Harriet Kang, MD
About Me
Harriet Kang, MD is an Ajunct Assistant Professor of Neurology at Mount Sinai Health System. Those seeking an epileptologist, please visit The Epilepsy Program.
Dr. Kang received her medical degree from The Johns Hopkins UniversitySchool of Medicine where she also completed her pediatrics residency. After this, Dr. Kang completed a residency in Neurology and Child Neurology, followed by a Fellowship in clinical Neurophysiology at the University of Minnesota Hospitals. Shedid an additional Fellowship at the Epilepsy Research Laboratory at the CornellUniversity Medical Center.
Prior to coming to the Mount Sinai Health System, Dr. Kang was an assistant professor of Neurology and Pediatrics and the Director ofthe Adult Seizure Clinic at the University of Wisconsin Hospital and Clinics, and shewas the Vice President of the Wisconsin Epilepsy Association. She was the Chief ofChild Neurology at Albany Medical College, and the associate director of theComprehensive Epilepsy Management Center and chief of the pediatric neurologyoutpatient clinic at Montefiore Medical Center in the Bronx. She came to Beth IsraelMedical Center (Now Mount Sinai Beth Israel) in 2005, and joined Mount Sinai in 2015 as a researcher and provider.
Dr. Steven Wolf and Dr. Patricia McGoldrick conducted all of their clinical researchwith Dr. Kang. Over the course of her impressive clinical career, Dr. Kang has alsoparticipated in numerous clinical trials and other research projects. She has beenan investigator on trials for topiramate, vigabatrin, felbamate, gabapentin,oxcarbazepine, tigabine, fosphenytoin, pregabalin, cannabidiol, diazepam buccalsoluble film, intranasal diazepam, inhaled alprazolam, intravenous and oralbrivaracetam, perampanel, and fenfluramine.
She serves on the Board of Directors of the Epilepsy Foundation of Northeast NewYork and on the Advisory Council for the New York State Office for People with Developmental Disabilities. Dr. Kang has dedicated her work to improving the livesof children and adults with epilepsy, through using the best treatments availableas well as seeking out investigational treatments in the hopes of better controllingthe seizures of not only her patients, but all of those living with epilepsy.
RESEARCH
RENYC:
Rare Epilepsies in New York City: Epidemiology and Health Outcomes.Improving Surveillance with Text Processing of Clinical Notes in Electronic HealthRecords
The central idea of our proposal is that text processing of clinical notes willimprove surveillance and epidemiology of the rare epilepsies. We will use the NYC-
CDRN to identify affected individuals using EHRs from multiple academic medicalcenters. We will describe the incidence, prevalence, comorbidities, mortality, andquality of ambulatory care for these individuals. Finally, we will develop,characterize, and disseminate specifications for searching text (a set of "regularexpressions") to find affected individuals in clinical notes.
PREVeNT
PReventing Epilepsy using Vigabatrin in iNfants with Tuberous sclerosis complex
The study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with TSCwho are less than 6 months of age prior to the onset of their first seizure. There aretwo hypotheses, (1) prophylactic treatment with Vigabatrin will prevent drug-resistant epilepsy in patients with TSC, and (2) Video EEG biomarkers can be foundto help identify patients at risk of developing drug-resistant epilepsy.
Neuropace
A Retrospective Chart Review of Patients Less than 18 Years of Age at the Time ofImplant with the RNS System Treated for Medically Intractable Epilepsy
Epilepsy is a common neurologic disorder of children and adolescents. Onepercent of children from birth to 17 years old are diagnosed with recurrentseizures. Adolescents with medically intractable partial onset seizures are at riskfor poor quality of life, including psychological symptoms, and this can belessened with better seizure control. The responsive neurostimulator (RNS)stimulator works like a pacemaker implanted in the brain. It is currently approvedby the FDA as an adjunctive therapy in reducing the frequency of seizures inindividuals 18 years of age and older with partial onset seizures who haveundergone diagnostic testing that localized no more than 2 epileptogenic foci, arerefractory to two or more antileptic medications, and currently have frequent anddisabling seizures (e.g., motor partial seizures, complex partial seizures, and/orsecondarily generalized seizures). The RNS system has demonstrated safety andeffectiveness in patients who average 3 or more disabling seizures per month.Physicians have used the RNS system in patients younger than 18 during the
course of clinical care. This study aims to use the safety and efficacy data fromthese patients' charts to support an expansion of the indication for use to includepatients under the age of 18.
