilepsy therapy, most agents entering ... ...

Abstract	Antiseizure drugs (ASDs) prevent the occurrence of seizures; there is no evidence that they have disease-modifying properties. In the more than 160 years that orally administered ASDs have been available for epilepsy therapy, most agents entering clinical practice were either discovered serendipitously or with the use of animal seizure models. The ASDs originating from these approaches act on brain excitability mechanisms to interfere with the generation and spread of epileptic hyperexcitability, but they do not address the specific defects that are pathogenic in the epilepsies for which they are prescribed, which in most cases are not well understood. There are four broad classes of such ASD mechanisms: (1) modulation of voltage-gated sodium channels (e.g. phenytoin, carbamazepine, lamotrigine), voltage-gated calcium channels (e.g. ethosuximide), and voltage-gated potassium channels [e.g. retigabine (ezogabine)]; (2) enhancement of GABA-mediated inhibitory neurotransmission (e.g. benzodiazepines, tiagabine, vigabatrin); (3) attenuation of glutamate-mediated excitatory neurotransmission (e.g. perampanel); and (4) modulation of neurotransmitter release via a presynaptic action (e.g. levetiracetam, brivaracetam, gabapentin, pregabalin). In the past two decades there has been great progress in identifying the pathophysiological mechanisms of many genetic epilepsies. Given this new understanding, attempts are being made to engineer specific small molecule, antisense and gene therapies that functionally reverse or structurally correct pathogenic defects in epilepsy syndromes. In the near future, these new therapies will begin a paradigm shift in the treatment of some rare genetic epilepsy syndromes, but targeted therapies will remain elusive for the vast majority of epilepsies until their causes are identified. This article is part of the special issue entitled 'New Epilepsy Therapies for the 21st Century - From Antiseizure Drugs to Prevention, Modification and Cure of Epilepsy'.
MeSH term(s)	Animals ; Anticonvulsants/metabolism ; Anticonvulsants/pharmacology ; Anticonvulsants/therapeutic use ; Calcium Channels/metabolism ; Epilepsy/drug therapy ; Epilepsy/metabolism ; Humans ; Ion Channels/metabolism ; Potassium Channels, Voltage-Gated/metabolism ; Receptors, GABA-A/metabolism ; Voltage-Gated Sodium Channels/metabolism
Chemical Substances	Anticonvulsants ; Calcium Channels ; Ion Channels ; Potassium Channels, Voltage-Gated ; Receptors, GABA-A ; Voltage-Gated Sodium Channels
Language	English
Publishing date	2020-01-14
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	218272-5
ISSN	1873-7064 ; 0028-3908
ISSN (online)	1873-7064
ISSN	0028-3908
DOI	10.1016/j.neuropharm.2020.107966
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Article ; Online: A fatty acid in the MCT ketogenic diet for epilepsy treatment blocks AMPA receptors.

Rogawski, Michael A

Brain : a journal of neurology

2016 Volume 139, Issue Pt 2, Page(s) 306–309

MeSH term(s)	Animals ; Decanoic Acids/metabolism ; Decanoic Acids/therapeutic use ; Female ; Male ; Receptors, AMPA/antagonists & inhibitors ; Receptors, AMPA/metabolism ; Seizures/drug therapy ; Seizures/metabolism
Chemical Substances	Decanoic Acids ; Receptors, AMPA
Language	English
Publishing date	2016-02
Publishing country	England
Document type	Comment ; Journal Article
ZDB-ID	80072-7
ISSN	1460-2156 ; 0006-8950
ISSN (online)	1460-2156
ISSN	0006-8950
DOI	10.1093/brain/awv369
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Article ; Online: A New SV2A Ligand for Epilepsy.

Rogawski, Michael A

Cell

2016 Volume 167, Issue 3, Page(s) 587

Abstract: Since the 1970s, racetams have been in use as cognitive enhancers. Levetiracetam was discovered to have antiseizure activity in animal models and was then found to bind to SV2A in synaptic and endocrine vesicles. Brivaracetam, an analog of levetiracetam, ...

