A study testing hydroxychloroquine to reduce brain inflammation in patients with progressive multiple sclerosis

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What is this study about?

This study is looking at Multiple Sclerosis, a condition where the body’s immune system attacks the protective covering of nerves in the brain and spinal cord. The study focuses on people with progressive forms of this disease, meaning their symptoms gradually worsen over time rather than coming and going in episodes. The treatment being tested is hydroxychloroquine, a medication that may help reduce inflammation in the brain caused by certain immune cells called microglia. Some participants will receive hydroxychloroquine tablets while others will receive placebo tablets that look the same but contain no active medication.

The purpose of this study is to see whether hydroxychloroquine can reduce the activity of microglia in the brains of people with progressive Multiple Sclerosis over twelve months compared to placebo. Microglia are immune cells in the brain that can become overactive and contribute to ongoing damage in Multiple Sclerosis. The study will use special brain scans called TSPO-PET imaging to measure microglial activity at the beginning and end of the treatment period. Participants will also have regular MRI scans, which are detailed pictures of the brain that help doctors see changes in the disease.

During the study, participants will take their assigned medication for twelve months. They will have various tests and assessments to measure how their Multiple Sclerosis is affecting them, including tests of walking speed, hand coordination, thinking abilities, and overall quality of life. Blood samples will be taken to measure substances that indicate nerve damage. The study will also track any unwanted effects that participants experience while taking the medication. All participants will be closely monitored throughout the twelve-month treatment period to gather information about the safety and potential benefits of hydroxychloroquine for progressive Multiple Sclerosis.

1 Starting the treatment

After joining the study, you will be randomly assigned to receive either hydroxychloroquine tablets or placebo tablets. Hydroxychloroquine is a medication that may reduce inflammation in the brain. A placebo is an inactive tablet that looks identical to the real medication but contains no active ingredient.

You will take the assigned tablets by mouth.

The dosage is 200 mg twice daily, meaning you will take one tablet in the morning and one tablet in the evening.

The treatment will continue for twelve months.

Neither you nor the medical staff will know which treatment you are receiving during the study.

2 Baseline brain imaging

At the beginning of the study, you will undergo a TSPO-PET scan. This is a specialized brain imaging procedure that measures inflammation in the brain by detecting active immune cells called microglia.

You will also have a baseline MRI scan of your brain. This imaging technique uses magnetic fields to create detailed pictures of your brain structure and identify any lesions or areas of damage.

3 Physical function assessments

You will complete the Timed 25 Foot Walk test, which measures how long it takes you to walk 25 feet. This test evaluates your walking speed and mobility.

You will perform the 9-Hole Peg Test, which assesses your hand function and coordination by measuring how quickly you can place nine pegs into holes.

A neurologist will evaluate your disability level using the Expanded Disability Status Scale, which is a standard measure of disability in multiple sclerosis ranging from 0 to 10.

4 Cognitive testing

You will complete the Symbol Digit Modalities Test, which evaluates your information processing speed and cognitive function. In this test, you match symbols to numbers as quickly as possible.

5 Questionnaires

You will fill out several questionnaires to assess your quality of life and symptoms.

The RAND 36-Item Health Survey and Multiple Sclerosis Impact Scale measure how multiple sclerosis affects your daily life and overall well-being.

The Modified Fatigue Impact Scale and Fatigue Severity Scale evaluate the level of tiredness you experience and how it impacts your activities.

6 Blood sample collection

Blood samples will be collected to measure specific proteins in your blood.

These include neurofilament light chain, a protein that indicates nerve damage, and glial fibrillary acidic protein, which indicates damage to support cells in the brain called astrocytes.

These measurements help assess disease activity and progression.

7 Taking medication daily

Throughout the twelve-month treatment period, you will continue taking your assigned tablets twice daily as instructed.

It is important to take the tablets consistently at approximately the same times each day.

8 Follow-up assessments during treatment

During the twelve-month treatment period, you will have regular follow-up visits.

At these visits, the physical function tests, cognitive tests, and questionnaires will be repeated to monitor any changes.

Additional blood samples may be collected at scheduled intervals.

