Overview of Trial Designs and Outcomes

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Overview of Trial Designs and Outcomes
April 28, 2008 Karl Kieburtz, MD, MPH University
of Rochester Medical Center
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DISCLOSURE

• Research Grants From NIH, FDA, Amarin,
  Boehringer-Ingelheim, Medivation, Neurosearch
• Consulting Paid to UR Abbott, Antipodean,
  Boehringer-Ingelheim, Cregene, Eisai, FoldRx,
  Lilly, Legal consulting, Merz, Novartis, Pfizer,
  Prestwick, Teva, Schering Plough, Schwarz,
  Vernalis, Welding
• Personal Payments FDA, CME talks (various
  sponsors)

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Effects of Tocopherol and Deprenyl on the
Progression of Disability in Early Parkinsons
Disease The Parkinson Study Group
NEJM 1993328176-83
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The effect of deprenyl and levodopa on the
progression of Parkinsons Disease
CW Olanow, RA Hauser, L Gauger, T Malapira, W
Koller, J Hubble, K Bushenbark, D Lilienfeld, and
J Esterlitz Ann Neurol 199538771-777
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Effects of Coenzyme Q10 in early Parkinson
disease. Evidence of slowing of the functional
decline
CW Shults, D Oakes, K Kieburtz, MF Beal, R Haas,
S Plumb, JL Juncos, J Nutt, I Shoulson, J Carter,
K Kompoliti, JS Perlmutter, S Reich, M Stern, RL
Watts, R Kurlan, E Molho, M Harrison, M Lew, and
the Parkinson Study Group. Arch Neurol
2002591541-1550.
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The Parkinson Study Group PRECEPT Investigators.
Neurology 2007691480-1490.
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A 2-year, multicenter, placebo-controlled,
double-blind, parallel-group study of the effect
of riluzole on Parkinsons disease
O. Rascol, W. Olanow, D. Brooks, G. Koch, P.
Truffinet, R. Bejuit. Mov Dis 200217(5)S39.
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Immediate-release and controlled-release
carbidopa/levodopa in PD A 5-year randomized
multicenter study
WC Koller, JT Hutton, E Tolosa, R Capilldeo, and
the Carbidopa/Levodopa Study Group. Neurology
1999531012-1019.
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Early treatment of Parkinsons disease with
cabergoline delays the onset of motor
complications. Results of a double-blind
levodopa controlled trial
UK Rinne, F Bracco, C Chouz, E Dupont, O
Gershanik, JF Marti Masso, JL Montastruc, CD
Marsden, and the PKDS009 Study Group. Drugs 1988
(55)23-29.
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Pramipexole vs. levodopa as Initial Treatment for
Parkinson Disease. A randomized controlled trial
Parkinson Study Group JAMA 20002841931-1938
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Dopamine transporter brain imaging to assess the
effects of pramipexole vs. levodopa on Parkinson
disease progression

• Parkinson Study Group
• JAMA 20022871653-1661

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A five-year study of the incidence of dyskinesia
in patients with early Parkinsons disease who
were treated with ropinirole or levodopa
O Rascol, DJ Brooks, AD Korczyn, PP DeDeyn, CE
Clarke and AE Lang for the 056 Study Group. NEJM
20003421484-91.
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