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EPILEPSY Neuroscience Nursing Orientation Johns Hopkins Epilepsy Center Rebecca E. Fisher RN BSN CNRN Alison Griffiths RN ASN.

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Presentation on theme: "EPILEPSY Neuroscience Nursing Orientation Johns Hopkins Epilepsy Center Rebecca E. Fisher RN BSN CNRN Alison Griffiths RN ASN."— Presentation transcript:

1 EPILEPSY Neuroscience Nursing Orientation Johns Hopkins Epilepsy Center Rebecca E. Fisher RN BSN CNRN Alison Griffiths RN ASN

2 Seizure Disorder Definition Seizure Seizure –A transient disturbance in cerebral function due to paroxysmal neuronal discharges –Irritation and excitability Epilepsy Epilepsy –Occurrence of two or more seizures

3 Prevalence Single Seizure Single Seizure –10% of the US population Epilepsy Epilepsy –1-2% of the US population by the age of 20. It reaches 3% by the age of 75 –5 to 8 in 1000, of approximately 1.25 to 2 million people

4 Incidence Third most common neurological disorder Third most common neurological disorder –80% will respond well to treatment Intractable seizures 20-25% Intractable seizures 20-25% Febrile seizures in children 2-5% Febrile seizures in children 2-5% Close relatives of epilepsy patients have a threefold increase in incidence. Close relatives of epilepsy patients have a threefold increase in incidence. –5-10% inherited

5 Etiology Primary (idiopathic) Primary (idiopathic) –50% of all epilepsy Secondary (organic) Secondary (organic) –Birth trauma –Head trauma –Tumors –Infections –Biochemical –CVA –Degenerative Diseases

6 Terms Ictal Ictal –The time during a seizure Post Ictal Post Ictal –The time following a seizure Interictal Interictal –The time between seizures

7 International Classifications of Seizures Primary Generalized Epilepsy Primary Generalized Epilepsy –Involves both hemispheres at the start of the seizure (usually starts deep within the brain) Partial Epilepsy Partial Epilepsy –Involves a focal area of the brain that may or may not spread

8 Primary Generalized Seizures Absence- brief staring spells (3-5 secs) Absence- brief staring spells (3-5 secs) Myoclonic- abrupt brief jerking of limbs Myoclonic- abrupt brief jerking of limbs Clonic- muscle contraction and relaxing Clonic- muscle contraction and relaxing Tonic- stiffening, extension of limbs Tonic- stiffening, extension of limbs Atonic- drop attacks Atonic- drop attacks

9 Partial Epilepsy Simple (consciousness is not impaired) Simple (consciousness is not impaired) –Motor- abnormal movement of arm, leg, hand, and face –Somatosensory or special sensory- epigastric feeling, visual symptoms, smell, and auditory –Numbness or tingling in limb –Autonomic- tachycardia, flushing, and respiration –Psychic- déjà vu, and fear –Aura is a simple partial seizure

10 Partial Epilepsy Complex (consciousness is impaired) Complex (consciousness is impaired) –Most common in adult epilepsy population –May or may not start with simple partial –May see staring lasting seconds to minutes –May see semipurposeful repetitive movements (i.e. fumbling, lip smacking, swallowing, vocalizations, and wandering)

11 Evolving into Secondary Generalized Seizures May start as simple, or complex seizure, then progress to tonic-clonic movements. May start as simple, or complex seizure, then progress to tonic-clonic movements.

12 Psychogenic Seizures Seizures that originate from an emotional disorder rather than paroxysmal neuronal discharges. Seizures that originate from an emotional disorder rather than paroxysmal neuronal discharges. EEG will be normal EEG will be normal Patients can have a mixture of Epilepsy and Psychogenic seizure activity. Patients can have a mixture of Epilepsy and Psychogenic seizure activity.

13 Possible clinical signs Asymmetrical or thrashing of limbs, pelvic thrusting, side to side head movement, gradual onset, multiple manifestations, prolong duration, purposeful activity, initiation or termination by suggestion, lack of amnesia, little postictal period. Asymmetrical or thrashing of limbs, pelvic thrusting, side to side head movement, gradual onset, multiple manifestations, prolong duration, purposeful activity, initiation or termination by suggestion, lack of amnesia, little postictal period.

