a link to dr. klein's curriculum vitae

CURRICULUM VITAE

Name: Pavel Klein, M.B., B.Chir.Address: 9 Watchwater Way

Rockville, MD 20850Telephone: 301-424-1658E-mail: [email protected]

EDUCATION

1977 B.A., Oxford University1980 M.B., B.Chir., Cambridge University1983 M.A., Oxford University

POSTDOCTORAL TRAINING

1981-82 House Officer, General Surgery & Internal Medicine, William Harvey Hospital, Ashford, UK

1982-83 Senior House Officer, Neurology & Geriatrics/Neurology, University College Hospital, London, UK

1983 Fellow in Clinical Neuropharmacology, University College Hospital, London, UK

1983-85 European Exchange Fellowship in Clinical Medicine: Respiratory Medicine, Cardiology & Internal Medicine 1983-84 Guy’s Hospital, London UK 1984-85 University Hospital, Hamburg Germany

1986 Neurology Research Assistant, University of Virginia, Charlottesville, VA1986-89 Resident in Neurology, University of Virginia, Charlottesville, VA1989-90 Fellowship in EEG/Epilepsy, University of Virginia, Charlottesville VA1995-97 Fellowship in Neuroendocrinology, Beth Israel Deaconess Medical Center,

Boston, MA1997-98 Fellowship in Sleep Medicine, Beth Israel Deaconess Medical Center, Boston,

MA

EMPLOYMENT HISTORY

1990-94 Private Practice, Neurology, Chattanooga, TN1995-98 Attending Physician, Beth Israel Deaconess Medical Center, Boston, MA1999-8/2003 Attending Physician, Georgetown University Medical Center, Washington, D.C.9/2003-present Director, Mid-Atlantic Epilepsy and Sleep Center, L.L.C. 7/2008-present Associate Professor, Neurology and Pediatrics, Children’s National

Medical Center, The George Washington University, Washington, D.C.

LICENSURE AND CERTIFICATION

1990 American Board of Psychiatry and Neurology1992 American Board of Psychiatry and Neurology with added qualifications in

Clinical Neurophysiology2000 Diplomate, American Board of Sleep Medicine1990 Georgia License Registration1991 Tennessee License Registration1995 Massachusetts License Registration1998 Maryland License Registration1998 Virginia License Registration1998 District of Columbia License Registration

AWARDS AND HONORS

1974 Open Exhibition, University College, Oxford1975 Plumbton Mynor Scholarship, University College, Oxford1983 European Exchange Fellowship in Clinical Medicine, Guy’s Hospital, London,

UK

PROFESSIONAL SOCIETIES

1986- American Academy of Neurology 1992- American EEG Society1999- American Academy of Sleep Medicine 1999- American Epilepsy Society

ACADEMIC APPOINTMENTS AND AFFILIATIONS

1995-99 Instructor in Neurology, Harvard Medical School, Boston, MA1999-03 Assistant Professor, Georgetown University Hospital, Washington, DC1999-03 Director, Epilepsy Center, Georgetown University Hospital, Washington, DC 1999-03 Director, Clinical Neurophysiology Laboratory, Georgetown University

Hospital, Washington, D.C.1999-03 Director, Neuroendocrinology Unit, Georgetown University Hospital, Washington, DC2008- Adjunct Associate Professor, Neurology and Pediatrics, Children’s National Medical Center, The George Washington University, Washington, D.C.

HOSPITAL APPOINTMENTS

1995-99 Attending Neurologist, Beth Israel Deaconess Medical Center, Boston, MA1999-03 Attending Neurologist, Georgetown University Hospital, Washington, DC2003- Attending Neurologist, Holy Cross Hospital, Silver Spring, MD

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PROFESSIONAL ACTIVITIES

Peer Review and Editorial ActivitiesAd hoc reviewer for Annals of Neurology, Neurology, Epilepsia, Epilepsy and Behavior, Brain Research, Neuroendocrinology, Steroid, CNS Drugs.