MRI scans may be repeated during the treatment period to track changes in your brain.

9 End-of-treatment imaging

After completing twelve months of treatment, you will undergo another TSPO-PET scan to measure changes in brain inflammation compared to the baseline scan.

You will also have a final MRI scan to assess changes in brain structure, lesion size, and volume of different brain regions.

Additional specialized MRI techniques will be used, including Quantitative Susceptibility Mapping, which detects iron deposits in lesions, and Diffusion Tensor Imaging, which measures nerve fiber integrity.

10 Final assessments

At the end of the treatment period, you will repeat all physical function tests, including the Timed 25 Foot Walk and 9-Hole Peg Test.

The cognitive test and all questionnaires will be completed again.

A final neurological examination will be performed to assess your disability status.

Final blood samples will be collected to measure the proteins indicating nerve and brain cell damage.

Who Can Join the Study?

You must provide written informed consent, which means you agree in writing to take part in the study after understanding all the information about it
You must be a man or woman between 18 and 70 years of age at the time you agree to join the study
You must have Multiple Sclerosis (a disease affecting the brain and spinal cord) of a specific type: either PPMS (primary progressive multiple sclerosis, which worsens from the start) or non-relapsing SPMS (secondary progressive multiple sclerosis without sudden attacks in the last 2 years), or you may have RRMS (relapsing-remitting multiple sclerosis) with no relapses or new lesions in the last 24 months but showing signs your disease is getting worse
Your disease must have shown progression during the last 24 months, meaning it has gotten worse, shown by an increased EDSS score (a scale that measures disability from 0 to 10), or increased points on Kurzke’s Functional Systems (a way to measure how different body functions are affected), or growing T1 lesions (damaged areas visible on brain scans), or other signs of worsening noted by both you and your treating doctor
Your EDSS score at the screening visit must be between 3.0 and 7.5, which indicates a moderate to severe level of disability
You must have experienced worsening of Multiple Sclerosis symptoms or enlarging T1 lesions in brain scans during the previous 2 years, confirmed by your doctor’s examination or visual review of your scans
Your doctor must believe you are reliable and physically capable of following all study procedures, including having sufficient vision and hearing, and you must have completed at least 8th grade education
You must be fluent in the Finnish language

Who Cannot Join the Study?

The study does not list specific reasons why patients cannot participate
General exclusion criteria, which are reasons that prevent someone from joining a study, have not been provided in the available information
If you are interested in this study for Multiple Sclerosis, which is a condition affecting the brain and spinal cord, you would need to check with the research team for the complete list of reasons that might prevent participation

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Vcesedqwqmljerkh hgmnegevqrwgqyw	Turku	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	01.01.2026

Trial locations

Investigated drugs:

Hydroxychloroquine Sulfate

Hydroxychloroquine is a medicine that is being tested to see if it can reduce inflammation in the brain caused by immune cells called microglia. In this study, it is being used to find out if it can help slow down the progression of multiple sclerosis by decreasing the activity of these immune cells in the brain.

Placebo is an inactive substance that looks like the real medicine but contains no active ingredients. It is used in this study to compare the effects of hydroxychloroquine against no treatment, helping researchers understand if the medicine truly works.

Investigated diseases:

Multiple Sclerosis – Multiple Sclerosis is a chronic disease of the central nervous system where the immune system mistakenly attacks the protective covering of nerve fibers called myelin. This damage disrupts the normal flow of electrical signals along the nerves, affecting communication between the brain and the rest of the body. The disease can cause a wide variety of symptoms including problems with vision, muscle control, balance, and sensation. Multiple Sclerosis progresses differently in each person, with some experiencing periods of new symptoms or worsening followed by periods of recovery, while others may have a gradual worsening over time. The progressive form of the disease involves a steady decline in neurological function without distinct periods of recovery. As the disease advances, it can lead to increased disability affecting mobility, cognitive function, and daily activities.

Trial ID:

2025-522573-11-00

Trial Phase:

Therapeutic exploratory (Phase II)

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A study testing hydroxychloroquine to reduce brain inflammation in patients with progressive multiple sclerosis

What is this study about?

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Who Cannot Join the Study?