14 Treatment Varies depending on psychiatric diagnosis Varies depending on psychiatric diagnosis –Antidepressants –Psychotherapy –Relaxation techniques

15 First Aid Generalized Seizures Help to lying position with something soft under the head Help to lying position with something soft under the head Position to side if possible Position to side if possible Remove glasses and loosen tight clothing Remove glasses and loosen tight clothing Clear area of sharp or hard objects Clear area of sharp or hard objects Do not restrain of force anything in the mouth Do not restrain of force anything in the mouth Suction airway only if necessary Suction airway only if necessary Time event, check vitals and neuro status, examine for injuries, monitor until return to baseline Time event, check vitals and neuro status, examine for injuries, monitor until return to baseline

16 First Aid Complex Partial Seizures Stay with patient and ensure safety Stay with patient and ensure safety Clear area of sharp and hard objects Clear area of sharp and hard objects Do not restrain Do not restrain Monitor patient until return to baseline Monitor patient until return to baseline

17 Notification of MD New onset of seizures New onset of seizures Change in seizure type and frequency or duration Change in seizure type and frequency or duration Seizure > 5 minutes Seizure > 5 minutes Failure to return to baseline Failure to return to baseline

18 Status Epilepticus A seizure that persists for a sufficient period of time ( 10 minutes) or is repeated frequently so that recovery between attacks does not occur. Diagnosis for status is at 30 minutes. A seizure that persists for a sufficient period of time ( 10 minutes) or is repeated frequently so that recovery between attacks does not occur. Diagnosis for status is at 30 minutes. Patients in status may appear conscious Patients in status may appear conscious

19 Complications Shock Shock Hypoxia Hypoxia ICP ICP Acidosis Acidosis Fever Fever Arrythmia Arrythmia Hemorrhage Hemorrhage Neuronal Death Neuronal Death

20 Etiology Anticonvulsant withdrawal Anticonvulsant withdrawal Acute metabolic disturbances (hypoglycemia, hyponatremia, hypocalcemia) Acute metabolic disturbances (hypoglycemia, hyponatremia, hypocalcemia) CVA CVA CNS infection CNS infection CNS trauma CNS trauma Tumors Tumors

21 Treatment Anticonvulsant Anticonvulsant –Start with Benzodiazepines –Diazepam (Valium): 0.25mg/kg up to 20mg IV. Give slowly 1-2mg/min –**May also give rectally (Diastat-rectal gel) –Lorazepam (Ativan) 0.05mg/kg up to 10mg IV. Give slowly 2mg/min (this is the preferred medication because it lasts longer than the Valium in the body) –Midazolam 5-10mg, well absorbed IM

22 Long-acting AED Phenytoin (Dilantin): 18-20mg/kg IV Phenytoin (Dilantin): 18-20mg/kg IV –Do not give faster than 50mg/kg –Use only with normal saline –Monitor vital signs carefully –Avoid IV infiltration (purple glove syndrome) –Different institutions have different guidelines concerning the administration of this drug

23 Follow up with long-acting AEDs Fosphenytoin (Cerebyx): prodrug of phenytoin Fosphenytoin (Cerebyx): prodrug of phenytoin –Water soluble (does not contain propylene glycol) fewer IV site and cardiac complications –Dispensed in phenytoin equivalents (1 PE of fosphenytoin=1 mg of Dilantin) –Loading dose PE/kg –Max rate is 150 PE/min IV with cardiac and BP monitoring –May be given IM (large volumes i.e. 20ccs split in two IM sites)

24 Long-acting AED Fosphenytoin continued Fosphenytoin continued –Side effects- same as phenytoin (hypotension, cardiac arrthymias, rash, dizziness, and itching groin) –Each institution has specific guidelines concerning administration of this drug

25 Long-acting AED Phenobarbital: 10-20mg/kg Phenobarbital: 10-20mg/kg –Do not give faster than mg/min. –Caution following BZD (increase risk of respiratory depression and hypotension)

26 Depacon (Valproate Sodium Injection) For use in Myoclonic Status and when unable to take po Valproic Acid For use in Myoclonic Status and when unable to take po Valproic Acid Dispensed in Valproic Acid equalents (500mg po = 500mg IV) Dispensed in Valproic Acid equalents (500mg po = 500mg IV) Administer over 60 minutes Administer over 60 minutes In 50ccs (Normal Saline, LR, or D5W) In 50ccs (Normal Saline, LR, or D5W) No more than 20mg/minute No more than 20mg/minute Give the same frequency as po Give the same frequency as po Some institutions has a policy and procedure concerning administration Some institutions has a policy and procedure concerning administration