Ad hoc grant reviewer CURE Epilepsy: 2009, NIH (NINDS) 2014, 2016 Invited Lectures/symposiaSymposia:2002: Co-Founder, Neuroendocrine Special Interest Group, American Epilepsy Society2002-2008: Co-organizer and Co-chair of annual Neuroendocrine SIG meetings at annual AES meetings.2006: Co-organizer, NIH workshop: Biomarkers of epileptogenesis. 2011: Co-Founder, Private Practice Epilepsy, Special Interest Group, American Epilepsy Society.2011-: Co-organizer and Co-chair, annual Private Practice Epilepsy Special Interest Group meetings at annual AES meetings. Lectures:2002: Stress and Epilepsy. Presentation, neuroendocrinology special interest group meeting, Annual Meeting of the American Epilepsy Society (AES), 2002.2005: Hormonal Influences on circadian seizure fluctuation. Presentation, neuroendocrinology special interest group meeting, Annual Meeting of the AES.2006: Biomarkers of epileptogenesis: NIH workshop. 2007: Hormonal influences and treatments in adolescents with epilepsy. Special symposium, “Professionals in Epilepsy”. Annual Meeting of the AES, 2007.2004, 2007-2009: Lecturer/panel discussant, TopScholar Symposium at the Annual Meeting of the AES2011-2014: Epilepsy Research in Private Practice. Presentation, Annual Meeting of the American Epilepsy Society. 2002-2015: Numerous neurology grand rounds, seminars and lectures at local, national and international academic institutions and community hospitals including, among others: National Institutes of Health, Georgetown University Hospital, George Washington University Hospital, Bethesda Naval Hospital, Walter Reed Army Hospital, Howard University, Virginia Commonwealth University, Richmond, VA, University of Michigan, Ann Arbor, MI, New York, Boston, Seattle, San Francisco, Cleveland, Pittsburgh, Oslo University, Norway, Toronto, Canada, Brussels, Belgium, Charles University, Prague, Czech Republic.

National level committee activities1999-2005: Member, Task force, women’s issues in epilepsy, American Epilepsy Society2006-2009: Member, Investigator’s workshop committee, American Epilepsy Society

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2009-2011: Member, Clinical Practice Committee, American Epilepsy Society2009-2012: Member, Health Reform Task Force, American Epilepsy Society2010-2012: Member, AES annual meeting Science Program Committee, American Epilepsy Society2010-2014: Member, AES Treatment Committee, American Epilepsy Society2012-current: Member, AES Treatment Committee, Devices American Epilepsy Society2010-current: Member, American Academy of Neurology Neuroendocrine Research Award Subcommittee2010-2012: Member, Development Committee, American Society of Experimental NeuroTherapeutics2012-current: Member, Corporate Advisory Committee, American Epilepsy Society2011-current: Co-founder and Co-Chair, Consortium of Private Epilepsy Centers of North America

PUBLICATIONS

1. Klein P, Lees A, Stern G. Consequences of chronic 5-hydroxytryptophan in parkinsonian instability of gait and balance and other neurological disorders. Advances in Neurology 1986; 45:603-604.

2. Klein P, Rubinstein L. Benign symptomatic glial cysts of the pineal gland. Journal of Neurology, Neurosurgery, and Psychiatry 1988; 52:991-995.

3. Klein P, Haley EC, Wooten GF, Vandenberg SR. Focal cerebral infarctions associated with perivascular tumor infiltrates in carcinomatous leptomeningeal metastases. Arch Neurol 1989; 46:1149-1151.

4. Klein P. Cerebellar ataxia. Archives of Neurology 1989; 46:1166.5. Klein P, Zientek G, Vandenberg SR, Lothman EW. Primary CNS lymphoma:

Lymphomatous meningitis presenting as a cauda equina lesion in an AIDS patient. Canadian Journal of Neurological Science 1990; 17:329-331.

6. Larner JM, Kersch CR, Constable WC, Klein P, Ferguson R, Short R, Jane JA. Phase I/II trial of arterial 5FU infusion for patients with glioblastoma. Journal of Clinical Oncology 1991; 14:514-518.

7. Klein P, Oertel J. Depression associated with pontine vascular malformation. Biological Psychiatry 1997; 42:519-521.

8. Herzog AG, Klein P, Ransil BJ. Three patterns of catamenial epilepsy. Epilepsia 1997;38:1082-1088.

9. Klein P, Herzog AG. Emerging applications of hormonal therapy of paroxysmal central nervous system disorders. Expert Opinion on Investigational Drugs 1997;6(10):1337-1349.

10. Herzog AG, Klein P, Jacobs AR. Testosterone versus testosterone and testolactone in treating reproductive and sexual dysfunction in men with epilepsy and hypogonadism. Neurology 1998; 50:782-784.

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11. Silveira DC, Liu Z, de LaCalle S, Jun L, Klein P, Holmes GL, Herzog AG. Activation of the locus coreruleus following amygdaloid kindling. Epilepsia 1998; 39(12):1261-1264.

