Ongoing Clinical Trials for Progressive Multiple Sclerosis
Currently, 7 clinical trials are investigating new treatments for progressive multiple sclerosis across Europe. These studies are testing various approaches including immune-modulating drugs, cell therapies, and repurposed medications to slow disease progression and reduce brain inflammation. Trials are taking place in Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Poland, and Romania.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Denmark
- Finland
- France
- Germany
- Italy
- Study on Human Fetal Neural Precursor Cells and Tacrolimus for Patients with Progressive Multiple Sclerosis
- Study on the Effectiveness and Safety of Ocrelizumab for Patients with Progressive Multiple Sclerosis
- Study on the Effects of Siponimod for Patients with Secondary Progressive Multiple Sclerosis
- Study on the Effects of Siponimod on Imaging and Immune Markers in Patients with Progressive Multiple Sclerosis
- Netherlands
- Poland
- Romania
Study on the Effects of Siponimod for Patients with Secondary Progressive Multiple Sclerosis
This study is investigating siponimod (marketed as Mayzent) for secondary progressive multiple sclerosis, a form where the disease gradually worsens over time. The medication is taken as film-coated tablets and the study lasts two years.
Who can join: Adults aged 18 to 65 with secondary progressive MS who have shown disease progression in the past two years. Participants must have an EDSS score between 3.0 and 6.0, have had an MRI scan within the last two years, and been in the progressive phase for less than five years. Women of childbearing age and men must use effective birth control.
Who cannot join: People who do not have secondary progressive MS, those outside the specified age range, and individuals from vulnerable populations requiring special protection.
What the study investigates: Researchers will monitor how siponimod affects chronic inflammation in the brain and spinal cord by analyzing blood and cerebrospinal fluid samples. Regular MRI scans will track changes in the brain and spinal cord, while assessments will measure cognitive function and physical abilities. The goal is to determine whether siponimod can effectively manage disease progression and identify any side effects.
Treatment tested: Siponimod is a sphingosine-1-phosphate receptor modulator administered orally. The dosage begins with 0.25 mg tablets and gradually increases to 2 mg tablets as tolerated, taken daily throughout the two-year study period.
Study on the Effects of Siponimod on Imaging and Immune Markers in Patients with Progressive Multiple Sclerosis
This trial examines siponimod’s effects on specific brain lesions visible on MRI scans in patients with secondary progressive MS. The study uses advanced imaging techniques to measure changes in these lesions over a two-year period.
Who can join: Adults between 18 and 65 years old with active progressive MS showing at least a 1-point increase in EDSS score, with evidence of disease activity in the last two years. Participants must have a 3T MRI scan from the past two years, detailed medical records including recent neurological evaluations, an EDSS score between 3.0 and 6.0, and been in the progressive phase for less than five years. Female participants must not be pregnant or breastfeeding.
Who cannot join: Individuals with an actively progressing course after an initial relapse are excluded from this specific study.
What the study investigates: The study focuses on evaluating changes in paramagnetic rim lesions, which are areas of damage in the brain, comparing them before and after siponimod treatment. Researchers will also examine markers in blood and cerebrospinal fluid to understand the medication’s impact on the immune system and nerve damage. Regular follow-up visits include MRI scans and blood tests to track disease progression.
Treatment tested: Siponimod is administered as oral film-coated tablets with dosage determined by the study protocol, taken over a period of up to two years.
Study on the Effects of Vidofludimus Calcium (IMU-838) in Patients with Progressive Multiple Sclerosis
This study tests IMU-838, a new medication aimed at slowing brain shrinkage in progressive MS. The trial compares IMU-838 with placebo over a 120-week main treatment period, with an optional open-label extension where all participants receive the active medication.
Who can join: Adults aged 18 to 65 with either secondary progressive MS or primary progressive MS, without signs of relapse in the past 24 months. For secondary progressive MS, patients can be included with or without recent MRI changes. Primary progressive MS should have been diagnosed according to specific criteria and present for 10 years or less. Participants must have an EDSS score between 3.0 and 6.5 and demonstrate worsening disability in the past 24 months not related to relapses. Both men and women must use effective birth control throughout the study.
Who cannot join: Patients with non-progressive forms of MS, those outside the age range, and individuals from vulnerable populations.
What the study investigates: The primary goal is to measure changes in brain volume using advanced MRI techniques. The study will monitor disability progression and assess whether IMU-838 can slow the rate of brain atrophy compared to placebo. Regular assessments include MRI scans and evaluations using the expanded disability status scale.
Treatment tested: IMU-838 (vidofludimus calcium) is taken orally in tablet form, available in dosages of 22.5 mg or 45 mg. It works by inhibiting an enzyme involved in immune cell proliferation, thereby reducing inflammation. The medication is classified as an immunomodulatory agent.
Study on Human Fetal Neural Precursor Cells and Tacrolimus for Patients with Progressive Multiple Sclerosis
This innovative study explores a regenerative medicine approach using human fetal neural precursor cells injected into the spinal fluid, combined with the immune-suppressing medication tacrolimus. The treatment aims to repair or regenerate damaged nerve tissue.
Who can join: Men and women aged 18 to 65 with a diagnosis of progressive MS according to 2017 revised McDonald criteria. Participants must have an EDSS score between 3.0 and 8.0 and have experienced failure, intolerance, or ineligibility for approved therapies. They must be able to take oral medication and willing to follow study procedures. Women of childbearing age must use highly effective birth control for at least one month before and throughout the study. Men must use effective birth control and agree not to donate sperm during the study.
Who cannot join: People without progressive MS, those outside the specified age range, individuals unable to receive intrathecal injections six months apart, those unable to undergo sham procedures, and individuals from vulnerable populations.
