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Joint Session with ACOFP and Mayo Clinic

So One of Your Patients has Seizures?

William Tatum IV, DO

9/30/2015

Faculty Disclosure

• Financial Involvement So Someone You Know Has – National Board Affiliations (Neurophysiology) • ABCN, ACNS ? – Consultant/speaker’s bureau/honoraria • Demos Publishers, Springer Publishers – Research support William O. Tatum IV, DO, FAAN, FACNS • Brain Sentinel Professor of Neurology Mayo College of Medicine • Significant Financial Involvement creating a Senior Consultant conflict of interest Mayo Clinic in Florida Director, Epilepsy Monitoring Unit – None Jacksonville, Florida USA • Off label discussion – None

1 9/30/2015

KH is a 24 year old female with a prior Oligodendroglioma presents to the ED after 3 witnessed “grand mal” seizures. She is taking Buspar 10 mg PO TID, Xanax 1 mg PO TID, and Tegretol XR 400 mg PO BID with Epilepsy weekly attacks failing LTG and GBP.... • Definition: Epilepsy exists after a single unprovoked seizure when the risk of a recurrence is >60%.1 – Nearly 3 million people in U.S (50 million worldwide) – One epileptic seizure/life-time occurs in 1/10 people • Approximately 70% of adults with new-onset epilepsy have focal seizures. • The cause is unknown in 62%. – In the rest, stroke in 9%, trauma 9%, 6%, neurodegenerative dz 4%, static encephalopathy 3.5%, brain tumor 3%, and infection in 2%. – An age-related predisposition exists that reflects cause.

1. Fisher R et al. Epilepsia 2014;DOI: 10.1111/epi.12550 Does this patient have epilepsy? 2. French JA, Pedley TA. N Engl J Med 2008;359:166-76.

2 9/30/2015

Seizures are a Symptom EEG

• Sensitivity: (Low-moderate) – First recording is “+” IEDs in 29-55%. – Recovery is related to brain location (temporal v frontal). – Increases to 85% with repeated study, sleep deprivation, < 24 hrs. • Specificity: (Very high) – IEDs are rare in non-epileptic people (1-2%). – More common in kids (1.9-3.5%) than adults (0.2-0.5%). • Video-EEG: definitive means of diagnosis, • Brain malformations and infection during childhood classification, and characterization2. • Trauma and brain tumor in mid-life

• Stroke and dementia in later life 1. Pillai J, Sperling MR. Epilepsia 2006;47(suppl 1):14-22. 2. Tatum W O. J Clin Neurophys 2001;18(5):442-455.

Annegers JF. The Epidemiology of Epilepsy. In: Wyllie E, ed. The treatment of epilepsy: principles & practice. 3rd edition. Philadelphia: Lippincott Williams & Wilkins, 2001:165-72.

3 9/30/2015

A 58 y/o M awoke with a feeling “everything was spinning” worsened by head movement with concomitant nausea and sweating. No LOC was noted and he was A & O x3. A Treatment Plan

ED= Vertigo Newly EEG: rd Diagnosed 1st 2nd 3 Mono or Generalized Monotherapy Monotherapy Polytherapy Spike-waves

Told no Seizure freedom Video-EEG No Driving. No Side effects Monitoring Diagnosis: “Seizure D/O”. ASDs (Polytherapy) Epilepsy Neurostimulation Surgery Drug Couldn’t Ketogenic Diet get to work. (children) Resistant “Sick” Seizure reduction from CBZ EEG with bilateral myogenic artifact created by movement of the muscles of mastication (presumed chewing). Note brief “spikes” and polyphasic Minimize AED side effects artifact followed by an apparent “slow wave” at 1.5-2Hz. Parameters: longitudinal bipolar montage; sensitivity 7 uv; filters 1-70 Hz. Adapted from Wheless JW. Neurostimulation Therapy for Epilepsy. In: Wheless JW, Willmore LJ, Brumback RA, Optimize quality of life eds. Advanced Therapy in Epilepsy. Hamilton, Ontario: BC Decker, Inc. 2008. Tatum WO. www.epilepsy.com Clinical Corner September 2011. Tatum WO. Artifact-related epilepsy. Neurology 2012 (in press).