27 Side effects of Depacon Not like po-wt gain and hair loss Not like po-wt gain and hair loss Somnolence Somnolence Dizziness Dizziness Paresthesia Paresthesia Nausea Nausea H/A H/A Pain at injection site Pain at injection site

28 Other Treatments Petobarbital coma, propofol Petobarbital coma, propofol Supportive Care Supportive Care –Airway –Protection –Lab tests (CBC, BMP, ABGs, AED levels) –Fluids –VS, EKG –Drug Therapy –Investigate Cause

29 Other options Keppra Keppra –IV option coming in the near future

30 Diagnostic Studies History History Physical Exam Physical Exam Blood work Blood work Epilepsy Protocol MRI- structural changes Epilepsy Protocol MRI- structural changes 3Tesla MRI 3Tesla MRI fMRI- language function fMRI- language function CT CT Epilepsy monitoring unit Epilepsy monitoring unit EEG (dont seizure on demand) EEG (dont seizure on demand) PET-metabolism changes PET-metabolism changes WADA-side of language and memory dominance WADA-side of language and memory dominance Neuropsych/Cognitive functioning testing Neuropsych/Cognitive functioning testing MRS-biochemical MRS-biochemical SPECT-perfusion changes SPECT-perfusion changes MEG-localization of interictal epileptiform activity with focal seizures used with MRI and EEG MEG-localization of interictal epileptiform activity with focal seizures used with MRI and EEG

31 Treatment Anticonvulsant Therapy Anticonvulsant Therapy Ketogenic Diet/Atkins Diet Ketogenic Diet/Atkins Diet Vagus Nerve Stimulator Vagus Nerve Stimulator Surgery Surgery

32 Potential Efficacy of AEDs Carbamazepine Carbamazepine –Simple Complex –Complex Partial –Tonic Clonic Phenytoin Phenytoin –Simple Partial –Complex Partial –Tonic Clonic

33 Potential Efficacy continued Valproate Valproate –Simple Partial –Complex Partial –Tonic-Clonic –Atonic –Myoclonic –Atypical Absence –Absence

34 Potential Efficacy continued Gabapentin Gabapentin –Simple Partial –Complex Partial –Tonic-Clonic Lamotrigine Lamotrigine –Simple Partial –Complex Partial –Tonic-Clonic –Atonic –Myoclonic –Absence and atypica absence

35 Potential Efficacy continued Topiramate Topiramate –Simple Partial –Complex Partial –Tonic-Clonic –Lennox-Gastaut –Infantile Spasms –Primary generalized

36 Potential Efficacy Continued Tiagabine Tiagabine –Simple Partial –Complex Partial –Tonic-Clonic –Infantile Spasms Levetiracetam Levetiracetam –Simple Partial –Complex Partial –Tonic-Clonic –Absence –Myoclonic

37 Potential Efficacy Continued Oxcarbazepine Oxcarbazepine –Simple Partial –Complex Partial –Tonic-Clonic Zonisamide Zonisamide –Simple Partial –Complex Partial –Tonic-Clonic –Absence –Infantile spasms –Myoclonic

38 Potential Efficacy Continued Pregablin Pregablin - Simple partial - Simple partial - Complex partial - Complex partial

39 Dilantin Capsules 100mg, 30mg Brand name Capsules 100mg, 30mg Brand name Dosing mg Dosing mg Half life 22 hours Half life 22 hours Blood levels (if no side effects MDs may push the top level) Blood levels (if no side effects MDs may push the top level) High incidence of drug interaction with all other medications High incidence of drug interaction with all other medications Side effects Side effects –Ataxia –Rash –Blood changes –Osteomalacia –Cosmetic changes –Dental changes

40 Tegretol, Tegretol XR, & Carbatrol Tabs 100mg, 200mg, 300mg (Carbatrol), & 400mg (Tegretol XR) Tabs 100mg, 200mg, 300mg (Carbatrol), & 400mg (Tegretol XR) Dose mg Dose mg Half life hrs Half life hrs Levels 4-12 Levels 4-12 XR & Cabatrol BID dosing XR & Cabatrol BID dosing Side effects Side effects –Weight gain –GI upset –Ataxia –Blurred vision –Decreased WBC –Hyponatremia –Hepatotoxicity

