Take part in the TUDCA-ALS Clinical Trial

Take Part

We are currently in the process of setting up the clinical trial part of the TUDCA-ALS project. The TUDCA-ALS partners at all sites are making good progress with the huge amount of work entailed in setting up a Phase III clinical trial across several European countries. As soon as everything is ready, information on what the clinical trial involves and how to take part will be available on this page.

Inclusion Criteria:

  • Either gender
  • 18 to 80 years of age (inclusive)
  • Probable, laboratory-supported probable or definite ALS as defined by El Escorial Re-vised ALS diagnostic criteria
  • Disease duration ≤ 18 months
  • No swallowing difficulties (4 on ALSFRS-R subscore for swallowing)
  • Forced vital capacity ≥70% of normal
  • Stable on riluzole treatment for 3 months in the lead-in period (month -3 to month 0) or no riluzole
  • Signed informed consent

Exclusion Criteria:

  • Other causes of neuromuscular weakness
  • Presence of other neurodegenerative diseases
  • Significant cognitive impairment, clinical dementia or psychiatric illness
  • Severe cardiac or pulmonary disease
  • Other diseases precluding functional assessments
  • Other life-threatening diseases
  • Women of child-bearing age without contraception, who are pregnant or breast feeding
  • Any clinically significant laboratory abnormality
  • Other concurrent investigational medications
  • Active peptic ulcer
  • Previous surgery or infections of small intestine
  • Patients unable to easily swallow the treatment pills at time of enrolment
  • Occurrence of frequent biliary colic, biliary infections, severe pancreatic abnormalities
  • Subjects who weigh 88lbs (40 kgs) or less at screening
  • Aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
  • Creatinine clearance of 50ml/min or less
  • Previous exposure to bile acids
  • Any clinically significant neurological, haematological, auto-immune, endocrine, cardiovascular, neoplastic, renal, gastro-intestinal, or other disorder that, in the investigator’s opinion, could interfere with subject’s participation in the study, place the subject at increased risk, or confound interpretation of study results
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive TUDCA or that the subject is unable or unlikely to comply with the dosing schedule or study evaluations

Frequently Asked Questions:

The answers to a number of frequently asked questions that arise during the clinical trial will be provided here.