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Ongoing Clinical Trials for Multiple Sclerosis

This article provides information about 44 ongoing clinical trials investigating treatments for multiple sclerosis, a chronic disease affecting the central nervous system. These trials are testing various medications and therapies across multiple countries in Europe, aiming to improve treatment options for people living with different forms of multiple sclerosis.

Clinical trial locations

Study Comparing Rituximab and Ocrelizumab for Patients with Relapsing Multiple Sclerosis Starting Anti-CD20 Therapy

This trial, conducted in the Netherlands, is comparing two medications used to treat relapsing multiple sclerosis: rituximab and ocrelizumab. Both are given through intravenous infusion.

Who can participate: Adults aged 18-65 years with relapsing-remitting multiple sclerosis according to 2017 McDonald criteria, who need to start anti-CD20 therapy. Participants must have an EDSS score of 6.5 or lower and be able to understand Dutch or English.

Who cannot participate: Patients without a multiple sclerosis diagnosis, those under 18, pregnant or breastfeeding women, individuals unable to provide informed consent, and those with serious medical conditions that would interfere with the study.

Main focus: The study aims to determine if rituximab is as effective as ocrelizumab in preventing new or enlarged brain lesions over 24 months. Researchers will monitor relapses and areas of active inflammation in the brain using MRI scans.

Medications tested: Rituximab and ocrelizumab both work by targeting B-cells in the immune system that contribute to nerve damage in multiple sclerosis. These medications help reduce inflammation and slow disease progression.

Study of psilocybin therapy for psychological distress in patients with COPD, ALS, multiple sclerosis, or atypical Parkinson’s disorders

This multi-country trial (Czechia, Netherlands, Denmark, Portugal) is testing psilocybin therapy for reducing depression in patients with serious medical conditions including multiple sclerosis. The study uses different doses of psilocybin capsules (1 mg, 15 mg, and 25 mg) taken orally.

Who can participate: Adults aged 18-64 with confirmed MS diagnosis for more than 6 months, chronic neuropathic pain for at least 6 months, stable disease-modifying therapy, and depression scores above 19 on the MADRS scale. Life expectancy must be at least 6 months.

Who cannot participate: People with personal or family history of schizophrenia, psychosis, or bipolar disorder; current suicidal thoughts; substance abuse in past 6 months; severe heart, liver, or kidney problems; pregnancy or breastfeeding; or inability to provide informed consent.

Main focus: The study evaluates whether medium to high doses of psilocybin therapy are safe and effective in reducing depression symptoms compared to low doses. Assessments occur before treatment and six weeks after the second dose, with monitoring of psychological well-being and quality of life.

Medications tested: Psilocybin is a naturally occurring psychedelic compound given with psychological support. It works by binding to serotonin receptors in the brain, potentially helping reduce psychological distress and improve comfort for patients with serious conditions.

Study on Frexalimab for Adults with Nonrelapsing Secondary Progressive Multiple Sclerosis

This trial across 13 European countries is testing frexalimab, a monoclonal antibody given by intravenous infusion, for patients with nonrelapsing secondary progressive MS. The study is double-blind, meaning neither participants nor researchers know who receives active treatment versus placebo.

Who can participate: Adults aged 18-65 with nonrelapsing secondary progressive MS according to 2017 McDonald criteria, EDSS score between 4-7, disease duration of 2-18 years, and documented disability progression over the past 12 months. No relapses should have occurred for at least 24 months.

Who cannot participate: People with other significant health conditions, pregnant or breastfeeding women, recent infections or illnesses, those in other clinical trials, history of allergic reactions to similar medications, or those unable to follow study procedures.

Main focus: The study aims to determine if frexalimab can delay disability progression in nonrelapsing secondary progressive MS. Researchers will monitor new or enlarging brain lesions using MRI scans, changes in brain volume, and cognitive function over the study period.

Medications tested: Frexalimab is a monoclonal antibody that targets specific immune pathways to reduce inflammation and immune system activity contributing to nerve damage. It is designed to slow disease progression and potentially improve neurological function.

Study on Masitinib for Treating Primary or Secondary Progressive Multiple Sclerosis in Patients Without Relapse

This trial in Greece, Spain, Poland, and France is testing masitinib, a tyrosine kinase inhibitor taken orally as a coated tablet, for treating progressive forms of MS without relapses. The study lasts 96 weeks with dose escalation.

Who can participate: Patients aged 18-65 with primary progressive or secondary progressive MS without relapses, symptoms starting at least 5 years before screening, EDSS score between 3.0-6.0, documented disease progression, no gadolinium-enhancing brain lesions, and BMI between 18-35.

Who cannot participate: Patients with recent relapses, those taking interfering medications, serious health conditions, pregnant or breastfeeding women, recent clinical trial participants, allergies to study medication, or inability to follow study procedures.