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Treatments The First Seizure as Epilepsy • ASD treatment renders 65- 85% seizure free.1 • Medical1 • Recurrence greatest in the – Seizure reduction 1st 2 years (21-45%). – SE reduction – Response to the first ASD predicts control.1 High Risk for Seizure: No • Non-medical2 – + risk factors double the Treatment – Neurostimulation3 likelihood & tx halves it. – Ketogenic Diet4 • Prior brain insult (level A) • Epileptiform EEG (level A)

1.Kwan P, Brodie MJ. Neurology 2003;60(Suppl 4):S2-S12. 2.Wiebe S et al. NEJM 2001;345:311-318. • Abnormal MRI (level B) 3.Cascino GD. Epilepsia 2008;49(Suppl 9):79-84. 4.Sirven J et al. Epilepsia 1999;40:1721-1726. • SE in 7-31% (level B)

Brodie MJ et al. Neurology 2012;78:1548–1554. Krumholz A et al. Neurology 2015;84:1705–1713. Hakami T, et al. Neurology 2013;81(10):920-7.

5 9/30/2015

Anti-Seizure Drugs Choose the Most Effective ASD

• None alter the course of the disease process (“AEDs”). • The mainstay of treatment in >90% of patients. • All current ASDs provide symptomatic treatment. • Choices1 – Effective in focal seizures 2/3rds of the time. – Conventional: PB, PHT, CBZ, VPA – Effective in generalized seizures 80-85% of the time. – Newer: LTG, TPM, GBP/PGB, OXC, LEV, ZNS, LCS, RUF, – Response to treatment has been stable over time. CLB, GVG, EZO, PER, ESLI [FBM, TGB] – Choice based on seizure type and epilepsy syndrome • All ASDs potentially have adverse events and none treat • Focal Epilepsy: Essentially all ASDs the non-seizure symptoms (neurocognitive/psychosocial). • Generalized Epilepsy: VPA, LTG, TPM, ETH (absence only) • No ASDs are truly prophylactic for prevention of epilepsy • Advantages of the newer ASDs include tolerability (due to trauma, stroke, brain tumor etc.). and the advantages of conventional ASDs is cost.

1. Marson A et al. The Lancet 2007;369:1000-1026. Mohanraj R, Brodie MJ. Eur J Neurol 2006;13:277–282. Kwan P, Schachter SC, Brodie MJ. N Engl J Med 2011;369:919–926.

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Consider Safety Women of Childbearing Potential

• Steven-Johnson Syndrome – Most of the ASDs • Childbearing potential 12-44 years old • – , , • Contraception • Organ Failure (e.g. hepatic) – , felbamate • Pregnancy • Depression – , , leviteracetam, , • Vitamin supplementation • Nephrolithiasis – Topiramate, zonisamide • Precautions • Visual loss – , ezogabine

• Weight Loss Harden CL, Hopp J, Ting TY, et al. Practice parameter update: management issues for women with epilepsy: focus on pregnancy (an – Felbamate, topiramate, zonisamide evidence-based review): obstetrical complications and change in seizure frequency: report of the Quality Standards Subcommittee and Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and • Weight Gain American Epilepsy Society. Neurology 2009;73:126-132. – , , perampanel, vigabatrin, valproate • Teratogenesis – All ASDs

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How Many Drugs Do You See? Spectrum of Use

40% • The brand of ASD should remain stable. Focal Generalized50% seizure reduction (Fomincusalplacebo) and Spectrum Not GeneralizedOXC Established 1 • Seizures or clinical toxicity may occur in some . 5 Carbamazepine EthosuximideTPM1 LevetiracLVTetam LPGacosamideB – Little data exists to justify safety. 35% 1 – Discrepancy exists with FDA position Oxcarbazepine RufiTGnBamide Ezogab30%ine ZN • FDA considers a “generic” drug “equivalent” to a Gabapentin Zonisamide S Perampa25%nel ts n Pregabalin LTG1 Valproic acid Pa brand with same amount of active ingredient. e ti ati GPB1 20% en – Identity, purity, quality, strength, dose P Topiramate ts 15% – Drug concentration time curve and maximum concentration Vigabatrin Felbamate 10% within 80-125% of reference Rx (+Spasms) 5% • “Generic AEDs should not be substituted for brand Eslicarbazepine 0% AEDs without knowledge of the patient and the Dose (mg) Phenobarbital attending physician.2” *New AEDs used as adjunctive therapy in patients refractory to stCloandardbazAaEDms in RCTs.

