RESEARCH: Clinical Trials

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A Multicenter, Double-Blind, Placebo-Controlled, Study to Investigate the Safety and Efficacy of Lithium in combination with Riluzole in ALS

Design:

• The primary study objective is to compare the efficacy of lithium in combination with riluzole to riluzole and placebo in volunteers with ALS.
  
  
• Primary efficacy will be measured by analyzing disease progression in the revised ALS functional rating scale (ALSFRS-R)
  
  
• Secondary measures of efficacy will include rate of decline in ALSFRS-R and slow vital capacity, ALS specific quality of life questionnaire, and tracheostomy-free survival.

Eligibility:

• Diagnosis of ALS as determined by the El EScorial ALS Diagnostic criteria, which includes possible, laboratory-supported probable, probable and definite.
  
  
• Duration of disease must be <36 months since symptom on-set.
  
  
• On stable dose of riluzole 50mg bid for at least 30 days prior to screening
  
  
• creatinine = 1.5mg/dl (133 umol/L)
  
  
• participants with psoriasis must have inactive disease for at least 30 days before SV
  
  
• vital capacity equal to or more than 60% predicted value for gender, height and age at SV
  
  
• Fluency in English, Spanish or French (Canadian)