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A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis

The objective of the study is to compare the safety and efficacy of masitinib at 4.5 mg/kg/day or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after three month of treatment versus placebo in the treatment of patients with…

A randomized, open-label, two-way crossover study to assess the relative bioavailability of Laquinimod 0.6 mg test tablet versus Laquinimod 0.6 mg reference capsule after single dose administration with a single sequence extension to assess the pharmacokinetics of Laquinimod and its metabolites after single and multiple oral 0.6 mg dose administration in healthy subjects.

The study will be performed in 2 parts, Parts 1 and 2. In Part 1, single doses of laquinimod will be administered whereas in Part 2, multiple doses of laquinimod will be administered. The study will be performed in a maximum of 20 healthy male and…

A phase 1, open-label, single-center study of absorption, metabolism and excretion and absolute bioavailability in humans of leriglitazone (MIN-102) in 2 parallel cohorts of male healthy subjects

In this study we will investigate how safe the compound leriglitazone is and how well it is tolerated when it is used by healthy participants.Apart from extensive laboratory and animal testing, leriglitazone has been used in the past both in healthy…

Pilot Study of Faecal Microbiota Transplantation in Multiple Sclerosis, a Phase-1 Study

Overall the safety to perform FMT has to be assessed before potential trial powered for efficacy can be performed. In this study we aim to treat 10 patients with different forms of MS to assess if FMT is safe to perform.Primary Objective: To assess…

Partial oral antibiotic treatment for bacterial brain abscess: An open-label randomised non-inferiority trial.

This study has been transitioned to CTIS with ID 2023-505483-11-00 check the CTIS register for the current data. To investigate if early transition to oral treatment after two weeks or longer of IV antibiotic therapy is non-inferior to standard six…

A PHASE 1, OPEN-LABEL STUDY TO ASSESS THE MASS BALANCE AND PHARMACOKINETICS OF [14C]-IMU-838 IN HEALTHY MALE SUBJECTS

In this study we will investigate the safety of the study compound IMU-838 and how well it is tolerated when it is used by healthy subjects. Please note that when the term *study compound* is used in this document, we mean IMU-838.The study will…

A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

This study has been transitioned to CTIS with ID 2023-505974-14-00 check the CTIS register for the current data. Main objective:English To evaluate the longer-term safety of ocrelizumab in participants diagnosed with MS who were previously enrolled…

Pituitary Gland Stimulation for pain relief

To establish if targeted pituitary stimulation results in pain relief in cancer patients with opioid refractive pain or intolerance to opioids and patients with severe central neuropathic pain.

Imlifidase treatment for acute inflammation in AQP4-IgG associated neuromyelitis optica spectrum disorder

To analyse in what proportion of NMOSD patients with an episode of acute inflammation circulating pathogenic anti-AQP4 IgG antibodies are depleted below detection limits, as measured with a state-of-the-arts cell-based assay, in the timeframe within…

Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis

This study has been transitioned to CTIS with ID 2024-513854-31-00 check the CTIS register for the current data. To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model-predicted) evidence for a treatment response.

A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD)

Primary• To evaluate the effect of ravulizumab on adjudicated On-Trial Relapses in adult patients with NMOSDSecondary• To evaluate the safety of ravulizumab in adult patients with NMOSD• To evaluate the effect of ravulizumab on adjudicated…

A Phase I, single*center, double-blind, randomized, placebo-controlled, single and multiple ascending dose trial to evaluate the safety and pharmacokinetics of PTC857 in healthy volunteers.

Primary ObjectivesPart 1 * Single Ascending DoseThe primary objective of the single ascending dose (SAD) part of the study is to characterize the safety and tolerability of a single dose of PTC857 in healthy subjects.Part 2 * Multiple Ascending…

Depression in Multiple Sclerosis: The effectiveness of web-based self-help treatment

The goal of this research project is to evaluate effectiveness of a cognitive behavioural therapy self-help intervention offered through the Internet in multiple sclerosis (MS) patients with a co-morbid depressive symptoms. With the online guided…

Plegridy* (peginterferon β-1a) Real World Effectiveness and Safety Observational Program (POP)

This study will be conducted as a prospective, observational study of patients with relapsing forms of MS initiating treatment with Plegridy in routine clinical practice and patients who participated in Study 105MS302 or Study 105MS303. Enrolled…

A single-center randomized, adaptive, investigator/participant blind, single oral ascending dose, placebo-controlled Phase I study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7189752 in healthy male participants.

The purpose of this study is to investigate how safe the new compound RO7189752 is and how well it is tolerated when it is administered as a drink to healthy male volunteers. RO7189752 has not been administered to humans before. It has been…