Ongoing Clinical Trials for Multifocal Motor Neuropathy
Currently, there are 3 ongoing clinical trials investigating new treatments for Multifocal Motor Neuropathy, a rare neurological disorder causing progressive muscle weakness primarily in the arms and hands. These international studies are testing investigational medications including empasiprubart, DNTH103, and ARGX-117 as potential alternatives or additions to standard intravenous immunoglobulin therapy. Trials are being conducted across multiple European countries.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Estonia
- France
- Germany
- Greece
- Italy
- Latvia
- Lithuania
- Netherlands
- Norway
- Poland
- Portugal
- Slovakia
- Slovenia
- Spain
- Sweden
Study comparing empasiprubart versus intravenous immunoglobulin for treating adults with multifocal motor neuropathy
This study directly compares a new investigational medication called empasiprubart with the current standard treatment, intravenous immunoglobulin (IVIg), for adults with Multifocal Motor Neuropathy. The condition is a rare neurological disorder that affects motor nerves, causing progressive muscle weakness primarily in the arms and hands.
Main focus: The primary goal of this research is to determine whether empasiprubart is as effective as IVIg at improving muscle strength in people with this condition. Both treatments are given directly into a vein through infusion. The study includes a 24-week treatment period followed by extended monitoring. Researchers will carefully measure changes in muscle strength, particularly hand strength, and monitor how well participants can perform daily activities.
Who can participate: Adults aged 18 years or older with a confirmed diagnosis of Multifocal Motor Neuropathy who have previously responded well to IVIg treatment within the past 5 years. Participants must currently be receiving regular IVIg treatment every 2 to 5 weeks at a specific dose range, and their treatment plan must have been stable for at least 8 weeks before joining the study. Required vaccinations against certain bacteria must be completed at least 14 days before starting the study medication.
Who cannot participate: People with a history of severe allergic reactions to immunoglobulin treatments, those with other neurological conditions that could affect muscle strength assessment, individuals with active infections or severe illnesses, pregnant or breastfeeding women, and those with significant kidney or liver disease. Recent surgery within the past 3 months, blood clotting disorders, uncontrolled high blood pressure, and history of cancer within the past 5 years are also exclusions.
Investigational drugs: The study tests empasiprubart, an experimental medication being developed as a potential alternative to current treatments. It is compared against intravenous immunoglobulin, a treatment made from donated blood plasma containing healthy antibodies that helps reduce inflammation and support the immune system.
Study on the Safety and Effects of DNTH103 for Adults with Multifocal Motor Neuropathy
This clinical trial evaluates a new treatment called DNTH103, a type of protein medication known as a monoclonal antibody. The medication is designed to target specific parts of the immune system that may be involved in causing nerve damage and muscle weakness.
Main focus: The study primarily aims to assess how safe and well-tolerated DNTH103 is in adults with Multifocal Motor Neuropathy. The treatment can be given either through a vein (intravenously) or under the skin (subcutaneously). Throughout the 17-week study period, researchers will closely monitor participants for any side effects and measure changes in grip strength, ability to perform daily activities, and overall health indicators. The study is double-blinded, meaning neither participants nor researchers know who receives the actual medication or a placebo.
Who can participate: Adults between 18 and 75 years old weighing between 40 and 120 kilograms with a confirmed diagnosis of definite or probable Multifocal Motor Neuropathy. Participants must have shown responsiveness to immunoglobulin treatment and be receiving a stable treatment regimen. Required vaccinations against certain types of bacteria must be documented. Female participants of childbearing potential must agree to use effective contraception and not attempt to become pregnant. Male participants must also agree to use acceptable contraception methods.
Who cannot participate: Individuals with other serious health conditions that could interfere with the study, recent infections or illnesses, those currently taking medications that might interfere with the study treatment, people with a history of allergic reactions to similar treatments, pregnant or breastfeeding individuals, recent participants in other clinical trials, those with a history of drug or alcohol abuse, individuals with mental health conditions affecting participation ability, and people diagnosed with different types of neuropathy.
Investigational drug: DNTH103 is a monoclonal antibody being studied for its potential to help people with Multifocal Motor Neuropathy by targeting specific immune system components that may contribute to nerve damage and muscle weakness.
Study on Long-term Safety and Effects of ARGX-117 for Adults with Multifocal Motor Neuropathy
This is a long-term follow-up study evaluating ARGX-117, another monoclonal antibody medication. This trial is an extension study, meaning it continues to follow participants who have already been involved in earlier research with ARGX-117.
Main focus: The primary purpose is to evaluate the long-term safety and tolerability of ARGX-117 over an extended period. The medication is given as an infusion directly into the bloodstream. Researchers will monitor various aspects of health including any side effects, changes in muscle strength, grip strength, overall disability levels, and general well-being. The study aims to gather comprehensive information about how the treatment works over a longer timeframe and to ensure it remains safe for continued use. The trial is expected to run until August 2027.
Who can participate: Adults who have completed the previous ARGX-117-2002 trial and are eligible for continued treatment with the medication. Participants must be able to provide informed consent, meaning they understand the study and can read and write. Male participants must agree to use acceptable birth control methods until at least 15 months after the last dose of medication. Female participants who can become pregnant must have a negative pregnancy test before starting treatment.
Who cannot participate: People under 18 years of age, individuals who do not have Multifocal Motor Neuropathy, and patients who are part of vulnerable populations that might need special protection or care.
Investigational drug: ARGX-117 is an immunomodulatory agent, meaning it helps regulate the immune system’s activity. It is administered intravenously and works by targeting specific proteins involved in the immune response, potentially reducing inflammation and nerve damage. The medication is designed to help manage symptoms by regulating immune system activity that may contribute to nerve damage.
Summary
Three ongoing clinical trials are currently investigating new treatment options for Multifocal Motor Neuropathy across Europe. The trials are notably concentrated in countries with established neurology research centers, particularly France, Poland, Italy, Spain, the Netherlands, Belgium, and Germany, where multiple studies are being conducted simultaneously.
All three studies focus on developing alternatives or additions to the current standard treatment of intravenous immunoglobulin. The investigational medications—empasiprubart, DNTH103, and ARGX-117—represent different approaches to targeting the immune system mechanisms believed to cause nerve damage in this condition. While empasiprubart is being directly compared to standard IVIg therapy in a large international study spanning 19 countries, DNTH103 and ARGX-117 are in earlier phases focusing primarily on safety and tolerability assessment.
A common requirement across all trials is prior positive response to immunoglobulin treatment, and all studies require participants to be vaccinated against certain bacterial infections before starting experimental treatments. The trials vary in duration from 17 weeks to several years, with one study designed specifically as a long-term extension to monitor safety over time. These studies represent important steps in developing new treatment options for this rare neurological condition that currently has limited therapeutic alternatives.