What the study investigates: The study evaluates whether transplanting human fetal neural progenitor cells can improve or stabilize the condition. Participants receive two doses of cells six months apart, administered directly into the spinal fluid. The 96-week study monitors changes in brain volume using MRI scans and assesses cognitive function and physical abilities.
Treatment tested: Human fetal neural precursor cells at a dose of 200 million cells per administration, delivered intrathecally. These cells are believed to support neural repair by differentiating into various types of neural cells and releasing factors that promote cell survival and growth. Tacrolimus is taken orally as an immune suppressant to prevent rejection of the transplanted cells.
Study on Istradefylline for Reducing Brain Inflammation in Patients with Progressive Multiple Sclerosis
This study investigates whether istradefylline, a medication originally developed for Parkinson’s disease, can reduce brain inflammation by decreasing the activation of microglia, immune cells involved in the inflammatory process.
Who can join: Men and women aged 18 to 67 with primary progressive MS or non-active secondary progressive MS without relapses in the last two years. Participants must have an EDSS score between 3.5 and 7.5, show evidence of disease worsening in the past two years, and be able to follow all study procedures. Fluency in Finnish language is required, along with completion of at least 8th grade education.
Who cannot join: Patients without progressive MS and those outside the specified age range.
What the study investigates: The study uses specialized PET scans to measure microglial activation in the brain, comparing activity levels before and after treatment. Participants also undergo MRI scans to assess brain lesions, along with tests evaluating hand dexterity, walking speed, cognitive function, and quality of life. The treatment period lasts up to six months.
Treatment tested: Istradefylline is taken orally as a 40 mg tablet once daily. It works by blocking adenosine A2A receptors, which may help reduce inflammation and neurodegeneration. The medication is classified as an adenosine receptor antagonist.
Study on Metformin for Delaying Progression in Non-Active Progressive Multiple Sclerosis Patients
This trial investigates whether metformin, a common diabetes medication, can be repurposed to slow disease progression in people with non-active progressive MS. The study examines whether adding metformin to existing treatment can improve walking speed and other health measures.
Who can join: Adults aged 18 to 70 with non-active progressive MS, meaning the disease is worsening but without new attacks or brain lesions in the past 1-2 years. Participants must have an EDSS score between 2.0 and 6.5, speak Dutch/Flemish or French, and have been on stable disease-modifying therapy or no treatment for at least the past year. Women of childbearing age must use adequate contraception during the study.
Who cannot join: Patients with active forms of MS, those outside the specified age range, and individuals from vulnerable populations unable to give informed consent.
What the study investigates: The triple-blind study compares metformin with placebo over 96 weeks, focusing on changes in walking speed as the primary measure. Secondary assessments include cognitive function using the Symbol Digit Modalities Test, hand function, quality of life, and MRI evaluations of brain volume and structure. Regular follow-up visits track changes throughout the study period.
Treatment tested: Metformin STADA 850 mg film-coated tablets taken orally daily for 96 weeks. Metformin works by activating a protein that helps regulate energy use and cell growth, potentially protecting nerve cells from damage. It is classified as a biguanide.
Study on the Effectiveness and Safety of Ocrelizumab for Patients with Progressive Multiple Sclerosis
This four-year study evaluates ocrelizumab, an established MS treatment that targets specific immune cells believed to contribute to disease progression. The trial assesses both effectiveness and long-term safety.
Who can join: Patients with confirmed progressive MS and an EDSS score of 6.5 or less, showing evidence of disability worsening over the past two years independent of relapses. Participants must meet at least one of 21 specific criteria demonstrating disability progression, have smartphone experience with Wi-Fi connectivity, and women of childbearing age must agree to use birth control during the study and for at least six months after the last dose.
Who cannot join: Individuals without progressive MS, those outside the specified age range, patients not in the specified clinical trial group, and those from certain vulnerable populations.
What the study investigates: The study monitors disease progression over four years through regular assessments of cognitive function, mobility, and impact on daily life. Tests include the Symbol Digit Modalities Test and Brief Visuospatial Memory Test. MRI scans evaluate changes in brain volume and lesion characteristics. Patient-reported outcomes use scales including the Multiple Sclerosis Impact Scale and Fatigue Scale. The goal is to determine the proportion of patients with no evidence of progression and no active disease sustained for at least 24 weeks.
Treatment tested: Ocrelizumab is administered as an intravenous infusion at 300 mg doses, repeated at specified intervals. Additional medications include diphenhydramine hydrochloride (50 mg tablet), paracetamol (1000 mg oral solution), and methylprednisolone infusion (500 mg) to manage potential infusion-related reactions. Ocrelizumab is a monoclonal antibody that targets and depletes CD20-positive B cells involved in the abnormal immune response.
Summary
The seven ongoing clinical trials for progressive multiple sclerosis reflect diverse therapeutic approaches to address this challenging condition. Italy leads in trial participation with four studies, followed by multiple trials across Central and Western Europe. Germany, Netherlands, Poland, and Czechia each host multiple studies, indicating strong research infrastructure in these countries.
Treatment strategies vary considerably. Siponimod appears in two Italian studies focusing on immune modulation and brain inflammation. The innovative cell therapy approach using human fetal neural precursor cells represents a unique regenerative medicine strategy exclusive to Italy. Several trials investigate immune-modulating medications including ocrelizumab, which is being tested across seven European countries in the largest multi-national trial.
Notably, researchers are exploring repurposed medications, with metformin being tested in Belgium and istradefylline in Finland, demonstrating interest in finding new applications for established drugs. The IMU-838 study spans six countries, reflecting significant investment in this new immunomodulatory agent. Most trials focus on slowing brain atrophy and reducing inflammation, with study durations ranging from six months to four years, allowing researchers to assess both short-term effects and long-term disease progression.