12. Klein P, Herzog AG. Hormonal Effects on Epilepsy in Women. Epilepsia 1998; 39 (Suppl 8):S9-S16.

13. Klein P, Herzog AG, Versi E. Mood and the menopause. Br J Ob Gyn 1999; 106:1-4.14. Silveira DC, Klein P, Liu Z, Holmes GL, Elmquist J, de LaCalle S, Herzog AG.

Asymmetric activation of hypothalamic neurons with unilateral amygdaloid seizures in female rats. Epilepsia 2000;41:34-42.

15. Klein P, Pezzullo JC, Serje A. Premature ovarian failure in women with epilepsy. Epilepsia 2001;42:1584-1590.

16. Klein P, Clark L, Pezzullo JC. Onset of Epilepsy at the time of menarche. Neurology 2003;60:495-7.

17. Herzog AG, Coleman AE, Jacobs AR, Klein P, Friedman MN, Drislane FW, Schomer DL. Relationship of sexual function to the laterality and reproductive hormone levels in women with temporolimbic epilepsy. Epilepsy Behav 2003;4:407- 13.18. Herzog AG, Coleman AE, Jacobs AR, Klein P, Friedman MN, Drislane FW, Ransil BJ, Schomer DL. Interictal EEG discharges, reproductive hormones and menstrual disorders in epilepsy. Ann Neurol 2003;54:625-37.19. Sahoo S, Klein P. Maternal Complex partial seizure associated with fetal distress. Arch Neurol 2005;62:1304-05.20. Klein P, Sahoo S. Effect of ACTH-induced hypercortisolemia on EEG in patients with stress-related epilepsy. Epilepsy Behav 2005;6:187-190.21. Klein P, van Passell-Clark L. Effect of stress related to the 9/11/2001 terror attack on seizures in patients with epilepsy. Neurology 2005;64:1815-16.22. Thorneycroft I, Klein P, Simon J. Impact of antiepileptic drug therapy on steroidal contraceptive efficacy. Epilepsy Behav 2006; 9:31-39.23. Klein P, Janousek J, Barber A, Weissberger R. Ketogenic diet treatment in adults with refractory epilepsy. Epilepsy Behav. 2010; 19:575-9.24. Klein P, Herr D, Pearl PL, et.al. Results of phase II safety and feasibility study of treatment with levetiracetam for prevention of posttraumatic epilepsy. Arch Neurol 2012; 69:1290-95. 25. Klein P, Herr D, Pearl PL, et.al. Results of phase II pharmacokinetic study of levetiracetam for prevention of posttraumatic epilepsy. Epi Behav 2012; 24: 457-61. 26. Janousek J, Barber A, Goldman L, Klein P. Obesity in adults with epilepsy. Epi Behav 2013;28:391-394. 27. Pearl PL, Herr D,…Klein P. Results of phase II levetiracetam trial following acute head injury in children at risk for post-traumatic epilepsy. Epilepsia 2013; 54: (9):e135-7. doi: 10.1111/epi.12326. Epub 2013 Jul 22.28. Klein P, Mathews GC. Antiepileptic drugs and neurocognitive development, Editorial. Neurology 2014; 82:194-195.29. Klein P, Tyrlikova I, Mathews GC. Dietary treatment of refractory epilepsy in Adults. Neurology 2014; 83:1978-85.30. Tomson T, Klein P. Fine-tuning risk assessment with antiepileptic drug use in

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pregnancy. Editorial. Neurology 2015; 83:339-341.31. Lee D, Kalu U, Halford J, Biton V, Cloyd J, Klein P, ...Tolbert D. Intravenous carbamazepine as short- term replacement therapy for oral carbamazepine in adults with epilepsy: Pooled tolerability results from two open-label trials. Epilepsia 2015; 32. Klein P, Schiemann J, Sperling M, Whitesides J, Liang W, Stalvey T, Brandt C, Kwan P. A randomized, double-blind, placebo- controlled, multicenter, parallel- group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia 2015;56:1890-1898; doi: 10.1111/epi.13212. Epub 2015 Oct 16.33. Klein P, Tyrlikova, I, Brazdil I, Rektor P. Brivaracetam for the treatment of epilepsy. Expert Opinion Pharmacoterhapy. 2016; Jan 13:1-13 [Epub ahead of print].34. Klein P, Biton V, Dilley D, Barnes M, Schiemann J, Lu S. Safety and tolerability of adjunctive brivaracetam as intravenous infusion or bolus in patients with epilepsy. Epilepsia 2016; 57:1130-38.35. Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology 2016; 87:314-323.Published ahead of print Jun2 22,2016.

