Study on the Effectiveness of Vidofludimus Calcium (IMU-838) in Adults with Relapsing Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying Relapsing Multiple Sclerosis, a condition where the immune system mistakenly attacks the protective covering of nerves, causing communication problems between the brain and the rest of the body. The study is testing a medication called IMU-838, which is taken in tablet form. The purpose of the study is to evaluate how effective, safe, and tolerable IMU-838 is compared to a placebo in adults with this condition.

Participants in the study will be randomly assigned to receive either IMU-838 or a placebo. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. The study will monitor the time it takes for participants to experience their first relapse, which is a return of symptoms after a period of improvement. This will help determine if IMU-838 can delay these relapses.

Throughout the study, participants will undergo various assessments, including MRI scans, to track changes in the brain and measure the effectiveness of the treatment. The study will also look at other factors, such as changes in disability levels and brain volume, to gather comprehensive data on the impact of IMU-838 on Relapsing Multiple Sclerosis. The study is expected to continue for several years to gather sufficient data on the long-term effects of the treatment.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where you will be provided with detailed information about the trial. You will be required to read and understand this information and provide written informed consent to participate in the trial.

During this visit, you will undergo a series of assessments to confirm your eligibility for the study. This includes a review of your medical history and a physical examination.

2 baseline assessments

If eligible, you will undergo baseline assessments, which include a magnetic resonance imaging (MRI) scan to evaluate your brain and spine. This will help establish a starting point for measuring changes during the trial.

You will also complete various tests to assess your neurological status and overall health.

3 randomization and treatment

You will be randomly assigned to receive either the study medication, IMU-838, or a placebo. This process is double-blinded, meaning neither you nor the study team will know which treatment you are receiving.

The study medication is administered in tablet form. If you receive IMU-838, the dosage will be either 30 mg or 15 mg, taken orally. The frequency and duration of administration will be specified by the study protocol.

4 regular follow-up visits

Throughout the trial, you will attend regular follow-up visits. These visits are scheduled to monitor your health and the effects of the treatment.

During these visits, you will undergo various assessments, including physical examinations, MRI scans, and neurological tests. These assessments help track any changes in your condition and ensure your safety.

5 end of main period

The main period of the trial lasts up to 72 weeks. At the end of this period, you will have a final visit, which includes a comprehensive evaluation of your health and condition.

This visit will include an MRI scan and other assessments to determine the impact of the treatment on your condition.

6 extension period

If you complete the main period and meet certain criteria, you may be eligible to participate in an extension period of the trial. This period allows for continued monitoring and treatment.

Participation in the extension period is optional and will be discussed with you at the end of the main period.

Who Can Join the Study?

Must be a male or female aged between 18 and 55 years.
Must have a confirmed diagnosis of Multiple Sclerosis (MS) according to specific medical guidelines.
Must have a type of MS called Relapsing Multiple Sclerosis (RMS), which includes relapsing-remitting MS (RRMS) and active secondary progressive MS.
Must have an active disease, shown by:
- At least 2 relapses in the last 24 months, or
- At least 1 relapse in the last 12 months, or
- A positive Gd+ MRI scan (a type of brain or spine scan) in the last 12 months.
Must have an EDSS score (a measure of disability in MS) between 0 and 5.5.
Female patients must:
- Be unable to have children (due to surgery or menopause), or
- If able to have children, have a negative pregnancy test and use effective birth control methods.
Male patients must agree not to father a child or donate sperm during the trial and for 30 days after.
Must be willing and able to follow the trial rules and procedures.
Must be able to read and understand the trial information and give written consent to participate.

Who Cannot Join the Study?

Patients who have a different type of multiple sclerosis other than Relapsing Multiple Sclerosis cannot participate.
Patients who are under 18 years old or over 65 years old are not eligible.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have participated in another clinical trial within the last 30 days are excluded.
Patients with a history of severe allergic reactions to any of the study medications are not allowed to join.
Patients with significant liver or kidney disease cannot participate.
Patients with uncontrolled high blood pressure are excluded.
Patients with a history of cancer within the last 5 years, except for certain skin cancers, are not eligible.
Patients with active infections that require treatment are not allowed to join the study.
Patients who have received certain treatments for multiple sclerosis in the past 6 months are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD	Blagoevgrad	Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD	Sofia	Bulgaria
Diagnostic Consultative Center 14 Sofia EOOD	Sofia	Bulgaria
UMHAT “Medica Ruse” OOD	Ruse	Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Multispecialty hospital for active treatment Sveta Sofia EOOD	Sofia	Bulgaria
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD	Sofia	Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Medical Institute Ministry Of Interior	Sofia	Bulgaria
MBAL Sveta Marina EAD	Varna	Bulgaria
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Multiprofile Hospital For Active Treatment Avis Medika OOD	Pleven	Bulgaria
Mzkdpov Clqpyx Vzsr 1 Ljml	Pleven	Bulgaria
Mylqlsz Cygdko Eyvoaw Mwbkaa Ogh	Pleven	Bulgaria
Udoglnoyaqkuysayiibdi Mmaisqzt Asq	Munster	Germany
Mzlqgtfv Mkfckwx Askbotv	Pleven	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	13.02.2023
Germany	Not recruiting	13.02.2023
Lithuania	Not recruiting	13.02.2023
Poland	Not recruiting	13.02.2023

Trial locations

Investigated drugs:

Vidofludimus Calcium

IMU-838 is a medication being studied for its potential to help people with relapsing multiple sclerosis (RMS). This condition is a type of multiple sclerosis where patients experience episodes of new or worsening symptoms, known as relapses. The goal of using IMU-838 in this clinical trial is to see if it can effectively delay the time until the next relapse occurs. By doing so, it may help manage the symptoms and improve the quality of life for people with RMS. The study is designed to compare the effects of IMU-838 with a placebo, which is a substance with no active medication, to determine how well IMU-838 works in treating this condition.

Investigated diseases:

Relapsing multiple sclerosis

Relapsing Multiple Sclerosis – Relapsing Multiple Sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It is characterized by episodes of new or worsening neurological symptoms, known as relapses, followed by periods of partial or complete recovery. During a relapse, inflammation damages the protective covering of nerve fibers, called myelin, leading to disrupted communication between the brain and the rest of the body. Symptoms can vary widely, including fatigue, difficulty walking, numbness, and vision problems. Over time, the disease may lead to a gradual decline in neurological function. The progression of symptoms can be unpredictable, with some individuals experiencing frequent relapses and others having long periods of stability.

Trial ID:

2024-514618-11-00

Protocol code:

P3-IMU-838-RMS-01

NCT ID:

NCT05134441

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Vidofludimus Calcium (IMU-838) in Adults with Relapsing Multiple Sclerosis

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