1. Lowe K et al. AAN Position Statement. Neurology 2007;68:1249-1250. Tatum WO. Current Treatment Neurology 2013 French JA, et al. Neurology. 2003;60:1631-1637. Slide courtesy of Jacqueline French, MD

8 9/30/2015

Genetic Generalized Epilepsy Juvenile Myoclonic Epilepsy

• Absence, myoclonic, • A 21 year old female has been out (clonic)-tonic-clonic late at night with her friends in college. She has been active in • Genetic influence sports and is a cheerleader at University of Florida. She may have • Common in children had someone slip something into her • Normal neuroimaging drink at the party. She recalls that she felt like she had been struck and intelligence several times with a lightening bolt and then “blacked out”. Her friends • Treatment responsive later noted that she had a “grand mal – ETH for CAE1,3 seizure” and suggested that she see – VPA1,3 (JAE, JME, GTC) you. – LEV, LTG, TPM, ZNS • What is her diagnosis? 1. Nadkarni S et al. Neurology 2005;64(suppl3):S2-S11. 2. Nicolson A et al. JNNP 2004;75:75-79. 3. Karceski S et al. Epilepsy & Behavior 2005;7:S1-S64.

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Consider Co-morbidities Encephalopathic Epilepsy

• Mental Health issues – Select: LTG, VPA, OXC, PGB • Clinical features – Avoid: PB, TPM, LEV, ZNS, PER – Cognitive impairment • Pain – Refractory seizures – Select: GBP, PGB, TPM, CBZ – Severe EEG abnormalities • Eating disorder: avoid drugs that impact weight • Seizures – Weight gain: VPA, GBP, PGB, CBZ, OXC, EZO – Mixed seizure types – Weight loss: TPM, ZNS, FBM – Generalized motor – Tonic and atonic • Hyponatremia (elderly, on diuretics) • Refractory to treatment • Quality of Life – Avoid: CBZ, OXC, ESLI (CBZ derivatives) often with recurrent injury • Limit ASDs • Cardiovascular risks (e.g. high ) – Broad spectrum ASDs • Side effect reduction – Avoid: CBZ, PHT (“inducers) – Surgical procedures • Minimize injury • Limit ED visitation Winesett P, Tatum WO. The Treatment of Epilepsy,6th edition, Chapter 21. In: W yllie, E, ed. Baltimore, Lippincott. 2016 (in press).

10 9/30/2015

Lennox-Gastaut Syndrome More than 30 ASDs Exist Globally

40 Lacosamide • A 28 year old mentally retarded 35 Pregabalin hispanic male experienced Third generation Tiagabine Topiramate episodes of “flinching” at 8 30 Gabapentin Felbamate months old. Development had Oxcarbazepine Lamotrigine global delay of milestone in Zonisamide 25 Vigabatrin development. Seizures occurred EDs A Valproate

multiple times daily and was given f Carbamazepine o 20

r

e Second generation a “steroid”. At 2 years old he Sulthiame b Chlordiazepoxide began to manifest multiple seizure m u N 15 types including “grand mal”, “petit Methsuximide mal”, “dropping”, “falls”, and 10 First generation Corticosteroids/ACTH “jerks”. He has failed 11 ASDs. 5 Phenytoin • What are his options? Phenobarbital Mephobarbital Borax 0 1850 1870 1890 1910 1930 1950 1970 1990 2010 Year of introduction

AES 2013 Page B. Pennell

11 9/30/2015

Vagus Nerve Stimulation Focal Epilepsy • VNS has efficacy equal to new ASDs in RCTs.1 • Guideline Subcommittee of the AAN.2 • Most common type in adults – Recommendation: VNS may be considered for seizures in children, for LGS- – > 60% of associated seizures, and for improving mood in adults with epilepsy (Level C). – Focal seizures with and without – VNS may be considered to have improved efficacy over time (Level C). impaired consciousness – Focal evolving to convulsion • Long Term Effectiveness Trial3 – Improvement in HRQoL compared with BMP. • Due to focal CNS “lesion” • VNS reduced cardiac electrical instability.4 • EEG may clarify seizure – T-wave alternans (biomarker for SUDEP) was reduced. classification. • Treatment – *Initial: CBZ, LTG, OXC – Alternate: LEV

*Karceski S et al. Epilepsy & Behavior 2005;7:S1-S64. Fisher RS, Handforth A. Neurology 1999;53:666-669. Morris GL et al. Neurology 2013;81(16):1453-1459. Ryvlin P et al. Epilepsia 2014;DOI: 10.1111/epi.12611. Schomer AC et al. Epilepsia 2014;55(12):1996-2002.