REVIEWS & CHAPTERS

1. Klein P, Herzog AG. Endocrine Aspects of Partial Epilepsy. In: Schachter SC and Schomer DL, eds. The Comprehensive Management and Treatment of Epilepsy. Academic Press, San Diego 1997, Chapter 12, pp. 207-232.

2. Klein P, Herzog AG. Endocrine Aspects of Epilepsy. In: Pretel S, Knigge KM, and Prasad A, eds. MCH and Seizures: Neuromolecular and Neuroendocrine Aspects. Research Signpost, India 1997, pp. 111-139.

3. Herzog AG, Klein P. Hormonal Therapy. In: Sperling M. Medical Management of Epilepsy. Marcel Dekker 1998.

4. Klein P, Herzog AG. Hormones and Epilepsy. In: Schmidt S and Schachter SC, eds. Epilepsy: Problem Solving in Clinical Practice. Martin Dunitz Ltd., London 2000, Chapter 32, pp 413-434.

5. Klein P. Exacerbation of seizures in a young woman. In: Schmidt D, Schachter SC, eds. 110 Puzzling Cases of Epilepsy. Martin Dunitz Ltd., London 2001, Chapter 61, pp 237-241.

6. Klein P, Janousek J. Impact of Neuroendocrine Factors in Seizure Genesis and Treatment. In: Rho JM, Cavazzos JE, eds. Epilepsy: Scientific Foundations of Clinical Management. Marcel Dekker 2004. Revised, second edition, 2009.

7. Klein P. Mood and the Menopause. In: Studd J, ed. The management of the menopause. The Parthenon Publishing Group, Lancaster (UK) 2003.

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8. Klein P, Schomer D. Effect of Ovarian Hormones on the Nervous System. In Kaplan P, ed. Neurologic Disease in Women. Martin Dunitz Ltd., London 2005.

9. Klein P, Janousek J. Hormones and antiepileptic drugs. In: Bui E, Klein AM, eds. Women with Epilepsy. Cambridge University Press, Cambridge (UK), 2013.

10. Tyrlikova I, Klein P. Ketogenic diet treatment in adults with refractory epilepsy. In: Watson RR, Preedy V, eds. Bioactive Nutriceuticals and Dietary Supplements in Neurological and Brain Disease: Prevention and Therapy. Elsevier, 2014.11. Klein P. Status epilepticus. In: Koubeissi MZ, Azar N, eds. Epilepsy Board Review:

A Comprehensive Guide. Springer Science +Business Media, 2016; in press.

RECENT ABSTRACTS

1. Klein P, Jacobs AR, Herzog AG. A comparison of testosterone versus testosterone and testolactone in the treatment of reproductive/sexual dysfunction in men with epilepsy and hypogonadism. Neurology 1996; 46:177.

2. Herzog AG, Klein P. Three patterns of catamenial epilepsy. Epilepsia 1996; 37:83.3. Klein P, Silveira DC, Liu Z, Holmes GL, Elmquist J, de LaCalle S, Herzig AG.

Asymmetric activation of hypothalamic neurons with unilateral amygdaloid seizures in male rats. European Journal of Neurology 1997; 4:S14.

4. Silveira DC, Liu Z, LaCalle S, Lu J, Klein P, Holmes GL, Herzog AG. Locus coeruleus fos-immunoreactivity following amygdala-kindled generalized seizures. Epilepsia 1997;38:186.

5. Joseph J, Klein P, Kleefield J. Vasospasm neuroradiology and pathology. J Neurol Exp Neuropathol 1997.

6. Herzog AG, Klein P, Jacobs AR, Coleman AC, Drislane FW, Schomer DL. Abnormal interictal prolactin elevations particularly among men and women with complex partial seizures of right temporal origin. Epilepsia 1997; 38:48.

7. Herzog AG, Coleman AE, Jacobs AR, Klein P et al. Menstrual Disorders, reproductive endocrine dysfunction and interictal discharge frequency in women with temprolimbic epilepsy. Neurology 1999; 52;(Suppl 2) A2:24.

8. Klein P. Effect of stress on localization-related epilepsy. Epilepsia 2000, 41; (Suppl. 7):S112).

9. Serje A, Klein P. Premature Ovarian Failure in women with epilepsy. Epilepsia 2000, 41;(Suppl.7):S 198.

10. Herzog AG, Coleman AE, Jacobs AR, Klein P, et al. Acute hypothalamopituitary dysfunction following interictal unilateral temporal epileptiform discharges in women with epilepsy. Epilepsia 2000, 41; (Suppl. 7):S 167.

