Ongoing Clinical Trials for Primary Progressive Multiple Sclerosis
There are currently 7 clinical trials ongoing for Primary Progressive Multiple Sclerosis, a form of multiple sclerosis characterized by a gradual worsening of symptoms without periods of remission. These trials are investigating various treatments including immunomodulatory therapies, cell-based approaches, and repurposed medications, with studies taking place across multiple European countries.
Clinical trial locations
- Austria
- Belgium
- Study on Metformin for Delaying Progression in Non-Active Progressive Multiple Sclerosis Patients
- Study on the Effectiveness and Safety of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
- Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
- Study on Tolebrutinib for Patients with Primary Progressive Multiple Sclerosis
- Bulgaria
- Croatia
- Czechia
- Denmark
- Estonia
- France
- Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis
- Study on the Effectiveness and Safety of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
- Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
- Study on Tolebrutinib for Patients with Primary Progressive Multiple Sclerosis
- Germany
- Greece
- Hungary
- Italy
- Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis
- Study on the Effectiveness and Safety of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
- Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
- Study on Tolebrutinib for Patients with Primary Progressive Multiple Sclerosis
- Netherlands
- Norway
- Poland
- Portugal
- Romania
- Spain
- Study on the Safety and Effectiveness of Melatonin and Ocrelizumab for Patients with Primary Progressive Multiple Sclerosis
- Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis
- Study on the Effectiveness and Safety of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
- Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
- Study on Tolebrutinib for Patients with Primary Progressive Multiple Sclerosis
- Sweden
Study on the Safety and Effectiveness of Melatonin and Ocrelizumab for Patients with Primary Progressive Multiple Sclerosis
This trial, conducted in Spain, is investigating whether adding melatonin to the standard treatment with ocrelizumab can help slow disease progression. The study focuses on patients already taking ocrelizumab and evaluates whether melatonin can provide additional benefits.
Main inclusion criteria: Participants must be adults aged between 18 and 65 years with a confirmed diagnosis of the condition. They need to have an Expanded Disability Status Scale score between 2 and 7, meaning they can range from having no disability to needing walking support. Patients must have been on stable doses of ocrelizumab for at least 9 months before joining. They should not have used melatonin or antioxidant supplements in the month before the trial and must not have received other immune-modifying treatments in the past three months.
Main exclusion criteria: The study excludes individuals who do not have this specific form of the disease, those outside the required age range, and members of vulnerable populations such as children or people unable to give informed consent.
Trial focus: The research aims to evaluate both the safety and effectiveness of combining melatonin with ocrelizumab. The study monitors various health indicators including disease progression, side effects, quality of life, fatigue levels, and sleep patterns. Participants receive either melatonin or a placebo alongside their regular ocrelizumab treatment in a single-blind design.
Investigational drugs: Ocrelizumab is a medication that targets specific immune cells thought to contribute to nerve damage. Melatonin, naturally produced by the body to regulate sleep, is being tested for its potential anti-inflammatory and immune-modulating effects.
Study on the Safety and Effects of YTB323 and Drug Combination in Patients with Progressive Multiple Sclerosis
This innovative trial takes place across Spain, France, Germany, and Italy, investigating a cell therapy approach called YTB323. The study explores whether modified immune cells from patients themselves can help fight the disease.
Main inclusion criteria: Patients must be between 18 and 60 years old and able to communicate effectively with the study team. They need a confirmed diagnosis of either Secondary Progressive or Primary Progressive form, with disease duration less than 15 years. Participants must be able to walk and have an EDSS score between 3 and 6.5. They must be capable of undergoing procedures like lumbar punctures and brain MRI scans.
Main exclusion criteria: Anyone with other forms of the disease not classified as non-active progressive, those outside the specified age range, or individuals from vulnerable populations cannot participate.
Trial focus: The primary goal is to assess the safety of different doses of YTB323. Before receiving the main treatment, participants undergo preparation with cyclophosphamide and fludarabine phosphate through intravenous infusion. The study closely monitors participants through regular follow-up visits, blood tests, and MRI scans to track disease progression and treatment response.
Investigational drugs: YTB323 is an experimental immunotherapy using modified cells from the patient’s own immune system, designed to target and reduce the damage caused by the disease. The therapy is given through intravenous infusion after preparation with supporting medications.
Study Comparing Rituximab and Ocrelizumab for Patients with Active Multiple Sclerosis
This Danish trial compares two similar medications to determine if rituximab, a biosimilar, is as effective as the approved ocrelizumab. The study runs for 24 months with an optional 36-month extension.
Main inclusion criteria: Participants must be between 18 and 65 years old with a diagnosis according to 2017 McDonald criteria. They need an EDSS score of 6.5 or less. For those never treated or untreated in the past three months, eligibility requires at least two relapses in the past year or one relapse with specific brain lesion patterns. Previously treated patients need at least one relapse or specific lesion activity in the past year. Those with progressive forms need evidence of recent disease activity through relapses, lesions, or elevated neurofilament light chain levels.
Main exclusion criteria: Individuals without the condition, those outside the age range, or vulnerable populations are excluded.
Trial focus: The main objective is determining whether rituximab matches ocrelizumab’s effectiveness in preventing new or enlarging brain lesions over 24 months. The extension phase examines long-term safety and whether extending the time between doses benefits stable patients.
Investigational drugs: Both ocrelizumab and rituximab target CD20-positive B cells to reduce immune system attacks on the nervous system. They are administered as intravenous infusions.
Study on Metformin for Delaying Progression in Non-Active Progressive Multiple Sclerosis Patients
This Belgian trial investigates whether metformin, commonly used for diabetes, can slow disease progression when added to existing treatments. The study runs for 96 weeks.
