Prospective, randomized, double-blind, placebo-controlled, single-center comparative trial evaluating oral hydroxychloroquine 200 mg BID for reducing microglial activation in the brain of patients with progressive multiple sclerosis (MS)
This research study, called a clinical trial, is looking at whether a medicine called hydroxychloroquine (referred to as HCQ) can help people with progressive multiple sclerosis (MS). MS is a condition that affects the brain and spinal cord. Researchers believe that inflammation in the brain might play a role in MS progression, and they are using special brain scans to see if hydroxychloroquine can reduce this inflammation. The study will compare people taking the actual drug with those taking a dummy pill (placebo) to see if there's a real effect. Beyond brain scans, the study will also measure how people's walking, hand movements, thinking abilities, and general well-being change over time to understand the wider impact of the treatment. This is a Phase II trial, meaning it's an early-stage study to learn more about the drug's effectiveness and safety.
At a glance
What is this study about?
This study is investigating a drug called hydroxychloroquine, sometimes known by its brand name Oxiklorin, for people living with progressive multiple sclerosis (MS). Progressive MS means that the condition tends to steadily worsen over time. Researchers are particularly interested in seeing if this medicine can reduce something called "microglial activation" in the brain. Microglia are a type of immune cell in the brain, and when they become too active, they can cause inflammation and damage. The scientists think reducing this activity might help slow down the progression of MS.
To see if the drug works, participants will undergo special brain scans, called TSPO-PET scans, at the beginning and end of the study. These scans help scientists measure the amount of microglial activity in different parts of the brain. By comparing the scans, they can see if hydroxychloroquine helps to reduce this activity more than a dummy pill (placebo). This is a 'double-blind' study, meaning neither the participants nor the doctors will know who is getting the real drug and who is getting the placebo, which helps make the results fairer and more reliable.
But the study isn't just about what happens in the brain; it also wants to understand how the drug affects people's daily lives. Researchers will measure changes in things like walking speed, how well people can use their hands, their memory and thinking skills, and their overall quality of life and fatigue levels. They will also collect blood samples to look for signs of nerve damage and use different types of MRI scans to check for changes in the brain. All these different measurements help build a complete picture of whether the treatment is helpful and safe.
Key takeaways
- This study is testing hydroxychloroquine for progressive MS.
- It aims to reduce brain inflammation and improve daily life.
- Participants will receive either the drug or a dummy pill.
- Brain scans, physical tests, and questionnaires will be used.
- It's a Phase II study, seeking to understand effectiveness and safety.
- Participation involves regular visits and medication over time.
Who may be eligible?
This study is particularly looking for adults aged 18 or older who have been diagnosed with progressive multiple sclerosis. This means your MS is likely to be steadily worsening rather than having periods of clear attacks and recovery.
There will be other, more detailed criteria to make sure the study is safe for you and that the results are clear. For example, you might need to have certain health conditions or not be taking certain medications to qualify. These are important for your safety and the accuracy of the study results.
- Are you 18 years old or older?
- Do you have a diagnosis of progressive multiple sclerosis?
- Are you able to attend regular appointments for tests and scans?
- Do you understand that you might receive a placebo?
- Are you willing to take daily medication for the study duration?
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 in this study, you would be asked to take study medication, either hydroxychloroquine or a placebo (a dummy pill), twice a day. You wouldn't know which one you're taking, and neither would your doctor. You would have several visits to the study centre for health checks, questionnaires, and specialised tests. These tests include regular brain scans (PET and MRI scans), blood tests, and physical assessments like walking tests and hand dexterity tests. You'd also complete questionnaires about your quality of life and how tired you feel. The total duration of your participation in the study has not been specifically stated but typically these types of studies involve several months of treatment and follow-up appointments.
Potential risks and benefits
Locations (1)
- —Finland
Common questions
What is hydroxychloroquine and why is it being studied for MS?
Hydroxychloroquine is a medicine that reduces inflammation and is used for other conditions. Researchers want to see if it can reduce brain inflammation in MS and help slow down the disease.
What does 'progressive MS' mean?
Progressive MS means your symptoms tend to get steadily worse over time, rather than having clear attacks and recovery periods.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It helps researchers compare the real drug's effects accurately.
Will I know if I'm getting the real drug or the placebo?
No, neither you nor your study doctor will know during the study. This is called 'double-blind' and helps ensure fair results.
What kind of tests will I have?
You'll have special brain scans (PET and MRI), blood tests, walking and hand tests, and complete questionnaires about your well-being.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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