41 Depakene, Depakote, &Depakote ER Caps 125mg,250mg, 500mg Caps 125mg,250mg, 500mg Dose mg Dose mg Half life 8-12 hrs Half life 8-12 hrs Blood levels Blood levels May be used for migraine management May be used for migraine management Interacts with Lamictal Interacts with Lamictal First line drug for myoclonic seizures (IV) First line drug for myoclonic seizures (IV) Side effects Side effects –Weight gain –Tremors –Uterine changes –Sedation –Disturb menses –Hair loss –H/A –Dizziness –Increase ammonia levels

42 Phenobarbital Tabs 15mg, 30mg, 60mg, & 100mg Tabs 15mg, 30mg, 60mg, & 100mg Dosing 30mg or 100mg Dosing 30mg or 100mg Half life 72 hrs Half life 72 hrs Blood levels Blood levels Side effects Side effects –Sedation –Hyperactivity –Confusion –Mood changes

43 Mysoline (Metabolizes to Primidone & Phenobarbital) Tabs 250mg Tabs 250mg Dose mg Dose mg Half life PRM 3-12hrs Half life PRM 3-12hrs –PBB 72 hrs Levels PRM 6-12 Levels PRM 6-12 –PBB Side effects Side effects –Sedation –Hyperactivity –Mood changes

44 Neurontin Caps 100mg, 300mg, & 400mg, Tabs 600mg & 800mg Caps 100mg, 300mg, & 400mg, Tabs 600mg & 800mg Dose 3600mg (no research telling how high to go) Dose 3600mg (no research telling how high to go) Dosing TID or QID Dosing TID or QID Half life 5-8 hrs Half life 5-8 hrs Blood levels-not done Blood levels-not done Use in management of migraines Use in management of migraines Side effects Side effects –Sedation –Ataxia –Dizziness

45 Lyrica Capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Capsules 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, 300mg Newest drug Newest drug Dosage for Epilepsy mg/day Dosage for Epilepsy mg/day Dosing BID Dosing BID Half Life Half Life No blood levels No blood levels Medication is also used for pain management Medication is also used for pain management Side effects Side effects -Double vision -Double vision -Ataxia -Ataxia -Edema -Edema -Weight gain -Weight gain - Dry mouth - Dry mouth - Trouble concentrating - Trouble concentrating

46 Benzodiazepines Valium Valium Ativan Ativan Tranxene Tranxene Klonopin Klonopin Side effects Side effects –Drowsiness –Fatigue –Ataxia –Slurred speech –Diplopia

47 Lamictal Tabs 25mg, 100mg, 150mg, & 200mg Tabs 25mg, 100mg, 150mg, & 200mg Dosage mg Dosage mg –If miss a dose may double up on next dose Half life hrs Half life hrs Blood levels 4-20 Blood levels 4-20 Depakote increases Lamictal Depakote increases Lamictal Needs to be adjusted if birth control is added Needs to be adjusted if birth control is added May make JME worse May make JME worse Side effect Side effect –Rash (slow titration stops this) –Depression –Dizziness –Somnolence –H/A –Blurred vision –Nausea/vomiting

48 Topamax Tabs 25mg, 50mg, 100mg, & 200mg Tabs 25mg, 50mg, 100mg, & 200mg Half life 21 hrs Half life 21 hrs Dose mg Dose mg May increase Dilantin May increase Dilantin May decrease Carbatrol, Phenobarb, i.e. May decrease Carbatrol, Phenobarb, i.e. Side effects Side effects –Memory problems –Word finding difficulties –Kidney stones –Dizziness –Ataxia –Somnolence

49 Trileptal Tabs 150mg, 300mg, & 600mg Tabs 150mg, 300mg, & 600mg Dose mg Dose mg Dosage BID Dosage BID Developed to improve on Tegretols side effects Developed to improve on Tegretols side effects If Allergic to Tegretol 20% chance to become allergic to Trileptal If Allergic to Tegretol 20% chance to become allergic to Trileptal Side effects Side effects –Somnolence –H/A –Dizziness –Rash –Weight gain –Alopecia –Nausea –Hyponatremia

50 Keppra Tabs 250mg, 500mg, & 750mg Tabs 250mg, 500mg, & 750mg Dose mg Dose mg Dosing BID Dosing BID Blood levels are drawn but results depend on the pt a good level can be from 20s-30s Blood levels are drawn but results depend on the pt a good level can be from 20s-30s Side effects Side effects –Mood changes (use of vitamin B6) –Lose of appetite –Weight lose –Diarrhea

