Randomized, Single-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Melatonin Administration in Patients With Multiple Progressive Primary Sclerosis (MELATOMS)
This research, called MELATOMS, is investigating whether melatonin, a substance our bodies naturally make to help us sleep, could be helpful for people living with Primary Progressive Multiple Sclerosis (PPMS). PPMS is a type of MS where symptoms gradually worsen over time. The main goal is to check how safe melatonin is and if it can slow down the disease's progression, meaning how quickly symptoms get worse. They will look at things like how much the disease affects movement and daily activities. This is one of the first times melatonin is being tested in people for this condition, and it aims to understand its potential benefits and any side effects.
At a glance
What is this study about?
This study, called MELATOMS, is looking into a treatment for a type of multiple sclerosis called Primary Progressive MS (PPMS). PPMS is a long-term condition where the symptoms of MS gradually get worse over time, rather than coming in attacks or relapses. Because there aren't many treatments for PPMS, researchers are always looking for new ways to help improve the lives of people with this condition.
The study is focusing on melatonin, which is a natural hormone that our bodies produce to help regulate sleep. Scientists are interested in whether melatonin might also have an effect on how the disease develops. They want to see if taking melatonin can help slow down the progression of the disease and how it affects things like movement and daily activities. This is considered an early study, which means it’s one of the first times this treatment is being tested in people for this specific condition.
The researchers will be carefully monitoring participants to see how the disease progresses. They'll also be looking at overall brain health, how people are feeling in terms of tiredness or 'fatigue', their quality of life, sleep patterns, muscle stiffness (spasticity), and even how the treatment might affect inflammation in the brain, damage to nerve cells, and the body's gut bacteria.
Key takeaways
- This study investigates melatonin for Primary Progressive MS.
- It aims to check safety and if it slows disease progression.
- Participants will receive either melatonin or a 'dummy' pill.
- All adults (18+) with PPMS are potentially eligible.
- Regular health checks and assessments will be part of participation.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 or over. There's no upper age limit, so people of all adult ages can potentially take part. Both men and women are welcome to participate in this research.
The most important requirement is that you must have a diagnosis of Primary Progressive Multiple Sclerosis. This study is specifically designed for people with this particular type of MS. The study team will check your medical history to make sure taking part is right for you, as there may be other health conditions or medications that could prevent you from joining for your safety.
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.
- Are you 18 years old or older?
- Do you have a diagnosis of Primary Progressive Multiple Sclerosis?
- Are you able to attend regular clinic appointments?
- Are you willing to take study medication as directed?
- Are you happy for your health to be carefully monitored during the study?
What does participation involve?
If you decide to take part in this study, you will be given capsules to take. Some participants will receive melatonin, while others will receive a 'dummy' pill (called a placebo) that contains only inactive ingredients, like microcrystalline cellulose and colloidal silica. This is done to fairly compare the effects of melatonin. Neither you nor your study doctor will know whether you are receiving melatonin or the placebo.
You will have regular appointments at a study clinic where the research team will monitor your health, perform various medical checks, and ask questions about your symptoms and how you're feeling. They will use specific tests to measure changes in your neurological function and how the disease is affecting your daily life. These assessments will help the doctors understand if the treatment is having any effect and to monitor your safety. The total length of your participation in the study, including all visits and follow-ups, will be explained to you by the study team.
Potential risks and benefits
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Common questions
What is Primary Progressive Multiple Sclerosis?
It's a type of MS where symptoms gradually get worse over time, rather than improving or having distinct relapses.
What is melatonin?
Melatonin is a natural hormone made by your body that helps control your sleep-wake cycle.
Why is a 'dummy pill' (placebo) used?
Using a dummy pill helps researchers compare the real effects of the study drug fairly, making the results more reliable.
Will I know if I'm getting melatonin or the dummy pill?
No, during the study, neither you nor your doctors will know which treatment you are receiving. This is called 'single-blind'.
How long will I be in the study?
The study team will tell you the exact duration, including how many visits and follow-up appointments you'll have.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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