A Learning Healthcare System for Pediatric Epilepsy
The goal of this study is to create a "learning healthcare system" for pediatricepilepsy, in which clinical data are collected, analyzed, and rapidly disseminated tochange practice and improve outcomes. The investigators have created a multi-centered collaborative group of pediatric epilepsy clinicians and researchers to (1)develop algorithms to identify individuals with specific sub-types of epilepsy, (2)create an active registry of children with epilepsy, (3) conduct five demonstrationprojects (three quality projects and two comparative effectiveness projects).
Retrospective SUDEP at Epilepsy Centers: A Case-Controlled Study
Through retrospective chart review, this study will compare cases of SuddenUnexpected Death in Epilepsy (SUDEP) against control cases to identify potentialrisk factors associated with SUDEP. Different epilepsy centers will participate inthe study where investigators will gather information from clinical charts, EEGvideo and videoEEG data, brain MRI, genetic studies, EKG's and laboratory resultsthat will allow them to identify high-risk groups. The goal of this research is torecognize patients at risk of SUDEP and start potential preventive measures thatwill eventually lead to greater seizure control.
Aquestive 160325
A Multicenter, Open Label Crossover Study to Assess the Pharmacokinetics andSafety of Diazepam Buccal Soluble Film (DBSF) in Pediatric Subjects with Epilepsy.
Diazepam is commonly used to treat a range of conditions, including seizures. Itcan be administered through many routes including by mouth. This study aims toassess the use of a new route of administration in pediatric patients with epilepsyduring the interictal state, and during the ictal/perictal state. The drug is approvedfor this population, but the new route is investigational. It is a soluble film that is
placed on the inside of the mouth on the cheek. The film can be applied during aseizure, or immediately after. There have been two studies in healthy subjects todetermine the amount of medication available in their blood, and one study hasbeen done to test dose-proportionality.
Acquestive 42-1703
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use ofDiazepam Buccal Soluble Film (DBSF) in Pediatric, Adolescent and Adult Subjectswith Epilepsy.
Acute repetitive seizures (ARS) including break through seizures, repetitiveseizures, and seizure clusters occur in a significant number of epilepsy patientswho are on established antiepileptic drug treatment. The only FDA approvedtreatment for ARS is Diastat Rectal Gel, a formulation of diazepam that must beadministered rectally. There is a need for diazepam that can be more easilyadministered at home and at school for patients with ARS. This study is a phase 3study looking at the long-term safety and tolerability of a novel route ofadministration of diazepam for ARS. The study drug is a soluble film that is placedinside the cheek of the subjects during ARS.
DIAZ.001.05
A 12-Month, Open-Label, Repeat-Dose Safety Study of NRL-1 In Epilepsy Subjects
This is an open-label study to evaluate diazepam administered into the nose forone year in subjects ages 6-65 experiencing seizure emergencies including acuterepetitive seizures (ARS). ARS is definied as intermittent increases of seizureactivity while on a stable regimen of antiepileptic drugs (AEDs). Diazepam givenintravenously (i.e., through a vein) has been used for over 30years for the treatmentof seizure emergencies, however a rectal gel formulation of diazepam calledDiastat is the current standard of care. Diastat is the only diazepam formulationthat is approved in the US for ARS. Due to the route of administration, the use ofDiastat has been limited primarily to children ages 2-12 years. The study product,NRL-1 was previously studied in health adults and based on the results, it is
estimated that diazepam exposure from the intranasal administration will becomparable to that seen in the rectal gel, but will present a more convenient routeof administration for patients and caregivers.
Eisai Inc. E2007-G000-410
Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel asMonotherapy or First Adjunctive Therapy in Subjects With Partial Onset SeizuresWith or Without Secondarily Generalized Seizures or With Primary GeneralizedTonic-Clonic Seizures.
Fycompa (perampanel) is an FDA approved add-on (adjunctive) therapy for thetreatment of primary generalized tonic-clonic seizures (formerly referred to asgrand mal seizures). Currently, there is limited information from clinical studiesregarding the use of perampanel as a first-line therapy; however, in clinicalpractice, doctors routinely prescribe antiepileptic drugs (AEDs) approved for add-on (adjunctive) use as a first-line therapy (monotherapy) or withdraw other drugsuntil the patient is only on one drug depending on their clinical response. Thisstudy looks to assess how long subjects stay on perampanel as a first-line therapyor as a first add-on therapy for either partial onset seizures or primary generalizedtonic-clonic seizures.