Abstract	Since the 1970s, racetams have been in use as cognitive enhancers. Levetiracetam was discovered to have antiseizure activity in animal models and was then found to bind to SV2A in synaptic and endocrine vesicles. Brivaracetam, an analog of levetiracetam, was identified in a medicinal chemistry campaign with the objective of discovering analogs with higher affinity at racetam-binding sites and greater antiseizure potency.
MeSH term(s)	Animals ; Anticonvulsants/chemistry ; Anticonvulsants/metabolism ; Anticonvulsants/therapeutic use ; Binding Sites ; Epilepsies, Partial/drug therapy ; Epilepsy, Generalized/drug therapy ; Humans ; Ligands ; Membrane Glycoproteins/chemistry ; Nerve Tissue Proteins/chemistry ; Piracetam/analogs & derivatives ; Piracetam/chemistry ; Piracetam/therapeutic use ; Protein Binding ; Protein Conformation ; Pyrrolidinones/chemistry ; Pyrrolidinones/therapeutic use
Chemical Substances	Anticonvulsants ; Ligands ; Membrane Glycoproteins ; Nerve Tissue Proteins ; Pyrrolidinones ; SV2A protein, human (148845-93-6) ; etiracetam (230447L0GL) ; brivaracetam (U863JGG2IA) ; Piracetam (ZH516LNZ10)
Language	English
Publishing date	2016-10-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	187009-9
ISSN	1097-4172 ; 0092-8674
ISSN (online)	1097-4172
ISSN	0092-8674
DOI	10.1016/j.cell.2016.09.057
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Zs.A 1167: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MG 58: Show issues

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Article ; Online: Perampanel, a potent AMPA receptor antagonist, protects against tetramethylenedisulfotetramine-induced seizures and lethality in mice: comparison with diazepam.

Zolkowska, Dorota / Dhir, Ashish / Rogawski, Michael A

Archives of toxicology

2021 Volume 95, Issue 7, Page(s) 2459–2468

Abstract: Tetramethylenedisulfotetramine (TETS), a noncompetitive GABA ...

Abstract	Tetramethylenedisulfotetramine (TETS), a noncompetitive GABA
MeSH term(s)	Animals ; Anticonvulsants/pharmacology ; Bridged-Ring Compounds ; Diazepam/therapeutic use ; Diazepam/toxicity ; Mice ; Nitriles/toxicity ; Pyridones ; Receptors, AMPA ; Seizures/chemically induced ; Seizures/prevention & control
Chemical Substances	Anticonvulsants ; Bridged-Ring Compounds ; Nitriles ; Pyridones ; Receptors, AMPA ; tetramethylenedisulfotetramine (F6TS3WME05) ; perampanel (H821664NPK) ; Diazepam (Q3JTX2Q7TU)
Language	English
Publishing date	2021-04-29
Publishing country	Germany
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	124992-7
ISSN	1432-0738 ; 0340-5761
ISSN (online)	1432-0738
ISSN	0340-5761
DOI	10.1007/s00204-021-03053-9
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Article ; Online: Intranasal Allopregnanolone Confers Rapid Seizure Protection: Evidence for Direct Nose-to-Brain Delivery.

Zolkowska, Dorota / Wu, Chun-Yi / Rogawski, Michael A

Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics

2021 Volume 18, Issue 1, Page(s) 544–555

Abstract: Allopregnanolone, a positive modulator of ... ...