51 Zonegran Caps 25mg, 50mg, & 100mg Caps 25mg, 50mg, & 100mg Dose mg and can be pushed higher Dose mg and can be pushed higher Dosing BID or Daily Dosing BID or Daily Levels Levels Side effects Side effects – This is a Sulfa drug –Kidney stones –Drowsiness –Loss of appetite –GI disturbance –Mania –Depression –Dizziness –Irritability

52 Ketogenic Diet High fat, low carbohydrate, limited protein diet High fat, low carbohydrate, limited protein diet Simulates metabolism of a fasting state (ketosis) Simulates metabolism of a fasting state (ketosis) Ketosis has an anticonvulsant effect Ketosis has an anticonvulsant effect Used in young children here at Johns Hopkins Epilepsy Center Used in young children here at Johns Hopkins Epilepsy Center Currently Thomas Jefferson has a program for adults Currently Thomas Jefferson has a program for adults

53 Nursing issues Avoid medication preparations containing sugar Avoid medication preparations containing sugar Need daily sugarless multivitamin with iron and calcium Need daily sugarless multivitamin with iron and calcium Monitor urine ketones Monitor urine ketones Give only allotted noncaloric liquids (may have diet decaffeinated soda) Give only allotted noncaloric liquids (may have diet decaffeinated soda)

54 Vagus Nerve Stimulator Stimulation wires placed around left vagus nerve in the neck. Stimulation wires placed around left vagus nerve in the neck. Subclavicular placement of transformer Subclavicular placement of transformer Nerve stimulus is typically on for 30 seconds and off for 5 minutes in cycles (like a buzz) Nerve stimulus is typically on for 30 seconds and off for 5 minutes in cycles (like a buzz) Need to evaluate over 6 months Need to evaluate over 6 months Often palliative treatment (add on to current medications) Often palliative treatment (add on to current medications) Magnet swiped over the transformer will cause the buzz to occur longer in order to stop the seizure. Magnet swiped over the transformer will cause the buzz to occur longer in order to stop the seizure.

55 VNS continued Magnet held over the transformer will turn off the VNS. Once the magnet is removed it will turn back on. Magnet held over the transformer will turn off the VNS. Once the magnet is removed it will turn back on. We in the Epilepsy Center can turn the generator completely off. We in the Epilepsy Center can turn the generator completely off. Status may result from turning off the VNS Status may result from turning off the VNS May be around microwaves and cell phones, etc. May be around microwaves and cell phones, etc. Cannot be around MRI unless the VNS is turned off. Cannot be around MRI unless the VNS is turned off.

56 Epilepsy Monitoring Performed at large teaching hospitals Performed at large teaching hospitals Most Epilepsy patients respond well to medication Most Epilepsy patients respond well to medication Monitoring and visits to Epilepsy Centers is usually reserved for those pts whose seizures are unresponsive to medication Monitoring and visits to Epilepsy Centers is usually reserved for those pts whose seizures are unresponsive to medication

57 Epilepsy Monitoring Admission for 2-7 days to a special unit Admission for 2-7 days to a special unit Epilepsy medications are reduced before and during admission (if seizures are infrequent) Epilepsy medications are reduced before and during admission (if seizures are infrequent) Clinical events (seizures) are recorded and EEG is reviewed and evaluated Clinical events (seizures) are recorded and EEG is reviewed and evaluated Type of Epilepsy is diagnosed and seizure onset is lateralized and localized (if possible) Type of Epilepsy is diagnosed and seizure onset is lateralized and localized (if possible)

58 Surgical Management Depth electrodes Depth electrodes Epidural Electrodes Epidural Electrodes Subdural Electrodes (Grid) Subdural Electrodes (Grid) –Brain mapping Lobectomy Lobectomy –Temporal most common, extratemporal resection Corpus Callosal Corpus Callosal –Atonic or GTC Hemispherectomy Hemispherectomy

59 Epilepsy Surgery Some patients may need to have depths placed. Some patients may need to have depths placed.

60 Epilepsy Surgery If not well localized pt may need to have bilateral strips placed to aid in localizing and lateralizing seizure onset If not well localized pt may need to have bilateral strips placed to aid in localizing and lateralizing seizure onset