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Focal Epilepsy What About Driving?

• A 58 year old female is seen for a seizure disorder. She has HTN, DM, osteoporosis, DJD, and • State-specific driving hypercholesterolemia on Coumadin for a PE. She has not laws exist (3 mos- 1 yr.). had a “grand mal” seizure since she was 19 years old. • Epilepsy increases the • She thinks she is having 1-2 risk of MVAs (up to 7x).1 “mini-mal” seizures per month. She is on multiple medications • Fatalities rare (<0.2%).2 and has been followed by her PCP for 40 years on Dilantin® 400 mg PO daily. She see Neurology • Most patients with adds CBZ 800 mg po qD added epilepsy are controlled but levels are low (PHT= 7 ug/dl and CBZ 3.6 ug/dl); seizures with ASDs and drive. increased. • What do you do?

Lings S. Neurology 2001;57(3):435-9. Sheth S et al. Neurology 2004;63(6):1002-7.

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A 24 year old male comes to clinic with his girlfriend. She describes starring spells followed by erratic behavior. The patient denies a problem and states that his girlfriend is making things up to Drug Induction get back at him for getting her pregnant. MRI brain and EEG is normal.

• Reasons • Treatment depends on seizure frequency. – Non-compliance • In-patient VEM: – “Fast metabolizer” (20% of AA for 2C9 drugs). • 39-49% of seizures were recognized.1,2 – Reciprocal induction: both ASDs together lead to • 30% of people denied all seizures • 1 combined reduction in serum concentrations. 23% of people were aware of all their seizures. • Solution • Out-patient CAA-EEG: 3 – Transition to CBZ monotherapy (3A4, 2C9) • 62% of seizures were recognized. – Substitute a different ASD to PHT (2C9) • Left temporal and bitemporal Sz a predictor4

1. Blum D et al. Neurology 1996;47:260-4. 2. Kerling F et al. Epilepsy & Behav 2006;9:281-5. 3. Tatum WO. J Clin Neurophysiol 2001;18:14-9. 4. Langston ME, Tatum WO. Epilepsy Res 2015;109:163-168.

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What about Epilepsy and Pregnancy? ASDs-Hormonal Contraception

• Globally 15 million WWE = child-bearing age. Pregnancy Potential Safe • Seizures may increase in 25% – Uncontrolled GTC Sz can have devastating • Carbamazepine, OXC, Esli • Divalproex consequences (> 5 associated with lower IQ). • Phenobarbital • Ethosuximide – 10-fold increase in SUDEP in pregnant WWE. • Phenytoin • Gabapentin • MCM in 4-8% • Primidone • Lamotrigine^ • Topiramate* • Levetiracetam • VPA impairs cognitive development • Rufinamide • Zonisamide – 6 years post-partum • Clobazam • Tiagabine – Lower IQ (~ 10 IQ points) • Eslicarbazepine • Lacosamide – Dose-dependence > 800 mg/day • Perampanel • Vigabatrin *Potential inactivation at 200mg/day Tatum WO et al. Arch Intern Med 2004;5(1):137-45. • Ezogabine Montouris G. Curr Med Res Opin. 2005;21:693-701. Baker GA et al. IQ after in utero exposure to AEDs: a controlledcohort study. Neurology 2015;84:382-390. ^HC interaction with LTG reduction Meador KJ et al. NEAD Sutdy Group. A prospective observational study. Lancet Neurol 2013;12:244-252. Adab N et al. The long term outcome of children born to mothers with epilepsy. JNNP 2004;75:1575-1583.

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Prevalence of Major Malformations What about Pharmacogenomics?

General Population: 1.1%

Scheffer I, Epilepsy Currents 2011. Chung, JAMA 2014 . Influence on management (e.g. SCN1A, GLUT-1 def, GRIN2A) . Influence on ASD treatment consequences.

