To determine if Triumeq improves survival in Amyotrophic Lateral Sclerosis (ALS) compared with placebo
This Randomised Double-Blind Placebo Controlled trial seeks to investigate whether the combination medicine Triumeq (dolutegravir 50mg, abacavir 600mg, lamivudine 300mg), already sold in Australia for HIV treatment is effective in delaying progression of theAmyotrophic Lateral Sclerosis (ALS) disease and if it is safe and well tolerated in patients with ALS. This medication is very commonly prescribed for patients with HIV. The secondary aim of this study is to assess patient's health outcomes whilst taking this medication for their ALS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
419
Dolutegravir 50mg, Abacavir 600mg and Lamivudine 300mg.
Matching placebo.
Measure overall survival at 24 months or after a minimum of 212 events
Overall survival is measured as death from any cause, in participants with ALS at 24 months, or after a minimum of 212 events.
Time frame: 24 months
Measure scoring in the ALS-Functional Rating Scale Revised (ALSFRS-R) at 3 monthly intervals.
The ALSFRS-R is a 12 item participant self-report measure that monitors ALS disease progression, where a higher score reflects a better outcome.
Time frame: 24 months
Number of participants with abnormal Slow Vital Capacity measured by hand spirometry at 3 monthly intervals
Slow vital capacity is measured in litres, and as a % of predicted.
Time frame: 24 months
Measure plasma creatinine at 3 monthly intervals
Plasma creatinine is assessed to monitor kidney function
Time frame: 24 months
Assign a value using the King's Staging Scale to describe degree of disease advancement over time
The King's Staging Scale is a clinical staging system defining four stages of ALS assessed by way of a semi-structured interview with the participant.
Time frame: 24 months
Evaluate the incidence of treatment-emergent adverse events
based on physical examinations and patient reported symptoms.
Time frame: 24 months
Measure study medication discontinuation
the number of participants who discontinue study medication will be assessed to assess tolerability
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MQ Health Neurology
North Ryde, New South Wales, Australia
Neuroscience Research Australia (NeuRA)
Randwick, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Calvary Health Care Bethlehem
Caulfield South, Victoria, Australia
The Perron Institute
Nedlands, Western Australia, Australia
Beaumont Hospital
Dublin, Ireland
UMC Utrecht
Utrecht, Netherlands
...and 18 more locations
Time frame: 24 months
Measure the score obtained with the Edinburgh Cognitive and Behavioural Assessment Screen (ECAS)
ECAS is a multidomain assessment questionnaire used in ALS to assess cognitive and behavioural changes where a higher score relates to a better outcome.
Time frame: 24 months
Measure the responses in the EQ-5D-5L quality of life health questionnaire.
The EQ-5D-5L questionnaire is a standardised measure of health-related Quality of Life, also incorporating a Visual Analogue Scale. A higher score relates to a better outcome.
Time frame: 24 months
Measurement of several biomarkers from blood and urine samples
Urinary P75ECD, plasma neurofilament light and heavy chain, HERV-K expression and genotyping (UNC13a / C9orf72) will be measured for post-trial exploratory analyses.
Time frame: 24 months