Karl D. Kieburtz, M.D., M.P.H.

Contact Information

Phone Numbers

Administrative: (585) 275-8911

Office: (585) 275-8911

Fax: (585) 273-1074

Locations

UR Medicine Neurology Neurology
919 Westfall Rd
Bldg. C, Suite 100
Rochester, NY 14618

Neurology: (585) 341-7500

Faculty Appointments

Professor (Part-Time) - Department of Neurology , Center for Health and Technology (SMD)

Biography

Professional Background

Karl Kieburtz, MD, MPH, is the Robert J. Joynt Professor in Neurology, Senior Associate Dean for Clinical Research and Director of the Clinical & Translational Science Institute at the University of Rochester Medical Center. He is also Professor of Public Health Sciences and of Environmental Medicine, and was the founding Director of the Center for Human Experimental Therapeutics (CHET). CHET conducts learning phase clinical trials in a wide spectrum of disorders in collaboration with investigators within the URMC as well as with colleagues throughout North America, Europe, Asia and Oceania. Dr Kieburtz's primary clinical and research interests are neurodegenerative diseases affecting the basal ganglia, particularly Parkinson disease, Huntington disease, and HIV related neurologic disorders. He is the principal investigator for the NINDS sponsored trials of neuroprotective agents for PD (NET-PD) and directed the Coordination Center for an NEI-funded consortium in Neuro-opthalmology. He completed his MD and MPH degrees at the University of Rochester, as well as his Neurology residency and a fellowship in Experimental Therapeutics.

Research

Dr. Karl Kieburtz MD MPH is the Robert J Joynt Professor in Neurology and the Director of the Clinical & Translational Science Institute and Senior Associate Dean for Clinical Research at the University of Rochester School of Medicine and Dentistry in Rochester, NY. He also has appointments as Professor of Environmental Medicine and of Public Health Sciences. His research career has focused on developing treatments for diseases with high unmet therapeutic needs, including HIV-related neurologic syndromes and neurodegenerative disorders, such as Alzheimer and Parkinson disease. His research program has had continuous independent funding from the National Institutes of Health for over 20 years and he has served as the principal investigator on over two dozen multi-center clinical trials. He has served as a consultant to United States government through the FDA (serving on and chairing the Peripheral and Central Nervous System Advisory Committee), Veterans Administration (chairing the Scientific Evaluation Committee for the Cooperative Studies Program) and the National Institute of Neurologic Disorders and Stroke (serving on the clinical trials study section). He has served as an officer or board member for multiple international professional organizations including the American Neurological Association, the American Society for Experimental Therapeutics and the Movement Disorders Society, and has served as Associate Editor of the journals Neurology and Movement Disorders. As the Director Clinical & Translational Science Institute he helps institutional investigators translate their clinical and bench-based research findings into potential human therapeutic agents. For his roles as an educator he has received the University of Rochester Medical Center's highest mentoring awards as well as a K24 award from the NIH for mentoring junior faculty. He also maintains an active clinical practice in neurology, primarily seeing patients with neurodegenerative disorders.

Credentials

Education

1980
BA | Amherst College
Neuroscience and Religion

1985
MD | Univ Rochester Sch Med/Dent
Medicine

1985
M.P.H. | University of Rochester

Post-doctoral Training & Residency

07/01/1986 - 07/01/1989
Residency in Family Medicine at University of Rochester Medical Center

06/17/1985 - 06/22/1986
Internship in Neurology at Highland Hospital of Rochester

Awards

HONORS: Phi Beta Kappa, Amherst College, 1980; Frank Dow Award in Chemistry, Amherst College, 1980; Logan Clendenning Fellowship in the History of Medicine, 1982; George W. Merck Dean's Teaching Scholar, University of Rochester School of Medicine 1994-1997; The Best Doctors in America, Woodward/White, Inc., 2nd edition, 1994

Alzheimer's Disease Cooperative Study
Sponsor: 5U01-AG010483
Location: Chair, Safety Monitoring Committee (L Thal, PI) 9/01-6/12

PSG PATCH Study: Topical Dopamine Agonist in PD
Sponsor: Industry Sponsored
Location: Coordination Center Director 6/99-12/00

PSG RAPID Study: Monoamine Oxidase Inhibitor in PD
Sponsor: Industry Sponsored
Location: Coordination Center Director 10/97-10/00

Ethylester of Levodopa in PD
Sponsor: Industry Sponsored
Location: Coordination Center Director 6/99-6/02

Early Randomized Surgical Epilepsy Trial
Sponsor: NIH R21 NS42372
Location: Coordination Center Director (J Engel PI) 7/01-6/06

Targeted Neuroprotection for HIV-1 Associated Neurologic Disease
Sponsor: NIH PO1 MH64570
Location: Project Co-PI (H Gelbard PI) 7/01-6/05

Neuroprotection Studies in PD: A Coordinating Center
Sponsor: NIH, NINDS NS43128
Location: Principal Investigator 9/01-7/06

