Lighthouse II phase 3
MND New Zealand is proud to have been able to contribute funding to secure access to Lighthouse II, an international clinical trial looking at whether human endogenous retroviruses (HERVs) play a role in motor neurone disease.
This trial is the first-ever phase 3 clinical trial to be offered to people with MND in New Zealand, across multiple locations.
Research teams in Bay of Plenty, Wellington, Christchurch and Dunedin have elected to participate in this trial. There are 20 places (approximately 5 per centre) available for MND New Zealand clients. Dr Alan Stanley, Hawkes Bay neurologist and MND New Zealand Council member will be the New Zealand Principal Investigator for this trial.
To be eligible for this trial, participants must be on the NZ MND Registry, reside in one of the four site locations – BOP, Wellington, Christchurch and Dunedin and meet the inclusion criteria set by the trial.
The Lighthouse II Project will investigate whether targeting HERVs with anti-retroviral therapy might slow disease progression in patients with MND/ALS. HERVs are ancient viruses that have left their genetic material in our DNA during the human evolution. In some people, this old genetic material may become activated and is believed to be a cause of MND.
Phase 2 of the Lighthouse Trial showed that Triumeq could suppress this genetic reactivation and may slow disease progression in patients with ALS. Triumeq is a drug that is used to treat patients with the human immunodeficiency virus (HIV) and is shown to be safe and well tolerated in patients with ALS. You can read more about this phase of the trial here.
Phase 3 also called Lighthouse II, will be a randomised, double-blind, placebo-controlled study. This means that participants will be randomly allocated to receive a treatment with either Triumeq or a placebo (dummy drug). Phase 3 of Lighthouse II is expecting to enroll 390 participants worldwide, with participants taking Triumeq (or placebo) for a maximum of 24 months. Of the 390 participants worldwide, 20 of these participants will be MND patients from New Zealand.
We strongly encourage all people with MND who wish to be considered for this trial and future opportunities to enrol with the NZ MND Registry as soon as possible before the end of August.
If you have already enrolled with the Registry you don’t need to enrol again.
To register online, please complete the participant NZ MNDR Consent and contact details form or contact the Registry Curator, Dympna Mulroy by email or phone on 0800 MND REG (0800 663 734).
Frequently Asked Questions
For clients to be eligible they must be on the NZ MND Registry, reside in one of the four site locations – BOP, Wellington, Christchurch and Dunedin and meet the inclusion criteria set by the trial. The NZ MND Registry will contact those eligible directly to see if they would like to participate, with the expectation that there will be approximately 5 clients enrolled from each each site.
To join the NZ MND register visit here
The inclusion and exclusion criteria can be found here: https://clinicaltrials.gov/ct2/show/NCT05193994
NB. MND New Zealand is sponsoring the New Zealand arm of this trial but is not involved in screening or selecting participants or any of the clinical aspects behind this trial.
Each site needs a neurologist and a research nurse available to run the trial. The number of sites is limited to those locations that have staff currently available to run the trial.
As this is the first time New Zealand has collaborated in a large international trial, and with a limited number of research staff available, the research team has needed to restrict the number of participants to ensure that the trial is conducted safely and effectively.
One of the important legacies of this first international trial will be establishing systems and processes that can be applied and expanded to accommodate larger trials in the future.
Further information about the trial will be shared on our website in the coming weeks, but the most important first step clients can take is to sign up to the NZ MND Registry so they can be considered against the trial’s inclusion/ exclusion criteria.
The following links provide further background on this international trial:
Lighthouse Project shines a beacon on HERVs and their role in ALS - MND Research Blog
Triumeq in Amyotrophic Lateral Sclerosis - Full Text View - ClinicalTrials.gov
For further information or to join the New Zealand Motor Neurone Disease Registry, they can contact the Registry Curator, Dympna Mulroy, via email or phone on 0800 MND REG (0800 663 734).
Alternatively, they can visit our website here and sign-up for the registry online by completing the participant information consent form.
The MND Research Network has a list of research that is taking place in New Zealand here.
In order to get onto a clinical trial in New Zealand a person with MND must be registered with the New Zealand Motor Neurone Disease Registry. This is a separate process to joining MND New Zealand. The role of the Registry is to connect people with MND to research trials that they are eligible for.
Some clinical trials are targeted at people whose MND is believed to be driven by mutations in a particular gene eg SOD-1 or C9orf72. People with MND may want to discuss genetic testing with their Specialist or consider participating in the University of Auckland MND Genetics study by registering with The New Zealand MND Registry. Be aware that some genetic therapies are not currently available in New Zealand.