RANDOMISED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 3 TRIAL OF TRIUMEQ IN AMYOTROPHIC LATERAL SCLEROSIS - LIGHTHOUSE II
This important study, called LIGHTHOUSE II, is designed to see if a medicine called Triumeq can help people living with Amyotrophic Lateral Sclerosis (ALS), also known as Motor Neuron Disease. We want to find out if Triumeq can improve how long people live and their ability to carry out everyday activities. Some participants will receive Triumeq, while others will get a dummy pill (placebo) that looks and tastes exactly the same. This is done to make sure we can accurately tell if any changes are due to the medicine itself. We’ll carefully monitor participants for any improvements in their health and daily functioning, as well as checking for any side effects.
At a glance
What is this study about?
This study, named LIGHTHOUSE II, is a research project designed to explore a new potential treatment for Amyotrophic Lateral Sclerosis (ALS), which is also known as Motor Neuron Disease. ALS is a condition that affects nerve cells in the brain and spinal cord, leading to muscle weakness and problems with movement. The medicine being tested is called Triumeq. Researchers want to understand if Triumeq can help people with ALS live longer and maintain their daily abilities.
To make sure the study gives reliable results, it's set up in a particular way. Some participants will receive the active medicine, Triumeq, while others will receive a 'dummy pill', called a placebo. This placebo looks exactly like the Triumeq tablets and tastes the same. This method is used because people's expectations can sometimes influence how they feel, and comparing to a placebo helps us truly see if the medicine is having a real effect. Neither you nor your doctor will know whether you are receiving Triumeq or the placebo until the study is over. This is called a "double-blind" study.
The main thing the researchers will be looking at is how long people live in the study. They will also be closely watching many other aspects of health, such as daily functioning (like your ability to do everyday tasks), your breathing, your overall quality of life, and any changes in your thinking. They will also carefully check for any side effects from the treatment to ensure it is safe and well-tolerated.
Key takeaways
- This study is testing a medicine called Triumeq for ALS (Motor Neuron Disease).
- It aims to see if Triumeq can help people live longer and improve daily functioning.
- Participants will receive either Triumeq or a dummy pill (placebo).
- Close medical monitoring and regular hospital visits will be part of the study.
- Anyone aged 18 or over, male or female, may be eligible, with other medical criteria.
- This is a Phase 3 study, meaning it's a large-scale final test of the treatment.
Who may be eligible?
To take part in this study, you need to be at least 18 years old. Both men and women are welcome to join.
Beyond these basic requirements, there will be other specific medical criteria that you would need to meet to ensure the study is right for you and that the results are as clear as possible. These might include things related to your current health, past medical history, and specific diagnostic information about your ALS.
Your doctor would be able to discuss all the detailed eligibility requirements with you if you are interested in potentially participating in this study.
- Are you 18 years old or older?
- Do you have a diagnosis of Amyotrophic Lateral Sclerosis (ALS) / Motor Neuron Disease?
- Are you able to attend regular hospital visits?
- Are you willing to potentially receive either the study drug or a placebo?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would receive either the study medication (Triumeq) or the placebo as capsules which look and taste like crushed Triumeq tablets. You would need to attend regular visits to the clinic so that the study team can monitor your health, check for any changes in your condition, and look for any side effects. These visits will involve various assessments, such as physical examinations, breathing tests, blood tests, and questionnaires about your daily activities and quality of life. The study will continue for a certain period, and there will be follow-up appointments even after you stop taking the study medication. The total duration of your involvement, including all visits and follow-up, will be clearly explained by the study team.
Potential risks and benefits
Locations (5)
- —Sweden
- —Netherlands
- —Spain
- —Slovenia
- —Ireland
Common questions
What is ALS?
ALS stands for Amyotrophic Lateral Sclerosis, also known as Motor Neuron Disease in the UK. It's a condition that affects nerve cells in the brain and spinal cord, leading to muscle weakness.
What is Triumeq?
Triumeq is a medicine being tested in this study to see if it can help people with ALS live longer and improve their daily lives.
What is a placebo?
A placebo is a 'dummy pill' that looks and tastes exactly like the actual medicine but doesn't contain any active ingredients. It helps researchers accurately compare the effects of the real medicine.
Why is it called 'double-blind'?
Double-blind means that neither you nor your doctors will know whether you are receiving the active medicine or the placebo until the study is finished. This helps to keep the study fair and unbiased.
Will I get the actual medicine?
Some participants will receive Triumeq, and others will receive the placebo. You won't know which one you are getting until the end of the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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