Triumeq is an approved medicine for HIV. The effectiveness of Triumeq in Amyotrophic Lateral Sclerosis (ALS) is being investigated in the Lighthouse II trial. This study aims to assess whether Triumeq is safe and effective at delaying ALS disease progression when given long term. It is available for participants who have completed the Lighthouse II study. The main measurements are safety, tolerability and survival. The study will go for approximately 2 years.
Treatment options for ALS are very limited and there is a high unmet need for effective treatments. Triumeq targets a known neuron toxic pathway and is currently under investigation in a double blind placebo controlled trial, Lighthouse II. This study will be open to participants who took part in, and were still taking the study drug when they completed the Lighthouse II trial, in Australia and New Zealand. The nature of the target and the mechanism of action of Triumeq are well understood. Participation in this rollover study is concurrent with standard of care, so participants are not limited in their use of therapies. Participants will be assessed for adverse events, discontinuation of study medication, survival, measures of daily functioning, plus biomarker assessments of blood and urine samples. Participant contacts may be face to face, or remote, and will be at 3 monthly intervals until approx December 2026 by which time it is anticipated the results of the Lighthouse II study will be available.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
One Triumeq tablet per day
Macquarie University, Neurology
North Ryde, New South Wales, Australia
Neuroscience Research Australia (NeuRA)
Randwick, New South Wales, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Flinders Medical Centre
Bedford Park, S.A., Australia
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
The primary endpoint of this trial is whether a patient had any drug related (definite, probable, possible) adverse events over the course of the extension trial. Tolerability is defined as the number of participants discontinuing study medication. Adverse events will be described in terms of relationship to temporary or permanent discontinuation of the study medication.
Time frame: Duration of the study plus 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Launceston General Hospital
Launceston, Tasmania, Australia
Calvary Health Care Bethlehem
Caulfield South, Victoria, Australia
The Perron Institute
Nedlands, W.A., Australia