Controlled-release Sinemet (CR-4): a double-blind crossover study in patients with fluctuating Parkinson's disease

Mayo Clin Proc. 1988 Sep;63(9):876-86. doi: 10.1016/s0025-6196(12)62690-1.

Abstract

Patients with moderate to advanced Parkinson's disease may have prominent levodopa-related motor fluctuations. In a double-blind crossover study, we compared the anti-Parkinson effects of standard Sinemet with a controlled-release formulation (Sinemet CR-4) in 23 patients with short-duration responses to standard Sinemet. With Sinemet CR-4, approximately half the patients who completed the study displayed a prolongation of their "on" response (optimal response to treatment), as assessed by monitoring individual drug-response cycles. A few patients experienced prolonged delays before the peak anti-Parkinson response developed to Sinemet CR-4. End-of-dose "wearing off" was favorably affected by Sinemet CR-4, but patients still had unpredictable "off" (parkinsonian) periods. Subjective ratings of Sinemet CR-4 varied, and 39% of patients who completed the study actually preferred standard Sinemet to the new formulation. We conclude that Sinemet CR-4 may benefit some patients with Parkinson's disease with a short-duration response to standard Sinemet; however, not all patients found it preferable to the standard formulation.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Activities of Daily Living
  • Adult
  • Aged
  • Aged, 80 and over
  • Antiparkinson Agents / administration & dosage*
  • Antiparkinson Agents / adverse effects
  • Antiparkinson Agents / therapeutic use
  • Carbidopa / administration & dosage*
  • Carbidopa / adverse effects
  • Carbidopa / therapeutic use
  • Clinical Trials as Topic
  • Consumer Behavior
  • Delayed-Action Preparations
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Combinations / administration & dosage
  • Drug Combinations / adverse effects
  • Drug Combinations / therapeutic use
  • Drug Evaluation
  • Dyskinesia, Drug-Induced / etiology
  • Female
  • Humans
  • Levodopa / administration & dosage*
  • Levodopa / adverse effects
  • Levodopa / therapeutic use
  • Male
  • Middle Aged
  • Parkinson Disease / drug therapy*
  • Random Allocation
  • Time Factors

Substances

  • Antiparkinson Agents
  • Delayed-Action Preparations
  • Drug Combinations
  • carbidopa, levodopa drug combination
  • Levodopa
  • Carbidopa