UCB Biopharma EP0065
A multicenter, open-label study to evaluate the pharmacokinetics, safety andtolerability of intravenous BRV in subjects ≥1 month to <16 years of age withepilepsy.
Epilepsy affects all races of both sexes at any age from the first hour of life toextreme old age. The prevalence of epilepsy is 1% to 2% of the population and 4%of pediatric population in those developed countries where they have beenstudied. The incidence of pediatric patients with Partial Onset Seizures (POS) isapproximately 16 to 80 per 100,000. Within the pediatric population, the incidenceis highest in children <5 years of age.
The existing treatment options for POS in the pediatric population generally followthe treatment options for adults with the same disorder; clinical experiencedemonstrates that children may have results comparable to adults withadministration of the conventional antiepileptic drugs (AEDs). More than 25% ofpediatric patients have inadequate seizure control on currently available AEDs orexperience significant adverse drug effects. There remains a need for potent AEDswith a positive benefit-risk profile in this population.
The study drug brivaracetam (Briviact, BRV), is currently approved for thetreatment of POS in ages 16 and older. The primary objective of this study is toevaluate the pharmacokinetics, safety, and tolerability of BRV administered as a15-minute IV infusion and iv bolus (up to 2-minute infusion) in subjects ≥1 month to<16 years of age with epilepsy.
UCB Biopharma N01266
Open-label, single-arm, multicenter, long-term study to evaluate safety and efficacyof brivaracetam used as adjunctive treatment in pediatric subjects with epilepsy.
The primary objective of this study is to provide long-term safety and tolerabilitydata on BRV in pediatric subjects with epilepsy, while providing access to BRV forsubjects who may benefit from long-term treatment.
Zogenix ZX008-1601
A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome(LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two FixedDoses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapyfor Seizures in Children and Adults with LGS, Followed by Part 2: An Open-labelExtension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS
This is a two part study of an investigation antiepileptic drug, fenfluraminehydrochloride (ZX008), for the adjunctive treatment of seizures in children andadults with Lennox Gastaut Syndrome. Part one of the study is a randomized,
placebo controlled, double blind trial which will last for one year, and the secondpart is an open label safety extension which will also last for one year.
Engage E-001 StATES
This is a double blind, placebo controlled study of STAP-001 in epilepsy patientswith predictable seizure patterns (i.e., patients who can reliable predict anoncoming seizure). STAP-001 is a hand-held, single-dose, single-use drug-devicecombination product. Oral inhalation through the product initiates the controlledrapid heating of a thin film of alprazolam to form a thermally generated, highly puredrug vapor. The vapor condenses into aerosol particles with a particle sizedistribution appropriate for efficient delivery to the deep lung. The rapid absorptionof the drug provides peak plasma levels in the systemic circulation within minutesafter administration. This method of delivery is very different from the methodsused for other benzodiazepines such as intravenous lorazepam and rectaldiazepam.
PUBLICATIONS
Ghatan SA, McGoldrick PE, Wolf SM, Kang H, and Kokoska M: “SurgicalManagement of Medically Refractory Epilepsy due to Early Childhood Stroke.”Journal of Neurosurgery: Pediatrics, 14(1): 58-67, 2014.
