The HIt HArd and hiT early in multiple sclerosis trial – HiHat trial
The HiHat study is an early-stage research project for people with relapsing-remitting multiple sclerosis (MS) who have been diagnosed within the last 10 years. The main goal is to check the safety of several different medicines, including ACICLOVIR, CETIRIZINE, RITUXIMAB, and others, when used to treat MS. Researchers want to find out how many people experience any side effects that might be linked to the treatments being tested. They will also look at how these medicines might affect new MS flare-ups, changes in brain scans (MRI), and overall symptoms, including how MS impacts daily life and thinking. This is a Phase II study, meaning it's still in the early stages of testing these treatments.
At a glance
What is this study about?
The HiHat trial is an important study exploring new ways to manage relapsing-remitting multiple sclerosis (MS). This type of MS involves periods of new symptoms or worsening symptoms (called relapses or flare-ups) followed by periods of recovery. The study is specifically looking at people who have been living with MS for less than 10 years, as finding effective treatments early might help prevent long-term problems.
The main purpose of this study is to see how safe several different medications are when used to treat MS. These medications include ACICLOVIR (often used for viral infections), CETIRIZINE (an allergy medicine), METHYLPREDNISOLONE (a steroid), RITUXIMAB (a drug that affects the immune system), CLADRIBINE (another immune system drug), SULFAMETHOXAZOLE AND TRIMETHOPRIM (antibiotics), and PARACETAMOL (a pain reliever). By carefully tracking any possible side effects, the researchers want to understand which treatments are safest for people with MS.
Beyond safety, the study will also look at whether these treatments can help with MS symptoms. This includes checking if they reduce new flare-ups, prevent new spots appearing on brain scans (MRIs), and improve or stabilise disability. They will also assess how these treatments affect daily quality of life and brain function, using various tests and questionnaires. The goal is to identify treatments that are not only safe but also show promise in slowing down or even improving the condition for people with early-stage MS.
Key takeaways
- This study is testing different medications for relapsing-remitting MS.
- It's for adults (18+) who have had MS for less than 10 years.
- The main focus is to understand the safety of the treatments.
- Researchers will also look at how treatments affect relapses, brain scans, and disability.
- This is an early-stage study (Phase II) exploring new treatment options.
- Participation involves regular check-ups, tests, and taking study medication.
Who may be eligible?
To be considered for the HiHat study, you need to be an adult, 18 years old or older. The study is open to both men and women.
A key requirement is that you must have relapsing-remitting multiple sclerosis (MS). This is the type of MS where you have clear attacks or flare-ups of symptoms, followed by recovery periods.
Another important factor is that you need to have been diagnosed with MS relatively recently – specifically, for less than 10 years. This study is focusing on people in the earlier stages of their MS journey.
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 relapsing-remitting multiple sclerosis?
- Have you had your MS diagnosis for less than 10 years?
- Are you comfortable with taking new study medication and attending regular appointments?
What does participation involve?
If you decide to take part in the HiHat study, you will receive one of the medications being tested. These could include ACICLOVIR, CETIRIZINE, METHYLPREDNISOLONE, RITUXIMAB, CLADRIBINE, SULFAMETHOXAZOLE AND TRIMETHOPRIM, or PARACETAMOL. You will have regular appointments with the study team, who will monitor your health closely. These appointments will involve check-ups, potentially some blood tests, and MRI scans to look at your brain. You will also be asked to complete questionnaires about your symptoms and how you are feeling to see how the treatment is affecting your MS and daily life. The study will track any side effects you might experience. The total duration of your involvement in the study will be explained in detail by the research team.
Potential risks and benefits
Locations (1)
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Common questions
What kind of MS is this study for?
This study is for people with relapsing-remitting multiple sclerosis (MS).
What medicines are being tested in this study?
Several medicines are being tested, including ACICLOVIR, CETIRIZINE, RITUXIMAB, CLADRIBINE, and others.
What is the main goal of the study?
The main goal is to check how safe these different treatments are for people with MS.
Do I have to be a certain age to join?
Yes, you need to be 18 years old or older.
What does 'Phase II' mean for a study?
Phase II means it's an early stage of research, primarily focusing on safety and whether the treatment shows promise.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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