RESEARCH: Clinical Trials

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A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects with ALS

Design:

• This will be a randomized, double-blind, placebo-controlled, parallel group 52 week trial
  
  
• The study aims to assess the efficacy, tolerability, and safety of oral administration of talampanel compared to placebo in subjects with ALS.
  
  
• There are 3 treatment groups that patients will be randomized into at a 2:1:2 ratios. The first two groups will be receiving active treatment (with one high dose and one low dose), and the third group will be receiving placebo.
  
  
• Patients will be required to come to our center for in-clinic visits at screening, baseline, week 4, week 12, week 26, week 40, and week 52; and with telephone calls at weeks 1, 2, 3, 6, 8, 17, 22, 31, 36, 44, and 48.

Eligibility:

• Males and females with definitey, probable, or probable laboratory-supported ALS according to the World Federation of Neurology revised El Escorial criteria (Either familial or sporadic ALS).
  
  
• Subjects must be between 18 and 80 years of age.
  
  
• Subjects must have experienced their first ALS symptoms within 3 years prior to screening visit.
  
  
• Subjects must have a Slow VC score equal to or greater than 70% of the predicted value for gender, height, and age at the screening and baseline visits.
  
  
• The sum of 3 respiratory items from the ALSFRS-R must total at least 10 points.
  
  
• Subjects taking Riluzole must be on a stable dose for at least 8 weeks prior to the screening visit.
  
  
• Participants must be able to take oral medication at the time of screening and baseline visits.