Study on the Effects of Vidofludimus Calcium 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 contains the active substance vidofludimus calcium. This medication is being compared to a placebo to evaluate its effectiveness, safety, and how well it is tolerated by patients.

The purpose of the study is to see if IMU-838 can delay the occurrence of relapses, which are episodes of new or worsening symptoms. Participants in the study will be randomly assigned to receive either the IMU-838 tablets 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. This helps ensure that the results are not influenced by expectations about the treatment.

Throughout the study, participants will take the medication orally in tablet form. The study will monitor the time it takes for participants to experience their first confirmed relapse, as well as other factors like changes in brain lesions seen on MRI scans and any changes in disability levels. The study aims to provide valuable information about the potential benefits of IMU-838 for people with Relapsing Multiple Sclerosis.

1 initial treatment phase

Upon joining the study, the patient will begin the initial treatment phase. This involves taking either IMU-838 or a placebo. The medication is administered orally in tablet form.

The dosage for IMU-838 is either 15 mg or 30 mg, depending on the specific group assignment. The tablets are taken once daily.

2 monitoring and assessment

Throughout the trial, the patient’s health and response to the treatment will be closely monitored. This includes regular visits to assess any changes in symptoms and overall health.

Magnetic resonance imaging (MRI) scans will be conducted to evaluate changes in brain lesions and overall brain volume.

3 evaluation of relapses

The primary goal is to determine the time to the first confirmed relapse. This is assessed by an independent committee and occurs after the start of treatment.

The evaluation period for relapses is up to 72 weeks, with assessments conducted at specific intervals.

4 secondary assessments

Secondary assessments include changes in the total volume of new T2-lesions, time to confirmed disability worsening, and changes in cognitive function as measured by the Symbol Digit Modalities Test.

These assessments help to provide a comprehensive understanding of the treatment’s impact on the patient’s condition.

5 completion of main period

The main period of the trial concludes at 72 weeks. At this point, a final evaluation is conducted to assess the overall effectiveness and safety of the treatment.

Patients who complete the main period may be eligible for an extension period, which involves open-label treatment with IMU-838.

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 criteria from 2017.
Must have Relapsing Multiple Sclerosis (RMS), which includes types like Relapsing Remitting MS (RRMS) and active secondary progressive MS. These are defined by certain criteria from 1996 and 2014.
Eligible if previous treatments for MS have not worked well, caused side effects, or if there are reasons they cannot take them.
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 Gadolinium-enhanced (Gd+) MRI scan of the brain or spine in the last 12 months.
Must have an EDSS score between 0 and 5.5. This score measures disability in MS.
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 agree to use effective birth control methods during the trial and for 30 days after.
Male patients must agree not to father a child or donate sperm during the trial and for 30 days after. They must use barrier contraception if they have a female partner.
Must be willing and able to follow the trial’s 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 that is not relapsing. Relapsing means the disease comes and goes, with periods of getting worse and then better.
Patients who are not adults. This study is only for adults, which means people who are 18 years or older.
Patients who are not experiencing active symptoms of relapsing multiple sclerosis. Active means the symptoms are currently happening or have happened recently.
Patients who are part of a vulnerable population that requires special protection. This could include people who might not be able to make decisions for themselves.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
Neuro-Medic Sp. z o.o.	Katowice	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland
Neurologia Slaska Centrum Medyczne	Katowice	Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
Novo-Med Zielinski I Wspolnicy Sp. j.	Katowice	Poland
Wielospecjalistyczne Centrum Medyczne IBISMED S.C	Zabrze	Poland
Clubul Sanatatii S.R.L.	Campulung	Romania
Aria Clinic S.R.L.	Sibiu	Romania
Spitalul Clinic Cai Ferate Constanta	Constanta	Romania
Clinic4U OÜ	Tallin	Estonia
Usplsejyjfdgfhasbtbnu Mvyikgoa Ang	Munster	Germany
Ipbmjargvqis Pihzqahq Lmketilq Pojbk dp hqfr nt mplp Ktrelm Rxxhtd	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Estonia	Not recruiting	29.04.2022
Germany	Not recruiting	29.04.2022
Poland	Not recruiting	29.04.2022
Romania	Not recruiting	29.04.2022

Trial locations

Investigated drugs:

Vidofludimus Calcium

IMU-838 is a medication being studied for its effectiveness in treating adults with relapsing multiple sclerosis (RMS). The goal of the trial is to see if IMU-838 can help delay the time until the first relapse of the disease. This medication is being compared to a placebo to determine its safety and how well it works in managing the symptoms of RMS.

Investigated diseases:

Relapsing multiple sclerosis

Relapsing Multiple Sclerosis – This is a chronic disease affecting the central nervous system, characterized by episodes of new or increasing neurological symptoms, known as relapses. These relapses are followed by periods of partial or complete recovery, during which the disease does not progress. Over time, the frequency and severity of relapses may vary, and some individuals may experience a gradual worsening of symptoms. The disease can lead to a range of symptoms, including fatigue, difficulty walking, numbness, and vision problems. The exact cause of relapsing multiple sclerosis is not fully understood, but it involves an abnormal immune response that damages the protective covering of nerve fibers. The progression of the disease can be unpredictable, with some individuals experiencing long periods of stability.

Trial ID:

2024-514619-88-00

Protocol code:

P3-IMU-838-RMS-02

NCT ID:

NCT05201638

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Vidofludimus Calcium in Adults with Relapsing Multiple Sclerosis

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