Effect of MK-458 (HPMC) in Parkinson's disease previously untreated with dopaminergic drugs. A double-blind, placebo-controlled multicenter study.
Ninety-four patients with early Parkinson's disease were investigated in a double-blind, placebo-controlled evaluation of MK-458 [hydroxypropyl methylcellulose/lactose matrix (HPMC)], a sustained release formulation of a novel naphthoxazine compound with selective D-2 dopamine receptor agonism. Patients were previously untreated with dopaminergic drugs. Efficacy was assessed by clinical rating scales and by patient self-evaluation. MK-458 (HPMC) caused a significant decrease in most parkinsonian symptoms. Though disability rating scores were lowered by the drug, the scores did not differ significantly from placebo. However, statistically significant improvement occurred with MK-458 (HPMC) on both the physician and the patient global assessments. Adverse reactions such as nausea and vomiting, sedation, confusion, and hallucinations occurred more with MK-458 (HPMC) than with placebo. MK-458 (HPMC) possesses antiparkinsonian efficacy in early Parkinson's disease; however, side-effects are frequently associated with its use. Selective D-2 receptor agonists, such as MK-458 (HPMC), may not be the ideal treatment as monotherapy for Parkinson's disease.
Koller
W C
WC
Department of Neurology, University of Kansas Medical Center, Kansas City 66103.
Block
G A
GA
Ahlskog
J E
JE
Ahrens
S
S
Cedarbaum
J M
JM
Cyhan
G
G
Goetz
C G
CG
LeWitt
P A
PA
Liss
C
C
McLean
L
L
D000368:Aged; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007785:Lactose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008875:Middle Aged; D010078:Oxazines; D010300:Parkinson Disease / Q000188:drug therapy*
D003692:Delayed-Action Preparations; D010078:Oxazines; D008747:Methylcellulose; C071191:MK 458; D007785:Lactose