11. Cantero, J, Klein P. Treatment of Exacerbation of partial seizures during perimenarche with natural progesterone. Epilepsia 2001;42 (Suppl 7) 290.

12. Sahoo S, Klein P. Effect of adrenocorticotropic hormone (ACTH)-induced acute hypercortisolemia on EEG in patients with stress-related epilepsy. Epilepsia 2001;42 (Suppl 7) 115.

13. Klein P. Onset of epilepsy at the time of menarche. Epilepsia 2001;42 (Suppl 7) 291.

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14. Clark L, Klein P. Seizure occurrence in relationship to the 9/11 terrorist attack among patients with epilepsy in the Washing, DC area. Epilepsia 2002; 43 (Suppl 7) 298.

15. Cantero J, Klein P. Effect of estrogen-containing contraceptives on seizure frequency in women with epilepsy. Epilepsia 2002; 43 (Suppl 7):242.

16. Klein P. Association of seizures with estrogen replacement therapy in menopause. Epilepsia 2002; 43 (Suppl 7):232.

17. Sahoo S, Klein P. Perimenstrual seizure exacerbation in non-ovulatory perimenarcheal girls that suggests that progesterone withdrawal is not the only factor responsible for catamenial seizure exacerbation. Epilepsia 2002; 43 (Suppl 7):234.

18. Pearl PL, Gaillard WD, Conry JA, Weinstein SL, Cogen PH, Salpekar J, Acosta M, Rosser T, Elling NJ, Cushner-Weinstein S, Kelodgie M, Klein P, Rogawski MA, Theodore WH, Gibson KM. Epilepsy and EEG characteristics in succinic semialdehyde dehydrogenase deficiency. Epilepsia 2002;43 (Suppl 7): 170.

19. Herzog AG, Coleman AE, Jacobs AR, Klein P, Friedman MN, Drislane FW, Schomer DL. Relationship of sexual function to epilepsy laterality and reproductive hormone levels in women. Neurology 2003; 60 (Suppl 2).20. Rezek R, Klein P. Prescribing of antiepileptic drugs in pregnancy in a nonacademic community. Epilepsia 2004; 45 (Suppl 7):233.21. Klein P. Lack of association of high serum estradiol levels during pregnancy with

seizures. Epilepsia 2004; 45 (Suppl 7):231.22. Klein P, Herr D, Pearl P, Natale JA, Levine Z, Nogay C, Mendoza M, Scarito

J, Tadzong B, Tsuchida T, VandenAnker J, Soldin S, McCarter R. Tolerability and Feasibility of Acute and Chronic 55 mg/kg/day Levetiracetam Treatment in Patients With Acute Traumatic Brain Injury at High Risk for Developing Posttraumatic Epilepsy. Epilepsia 2006; 47

23. Janousek J, Barber A, Klein P. Use of premarin as a seizure precipitant in women with localization-related epilepsy undergoing LTVEEG monitoring for pre-surgical evaluation. Epilepsia 2006; 47

24. Barber A, Randi Weissberger, Janousek J, Klein P. Ketogenic diet treatment in adults with refractory epilepsy and co-morbid obesity. Epilepsia 2008;Suppl 7.25. Janousek J, Barber A, Weissberger R, Klein P. Effect of ketogenic diet on EEG epileptiform discharges during KGD initiation in patients with refractory epilepsy. Epilepsia 2008; Suppl 7. 26. Klein P, Herr D, Pearl P. Safety, tolerability and pharmacokinetics of levetiracetam

in patients with acute traumatic brain injury with high risk for developing posttraumatic epilepsy. Epilepsia 2008;49;Suppl 7:81.

27. Barber, A, Weissberger R, Janousek J, Klein P. Ketogeinc diet treatment in adults with refractory epilepsy and co-morbid obesity. Epilepsia 2008;49; Suppl 7.28. Janousek J, Barber, A, Weissberger R, Klein P. Effect of ketogeinc diet on EEG epileptiform discharges during KGD initiation in patients with refractory epilepsy. Epilepsia 2008;49; Suppl 7. 29. Janousek J, Barber, A, Klein P. Prevalence of obesity in patients with epilepsy. Epilepsia 2009;50; Suppl 7.30. Janousek J, Barber, A, Klein P. Treatment of epilepsy in 2003-2009.