Neurobiological Predictors of Huntington's Disease (PREDICT-HD)
Sponsor: NINDS NS40068
Location: Coordination Center Director (J Paulsen PI) 11/01-10/06

Prospective Huntington At-Risk Observational Study (PHAROS)
Sponsor: Huntington's Disease Society of America & Hereditary Disease Fdn
Location: Coordination Center Director (I Shoulson, PI) 5/99-12/01

Prospective Huntington At-Risk Observational Study (PHAROS)
Sponsor: NIH / NHGRI / NINDS R01HG02449
Location: Coordination Center Director (I Shoulson, PI) 9/30/02-6/30/07

HSG Trend Study: A multicenter placebo-controlled efficacy and safety trial of an experimental membrane-stabilizing drug
Sponsor: ethyl-EPA in ambulatory Huntington's Disease patients
Location: Coordination Center Director (I Shoulson, PI) 3/05-6/08

HSG DOMINO Study: Double blind study of minocycline in Huntington's disease
Sponsor: FD-R-02588
Location: Coordination Center Director (M Cudkowicz, PI) 8/05-8/08

Multi-Center Phase 1-2A Open-Label Dose-Escalation & Randomized, Double-Blind, Placebo-controlled Study of Dimebon in Subjects
Sponsor: w/ HD (DIMOND) Industry Sponsored
Location: Principal Investigator 2/06-5/07

PSG Prami BID Study: A randomized, double-blind, active and placebo controlled, efficacy study of pramipexole in subjects w/ PD
Sponsor: Industry Sponsored
Location: Principal Investigator 3/1/06-1/08

The University of Rochester's Clinical and Translational Science Institute
Sponsor: UL1 RR024160, KL2 RR024136, TL1 RR024135
Location: Instructor (T Pearson, PI) 9/06-6/11

Neuroprotection Studies in PD: A Coordinating Center
Sponsor: NIH, NINDS NS43128
Location: Principal Investigator 12/1/06-11/30/11

Midcareer Investigator Award in Patient-Oriented Research
Sponsor: NINDS, NS02122
Location: Principal Investigator 1/99-12/04

Data Coordination and Biostatistics Center for the NORDIC Network
Sponsor: National Eye Institute, 1U10 EYO17387-01A1
Location: Principal Investigator 02/10/09 – 01/31/14

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate
Sponsor: Huntington Disease (HORIZON): Medivation
Location: Principal Investigator 3/15/09-3/15/11

A multi-center, N.A., randomized, double-blind, parallel group study comparing three doses of ACR16... (HART)
Sponsor: NeuroSearch Sweden AB
Location: Principal Investigator 11/1/07-3/31/10

Inosine for Parkinson's Disease: Safety and Trial Design Optimization
Sponsor: Michael J. Fox Foundation Rapid Response Innovation Award
Location: Principal Investigator, Data Coordination Ctr 2/15/08-2/14/12

Coordination and Statistics for CoQ10 in HD (2CARE)
Sponsor: NIH NINDS RO1 NS052619
Location: Co-Principal Investigator (M McDermott, PI) 9/1/05-8/30/09

Prophylactic Phenobarbital after Resolution of Neonatal Seizures (PROPHENO)
Sponsor: NICHD, RO1 HD057977
Location: Steering Committee (R Guillett, PI) 12/01/2008 – 11/30/2013

ERSET: A Multi-center Randomized Clinical Trial for Early Treatment of Epilepsy
Sponsor: NIH, NS37897
Location: Coordination Center Director (J Engel PI) 7/99-6/07

Midcareer Investigator Award in Patient-Oriented Research
Sponsor: NINDS, NS02122
Location: Principal Investigator 1/99-12/04

Effects of Coenzyme Q10 in Patients With Early, Untreated Parkinson's Disease
Sponsor: NIH R01 NS36714
Location: Co-Principal Investigator (C Shults PI) 6/98-6/01

Earlier vs. Later L-dopa in Parkinson's Disease
Sponsor: NIH, R01 NS34796-01A1
Location: Coordination Center Director (S Fahn PI) 6/98-6/01

Deprenyl and Tocopherol Antioxidant Therapy of Parkinsonism (DATATOP) NS24778
Sponsor: NINDS, NIH 11/89-4/94
Location: Medical Director and Steering Committee member

Dideoxyinosine treatment of AIDS Dementia
Sponsor: Industry Sponsored Clinical Trial 10/90-11/91
Location: Principal Investigator

Parkinson Study Group START Clinical Trials
Sponsor: Industry Sponsored 11/1/90-4/30/92
Location: Medical Director and Steering Committee member

AIDS Clinical Trial Group
Sponsor: National Institute of Allergy and Infectious Disease, NIH
Location: Member, Neurology Core Committee 7/90-7/94, 2UO1AI27658

Parkinson Study Group ROADS Clinical Trial
Sponsor: Industry Sponsored
Location: Medical Director and Steering Committee member 4/92-4/94

BLIND-DATE Clinical Trial
Sponsor: Industry Sponsored
Location: Medical Director, Parkinson Study Group 3/93-1/95