Shinnar S, Berg AT, Moshe SL, Kang H, Ballaban-Gil K, O’Dell C, Alemany M,Newstein D and Hauser WA: “What happens to children with epilepsy whoexperience aseizure recurrence after withdrawal of antileptic drugs?” Annals ofNeurology 40: 301-302, 1996
Shinnar S, Berg AT, Moshe SL, O’Dell C, Newstein D, Kang H, Goldensohn ES andHauser WA: “The risk of seizure recurrence following a first unprovoked afebrileseizure in childhood: An extended Follow-up.” Pediatrics 98: 216-225, 1996
Wolf S, Shinnar S, Kang H, Ballaban-Gil K, and Moshe SL: “Gabapentin toxicity inchildren manifesting as behavioral change.” Epilepsia 36: 1203-1205, 1995
O’Dell C, Maloney-Lutz K, Shinnar S, Ballaban-Gil K, Kang H, Lightstone L, ChesterL, Sinnott M, Moshe SL: “Protocol for ACTH administration in refractory childhoodseizures: Educational strategies.” Journal of Neuroscience Nursing 27: 363-369,1995
O’Dell C, Shinnar S, Eisenberg C, Ballaban-Gil K, Lightstone L, Clements P, Maloney-Lutz K, Kang H, Legatt A, Wysznski B, Moshe SL: “Comparison of outcomesbetween children and adults with psychogenic seizures.” Epilepsia 36 (suppl 4):149, 1995
Shinnar S and Kang H: “Idiosyncratic Phenobarbital toxicity mimicking aneurodegenerative disorder.” Journal of Epilepsy 7: 34-37, 1994
Shinnar S, Berg AT, Moshe SL, Kang H, O’Dell M, Goldensohn ES and Hauser WA:“Discontinuing antiepileptic drugs in children with epilepsy: A prospective study.”Annals of Neurology 35:534-545, 1994
Pelayo R, Barasch E, Kang H, Marion R, Moshe SL: “Progressively intractableseizures, focal alopecia and hemimegalencephaly.” Neurology 44(5): 969-971, 1994
Shinnar S, Berg At, Moshe SL, Kang H, Ballaban-Gil K, O’Dell c, Alemmany M,Newstein D and Hauser WA; “Long term outcomes of children with epilepsy afterwithdrawal of antileptic drugs.” Epilepsia 34 (suppl 8): 1994
O’Dell C, Ballaban-Gil K, Eisenberg C, Lightstone L, Clements P, Maloney-Lutz K,Kang H, Legatt A, Wysznksi B, Moshe SL and Shinnar S: “Characteristics ofpsychogenic seizures in children and adults.” Epilepsia 35 (suppl 8): 106, 1994
Berg AT, Steinschneider M, Kang H and Shinnar S: “Identifying complex features offebrile seizures: Medical review versus medical record review plus interview.”Journal of Epilepsy 6: 133-138, 1993
Pranzatelli MR, Kao PC, Tate ED, Chavez E, Chez M, Dobyns WB, Kang H, RothnerDA: “Antibodies to ACTH in opsoclonus-myoclonus.” Neuropediatrics 24(3): 131-133, 1993
Legatt AD, Ballaban-Gil K, Germano IM, Kang H, Shinnar S, Moshe SL:“Hippocampal spikes followed by inferior temporal spikes in patients with epilepsyof mesial temporal origin.” Neurology 43 (suppl 2): A304, 1993
Ballaban-Gil K, Shinnar S, Wolf S, Legatt A, Kang H, O’Dell C, Moshe SL:“Generalized seizures without electrographic correlate in young children.” Epilepsia34 (suppl 6): 82, 1993
Berg AT, Steinschneider M, Kang H and Shinnar S: “Classification of complexfeatures of febrile seizures: inter-rater agreement.” Epilepsia 33: 661-666, 1992
Shinnar S, Kang H, Berg AT, Moshe SL, Hauser WA and Goldensohn ES: “EEGAbnormalities in children with a first unprovoked seizure.” Epilepsia 31:653, 1990
Kang H and Shinnar S:“Phenobarbital toxicity presenting as a neurodegenerativesyndrome.” Epilepsia 31: 682, 1990
Kang H and Shinnar S: “ Discontinuing antiepileptic drug therapy in children withepilepsy.” In Hauser, WA, editor, Current Trends in Epilepsy, 2nd edition. EpilepsyFoundation of America, Landover MD, 1988
Rubin A and Kang H: “Neurology effects of Cyclosporin A toxicity.” Neurology 37:1072-1076, 1987
Dotson R, Dickinson L, Kang H and Dashieff R: “Effect of simultaneously ingestedmilk on phenytoin bioavailability.” Neurology 35: 1526-1527, 1985
Kang H and Kutt H: “Immunoassay techniques in the measurement of phenytoinlevels in uremic plasma.” Clinical Chemistry 30(6):1022, 1984
Kang H and Leppik IE: “Phenytoin binding in patients undergoing renaltransplantation.” Neurology 34: 83-86, 1984
Kang H and Chung RWM: “Animal models needed – Reye’s Syndrome.” Institute ofLaboratory Animal Resources News 26(2): 9-10, 1983
Moore GW, Hutchins GM, Brito JC and Kang H: “Congenital malformations of thesemilunar valves.” Human Pathology 11:367-372, 1980
Kang H and Mazzi E: “Apnea resulting from obstruction of the nares by an eyeshield.” Journal of Pediatrics 89:652, 1976
Language
Position
About Me
Harriet Kang, MD is an Ajunct Assistant Professor of Neurology at Mount Sinai Health System. Those seeking an epileptologist, please visit The Epilepsy Program.