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Epilepsia 2010;51; Suppl 7.31. Naritoku DK, Biton, Klein P, et al. Pharmacokinetics, safety and tolerability of levetiracetam extended-release in children and adults with epilepsy. Epilepsia 2010;51; Suppl 7.32. Janousek J, Klein P, Goldman L, Barber, A. Levetiracetam blood level during pregnancy and post-partum: a prospective study. Epilepsia 2011;52; Suppl 7.AES Poster #: 2.274 33. Klein P, Barber, A, Goldman L, Mathews, GC. Rapid response of nonconvulsive status epilepticus to low dose lacosamide. Epilepsia 2011;52; Suppl 7. AES Poster #: 2.266 34. Janousek J, Mathews, GC, Barber, A, Goldman L, Klein P. Lacosamide efficacy in patients with refractory epilepsy: a prospective open label study. Epilepsia 2012;53; Suppl 7. 35. Dheerendra S, Klein P, Biton V et al. I.v. carbazepine as short-term replacement therapy for oral carbamazepine in adults with epilepsy: primary results of a phase 3 safety trial. American Epilepsy Society 2013 poster # 3.30136. Klein P, Biton V, Dilley D, Barnes M, Schiemann J, Lu S. Safety/Tolerability of Adjunctive Intravenous (i.v.) Brivaracetam as Infusion or Bolus in Patients with Epilepsy. AES 2013 poster # 3.20137. Klein P, Schiemann J, Sperling M, Whitesides J, Liang W, Stalvey T. A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Adult Patients with Partial Onset Seizures. Epilepsy. AES 2014 poster # 4.34138. Gorlik D, Tyrlikova I, Janousek J, Azarion A, Goldman L, Barber A, Klein P. Efficacy of Clobazam add on treatment of refractory focal epilepsy in adults. AES 2014 poster # 2.30139. Laban O, Fertig E, Malik M, Dlapena, C, Klein P, Lancman M. Epilepsy and Reproductive Issues in Women with Epilepsy: Survey of an Unselected Community of Women with Epilepsy. AES 2014 poster # 2.23040. Rosenfeld W, Benbadis S, Klein P, Speccio LM, …Blum D. Incidence of Falls, Fractures, and Injuries with Adjunctive Eslicarbazepine Acetate in Patients with Refractory Partial- Onset Seizures: A Pooled Analysis of Three Placebo-Controlled Trials. AES 2014 poster # 1.31541. Klein P, Schiemann J, Sperling M, Whitesides J, Liang W, Stalvey T. A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Brivaracetam in Adult Patients with Partial Onset Seizures. Epilepsy. American Academy of Neurology 2015, Platform presentation S28.42. Abou-Khalil B, Klein P, Shah A, Ryvlin P, …Claus R.. Incidence of Treatment Emergent Adverse Events in Three Phase III Studies of Adjunctive Eslicarbazepine Acetate, in Patients Taking or Not Taking Lamotrigine at Baseline. AES 2015 poster # 1.18643. Laban-Grant O, Lancman M, de la Pena C, Malik M, Iyengar S, Fertig E, Klein P, Lancman M. Epilepsy and Reproductive Issues in Women of Hispanic Origin Living in United States. AES 2015 poster # 2.19644. Klein P, Quarato PP, Mameniskiene R, Ben-Menachem E, Eckhardt K, Johnson M,

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McDonough B, Schiemann J, Whitesides J Efficacy and safety of adjunctive brivaracetam for partial-onset (focal) seizures overall and in elderly patients: A pooled analysis from three Phase 3 studies. AES 2015 poster # 3.25345. Hegde M,McKenna K,Singh R,Boro A, Mays V, Klein P, French J, Dlugos D, Gidal, B.; on behalf of HEP Investigators. The Predictive Value Of EEG And MRI In Antiepileptic Drug Response In Newly Treated Focal Epilepsy: Interim Findings From The Human Epilepsy Project. AES 2015 poster # 3.19646. Klein P, Whitesides J, Schiemann J, Johnson ME.Safety, tolerability and efficacy of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: a post hoc analysis. AAN 201647. Klein P, Whitesides J, Schiemann J, Johnson ME. Efficacy, safety,and tolerability of brivaracetam (BRV) with concomitant lamotrigine (LTG) or concomitant topiramate (TPM) in pooled Phase III randomized, double-blind trials: a post hoc analysis AAN 2016.48. Klein P, Johnson M, Schiemann J, Whitesides J. Post Hoc Analysis of Time to Sustained 50% Responder Status in Three Phase III Studies of Brivaracetam (BRV) as Adjunctive Treatment for Partial-Onset (Focal) Seizures49. Chung S, Klein P, Sperling M, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy of Brivaracetam (BRV) as Adjunctive Therapy in Partial-Onset (Focal) Seizures among Patients with Prior Levetiracetam (LEV), Carbamazepine (CBZ), Lamotrigine (LTG), or Topiramate (TPM) Exposure AAN 2016

