Update: October 2016
What is the Lighthouse Project?
The Lighthouse Project is a clinical trial to test whether motor neurone disease (MND) is caused or triggered by human endogenous retroviruses (HERVs). People with MND should contact their State MND Association
or neurologist if they wish to discuss the trial further. For detailed information about the Lighthouse Project > click here
The Lighthouse Project is the first Phase 2 clinical trial in the world to use modern combination anti-retroviral therapy in patients with MND. The study aims to determine the safety and tolerability of an anti-retroviral therapy “Triumeq” and provide preliminary data on whether it is able to slow down the progression of MND. Triumeq is already used to treat HIV infection safely and effectively.
The Lighthouse Project is supported by the Motor Neurone Disease Research Institute of Australia and the Cure for MND Foundation.
What is involved?
The Phase 2 study
will be conducted at Calvary Healthcare Bethlehem Hospital in Melbourne and three sites in Sydney; The Brain and Mind Centre at The University of Sydney, Macquarie University and Westmead Hospital. The study began at Macquarie University in October 2016 and is now fully subscribed. Screening of patients for trial recruitment is underway at the other sites.
Ten participants that meet certain inclusion criteria will be recruited at each site. Triumeq will be taken orally once a day for 24 weeks.
Participants will be monitored physically and for respiratory function, quality of life and disease progression over a year. Blood will be taken to ensure treatment safety and to conduct further investigations on whether Triumeq has an effect on MND. The study may also measure levels of a novel biomarker of neural damage recently validated for MND and developed in the United Kingdom. To see details on what is involved > more
Is this related to sporadic or familial MND?
The study will recruit participants who have been diagnosed with sporadic amyotrophic lateral sclerosis (ALS) by a neurologist with neuromuscular sub-specialty training
. Patients with familial causes of MND are excluded. See inclusion and exclusion criteria > more
How far off is a treatment?
A possible treatment resulting from this study is many years away. This research will determine if Triumeq is safe to treat people with MND. It will also provide some preliminary data on whether Triumeq can slow down the progression of MND. Analysis of data from the trial will give researchers a clearer picture on whether Triumeq should be tested in larger studies to further investigate its potential.
Approximately 8% of human genes have retroviral origins. HERVs infected animals and humans over millions of years of evolution and eventually became part of our genetic makeup. HERVs were only discovered about 20 years ago and it is still not known exactly how they may be related to causing human diseases. However, there is very good evidence that in animals these viruses are associated with a number of neurological conditions.