Dr. Kang received her medical degree from The Johns Hopkins UniversitySchool of Medicine where she also completed her pediatrics residency. After this, Dr. Kang completed a residency in Neurology and Child Neurology, followed by a Fellowship in clinical Neurophysiology at the University of Minnesota Hospitals. Shedid an additional Fellowship at the Epilepsy Research Laboratory at the CornellUniversity Medical Center.
Prior to coming to the Mount Sinai Health System, Dr. Kang was an assistant professor of Neurology and Pediatrics and the Director ofthe Adult Seizure Clinic at the University of Wisconsin Hospital and Clinics, and shewas the Vice President of the Wisconsin Epilepsy Association. She was the Chief ofChild Neurology at Albany Medical College, and the associate director of theComprehensive Epilepsy Management Center and chief of the pediatric neurologyoutpatient clinic at Montefiore Medical Center in the Bronx. She came to Beth IsraelMedical Center (Now Mount Sinai Beth Israel) in 2005, and joined Mount Sinai in 2015 as a researcher and provider.
Dr. Steven Wolf and Dr. Patricia McGoldrick conducted all of their clinical researchwith Dr. Kang. Over the course of her impressive clinical career, Dr. Kang has alsoparticipated in numerous clinical trials and other research projects. She has beenan investigator on trials for topiramate, vigabatrin, felbamate, gabapentin,oxcarbazepine, tigabine, fosphenytoin, pregabalin, cannabidiol, diazepam buccalsoluble film, intranasal diazepam, inhaled alprazolam, intravenous and oralbrivaracetam, perampanel, and fenfluramine.
She serves on the Board of Directors of the Epilepsy Foundation of Northeast NewYork and on the Advisory Council for the New York State Office for People with Developmental Disabilities. Dr. Kang has dedicated her work to improving the livesof children and adults with epilepsy, through using the best treatments availableas well as seeking out investigational treatments in the hopes of better controllingthe seizures of not only her patients, but all of those living with epilepsy.
RESEARCH
RENYC:
Rare Epilepsies in New York City: Epidemiology and Health Outcomes.Improving Surveillance with Text Processing of Clinical Notes in Electronic HealthRecords
The central idea of our proposal is that text processing of clinical notes willimprove surveillance and epidemiology of the rare epilepsies. We will use the NYC-
CDRN to identify affected individuals using EHRs from multiple academic medicalcenters. We will describe the incidence, prevalence, comorbidities, mortality, andquality of ambulatory care for these individuals. Finally, we will develop,characterize, and disseminate specifications for searching text (a set of "regularexpressions") to find affected individuals in clinical notes.
PREVeNT
PReventing Epilepsy using Vigabatrin in iNfants with Tuberous sclerosis complex
The study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with TSCwho are less than 6 months of age prior to the onset of their first seizure. There aretwo hypotheses, (1) prophylactic treatment with Vigabatrin will prevent drug-resistant epilepsy in patients with TSC, and (2) Video EEG biomarkers can be foundto help identify patients at risk of developing drug-resistant epilepsy.
Neuropace
A Retrospective Chart Review of Patients Less than 18 Years of Age at the Time ofImplant with the RNS System Treated for Medically Intractable Epilepsy
Epilepsy is a common neurologic disorder of children and adolescents. Onepercent of children from birth to 17 years old are diagnosed with recurrentseizures. Adolescents with medically intractable partial onset seizures are at riskfor poor quality of life, including psychological symptoms, and this can belessened with better seizure control. The responsive neurostimulator (RNS)stimulator works like a pacemaker implanted in the brain. It is currently approvedby the FDA as an adjunctive therapy in reducing the frequency of seizures inindividuals 18 years of age and older with partial onset seizures who haveundergone diagnostic testing that localized no more than 2 epileptogenic foci, arerefractory to two or more antileptic medications, and currently have frequent anddisabling seizures (e.g., motor partial seizures, complex partial seizures, and/orsecondarily generalized seizures). The RNS system has demonstrated safety andeffectiveness in patients who average 3 or more disabling seizures per month.Physicians have used the RNS system in patients younger than 18 during the
course of clinical care. This study aims to use the safety and efficacy data fromthese patients' charts to support an expansion of the indication for use to includepatients under the age of 18.