RESEARCH SUPPORT – CURRENT

1. Lundbeck Inc. December 2014-Role: Study P.I.Prospective open label evaluation of Clobazam adjunctive treatment of adults with refractory focal epilepsy: a pilot study. Direct Cost, part 1 (completed): $ 47,600 Direct Cost, part 2: $ 92,000 Direct Cost, part 3: $ 92,000

2. Eisai, Inc. April 2015-Role: Study P.I.Rational polytherapy” using multiple Perampanel dual therapy anticonvulsant combinatorial treatment of adults with refractory focal epilepsy: a pilot study.Direct Cost: $ 202,680

RESEARCH SUPPORT – COMPLETED RECENT1. RO1-NSO456-O1A2 06.01.04-5.31.08

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Role: Study P.I. NINDSPilot: Levetiracetam to Prevent Post-Traumatic Epilepsy.Total cost: $1,817,467

3. American Epilepsy Society September 2006Role: OrganizerWorkshop on Biomarkers of Epilepsy (NINDS)Total cost: $ 10,000 2. UCB Pharma: 02.01.06-1.31.09Role: Study P.I. Evaluation of the Effect of Pregnancy on Serum Levels of Levetiracetam in Women with Epilepsy, and of Levetiracetam Levels in Breast milk and the Breast-fed Infant.Direct Cost: $ 73,560

3. Schwarz Pharma: SPM 927 Nov 2004 – Jul 2006Role: Site P.I. A multicenter, double-blind, randomized, placebo-controlled, parallel-group to investigate the efficacy and safety of SPM 927 (400 and 600 mg/day) as adjunctive therapy in subjects with partial seizures with or without secondary generalization.

4. Valeant Research and Development: VRX-RET-E22-301 Aug 2006-Dec 2007Role: Site P.I.A Randomized, Double-Blind, Placebo-Controlled Multicenter, Parallel-Group Phase 3 Study to Determine the Efficacy and Safety of Retigabine (1200 mg/day) Used as Adjunctive Therapy in Refractory Epilepsy Patients with Partial-Onset Seizures.

5. UCB Pharma:N01192 Jan 2006-May 2006Role: Site P.I. An open label, exploratory, dose-escalation, multicenter study examining the safety, tolerability and efficacy of ucb 44212 (seletracetam) used in doses of 10, 20, 40, and 8- mg b.i.d. (total daily doses of 20-160 mg) administration (oral capsules) in adult subjects (18-65 years) with refractory epilepsy suffering from partial onset seizures who are currently receiving levetiracetam (LEV) but still experiencing seizures.

6. UCB Pharma:N01193 Feb 2006-Jun 2006Role: Site P.I. A multicenter, randomized, placebo-controlled, 4 parallel groups, dose-ranging trial evaluating the efficacy and safety of brivaracetam used in b.i.d. administration (oral tablets of 2.5 or 10 mg) for a maximum of maximum of 7 weeks in subjects from 16 to 65 years with refractory epilepsy suffering from partial onset seizures whether or not secondarily generalized.

7. UCB Pharma:N01199 Apr 2006 –Apr 2010Role: Site P.I.

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An open label, multicenter, follow up trial to evaluate the long term safety and efficacy of brivaracetam used as adjunctive treatment at a flexible dose up to a maximum of 100 mg/day in subjects aged 16 years or older suffering from partial onset seizures.

8. UCB Pharma: NO N01253 Sep 2007-Feb 2008 Role: Site P.I. An international, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>16 to 70 years old) with Partial Onset Seizures. Phase 3.

9. UCB Pharma: NO N01253 Aug 2008-Dec 2009Role: Site P.I. An international, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>16 to 70 years old) with Partial Onset Seizures.

10. Marinus Pharmaceuticals, Inc. Ganaxolone 1042-0600 Sep 2007- Apr 2009 Role: Site P.I. A double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and efficacy of ganaxolone as add-on therapy in adult subjects with epilepsy consisting of uncontrolled partial-onset seizures.

