A confirmatory, randomized, placebo-controlled, group-sequential trial to investigate the efficacy and safety of Triumeq in patients with Amyotrophic Lateral Sclerosis (ALS): The Lighthouse II Trial

  • Gold, Julian, (Primary Chief Investigator)
  • Van den Berg, Leonard (Chief Investigator)
  • Chapman, Nicola, (Clinical Trial Unit Staff)

Project: Research

Project Details

Description

Objective: To investigate the efficacy and safety of Triumeq in patients with ALS.
Study design: A phase III, international, multi-center, group-sequential, double-blind placebo-controlled trial in 17 sites in Australia, Europe and the United Kingdom with the study controlled by the TRICALS group based at the University Medical Centre Utrecht, Utrecht, The Netherlands. The trial will be conducted to European Medicines Agency and Australian Therapeutic Goods Administration standards to ensure licensing of Triumeq for ALS if the trial meets the primary outcome of impacting on survival, which is a key aim of FightMND Foundation.
AcronymLighthouse II
StatusActive
Effective start/end date21/08/2031/12/22