Clinical investigation of medicinal products in the treatment of Parkinson's disease (CPMP note for guidance). European Agency for Evaluation of Medicinal Products

Eur Neuropsychopharmacol. 1999 Sep;9(5):443-9.

Abstract

These notes are intended to provide guidance for the evaluation of drugs in the treatment of Parkinson's disease. They should be read in conjunction with the Directive 75/318/EEC and 83-570/EEC and current and future EC and ICH guidelines, especially those on: Studies in support of special populations: geriatrics (ICH E7). The extent of population exposure to assess clinical safety for drugs intended for long-term treatment in non life threatening conditions (ICH E1). General considerations for clinical trials (ICH-E8). Statistical principles for clinical trials (ICH-E9). Pharmacokinetic studies in man Clinical testing of prolonged action forms, with special reference to extended release forms. Dose response information to support product authorisation

Publication types

  • Guideline
  • Practice Guideline

MeSH terms

  • Aged
  • Antiparkinson Agents / adverse effects
  • Antiparkinson Agents / therapeutic use*
  • Clinical Trials as Topic / methods*
  • Dopamine Agonists / therapeutic use
  • Drug Evaluation / methods
  • Drug Therapy, Combination
  • Humans
  • Levodopa / adverse effects
  • Levodopa / therapeutic use*
  • Middle Aged
  • Monoamine Oxidase Inhibitors / therapeutic use
  • Parkinson Disease / drug therapy*
  • Parkinson Disease / physiopathology
  • Patient Selection

Substances

  • Antiparkinson Agents
  • Dopamine Agonists
  • Monoamine Oxidase Inhibitors
  • Levodopa