A Learning Healthcare System for Pediatric Epilepsy
The goal of this study is to create a "learning healthcare system" for pediatricepilepsy, in which clinical data are collected, analyzed, and rapidly disseminated tochange practice and improve outcomes. The investigators have created a multi-centered collaborative group of pediatric epilepsy clinicians and researchers to (1)develop algorithms to identify individuals with specific sub-types of epilepsy, (2)create an active registry of children with epilepsy, (3) conduct five demonstrationprojects (three quality projects and two comparative effectiveness projects).
Retrospective SUDEP at Epilepsy Centers: A Case-Controlled Study
Through retrospective chart review, this study will compare cases of SuddenUnexpected Death in Epilepsy (SUDEP) against control cases to identify potentialrisk factors associated with SUDEP. Different epilepsy centers will participate inthe study where investigators will gather information from clinical charts, EEGvideo and videoEEG data, brain MRI, genetic studies, EKG's and laboratory resultsthat will allow them to identify high-risk groups. The goal of this research is torecognize patients at risk of SUDEP and start potential preventive measures thatwill eventually lead to greater seizure control.
Aquestive 160325
A Multicenter, Open Label Crossover Study to Assess the Pharmacokinetics andSafety of Diazepam Buccal Soluble Film (DBSF) in Pediatric Subjects with Epilepsy.
Diazepam is commonly used to treat a range of conditions, including seizures. Itcan be administered through many routes including by mouth. This study aims toassess the use of a new route of administration in pediatric patients with epilepsyduring the interictal state, and during the ictal/perictal state. The drug is approvedfor this population, but the new route is investigational. It is a soluble film that is
placed on the inside of the mouth on the cheek. The film can be applied during aseizure, or immediately after. There have been two studies in healthy subjects todetermine the amount of medication available in their blood, and one study hasbeen done to test dose-proportionality.
Acquestive 42-1703
An Open-Label, Safety and Tolerability Study of Chronic Intermittent Use ofDiazepam Buccal Soluble Film (DBSF) in Pediatric, Adolescent and Adult Subjectswith Epilepsy.
Acute repetitive seizures (ARS) including break through seizures, repetitiveseizures, and seizure clusters occur in a significant number of epilepsy patientswho are on established antiepileptic drug treatment. The only FDA approvedtreatment for ARS is Diastat Rectal Gel, a formulation of diazepam that must beadministered rectally. There is a need for diazepam that can be more easilyadministered at home and at school for patients with ARS. This study is a phase 3study looking at the long-term safety and tolerability of a novel route ofadministration of diazepam for ARS. The study drug is a soluble film that is placedinside the cheek of the subjects during ARS.
DIAZ.001.05
A 12-Month, Open-Label, Repeat-Dose Safety Study of NRL-1 In Epilepsy Subjects
This is an open-label study to evaluate diazepam administered into the nose forone year in subjects ages 6-65 experiencing seizure emergencies including acuterepetitive seizures (ARS). ARS is definied as intermittent increases of seizureactivity while on a stable regimen of antiepileptic drugs (AEDs). Diazepam givenintravenously (i.e., through a vein) has been used for over 30years for the treatmentof seizure emergencies, however a rectal gel formulation of diazepam calledDiastat is the current standard of care. Diastat is the only diazepam formulationthat is approved in the US for ARS. Due to the route of administration, the use ofDiastat has been limited primarily to children ages 2-12 years. The study product,NRL-1 was previously studied in health adults and based on the results, it is
estimated that diazepam exposure from the intranasal administration will becomparable to that seen in the rectal gel, but will present a more convenient routeof administration for patients and caregivers.
Eisai Inc. E2007-G000-410
Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Perampanel asMonotherapy or First Adjunctive Therapy in Subjects With Partial Onset SeizuresWith or Without Secondarily Generalized Seizures or With Primary GeneralizedTonic-Clonic Seizures.
Fycompa (perampanel) is an FDA approved add-on (adjunctive) therapy for thetreatment of primary generalized tonic-clonic seizures (formerly referred to asgrand mal seizures). Currently, there is limited information from clinical studiesregarding the use of perampanel as a first-line therapy; however, in clinicalpractice, doctors routinely prescribe antiepileptic drugs (AEDs) approved for add-on (adjunctive) use as a first-line therapy (monotherapy) or withdraw other drugsuntil the patient is only on one drug depending on their clinical response. Thisstudy looks to assess how long subjects stay on perampanel as a first-line therapyor as a first add-on therapy for either partial onset seizures or primary generalizedtonic-clonic seizures.