Main focus: The study evaluates masitinib’s effectiveness in slowing disability progression over 96 weeks. Assessments include EDSS scores, timed walking tests, hand dexterity tests, brain MRI scans to monitor brain volume and lesions, and measurement of blood biomarkers indicating disease activity.

Medications tested: Masitinib is a tyrosine kinase inhibitor that targets certain immune cells involved in MS progression. The initial dose is 3.0 mg/kg/day, increased to 4.5 mg/kg/day after four weeks, aiming to reduce chronic nerve damage and slow symptom progression.

Study on Modafinil for Improving Cognitive Deficits in Multiple Sclerosis Patients

This Portuguese trial is testing modafinil, taken as oral tablets, for improving cognitive function in MS patients experiencing thinking and memory difficulties. The study lasts three months with regular assessments including brain fMRI scans.

Who can participate: Adults aged 18-64 with relapsing-remitting MS or clinically isolated syndrome, EDSS score less than 6.5, subjective cognitive complaints, SDMT score of 55 or less, clinically stable for the last 6 months, and able to read and write.

Who cannot participate: People without MS diagnosis, under 18 years old, unable to give informed consent, pregnant or breastfeeding, history of drug or alcohol abuse, other serious medical conditions, current participation in another trial, or allergic reactions to modafinil.

Main focus: The study aims to identify features predicting how well patients respond to modafinil. Researchers use fMRI scans to observe brain function changes, along with tests and questionnaires evaluating cognitive function and quality of life over three months.

Medications tested: Modafinil is a wakefulness-promoting medication that influences neurotransmitters in the brain, particularly increasing dopamine availability. The trial investigates whether it can improve cognitive function by enhancing brain activity and connectivity.

Study on Monitoring Ocrelizumab Levels for Personalized Treatment in Patients with Relapsing-Remitting and Primary Progressive Multiple Sclerosis

This Czech trial is monitoring ocrelizumab blood levels to explore personalized treatment approaches for both relapsing-remitting and primary progressive MS. The medication is given as an intravenous infusion, with the study continuing until 2026.

Who can participate: Patients aged 18 or older with relapsing-remitting or primary progressive MS according to McDonald’s 2017 criteria, receiving ocrelizumab for at least 6 months, no steroid treatment in the past 3 months, and women of childbearing age must have negative pregnancy tests.

Who cannot participate: People without MS diagnosis, outside specified age range (adults and older adults), or belonging to vulnerable populations requiring special protection.

Main focus: The study explores relationships between ocrelizumab blood levels and various health indicators. Researchers monitor blood markers, conduct brain MRI scans, assess quality of life through questionnaires, and track disability progression using the EDSS scale over 24 months.

Medications tested: Ocrelizumab is a monoclonal antibody targeting CD20-positive B cells involved in MS. The trial investigates whether monitoring drug levels in the blood can help optimize treatment dosing for individual patients.

Study on Personalized Ocrelizumab Dosing for Patients with Relapsing Remitting Multiple Sclerosis

This Dutch trial is testing personalized ocrelizumab dosing at extended intervals, starting from every six weeks, for patients with relapsing-remitting MS. The study monitors participants over two years to assess safety and effectiveness of this individualized approach.

Who can participate: Adults aged 18 or older with relapsing-remitting MS according to 2017 criteria, having received at least six consecutive ocrelizumab infusions, EDSS score between 0-6.5, and providing written informed consent.

Who cannot participate: Patients with severe allergic reactions to ocrelizumab, other serious health conditions, pregnant or breastfeeding women, recent infections, participation in other trials, or inability to follow study procedures.

Main focus: The study evaluates safety and feasibility of extending intervals between ocrelizumab doses based on individual needs. Researchers monitor radiological disease activity through MRI scans to detect new or enlarging brain lesions over two years.

Medications tested: Ocrelizumab is a monoclonal antibody that blocks certain immune cells from reaching the brain and spinal cord, reducing inflammation and preventing relapses. The trial explores whether personalized dosing schedules maintain effectiveness while potentially reducing treatment burden.

Study on Stopping Dimethyl Fumarate and Drug Combination in Patients Aged 55+ with Inactive Relapsing-Remitting Multiple Sclerosis

This French trial is exploring whether stopping moderate efficacy therapies is non-inferior to continuing them in patients aged 55 and over with stable relapsing-remitting MS. The study lasts approximately two years with regular monitoring.

Who can participate: Patients aged 55 or older with relapsing-remitting MS according to revised McDonald 2017 criteria, first MS symptom more than 5 years ago, stable disease for the last 5 years (documented by MRI and EDSS), no relapses in past 5 years, and receiving moderate efficacy therapy for at least 5 consecutive years.

Who cannot participate: Patients without MS diagnosis, under 55, unstable condition, or belonging to vulnerable populations.

Main focus: The study demonstrates non-inferiority in disease activity-free survival between treatment continuation and discontinuation. Regular assessments at months 0, 6, 12, 18, and 24 monitor disease activity, progression, MRI changes, and various quality of life measures.

