Effect of MK-458 (HPMC) in Parkinson's disease previously untreated with dopaminergic drugs. A double-blind, placebo-controlled multicenter study

Clin Neuropharmacol. 1991 Aug;14(4):322-9. doi: 10.1097/00002826-199108000-00004.

Abstract

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Delayed-Action Preparations
  • Double-Blind Method
  • Female
  • Humans
  • Lactose / analogs & derivatives*
  • Lactose / therapeutic use
  • Male
  • Methylcellulose / analogs & derivatives*
  • Methylcellulose / therapeutic use
  • Middle Aged
  • Oxazines
  • Parkinson Disease / drug therapy*

Substances

  • Delayed-Action Preparations
  • Oxazines
  • Methylcellulose
  • MK 458
  • Lactose