UCB Biopharma EP0065
A multicenter, open-label study to evaluate the pharmacokinetics, safety andtolerability of intravenous BRV in subjects ≥1 month to <16 years of age withepilepsy.
Epilepsy affects all races of both sexes at any age from the first hour of life toextreme old age. The prevalence of epilepsy is 1% to 2% of the population and 4%of pediatric population in those developed countries where they have beenstudied. The incidence of pediatric patients with Partial Onset Seizures (POS) isapproximately 16 to 80 per 100,000. Within the pediatric population, the incidenceis highest in children <5 years of age.
The existing treatment options for POS in the pediatric population generally followthe treatment options for adults with the same disorder; clinical experiencedemonstrates that children may have results comparable to adults withadministration of the conventional antiepileptic drugs (AEDs). More than 25% ofpediatric patients have inadequate seizure control on currently available AEDs orexperience significant adverse drug effects. There remains a need for potent AEDswith a positive benefit-risk profile in this population.
The study drug brivaracetam (Briviact, BRV), is currently approved for thetreatment of POS in ages 16 and older. The primary objective of this study is toevaluate the pharmacokinetics, safety, and tolerability of BRV administered as a15-minute IV infusion and iv bolus (up to 2-minute infusion) in subjects ≥1 month to<16 years of age with epilepsy.
UCB Biopharma N01266
Open-label, single-arm, multicenter, long-term study to evaluate safety and efficacyof brivaracetam used as adjunctive treatment in pediatric subjects with epilepsy.
The primary objective of this study is to provide long-term safety and tolerabilitydata on BRV in pediatric subjects with epilepsy, while providing access to BRV forsubjects who may benefit from long-term treatment.
Zogenix ZX008-1601
A Two-Part Study of ZX008 in Children and Adults with Lennox-Gastaut Syndrome(LGS); Part 1: A Randomized, Double-blind, Placebo-controlled Trial of Two FixedDoses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as Adjunctive Therapyfor Seizures in Children and Adults with LGS, Followed by Part 2: An Open-labelExtension to Assess Long-Term Safety of ZX008 in Children and Adults with LGS
This is a two part study of an investigation antiepileptic drug, fenfluraminehydrochloride (ZX008), for the adjunctive treatment of seizures in children andadults with Lennox Gastaut Syndrome. Part one of the study is a randomized,
placebo controlled, double blind trial which will last for one year, and the secondpart is an open label safety extension which will also last for one year.
Engage E-001 StATES
This is a double blind, placebo controlled study of STAP-001 in epilepsy patientswith predictable seizure patterns (i.e., patients who can reliable predict anoncoming seizure). STAP-001 is a hand-held, single-dose, single-use drug-devicecombination product. Oral inhalation through the product initiates the controlledrapid heating of a thin film of alprazolam to form a thermally generated, highly puredrug vapor. The vapor condenses into aerosol particles with a particle sizedistribution appropriate for efficient delivery to the deep lung. The rapid absorptionof the drug provides peak plasma levels in the systemic circulation within minutesafter administration. This method of delivery is very different from the methodsused for other benzodiazepines such as intravenous lorazepam and rectaldiazepam.
PUBLICATIONS
Ghatan SA, McGoldrick PE, Wolf SM, Kang H, and Kokoska M: “SurgicalManagement of Medically Refractory Epilepsy due to Early Childhood Stroke.”Journal of Neurosurgery: Pediatrics, 14(1): 58-67, 2014.