61 Epilepsy Surgery If pt seizure focus is in or near an area of high function then a subdural grid may be placed to help map area of function and aid in surgery design If pt seizure focus is in or near an area of high function then a subdural grid may be placed to help map area of function and aid in surgery design

62 Teaching the family and patient About their seizures About their seizures First Aid First Aid Medication and Compliance Medication and Compliance Diagnostic tests, blood test, surgery Diagnostic tests, blood test, surgery Effects on Depression, Memory, Cognitive Function Effects on Depression, Memory, Cognitive Function Disability and Work Disability and Work Emotional Support Emotional Support Assist in Problem Solving Assist in Problem Solving Their State Driving Laws Their State Driving Laws Support Groups for all ages and their families Support Groups for all ages and their families

63 Pregnancy Counseling should be done prior to conception age Counseling should be done prior to conception age –Birth defects (increase by 1-2% above general population) Counseling on AEDs and contraception Counseling on AEDs and contraception –Interactions AED changes now prior to conception AED changes now prior to conception –Seizure control on AEDs with only dosage changes during pregnancy –AEDs with lowest Birth defect information Folic Acid daily (may be a higher dose) Folic Acid daily (may be a higher dose) –Neural tube development Planned pregnancies Planned pregnancies

64 Once Pregnant High Risk OB High Risk OB Increased number of clinic visits with Epilepsy Doctors Increased number of clinic visits with Epilepsy Doctors Communication between OB and Epilepsy MD Communication between OB and Epilepsy MD Teamwork Teamwork Monthly blood levels with already predetermined target blood level(s) Monthly blood levels with already predetermined target blood level(s) High level of communication with expected mother. (Teaching) High level of communication with expected mother. (Teaching) Pregnancy Registries (Harvard, Lamictal and Keppra Registries) Pregnancy Registries (Harvard, Lamictal and Keppra Registries)

65 Epilepsy Research at Johns Hopkins Neuropace Atkins for Adults Schwarz SP754 Progesterone

66 Not all patients are surgical candidates For these pts with intractable Epilepsy current research offers hope

67 Neuropace Surgical Implant A small generator is implanted with electrodes going to various seizure focci A small generator is implanted with electrodes going to various seizure focci

68 Neuropace Strip or depth leads are placed (1 or 2 leads) A cranial defect is created for the device Each lead can send out an electrical signal to stop seizure activity

69 Neuropace Age years Age years 4 seizures per month or more 4 seizures per month or more Able to localize seizure focus Able to localize seizure focus 2 or more Epilepsy meds tried 2 or more Epilepsy meds tried VNS will have to be turned off VNS will have to be turned off Live locally (lots of clinical visits) Live locally (lots of clinical visits)

70 Atkins trial for Adults Age 18 years or older Age 18 years or older 2 or more seizures per week 2 or more seizures per week No heart, kidney, cholesterol problems No heart, kidney, cholesterol problems No major psychiatric problems No major psychiatric problems Need to visit Johns Hopkins 4 times in 6 months Need to visit Johns Hopkins 4 times in 6 months Not have tried Ketogenic or Atkins diets prior to this trial Not have tried Ketogenic or Atkins diets prior to this trial

71 Atkins Pts are placed on a carefully planned Atkins diet and followed for 6 months to evaluated whether their seizure frequency is reduced. Pts are placed on a carefully planned Atkins diet and followed for 6 months to evaluated whether their seizure frequency is reduced. All labs, clinic visits and dietitian expenses are funded by the study All labs, clinic visits and dietitian expenses are funded by the study

72 Schwarz SP754 Medication trial Medication trial

73 Inclusion/Exclusion Inclusion (see attached) Inclusion (see attached) Age years Age years Partial onset seizures and or complex partial seizures Partial onset seizures and or complex partial seizures Must have had partial onset seizures for at least 2 years Must have had partial onset seizures for at least 2 years Exclusion (See attached) Exclusion (See attached) Hx of drug and or alcohol abuse Hx of drug and or alcohol abuse Medical or psychiatric condition Medical or psychiatric condition Primary generalized seizures Primary generalized seizures

74 Benefits Schwarz SP754 Patients are closely followed and evaluated Patients are closely followed and evaluated All lab and clinic visits are fully funded by the study All lab and clinic visits are fully funded by the study Helping a new medication to be developed Helping a new medication to be developed