Abstract	Allopregnanolone, a positive modulator of GABA
MeSH term(s)	Administration, Intranasal ; Animals ; Anticonvulsants/administration & dosage ; Anticonvulsants/pharmacokinetics ; Anticonvulsants/therapeutic use ; Bicuculline/pharmacology ; Brain/metabolism ; Diazepam/administration & dosage ; Diazepam/therapeutic use ; Dose-Response Relationship, Drug ; Male ; Mice ; Midazolam/administration & dosage ; Midazolam/therapeutic use ; Pentylenetetrazole/pharmacology ; Picrotoxin/pharmacology ; Pregnanolone/administration & dosage ; Pregnanolone/pharmacokinetics ; Pregnanolone/therapeutic use ; Reflex, Righting/drug effects ; Seizures/chemically induced ; Seizures/drug therapy
Chemical Substances	Anticonvulsants ; Picrotoxin (124-87-8) ; Pregnanolone (BXO86P3XXW) ; Diazepam (Q3JTX2Q7TU) ; Midazolam (R60L0SM5BC) ; Pentylenetetrazole (WM5Z385K7T) ; Bicuculline (Y37615DVKC)
Language	English
Publishing date	2021-01-06
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2316693-9
ISSN	1878-7479 ; 1933-7213
ISSN (online)	1878-7479
ISSN	1933-7213
DOI	10.1007/s13311-020-00985-5
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Article ; Online: Diazepam buccal film for the treatment of acute seizures.

Rogawski, Michael A / Heller, Allen H

Epilepsy & behavior : E&B

2019 Volume 101, Issue Pt B, Page(s) 106537

Abstract: Benzodiazepines, including diazepam and midazolam, are the mainstay of treatment for seizure emergencies, including acute repetitive seizures. Nonparenteral dosage forms are used when parenteral (intravenous or intramuscular) dosing is not feasible. ... ...

Abstract	Benzodiazepines, including diazepam and midazolam, are the mainstay of treatment for seizure emergencies, including acute repetitive seizures. Nonparenteral dosage forms are used when parenteral (intravenous or intramuscular) dosing is not feasible. Currently available nonparenteral dosage forms have limitations in terms of usability, patient and caregiver acceptance, speed of action, and portability. Diazepam buccal film (DBF) is a compact, easily administered diazepam formulation. When placed onto the buccal mucosa inside the cheek, DBF adheres firmly and then rapidly dissolves, delivering diazepam transbucally and via the gastric route. In fasted healthy male volunteers, plasma levels were achieved rapidly after DBF placement in a linear dose-proportional fashion. Bioavailability in adult patients with epilepsy was not significantly different when DBF was applied interictally or periictally (within 5 min of a seizure). Diazepam buccal film was successfully placed and generally used without difficulty, even without patient cooperation immediately after a seizure. In a crossover comparative study with diazepam rectal gel (Diastat®) in adult patients with epilepsy, DBF performed equivalently to the rectal gel, but peak exposures were less variable. Diazepam buccal film is a convenient alternative for out-of-hospital treatment of seizure exacerbations. Proceedings of the 7th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures.
MeSH term(s)	Acute Disease ; Administration, Buccal ; Anticonvulsants/administration & dosage ; Anticonvulsants/therapeutic use ; Diazepam/administration & dosage ; Diazepam/therapeutic use ; Humans ; Seizures/drug therapy
Chemical Substances	Anticonvulsants ; Diazepam (Q3JTX2Q7TU)
Language	English
Publishing date	2019-11-05
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2010587-3
ISSN	1525-5069 ; 1525-5050
ISSN (online)	1525-5069
ISSN	1525-5050
DOI	10.1016/j.yebeh.2019.106537
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Zs.A 5289: Show issues

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Article ; Online: Determination of minimal steady-state plasma level of diazepam causing seizure threshold elevation in rats.

Dhir, Ashish / Rogawski, Michael A

Epilepsia

2018 Volume 59, Issue 5, Page(s) 935–944

Abstract: Objective: Diazepam, administered by the intravenous, oral, or rectal routes, is widely used for the management of acute seizures. Dosage forms for delivery of diazepam by other routes of administration, including intranasal, intramuscular, and ... ...