11. Jazz Pharmaceutiacls, Inc.: JZP-8 Intranasal clonazepam Dec 2007-Dec 2008 Role: Site P.I. A phase 2 a, open label, proof-of-concept study to evaluate the efficacy, safety and pharmacokinetics of intranasal clonazepam in adult subjects with epileptic seizures.

12. UCB Pharma, Inc. Study N01340 Sep 2009-Mar 2010 Role: Site P.I. An open label, multicenter, parallel-group, two arm study comparing the pharmacokinetics of keppra XR in children with epilepsy aged 12 to 16 years old and in adults with epilepsy.

13. Eisai E2007-G000-304 Jun 2008-Oct 2010 Role: Site P.I. A double-blind, placebo-controlled, dose-escalation, parallel-group study to evaluate the efficacy and safety of E2007 (parampanel) given as adjunctive therapy in subjects with refractory partial seizures.

14. Sepracor Inc. BIA-2093-304 Jun 2010-Aug 2011 Role: Site P.I. Efficacy and safety of eslicarbazepine acetate (BIA2-093) as adjuncgtive therapy for refractory partial seizures in a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical trial.

15. UCB Pharma, Inc. Study N01340 Jun 2009-Mar 2010

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Role: Site P.I. An open label, multicenter, parallel-group, two arm study comparing the pharmacokinetics of keppra XR in children with epilepsy aged 12 to 16 years old and in adults with epilepsy.

16. Vertex Pharmaceuticals Inc. VX09-765-401 Mar 2010-Aug 2010Role: Site P.I. A phase 2a, randomized, double-blind, placebo-controlled study of VX-765 in subjects with treatment-resistant partial epilepsy.

17. UCB Pharma, Inc. Study SP0961 Mar 2011-Jun 2011 Role: Site P.I. An open label pilot study to assess the safety of oral lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures in subjects with idiopathic generalized epilepsy. Phase 2.

18. Vertex Pharmaceuticals Inc. VX09-765-402 Jan 2012-Jul 2013Role: Site P.I. A phase 2b, randomized, double-blind, placebo-controlled, parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of VX-765 in Subjects with Treatment-Resistant Partial Epilepsy.

19. SK Life Sciences, Inc.YKP3089 Aug 2011-Jun 2013Role: Site P.I. A phase 2b, multi-center, double-blind, randomized, adjunctive placebo-controlled trial to evaluate the efficacy and safety of YKP3089 in subjects with treatment resistant partial onset seizures.

20. UCB Pharma, Inc. Protocol NO1358 Jun 2011-Dec 2013Role: Site P.I. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of brivaracetam in subjects (≥16 to 80 years old) with partial onset seizures. Phase III.

21. Lundbeck Inc. Inc. Protocol 13181A Jun 2011-Jun 2012Role: Site P.I. Open-label study to assess the safety and tolerability of intravenous carbamazepine as short-term replacement of oral carbamazepine in adult patients with epilepsy.

22. Sunovion NCT01091662 Mar 2010-Dec 2012Safety and efficacy of Eslicarbazepine Acetate monotherapy in subjects with partial epilepsy not well controlled by current antiepileptic drugs.

23. UCB Pharma, Inc. Protocol NO1258 Jun 2011-Jan 2014 Role: Site P.I.

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A multi-center, open-label, four-arm, randomized trial evaluating the safety and tolerability of briviracetam intravenous infusion and bolus, administered in b.i.d. regimen as an adjunctive antiepileptic treatment in subjects from 16 to 70 years suffering from epilepsy.

24. SK Life Sciences, Inc. YKP 3089 C017 July 2013-Jul 2015Role: Site P.I. A multicenter, double-blind, randomized, placebo-controlled, dose-response trial of YKP3089 as adjunctive therapy in subjects with partial onset seizures with open label extension.

25. Marinus Pharmaceuticals, Inc. Ganaxolone 1042-0603 October 2013- Feb 2016Role: Site P.I. A multicenter, double-blind, randomized, placebo-controlled trial to determine the efficacy and safety of ganaxolone as adjunctive therapy in adults with drug-resistant partial-onset seizures followed by long term open-label treatment

5. Acorda Therapeutics,Inc. DZNS-EP-1019 February 2015-May 2016Role: Site P.I. An Open-Label, Randomized, Crossover Pharmacokinetic Study to Determine Relative Bioavailability, Safety and Tolerability of Single Doses of Diazepam Nasal Spray VersusDiazepam Rectal Gel (Diastat®) in Patients with Refractory Epilepsy

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a link to dr. klein's curriculum vitae

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