Study on the Effects of Vidofludimus Calcium (IMU-838) in Patients with Progressive Multiple Sclerosis

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What is this study about?

This clinical trial is focused on studying Progressive Multiple Sclerosis, a type of multiple sclerosis where symptoms gradually worsen over time. The study is testing a medication called IMU-838, which is taken in tablet form. The trial will compare the effects of IMU-838 to a placebo to see how well it works and how safe it is for patients with this condition.

The purpose of the study is to evaluate the effectiveness of IMU-838 in slowing down brain shrinkage, which is a common issue in progressive multiple sclerosis. Participants will be randomly assigned to receive either the IMU-838 tablets or a placebo. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, ensuring unbiased results.

Throughout the study, participants will undergo regular assessments, including MRI scans, to monitor changes in brain volume and any progression in disability. The study aims to provide valuable information on whether IMU-838 can help manage the symptoms of progressive multiple sclerosis and improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, the patient will be randomly assigned to receive either the IMU-838 medication or a placebo. This process is double-blind, meaning neither the patient nor the researchers know which treatment the patient is receiving.

2 medication administration

The patient will take the assigned medication orally in the form of tablets. The options include IMU-838 at a dosage of either 22.5 mg or 45 mg, or a placebo tablet.

The medication is to be taken as prescribed by the study protocol, which will specify the exact dosage and frequency.

3 main treatment period

During the main treatment period, the patient will continue taking the medication as directed. This period is designed to evaluate the effectiveness of IMU-838 in treating progressive multiple sclerosis.

The primary focus is on measuring changes in brain volume using MRI scans, which will help assess the medication’s impact on brain atrophy.

4 monitoring and assessments

Throughout the study, the patient will undergo regular assessments to monitor their health and the progression of their condition. This includes MRI scans and evaluations of disability status using the expanded disability status scale (EDSS).

These assessments are crucial for determining the time to any confirmed disability worsening over a 24-week period.

5 open-label extension period

After completing 120 weeks of the main treatment period, or upon experiencing confirmed disability worsening, the patient may enter the open-label extension period.

During this phase, all patients will receive IMU-838, allowing for further evaluation of its long-term effects.

Who Can Join the Study?

Must be an adult between 18 and 65 years old.
No signs of a relapse in the last 24 months before joining the study.
Must have a type of Multiple Sclerosis called either SPMS (Secondary Progressive Multiple Sclerosis) or PPMS (Primary Progressive Multiple Sclerosis). SPMS can be with or without certain brain or spinal cord changes seen in an MRI scan in the last 12 months. PPMS should be diagnosed according to specific guidelines and should have been present for 10 years or less.
Must have an EDSS score between 3.0 and 6.5. The EDSS is a scale used to measure disability in people with Multiple Sclerosis.
Must show signs of worsening disability not linked to a relapse in the last 24 months, confirmed by a reviewer. This can be shown by an increase in the EDSS score, a 20% or more worsening in walking or hand function tests, or a written summary of worsening from medical records.
Female participants must either be unable to have children (due to surgery or menopause) or, if they can have children, must have a negative pregnancy test and agree to use effective birth control methods during the study and for 30 days after.
Male participants must agree not to father a child or donate sperm during the study and for 30 days after. They must use barrier contraception if they have a female partner, and if the partner can have children, she should use effective birth control methods.
Must be willing and able to follow the study rules.
Must provide written consent to participate in the study before any study-related procedures begin.
For the OLE (Open-Label Extension) period, participants must have completed 120 weeks of the main treatment period or have confirmed disability worsening over 24 weeks, or be in the main treatment period when the study reaches a specific event, allowing them to enter the OLE treatment period.

Who Cannot Join the Study?

Patients with any other type of Multiple Sclerosis that is not a progressive form. Progressive forms mean the disease is getting worse over time.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial groups.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered part of a vulnerable population. This means groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Neuro-Medic Sp. z o.o.	Katowice	Poland
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p.	Lublin	Poland
University Medicine Greifswald	Greifswald	Germany
Spitalul Clinic Judetean De Urgenta Cluj	Cluj Napoca	Romania
Technische Universitaet Dresden	Dresden	Germany
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy	Poznan	Poland

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov	Sofia	Bulgaria
MBAL Sveta Marina EAD	Varna	Bulgaria
Krajska zdravotni a.s.	Teplice	Czechia
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
DataMed Klinische Studien GmbH	Cologne	Germany
Mbal Lyulin EAD	Sofia	Bulgaria
Medical Institute Ministry Of Interior	Sofia	Bulgaria
Euromedis Sp. z o.o.	Szczecin	Poland
Resmedica Sp. z o.o.	Kielce	Poland
Ma-Lek Clinical Sp. z o.o.	Katowice	Poland
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	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
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Complex Oncological Center – Shumen EOOD	Shumen	Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Neurocentrum Bydgoszcz Sp. z o.o.	Bydgoszcz	Poland
Neuro Centrum Science GmbH	Erbach	Germany
Uhihblgugx Mufizub Cnjabn Hqomrbdqqqjcgsjgm	Hamburg	Germany
Akykmti Zcrzksweyk Lyqlhb Pxrs Nfvhzuahtfe tvjtly Ck Hkbqempsdwr	Leiden	The Netherlands
Wg Mecgmnk Spoyott Swo z oiwz	Warsaw	Poland
Paftouqsuny Epyixnpjzohd	Wroclaw	Poland
Adrdhsxnb Und	Amsterdam	The Netherlands
Udiljbjauqhmeklcsootq Dgapkqydweq Avn	Duesseldorf	Germany
Msqynibs Mcpswyj Awrcglw	Pleven	Bulgaria
Ixwubelo Zjmsqli De Bnzuvlkyvunnbfgvi	Oświęcim	Poland
Iwdjbnnuqiuc Pgbgyijp Lwiegwow Ptqau db hsxa nf mdki Krqvtk Rifzwy	Lublin	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	15.11.2021
Czechia	Recruiting	15.11.2021
Germany	Recruiting	15.11.2021
Poland	Recruiting	15.11.2021
Romania	Recruiting	15.11.2021
The Netherlands	Recruiting	15.11.2021

Trial locations

Investigated drugs:

Vidofludimus Calcium

IMU-838 is a medication being studied for its potential to help patients with progressive multiple sclerosis. The trial aims to see how well this medication works in slowing down brain shrinkage, which is a common issue in this condition. The study uses advanced imaging techniques to measure changes in the brain, helping researchers understand the medication’s effectiveness.

Investigated diseases:

Progressive multiple sclerosis

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 clear periods of remission. The disease affects the central nervous system, leading to symptoms such as muscle weakness, difficulty with coordination and balance, and cognitive changes. As the disease progresses, individuals may experience increased disability. The progression can vary significantly from person to person, with some experiencing a slow decline and others a more rapid deterioration. The exact cause of the disease is not fully understood, but it involves an abnormal immune response that damages the protective covering of nerve fibers.

Trial ID:

2024-514617-35-00

Protocol code:

P2-IMU-838-PMS

NCT ID:

NCT05054140

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Vidofludimus Calcium (IMU-838) in Patients with Progressive Multiple Sclerosis

What is this study about?

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