Predictors of delay in the diagnosis and clinical trial entry of amyotrophic lateral sclerosis patients: A population-based study

Stefano Zoccolella, Ettore Beghi, Guerrino Palagano, Angela Fraddosio, Vito Samarelli, Paolo Lamberti, Vito Lepore, Luigi Serlenga, Giancarlo Logroscino

Research output: Contribution to journalArticlepeer-review


Background: The El Escorial and the revised Airlie House diagnostic criteria for amyotrophic lateral sclerosis (ALS) were introduced to select patients for clinical trials. Heterogeneity of clinical presentation at onset and delay in diagnosis may decrease the likelihood for trial entry. Objective: Identify risk factors for delay in the diagnosis and trial exclusion. Methods: ALS incident cases were identified with El Escorial (EEC) and Airlie House criteria (AHC) through a population-based registry established in Puglia, Southern Italy, in the years 1998-99. Results: 130 ALS incident cases were diagnosed with a median interval between onset of symptoms and diagnosis of 9.3 months and not different across both EEC and AHC categories. Twenty percent of cases were not eligible for clinical trials according to the AHC. About 5% of subjects in this series died with only lower motor neuron signs. Predictors for delay in the diagnosis were age between 65 and 75 years and spinal onset while fasciculations and cramps as first symptoms were predictors of exclusion from trials. Conclusions: In this population-based series, diagnostic delay was longer in subjects with spinal onset and age between 65 and 75 and fasciculation as first symptoms. About 80% of incident cases were trial eligible with AHC criteria. However, a significant number of subjects with ALS, characterized by a limited spread of signs, were not trial eligible while alive.

Original languageEnglish
Pages (from-to)45-49
Number of pages5
JournalJournal of the Neurological Sciences
Issue number1-2
Publication statusPublished - Dec 1 2006


  • Airlie House criteria
  • Amyotrophic lateral sclerosis
  • Clinical trials
  • Diagnostic delay
  • El Escorial criteria
  • Incidence

ASJC Scopus subject areas

  • Ageing
  • Clinical Neurology
  • Surgery
  • Neuroscience(all)
  • Developmental Neuroscience
  • Neurology


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