Medications tested: The trial involves moderate efficacy therapies including interferon beta (which modulates the immune system), glatiramer acetate (which prevents immune attacks on nerves), dimethyl fumarate (which reduces inflammation), and teriflunomide (which reduces active immune cells).

Study on the Effectiveness and Safety of Frexalimab and Teriflunomide for Adults with Relapsing Multiple Sclerosis

This trial across 18 European countries compares frexalimab (given as injection) with teriflunomide (taken as oral tablet) for treating relapsing forms of MS. The study is double-blind and lasts up to 160 weeks with regular monitoring.

Who can participate: Adults aged 18-55 at consent signing, diagnosed with relapsing MS (including relapsing-remitting and secondary progressive with relapses) according to 2017 McDonald criteria, EDSS score of 5.5 or less, and at least one documented relapse in the past year, or two in the past two years, or gadolinium-enhancing brain lesion on MRI within the previous year.

Who cannot participate: Pregnant or breastfeeding women, people with severe allergies to study medications, other serious health conditions, recent medication use affecting results, recent clinical trial participation, substance abuse history, or inability to follow procedures.

Main focus: The study assesses how well frexalimab works compared to teriflunomide in reducing relapse frequency. Researchers conduct MRI scans to detect brain changes, cognitive function tests, and monitor side effects throughout the study period.

Medications tested: Frexalimab is a monoclonal antibody targeting specific proteins in the immune response to reduce inflammation and relapses. Teriflunomide is an established treatment that limits activity of certain immune cells causing nervous system damage.

Study on the Effectiveness and Safety of Frexalimab and Teriflunomide in Adults with Relapsing Multiple Sclerosis

Similar to the previous trial, this study across 16 European countries also compares frexalimab (injection) with teriflunomide (oral tablet) for relapsing MS. The study lasts up to 160 weeks with comprehensive monitoring of safety and effectiveness.

Who can participate: Adults aged 18-55 with relapsing MS diagnosis according to 2017 McDonald criteria, EDSS score of 5.5 or less, and documented relapse history or gadolinium-enhancing brain lesion on MRI. Participants must use appropriate contraception methods.

Who cannot participate: People without MS diagnosis, outside age range, unwilling or unable to follow procedures, other medical conditions, pregnant or breastfeeding, current trial participation, recent infections, substance abuse history, or allergies to study medications.

Main focus: The trial evaluates frexalimab’s effectiveness versus teriflunomide in reducing relapse frequency. Regular assessments include MRI scans for brain changes, disability progression measurements, and comprehensive monitoring of side effects.

Medications tested: Frexalimab is an investigational immunomodulatory agent targeting specific immune cells to reduce inflammation. Teriflunomide is an established immunomodulatory drug that helps balance immune system activity by inhibiting certain immune cell functions.

Summary

These 10 trials represent diverse approaches to treating multiple sclerosis, from testing new medications like frexalimab and psilocybin to optimizing existing therapies like ocrelizumab. Several trials focus on progressive forms of MS, which historically have had fewer treatment options. Notable is the concentration of trials in Western European countries, particularly Belgium, France, Germany, the Netherlands, and Spain, which appear in multiple studies. Many trials are investigating personalized medicine approaches, such as monitoring drug levels to optimize dosing, and exploring whether stable patients might safely stop or reduce treatments. The studies encompass various administration routes including oral tablets, intravenous infusions, and subcutaneous injections, offering potential treatment options suited to different patient preferences and circumstances.

Ongoing Clinical Trials on Multiple sclerosis

  • Study on Personalized Ocrelizumab Dosing for Patients with Relapsing Remitting Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Effects of a Higher Dose of Ocrelizumab for Adults with Primary Progressive Multiple Sclerosis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Denmark France Germany Greece +5

  • Study on the Effectiveness and Safety of Ocrelizumab for Patients with Progressive Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark France Germany Italy The Netherlands +1

  • Study on the Safety and Effectiveness of Fingolimod and Interferon Beta-1a in Children with Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Romania Slovakia Spain

  • Study on B-Cell Levels in Infants Exposed to Ocrelizumab During Pregnancy for Mothers with Multiple Sclerosis or Clinically Isolated Syndrome

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

  • Study on the Effects of SAR443820 and Gadobutrol in Patients with Multiple Sclerosis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria France Germany Italy Poland +1

  • Study on the Effectiveness and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Children with Multiple Sclerosis

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Croatia Estonia France Germany +7

  • Study on the Safety of Tenofovir Alafenamide and Natalizumab for People with Multiple Sclerosis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Norway

  • Study on the Effectiveness and Safety of Ocrelizumab, Methylprednisolone, and Diphenhydramine Hydrochloride in Patients with Multiple Sclerosis

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Croatia Denmark France Hungary +8

  • Study Comparing Rituximab and Ocrelizumab for Patients with Relapsing Multiple Sclerosis Starting Anti-CD20 Therapy

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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