Glutamate Antagonist Tolerability in Huntington's Disease
Sponsor: Industry Sponsored Clinical Trial
Location: Principal Investigator 7/1/93-6/30/94

STEP-UP Clinical Trial
Sponsor: Industry Sponsored
Location: Medical Director, Parkinson Study Group 10/93-6/95

European Network for Striatal Transplantation in Huntington's Disease(NEST-HD):preclinical development & clinical trial method
Sponsor: European Economic Community
Location: Sub-proposer and Consultant

Experimental Therapeutics of HIV Neurology (part of Neurologic AIDS Research Consortium Program Project, David Clifford, PI)
Sponsor: NINDS, NIH
Location: Site Principal Investigator 12/1/93-11/30/95

SEESAW Clinical Trial
Sponsor: Industry Sponsored
Location: Medical Director, Parkinson Study Group 11/93-12/95

Ethics of Sham Surgery Controls to Test Novel Parkinson's Disease Interventions
Sponsor: Michael J. Fox Foundation Rapid Response Innovation Award
Location: Principal Investigator 11/07-05/08

Dana Foundation Consortium For The Treatment of HIV Dementia And Related Disorders
Location: Co-Principal Investigator (L Epstein PI) 1/94-12/96

Clozapine for Psychosis in PD
Sponsor: FDA, Orphan Drug Div.
Location: Medical Director (J Friedman PI) 7/94-6/97

Investigation of Tolerability of OPC-14117 in Huntington's Disease
Sponsor: Otsuka Pharmaceuticals
Location: Medical Director (I Shoulson PI) 9/94-9/95

Trial of a Glutamate Antagonist in PD and MSA
Sponsor: Industry Sponsored
Location: Principal Investigator 9/95-9/96

Evaluation of SPECT Imaging in The Diagnosis of PD
Sponsor: Industry Sponsored
Location: Director of Coordination Center (K Marek PI) 9/95-9/96

Comparison of Levodopa and a Dopamine Agonist in PD
Sponsor: Industry Sponsored
Location: Director of Coordination Center (I Shoulson PI) 10/95-10/02

PSG PRIME: Study of a Dopamine Agonist in Minority Persons
Sponsor: Industry Sponsored
Location: Director of Coordination Center (C Tanner PI) 10/95-3/97

TACT Study: Treatment of ADHD in Children with Tourette's
Sponsor: NIH NINDS, RO1 NS33654
Location: Director of Coordination Center (R Kurlan, PI) 7/96-7/99

PSG SPIRAL Study: Interaction Study of Remacemide and Levodopa in Parkinson's Disease
Sponsor: Industry Sponsored
Location: Principal Investigator 10/96-11/97

Clinical Trials Unit in HIV Dementia
Sponsor: NINDS, NIH, P01 NS32228
Location: Project PI (D Clifford, U of Washington, PPG PI) 12/93-4/02

Co-Enzyme Q10 and Remacemide Evaluation in Huntington's Disease
Sponsor: NIH, RO1 NS35284
Location: Principal Investigator 5/97-5/01

Neurocognitive Function, HIV Load and Surrogate Markers (NEAD)
Sponsor: NIH, P01 NS36519-01A1
Location: Data Management Core Director (L Epstein PI) 2/98-1/03

A Double Blind Study of Amitriptyline and Mexilitine for Painful HIV Neuropathy
Sponsor: AIDS Clinical Trials Group, Protocol 242, 2/94-2/96
Location: Study Chair

PSG PRECEPT study, CEP1347 in Early PD
Sponsor: Industry Sponsored
Location: Coordination Center Director (I Shoulson, PI) 12/01-8/04

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Publications

Journal Articles

5/2023
Siderowf A, Concha-Marambio L, Lafontant DE, Farris CM, Ma Y, Urenia PA, Nguyen H, Alcalay RN, Chahine LM, Foroud T, Galasko D, Kieburtz K, Merchant K, Mollenhauer B, Poston KL, Seibyl J, Simuni T, Tanner CM, Weintraub D, Videnovic A, Choi SH, Kurth R, Caspell-Garcia C, Coffey CS, Frasier M, Oliveira LMA, Hutten SJ, Sherer T, Marek K, Soto C, . "Assessment of heterogeneity among participants in the Parkinson's Progression Markers Initiative cohort using ?-synuclein seed amplification: a cross-sectional study." The Lancet. Neurology.. 2023 May; 22(5):407-417.

1/23/2023
LeWitt P, Liang GS, Olanow CW, Kieburtz KD, Jimenez R, Olson K, Klepitskaya O, Loewen G. "Opicapone Pharmacokinetics and Effects on Catechol-O-Methyltransferase Activity and Levodopa Pharmacokinetics in Patients With Parkinson Disease Receiving Carbidopa/Levodopa." Clinical neuropharmacology.. 2023 Jan 23; Epub 2023 Jan 23.

2023
McGarry A, Kieburtz K. "Adaptive clinical trials and master protocols." Handbook of clinical neurology.. 2023 193:313-323.

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Karl Kieburtz, M.D., M.P.H.