. Asians are at risk for TEN/SJS on CBZ when found to have a HLA-B 1502* allele.

. CYP2C genes (10q23.33) associated with PHT-related severe cutaneous reactions.

North American Pregnancy Registry Fall 2014 . HLA-B 1502* testing recommended in all Asians prior to starting CBZ and OXC.

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What’s Next in Line for “AEDs”? What About Weed?

• Schedule 1, illegal, ? harmful & no evidence for efficacy. • Treating chronic epilepsy is different than treating • Activates Endocannabinoid systems with receptors 1 (G- developing hyperexcitable networks in animal models. proteins) & 2 expressed in neocortex and hippocampus. – Animal models have shown benefit from canabidiol (CBD): No Controlled trials in humans yet. • Drugs that treat recurrent seizures may be ineffective – Anectdote: Charlotte Figi (Charlotte’s Web): extract high in /low in THC in preventing the development of a first seizure. • Adverse Events • Trials in patients with brain lesions (e.g. tumors and – Early use associated with poor cognitive development and younger first-episode psychosis. trauma) do not support the concept of prophylaxis. – Synthetics: “Spice” or “K-2” with MS changes, seizures, cardiotoxicity; JWH-018 with stroke. • Drugs • Questions remain whether ASD alternatives (e.g. anti- – Sativex® approved for spasticity/neuropathic pain in MS/cancer outside USA inflammatories, anti-oxidants, neuroprotectants or – 2013 FDA granted orphan drug status of CBD for Dravet syndrome (expanded access). inhibitors of neural sprouting can prevent epilepsy. – Safety/tolerability open-label trial with Epidiolex (plant liquid CBD multi-center Int’l peds study).

Collins T. Special Report: What Neurologists are doing about medical marijuana. Neurology Today 2014;14(8):28-33. Wilner AN. Medscape Neurology/ Epilepsy Notes. March 25, 2014.

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Drug Resistance Confirm the The Reasons Diagnosis

• Wrong Diagnosis • A 17 y/o boy grew up in a dysfunctional home environment. – Psychogenic (physiologic) NEA – Bizarre or another seizure type • He had a right craniotomy at 12 years for a parietal lesion (DNET) • Wrong Drug with subsequent CDH. – for seizure type – Drug interactions prevent use • Grand mal seizures began at age 13 years and he failed 5 ASDs. • Wrong Dose • He is taking LEV, TPM, KLN and – Too low (ie status) PB when he presents in serial – Side-effects limit use seizures/status epilepticus. • Wrong Lifestyle – Poor compliance • What is the next step? – Inappropriate lifestyle

Kwan P, Leung H. In:Therapeutic Strategies in Epilepsy. French J, Delanty N, eds. 2009:136.

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Avoid Wrong Drugs Inhibitor + Inducer • An 19 y/o male with migraine experienced his first “grand mal” seizure. He was partying the PM • Reason before. In the ED he was given IV – VPA and PHT are both highly protein bound ASDs and PHT and maintained on PHT 200 mg po BID (15 ug/dl). He compete for the carrier protein albumin. experience an increase in the – PHT free fractions rise (bioactive) with toxicity! “dropsies”. – The ASD with the higher concentration usually • In follow-up, VPA 250 mg po bid is predominates (VPA > PHT). added to PHT. VPA is increased to 1000 mg po q hs. He complains of • Solution dizziness, blurry vision and – Taper PHT difficulty walking. Levels are – Substitute an alternative ASD (e.g. LEV) “normal”. • What is going on?

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A 25 year old male developed jerks at age 12 years. GTC started at 14 years. Diagnosed with JME he remained refractory to ASDs despite VPA, LTG, LEV, and LCS. GTCs were monthly and he presented to clinic with a smartphone video. Compliance • SUComplianceDEP (24 x > gen. populus) • 1.1-3.8/1000 person years • Non-compliance is common. “Drugs– Young pedooplen’t20-work40 yearsif • 37% reported changing their – Males: females 7:4 behavior because of SUDEP you don’t take them.” disclosure. C. Everett Koop – Substance abuse – Included improved adherence – Epilepsy > 10 years to medication – potentially mitigating risk of – GTC seizures SUDEP. – Unattended/prone position • Most participants did not – MR/Symptomatic epilepsy report long-term anxiety (1/100) following disclosure.