75 Progesterone Therapy for Women with Epilepsy Study Hypothesis: Adjunctive cyclic natural progesterone therapy significantly improves the course of epilepsy in women. Study Hypothesis: Adjunctive cyclic natural progesterone therapy significantly improves the course of epilepsy in women. Women ages with intractable seizures that occur in relation to changes in reproductive hormone levels (catamenial epilepsy) despite trials of at least two AEDs Women ages with intractable seizures that occur in relation to changes in reproductive hormone levels (catamenial epilepsy) despite trials of at least two AEDs

76 Inclusion Documentation of focal paraoxysmal EEG discharges Documentation of focal paraoxysmal EEG discharges 2 seizures/month during previous 3 months 2 seizures/month during previous 3 months Stable optimal AEDs for 2 months Stable optimal AEDs for 2 months Nl breast exams and PAP smears 9 months prior for all over 21 Nl breast exams and PAP smears 9 months prior for all over 21 Menstrual cycle intervals between 23 and 35 days during 6 month prior Menstrual cycle intervals between 23 and 35 days during 6 month prior Sexually active women will use barrier and/or spermicidal forms of contraception Sexually active women will use barrier and/or spermicidal forms of contraception

77 Exclusion Pregnancy, lactation Pregnancy, lactation Progressive Neurological disorder Progressive Neurological disorder Abnl Liver function test Abnl Liver function test Major tranquilizer or reproductive hormones 3 months prior to study Major tranquilizer or reproductive hormones 3 months prior to study Sensitivity to natural progestrone Sensitivity to natural progestrone Unable to document seizures or follow protocol Unable to document seizures or follow protocol Hx of thromboembolic, thrombophlebitis disorders, CVA Hx of thromboembolic, thrombophlebitis disorders, CVA Malignancy of breast, uterus or ovary Malignancy of breast, uterus or ovary Vaginal bleeding Vaginal bleeding

78 If interested in participating in a study Call Call You will then be referred to the appropriate office You will then be referred to the appropriate office

79 Bill of Rights for People Living with Epilepsy Sponsored by Novartis Pharmaceuticals Corporation

80 The goal of the Bill Of Rights is to help you: Encourage the patients involvement in managing many aspects of living with their epilepsy, including making informed choices and activity participating in decisions about care Encourage the patients involvement in managing many aspects of living with their epilepsy, including making informed choices and activity participating in decisions about care Empower them to ask questions and seek answers from their or their loved ones healthcare team Empower them to ask questions and seek answers from their or their loved ones healthcare team Help them access information and support resources Help them access information and support resources Encourage them to speak up for their or their loved ones rights and needs Encourage them to speak up for their or their loved ones rights and needs

81 A first-of-its kind initiative Designed to educate, empower, and increase understanding of epilepsy Designed to educate, empower, and increase understanding of epilepsy A guide to managing life with epilepsy that was developed by the community for the community A guide to managing life with epilepsy that was developed by the community for the community It is not a legal document- these rights are aspirational goals that the epilepsy community is trying to achieve It is not a legal document- these rights are aspirational goals that the epilepsy community is trying to achieve None of the information should be used as medical or legal advice None of the information should be used as medical or legal advice

82 Goals of the Bill of Rights Goal #1: Educate and empower the people affected by epilepsy Goal #1: Educate and empower the people affected by epilepsy Goal #2: Increase understanding of epilepsy among the general public Goal #2: Increase understanding of epilepsy among the general public

83 Includes guidance on topics, such as: Social aspects of living with epilepsy Social aspects of living with epilepsy Communicating with your healthcare team Communicating with your healthcare team Current information on epilepsy and treatment options Current information on epilepsy and treatment options Rights at school Rights at school Rights in the workplace Rights in the workplace

84 Enroll in the SHARE (Support, Hope, And Resources for Epilepsy) Program to receive Bill of Rights materials and additional information about living with epilepsy from Novartis Program to receive Bill of Rights materials and additional information about living with epilepsy from Novartis Complete and mail your business reply card Complete and mail your business reply card Visit Visit Call toll-free ERIGHTS Call toll-free ERIGHTS

85 Resources Epilepsy Foundation of America Epilepsy Foundation of America American Epilepsy Society American Epilepsy Society American Association of Neuroscience Nurses American Association of Neuroscience Nurses

86 Resources continued MedicAlert Foundation MedicAlert Foundation Food and Drug Administration Food and Drug Administration INFO-FDA INFO-FDA


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