CompletedPhase IIIInterventional

Assessing the effect of Triumeq in amyotrophic lateral sclerosis

Amyotrophic lateral sclerosis (ALS) is a form of motor neurone disease with very few effective treatments. Scientists have found evidence that hidden viruses trapped inside our DNA may play a part in causing ALS. Because of this, researchers want to see if an antiviral medicine called Triumeq can help. Triumeq is an approved medication widely used to treat HIV. Early research suggests it is safe for people with ALS, but doctors now need to know if it can slow down the disease over time. This study lasts about two years. Participants will take either Triumeq or a dummy tablet (placebo) once a day alongside their usual care. Two out of three people will receive the active medicine. By joining, participants help researchers find out whether this treatment can offer hope for people living with ALS in the future.

At a glance

Status

Completed

Phase

Phase III

Enrolment target

390

Start

31 Jan 2022

Estimated completion

29 Sep 2024

Amyotrophic Lateral Sclerosis (ALS)

What is this study about?

Amyotrophic lateral sclerosis (ALS) is a condition that affects motor neurones, the specialised nerves that control our muscles. Over time, these nerves stop working properly, making movement and breathing difficult. Right now, there are very few treatments that can help slow ALS down, which is why researchers are urgently searching for new options.

Recent laboratory studies suggest that ancient, dormant viruses sitting within our natural DNA might be switched on and trigger nerve damage in some people with ALS. Triumeq is a well-established medication made of three antiviral drugs. It is already used safely around the world to treat HIV. Scientists believe Triumeq might also block these dormant ALS-related viruses and help protect nerve cells from further harm.

This trial, called the Lighthouse II study, is led by researchers at King's College London. It is a Phase III study, which means it tests the medicine in a large group of people to see if it truly slows disease progression compared to a dummy pill. Two out of every three people in the study will get Triumeq, while one out of three will receive a matching dummy pill.

Finding new ways to manage ALS is vital. If Triumeq proves successful, doctors may be able to repurpose an existing, well-tested medicine to give people with motor neurone disease more time and a better quality of life.

Key takeaways

The study is testing whether the antiviral medicine Triumeq can slow down ALS progression.
Triumeq is already approved for HIV, and early studies showed it was safe for people with ALS.
Participation lasts about two years and involves around 10 hospital visits.
Two out of three participants will receive Triumeq, while one in three receives a placebo dummy pill.
Taking part is entirely voluntary, and you can stop at any time without losing your usual NHS care.

Who may be eligible?

This study is open to adults aged 18 and older who have received a confirmed diagnosis of ALS. Participants must be well enough to complete the study visits and give their own informed consent.

If you take riluzole (the standard medication for ALS), your dose must have been steady for at least 30 days before starting the study. People who do not take riluzole can also take part, provided they stopped taking it at least 30 days beforehand. If you take certain supplements or antacids for heartburn, you may need to time them carefully around the study medicine or pause them.

Because the effects of Triumeq on unborn babies are not fully known, women who could become pregnant must have a negative pregnancy test and use reliable birth control throughout the study. Your study doctor will guide you through all medication and health checks to confirm whether the trial is a safe match for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been diagnosed with amyotrophic lateral sclerosis (ALS).
If I take riluzole, my dose has been the same for at least 30 days (or I stopped it 30 days ago).
I am able and willing to attend hospital visits roughly every three months for two years.
I am not pregnant and, if applicable, agree to use reliable contraception during the trial.

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts about two years (24 months). During this time, you will visit the clinic roughly 10 times, about once every three months. Each visit will take around two hours. You will also have telephone check-ins between visits so the research team can see how you are feeling.

At your visits, the team will check your overall health. This includes simple physical checks, blood and urine tests, quick breathing tests, heart tracings (an ECG), and questionnaires about your symptoms. You will also have routine swabs to check for infections like COVID-19.

You will take one tablet every day by mouth. A computer will randomly choose whether you get Triumeq or an identical dummy pill (placebo). Neither you nor your study doctor will know which one you are taking until the study ends, although your doctor can find out quickly in an emergency. You will continue to receive all your normal NHS care throughout the trial.

Potential risks and benefits

You may not get any direct personal benefit from taking part, though there is a chance the medicine could help slow your symptoms. You will also have regular, detailed health checks, and your participation will help doctors learn how to treat ALS better in the future. Like all medicines, Triumeq can cause side effects. Common ones include mild fever, feeling sick, low mood, tiredness, skin rash, and sleep trouble. Less common risks include nerve tingling, hair thinning, or changes in liver function. Your medical team will monitor you closely at every step. Joining is completely voluntary, and you are free to leave the study at any time without giving a reason and without it affecting your standard NHS care.

Locations (10)

King's College Hospital
Approximate
London, England
Royal Hallamshire Hospital
Approximate
Sheffield, England
John Radcliffe Hospital
Approximate
Oxford, England
The Walton Centre
Approximate
Liverpool, England
Royal Preston Hospital
Approximate
Preston, England
University College London
Unverified
London, England
Derriford Hospital
Unverified
Plymouth, England
Royal Stoke University Hospital
Unverified
Stoke-on-trent, England
St George's Hospital
Unverified
London, England
The Ann Rowling Clinic/University of Edinburgh
Unverified
Edinburgh, Scotland

Common questions

Will I definitely receive the real medicine?

Not definitely. Two out of three people will receive the real Triumeq tablet, and one out of three will receive an inactive dummy pill (placebo). A computer decides this at random.

Does taking an HIV medicine mean I have HIV?

No. Triumeq is being tested here because researchers believe the dormant viruses linked to ALS behave similarly to retroviruses like HIV. Taking it does not mean you have HIV or could catch it.

Can I continue taking my regular ALS medication?

Yes. If you take riluzole, you can usually stay on it as long as your dose has been stable for at least 30 days before joining.

What happens if I change my mind during the study?

You can leave the study at any point. Your decision will not change your relationship with your healthcare team or affect your normal NHS treatment in any way.

Will taking part cost me anything?

No, the study medication and all trial visits are provided free of charge. You can ask the study team if they can help cover travel expenses for clinic visits.

How to find out more

Elliott Phillips

LighthouseII@kcl.ac.uk +44 (0)20 7848 0368 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.