Shorvon S, Tomson T. SUDEP. The Lancet 2011;378(9808), 2028-2038. http://www.epilepsyscotland.org.uk

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Drug-Resistance Phase 1 Evaluation N= 3895 patients-Temporal • Surgery Candidates1 Seizure free rates Results > 5 years • Structural (pathology) – Disabled by seizures* Pooled data if > 2 studies – Brain MRI – Drug-resistant Seizure free rates1 • High resolution (defined by the authors; follow-up ≥ 5 years; – Localized/surgically 70% 66% results pooled if > 2 studies) • Epilepsy protocol 61% 59% accessible. 60% • Functional (physiology) 50% 46% 46% – Healthy/motivated for surgery. s t in 40% 35% 34% – EEG (neuron) e t pa 30% 27% – MEG (neuron) 1-3 % • Selection . – Tractography (axons) 20% 16% – PET (metabolism) – Surgical techniques vary 10% – MRS (neurochemistry) among centers. 0% TL HEMI TL+EXTRA PAR OCCI CALLO* EXTRA TL FRONT MST – SPECT/SISCOM (rCBF) – fMRI (vascular) – Patient selection and TL: temporal lobe HEMI: hemispherectomy – Neuropsychological testing/Wada evaluations varies over time. TL+EXTRA: grouped temporal and extratemporal lobe (function) PAR: parietal lobe; OCCI: occipital lobe 1. Sperling MR et al. Neurology 1992;;42(2):416. 2.Quarato PP et al. JNNP CALLO: callosotomy – freedom from drop attacks 2005;76:815-824. 1.Engel J Jr et al. Neurology 2003;60:538-547. EXTRA TL: grouped extratemporal lobe 3.Cascino GD et al. MRI based volume studies. Ann Neurol 1991;30:31-36. FRONT: frontal lobe 2.Vlooswijk MCG et al. Neurology 2010;75:395-402. MST: multiple subpial transection 3.Kobayashi E et al. Epilespia 2009;50(12):2549-2556. Téllez-Zenteno JF, et al. Brain 2005;128:1188-9 ©2011 MFMER | slide-418. ©2011 MFMER | slide-42

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Phase 2 Evaluation Minimally Invasive Surgery • Minimally invasive Laser Applicator approaches may achieve seizure freedom yet minimize adverse effects. • It may be more attractive to patients (13/17 chose • 2-5 treatments/patients (mean= 3) in SLAH v open resection).1 mean of 9.6 minutes (+/- 6.4). • Workstation thermometry monitors • 80% were DC in < 24 hrs.2 target/collateral tissue. • Rapid irreversible brain ablation at 60 C (range 40-90 C) with localized heating of tissue with sharp boundaries. • Optical fibers and laser energy are MR 1. W illie JT et al. Neurosurgery 74:569–585, 2014 compatible to enable real-time feedback 2. Petito G, Tatum W O. Epilepsia 2015A. control of laser and tissue ablation. Slide Courtesy of Greg Cascino MD ©2011 MFMER | slide-44

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Intracranial RNS for DRLRE Quality Indicators in Epilepsy

1. Seizure frequency and seizure intervention specified each encounter. • Delivers stimulation in response to seizures. 2. Etiology, seizure type and epilepsy syndrome specified each visit. • 18 years old • 1-2 epileptogenic 3. Ask about side-effects to ASDs each visit. foci 4. Personalize safety issues/education yearly. • Drug-resistant 5. Screen for psychiatric health each visit. • Frequent disabling 6. Counsel women of childbearing yearly. seizures 7. Refer drug-resistant patients to a CEC q 2 years.

Fountain NB et al. Quality Improvement in Neurology: Epilepsy Update Quality Measurement Set. Neurology 2015;84(14):1483-1487. Heck, C et al. Epilepsia 2014; 22 FEB 2014; DOI: 10.1111/epi.12534

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Conclusions

• The treatment of epilepsy requires a definitive diagnosis and classification of seizure/epilepsy type. • Management is individualized and a shift toward the new ASDs has been based upon Pks and tolerability. Thankyou • Drug-resistance is a real problem and non-medical therapies should be considered as a standard of care. [email protected] • The future promises better diagnosis and treatment for patients with epilepsy.

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