Main inclusion criteria: Patients must be adults between 18 and 70 years old with non-active progressive disease, meaning gradual worsening without new attacks or lesions in the past 1-2 years. They need an EDSS score between 2.0 and 6.5 and must speak Dutch, Flemish, or French. Participants should have been on stable disease-modifying therapy or no treatment for at least a year. Women of childbearing age must use adequate contraception.
Main exclusion criteria: Those with other forms of the disease, individuals outside the age range, and vulnerable populations unable to give informed consent are excluded.
Trial focus: The research evaluates whether metformin can improve or maintain walking speed over 96 weeks compared to placebo. The triple-blind study also assesses cognitive function, hand function, quality of life, and brain volume changes through MRI scans.
Investigational drugs: Metformin, taken as oral tablets, is being studied for its potential neuroprotective effects through activation of proteins that regulate energy use and cell growth.
Study on the Effectiveness and Safety of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
This large international trial spans Romania, Poland, Croatia, Portugal, Belgium, France, Spain, Italy, and Bulgaria. It evaluates ocrelizumab’s effectiveness in slowing disease progression through 2030.
Main inclusion criteria: Participants must be adults with confirmed diagnosis according to specific criteria, with an EDSS score between 3.0 and 8.0. Disease duration requirements vary by disability level: less than 20 years for EDSS 7.0-8.0, less than 15 years for EDSS 5.5-6.5, and less than 10 years for EDSS 5.0 or lower. Patients need evidence of specific proteins in cerebrospinal fluid and must complete a hand function test in more than 25 seconds. They should be neurologically stable for at least 30 days before starting.
Main exclusion criteria: Those with other forms, recent or current infections, cancer history (except certain skin cancers), pregnancy or breastfeeding, severe heart problems, allergies to similar medications, inability to undergo MRI scans, or participation in other trials are excluded.
Trial focus: The study monitors time to symptom progression, including worsening hand function or increased disability. Regular MRI scans track brain and spinal cord changes, while comprehensive assessments monitor side effects and disease progression.
Investigational drugs: Ocrelizumab, administered as intravenous infusion, targets and depletes CD20-positive B cells believed to contribute to nerve damage.
Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis
This trial across 11 European countries investigates whether a higher dose of ocrelizumab provides better results than the currently approved dose. The double-blind study compares the higher dose, approved dose, and placebo.
Main inclusion criteria: Participants must be between 18 and 55 years old with diagnosis according to 2017 revised McDonald criteria. They need an EDSS score between 3 and 6.5 and a score of 2.0 or higher on the pyramidal system functional scale. Brain MRI must show abnormalities consistent with the disease, and patients must be neurologically stable for at least 30 days before the trial.
Main exclusion criteria: Those with other disease forms, recent or current infections, cancer history, significant heart problems, severe liver disease, recent other clinical trial participation, allergies to the medication, pregnancy or breastfeeding, or history of substance abuse are excluded.
Trial focus: The primary goal is determining whether the higher dose better reduces disability progression risk. The study monitors disease progression through various measures including brain volume changes and blood protein levels related to nerve damage.
Investigational drugs: Ocrelizumab is given as intravenous infusion at different doses. Additional medications including paracetamol, methylprednisolone, and diphenhydramine may be used to manage symptoms or side effects.
Study on Tolebrutinib for Patients with Primary Progressive Multiple Sclerosis
This extensive trial across 19 European countries tests tolebrutinib, an oral medication taken as a film-coated tablet. The double-blind study compares tolebrutinib to placebo.
Main inclusion criteria: Participants must be between 18 and 55 years old with diagnosis according to 2017 guidelines. They need an EDSS score between 2.0 and 6.5 and must have positive cerebrospinal fluid oligoclonal bands or elevated IgG index. Patients must use appropriate birth control, and women cannot be pregnant or breastfeeding. Those with access to ocrelizumab may participate only if they cannot tolerate it due to side effects or if it does not work effectively for them.
Main exclusion criteria: Standard exclusions apply for those not meeting the medical criteria or belonging to vulnerable populations.
Trial focus: The study aims to determine if tolebrutinib can delay disability progression. Regular assessments monitor progression, brain imaging tracks structural changes, and cognitive function tests evaluate mental abilities. Safety and tolerability are closely observed throughout.
Investigational drugs: Tolebrutinib is an experimental immunomodulatory medication taken orally, designed to modulate the immune system to reduce inflammation and prevent nerve damage.
Summary
The seven ongoing trials for Primary Progressive Multiple Sclerosis demonstrate diverse therapeutic approaches. Several trials focus on ocrelizumab, a well-established treatment, examining its effectiveness alone or in combination with other substances like melatonin, and exploring whether higher doses might provide better outcomes. This concentration reflects ocrelizumab’s established role in treating this condition.
The geographic distribution shows strong representation across Western and Southern Europe, with Spain, Belgium, Italy, France, and Germany hosting multiple trials. Eastern European countries like Poland, Romania, Bulgaria, and Croatia also participate in several studies, indicating broad European research collaboration.
Innovative approaches include the YTB323 cell therapy trial and the metformin repurposing study, demonstrating researchers’ willingness to explore both cutting-edge and established medications. The tolebrutinib trial, spanning 19 countries, represents the most geographically extensive study, reflecting significant interest in this oral treatment option.
Most trials require participants to have moderate disability levels, typically EDSS scores between 2.0 and 6.5, targeting patients who can still benefit from interventions aimed at slowing progression. The age ranges generally span from young adults to middle age, reflecting the disease’s typical progression patterns.
