Study on Metformin for Delaying Progression in Non-Active Progressive Multiple Sclerosis Patients

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What is this study about?

This clinical trial is focused on studying the effects of adding metformin to the treatment of patients with Progressive Multiple Sclerosis (PMS). Metformin is a medication commonly used to treat diabetes, and researchers are investigating whether it can help slow down the progression of PMS. The study will compare the effects of metformin with a placebo, which is a substance with no active medication, to see if metformin can improve walking speed and other health measures over a period of 96 weeks.

Participants in the study will receive either metformin or a placebo and will be monitored for changes in their condition. The main focus is to see if metformin can delay the progression of the disease, as measured by walking speed. Other aspects of health, such as cognitive function, hand function, and quality of life, will also be assessed. These assessments will be done using various tests and measures, including the Expanded Disability Status Scale (EDSS) and the Symbol Digit Modalities Test (SDMT).

The study will also use MRI scans to look at changes in brain volume and other brain characteristics over time. The trial is designed to be “triple-blind,” meaning that the participants, the healthcare providers, and the researchers do not know who is receiving the metformin or the placebo. This helps ensure that the results are unbiased and reliable. The study aims to provide valuable information on whether metformin can be an effective add-on treatment for people with PMS.

1 enrollment and initial assessment

Upon joining the study, you will undergo an initial assessment to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the criteria for participation.

You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and potential risks involved.

2 baseline measurements

Before starting the treatment, baseline measurements will be taken. These include tests to assess your walking speed, hand function, cognitive function, and overall disability status.

An MRI scan will be conducted to evaluate your brain volume and structure.

3 treatment phase

You will be randomly assigned to receive either the study medication, metformin, or a placebo. The medication is taken orally in the form of Metformin STADA® 850 mg film-coated tablets.

The treatment will last for a total of 96 weeks, during which you will take the medication daily as prescribed.

4 regular follow-up visits

Throughout the 96-week treatment period, you will have regular follow-up visits. These visits are scheduled to monitor your health and assess the effects of the treatment.

During these visits, the same tests conducted at baseline will be repeated to track any changes in your condition.

5 final assessment

At the end of the 96-week treatment period, a final assessment will be conducted. This will include all the tests performed at baseline and during follow-up visits.

The results will help determine the effectiveness of the treatment in slowing disease progression.

Who Can Join the Study?

Have a diagnosis of non-active progressive multiple sclerosis. This means the disease is getting worse, but there are no new attacks or new brain lesions in the past 1-2 years.
Be between 18 and 70 years old.
Have an EDSS score between 2.0 and 6.5. EDSS is a scale used to measure disability in people with multiple sclerosis.
Be able to give informed consent. This means you understand the study and agree to participate by signing a form.
Speak Dutch/Flemish or French, as the study materials are available in these languages.
Have been using a stable disease-modifying therapy (DMT) or no treatment at all for at least the past year.
If you are a woman of childbearing age, you must use adequate contraceptive measures to prevent pregnancy during the study.

Who Cannot Join the Study?

Patients with any other type of multiple sclerosis that is not non-active progressive multiple sclerosis cannot participate. Non-active progressive multiple sclerosis is a form of the disease where symptoms gradually worsen over time, but without new relapses or attacks.
Patients who are not within the specified age range for the study cannot participate. The study is open to adults, which typically means individuals aged 18 and older.
Patients who are part of a vulnerable population, such as those unable to give informed consent, are not eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Noorderhart	Pelt	Belgium
Uaejjzejxm Oo Ahudmon	Edegem	Belgium
Nxxxzviaj Mxcchbou Sfhfmqau Cxzyveh Vdpzbz	Steenokkerzeel	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	23.11.2023

Trial locations

Investigated drugs:

Metformin is a medication commonly used to treat type 2 diabetes by helping to control blood sugar levels. In this clinical trial, it is being tested to see if it can help slow down the progression of multiple sclerosis, a disease that affects the brain and spinal cord. Researchers are interested in whether metformin can help improve or maintain walking speed in patients with this condition over a period of 96 weeks. The goal is to see if metformin can be an effective additional treatment for people with non-active progressive multiple sclerosis, potentially helping to protect the brain and nerves from further damage.

Investigated diseases:

Progressive Multiple Sclerosis – Progressive Multiple Sclerosis is a form of multiple sclerosis characterized by a gradual worsening of neurological function over time. Unlike relapsing forms, it does not have distinct relapses or remissions. The disease affects the central nervous system, leading to symptoms such as muscle weakness, difficulty with coordination and balance, and cognitive impairment. As the disease progresses, individuals may experience increased disability and a decline in physical abilities. The progression can vary significantly among individuals, with some experiencing a steady decline and others having periods of stability. The underlying cause involves immune system attacks on the protective covering of nerves, leading to nerve damage.

Trial ID:

2023-503190-38-00

Protocol code:

MACSiMiSE-BRAIN_v1.0

NCT ID:

NCT05893225

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Metformin for Delaying Progression in Non-Active Progressive Multiple Sclerosis Patients

What is this study about?

Who Can Join the Study?

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