PausedPhase 3Progressive MSNCT05441488

What it found

Still running

No result yet.

Reason given: The study has been suspended but may start again in the future.

What was tested

Treatment tested

  • Masitinib

    Fibroblast growth factor receptor 3 inhibitor|Platelet-derived growth factor receptor inhibitor|Stem cell growth factor receptor inhibitor

Placebo or sham

  • Placebo

What it measured

Main measures

  • Time to confirmed progression

    96 weeks

    Disability progression

Other measures (4)

  • Time to Expanded Disability Status Scale (EDSS) score of 7.0

    96 weeks

    Disability progression
  • Overall Change in Expanded Disability Status Scale (EDSS) Score

    96 weeks

    Disability progression
  • Brain Magnetic Resonance Imaging Assessments

    96 weeks

    MRI lesionsBrain volume loss
  • Multiple Sclerosis Quality of Life (MSQOL)-54

    96 weeks

    Quality of life (reported by participants)

Who could take part

Progressive MS · 18 to 65

Main inclusion criteria include: * Patients with either primary progressive or secondary progressive multiple sclerosis with onset of symptoms at least five years before baseline and with no relapse diagnosed according to the 2017 revised McDonald's criteria at least two years before screening * Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline * Patients with an EDSS score progression ≥1 point with no improvement during 2 years * Absence of T1 Gadolinium-enhancing brain lesions as measured by MRI at screening Main exclusion criteria include: * Patients suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions observed at screening * Inability to complete screening MRI (contraindications for MRI) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic * Patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline * Patients with lymphocytes \<1.0 × 10\^9/L at screening and at baseline

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.

Papers

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Related trials

History

    1. Started

      Jun 2022

    2. Main results due

      Dec 2028

    3. Finished

      Dec 2028

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