Transdermal dopaminergic D(2) receptor agonist therapy in Parkinson's disease with N-0923 TDS: a double-blind, placebo-controlled study.
N-0923 is a non-ergot, dopaminergic D(2) agonist designed to be transdermally available. It has anti-parkinsonian effects when infused intravenously. An adhesive matrix patch was developed to deliver N-0923 transdermally (N-0923 TDS). In this phase II trial, we evaluated the effectiveness of various doses of N-0923 TDS at replacing levodopa. Eighty-five Parkinson's disease (PD) patients were randomized to placebo or one of four doses of N-0923 TDS for 21 days. Change in daily levodopa dose was the primary efficacy measure. Significantly greater reductions in levodopa dose were achieved as compared to placebo for the two highest doses of N-0923 TDS. Patients treated with 33.5 mg and 67 mg N-0923 TDS decreased levodopa use by 26% and 28%, vs. 7% for placebo. N-0923 TDS was safe and well tolerated.
Hutton
J T
JT
Neurology Research & Education Center, Covenant Medical Center-Lakeside, 4102 24th St., Lubbock, TX 79410, USA. nrec@hub.ofthe.net
Metman
L V
LV
Chase
T N
TN
Juncos
J L
JL
Koller
W C
WC
Pahwa
R
R
LeWitt
P A
PA
Samii
A
A
Tsui
J K
JK
Calne
D B
DB
Waters
C H
CH
Calabrese
V P
VP
Bennett
J P
JP
Barrett
R
R
Morris
J L
JL
D000279:Administration, Cutaneous; D000368:Aged; D018491:Dopamine Agonists / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007980:Levodopa / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000188:drug therapy*; D017448:Receptors, Dopamine D2 / Q000819:agonists*; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage*; D013810:Therapeutic Equivalency; D013876:Thiophenes / Q000008:administration & dosage*; D016896:Treatment Outcome
D018491:Dopamine Agonists; D017448:Receptors, Dopamine D2; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; D007980:Levodopa; C047508:rotigotine