Shinnar S, Berg AT, Moshe SL, Kang H, Ballaban-Gil K, O’Dell C, Alemany M,Newstein D and Hauser WA: “What happens to children with epilepsy whoexperience aseizure recurrence after withdrawal of antileptic drugs?” Annals ofNeurology 40: 301-302, 1996
Shinnar S, Berg AT, Moshe SL, O’Dell C, Newstein D, Kang H, Goldensohn ES andHauser WA: “The risk of seizure recurrence following a first unprovoked afebrileseizure in childhood: An extended Follow-up.” Pediatrics 98: 216-225, 1996
Wolf S, Shinnar S, Kang H, Ballaban-Gil K, and Moshe SL: “Gabapentin toxicity inchildren manifesting as behavioral change.” Epilepsia 36: 1203-1205, 1995
O’Dell C, Maloney-Lutz K, Shinnar S, Ballaban-Gil K, Kang H, Lightstone L, ChesterL, Sinnott M, Moshe SL: “Protocol for ACTH administration in refractory childhoodseizures: Educational strategies.” Journal of Neuroscience Nursing 27: 363-369,1995
O’Dell C, Shinnar S, Eisenberg C, Ballaban-Gil K, Lightstone L, Clements P, Maloney-Lutz K, Kang H, Legatt A, Wysznski B, Moshe SL: “Comparison of outcomesbetween children and adults with psychogenic seizures.” Epilepsia 36 (suppl 4):149, 1995
Shinnar S and Kang H: “Idiosyncratic Phenobarbital toxicity mimicking aneurodegenerative disorder.” Journal of Epilepsy 7: 34-37, 1994
Shinnar S, Berg AT, Moshe SL, Kang H, O’Dell M, Goldensohn ES and Hauser WA:“Discontinuing antiepileptic drugs in children with epilepsy: A prospective study.”Annals of Neurology 35:534-545, 1994
Pelayo R, Barasch E, Kang H, Marion R, Moshe SL: “Progressively intractableseizures, focal alopecia and hemimegalencephaly.” Neurology 44(5): 969-971, 1994
Shinnar S, Berg At, Moshe SL, Kang H, Ballaban-Gil K, O’Dell c, Alemmany M,Newstein D and Hauser WA; “Long term outcomes of children with epilepsy afterwithdrawal of antileptic drugs.” Epilepsia 34 (suppl 8): 1994
O’Dell C, Ballaban-Gil K, Eisenberg C, Lightstone L, Clements P, Maloney-Lutz K,Kang H, Legatt A, Wysznksi B, Moshe SL and Shinnar S: “Characteristics ofpsychogenic seizures in children and adults.” Epilepsia 35 (suppl 8): 106, 1994
Berg AT, Steinschneider M, Kang H and Shinnar S: “Identifying complex features offebrile seizures: Medical review versus medical record review plus interview.”Journal of Epilepsy 6: 133-138, 1993
Pranzatelli MR, Kao PC, Tate ED, Chavez E, Chez M, Dobyns WB, Kang H, RothnerDA: “Antibodies to ACTH in opsoclonus-myoclonus.” Neuropediatrics 24(3): 131-133, 1993
Legatt AD, Ballaban-Gil K, Germano IM, Kang H, Shinnar S, Moshe SL:“Hippocampal spikes followed by inferior temporal spikes in patients with epilepsyof mesial temporal origin.” Neurology 43 (suppl 2): A304, 1993
Ballaban-Gil K, Shinnar S, Wolf S, Legatt A, Kang H, O’Dell C, Moshe SL:“Generalized seizures without electrographic correlate in young children.” Epilepsia34 (suppl 6): 82, 1993
Berg AT, Steinschneider M, Kang H and Shinnar S: “Classification of complexfeatures of febrile seizures: inter-rater agreement.” Epilepsia 33: 661-666, 1992
Shinnar S, Kang H, Berg AT, Moshe SL, Hauser WA and Goldensohn ES: “EEGAbnormalities in children with a first unprovoked seizure.” Epilepsia 31:653, 1990
Kang H and Shinnar S:“Phenobarbital toxicity presenting as a neurodegenerativesyndrome.” Epilepsia 31: 682, 1990
Kang H and Shinnar S: “ Discontinuing antiepileptic drug therapy in children withepilepsy.” In Hauser, WA, editor, Current Trends in Epilepsy, 2nd edition. EpilepsyFoundation of America, Landover MD, 1988
Rubin A and Kang H: “Neurology effects of Cyclosporin A toxicity.” Neurology 37:1072-1076, 1987
Dotson R, Dickinson L, Kang H and Dashieff R: “Effect of simultaneously ingestedmilk on phenytoin bioavailability.” Neurology 35: 1526-1527, 1985
Kang H and Kutt H: “Immunoassay techniques in the measurement of phenytoinlevels in uremic plasma.” Clinical Chemistry 30(6):1022, 1984
Kang H and Leppik IE: “Phenytoin binding in patients undergoing renaltransplantation.” Neurology 34: 83-86, 1984
Kang H and Chung RWM: “Animal models needed – Reye’s Syndrome.” Institute ofLaboratory Animal Resources News 26(2): 9-10, 1983
Moore GW, Hutchins GM, Brito JC and Kang H: “Congenital malformations of thesemilunar valves.” Human Pathology 11:367-372, 1980
Kang H and Mazzi E: “Apnea resulting from obstruction of the nares by an eyeshield.” Journal of Pediatrics 89:652, 1976