Abstract	Objective: Diazepam, administered by the intravenous, oral, or rectal routes, is widely used for the management of acute seizures. Dosage forms for delivery of diazepam by other routes of administration, including intranasal, intramuscular, and transbuccal, are under investigation. In predicting what dosages are necessary to terminate seizures, the minimal exposure required to confer seizure protection must be known. Here we administered diazepam by continuous intravenous infusion to obtain near-steady-state levels, which allowed an assessment of the minimal levels that elevate seizure threshold. Methods: The thresholds for various behavioral seizure signs (myoclonic jerk, clonus, and tonus) were determined with the timed intravenous pentylenetetrazol seizure threshold test in rats. Diazepam was administered to freely moving animals by continuous intravenous infusion via an indwelling jugular vein cannula. Blood samples for assay of plasma levels of diazepam and metabolites were recovered via an indwelling cannula in the contralateral jugular vein. Results: The pharmacokinetic parameters of diazepam following a single 80-μg/kg intravenous bolus injection were determined using a noncompartmental pharmacokinetic approach. The derived parameters V Significance: Diazepam elevates seizure threshold at steady-state plasma concentrations lower than previously recognized. The minimally effective plasma concentration provides a reference that may be considered when estimating the diazepam exposure required for acute seizure treatment.
MeSH term(s)	Animals ; Anticonvulsants/administration & dosage ; Anticonvulsants/blood ; Anticonvulsants/pharmacokinetics ; Diazepam/administration & dosage ; Diazepam/blood ; Diazepam/pharmacokinetics ; Dose-Response Relationship, Drug ; Male ; Rats ; Rats, Sprague-Dawley ; Seizures/drug therapy
Chemical Substances	Anticonvulsants ; Diazepam (Q3JTX2Q7TU)
Language	English
Publishing date	2018-04-06
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	216382-2
ISSN	1528-1167 ; 0013-9580
ISSN (online)	1528-1167
ISSN	0013-9580
DOI	10.1111/epi.14069
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Zs.A 517: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: The intrinsic severity hypothesis of pharmacoresistance to antiepileptic drugs.

Rogawski, Michael A

Epilepsia

2013 Volume 54 Suppl 2, Page(s) 33–40

Abstract: Pharmacoresistance to antiepileptic drugs (AEDs) is a barrier to seizure freedom for many persons with epilepsy. For nearly two decades, pharmacoresistance has been framed in terms of factors affecting the access of AEDs to their molecular targets in the ...

Abstract	Pharmacoresistance to antiepileptic drugs (AEDs) is a barrier to seizure freedom for many persons with epilepsy. For nearly two decades, pharmacoresistance has been framed in terms of factors affecting the access of AEDs to their molecular targets in the brain or the actions of the drugs on these targets. Shortcomings in this prevailing view led to the formulation of the intrinsic severity hypothesis of pharmacoresistance to AEDs, which is based on the recognition that there are neurobiologic factors that confer phenotypic variation among individuals with etiologically similar forms of epilepsy and postulates that more severe epilepsy is more difficult to treat with AEDs. In recent years, progress has been made identifying potential genetic mechanisms of variation in epilepsy severity, including subclinical mutations in ion channels that increase or reduce epilepsy severity in mice. Efforts are underway to identify clinically important genetic modifiers. If it can be demonstrated that such severity factors play a role in pharmacoresistance, treatments could be devised to reverse severity mechanisms. By overcoming pharmacoresistance, this new approach to epilepsy therapy may allow drug refractory patients to achieve seizure freedom without side effects.
MeSH term(s)	Animals ; Anticonvulsants/therapeutic use ; Drug Resistance/genetics ; Epilepsy/diagnosis ; Epilepsy/drug therapy ; Epilepsy/genetics ; Humans ; Multidrug Resistance-Associated Proteins/genetics ; Pharmacogenetics/methods ; Pharmacogenetics/trends ; Severity of Illness Index
Chemical Substances	Anticonvulsants ; Multidrug Resistance-Associated Proteins
Language	English
Publishing date	2013-05
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	216382-2
ISSN	1528-1167 ; 0013-9580
ISSN (online)	1528-1167
ISSN	0013-9580
DOI	10.1111/epi.12182
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