MAXIMS
What it found
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 progressionOverall Change in Expanded Disability Status Scale (EDSS) Score
96 weeks
Disability progressionBrain Magnetic Resonance Imaging Assessments
96 weeks
MRI lesionsBrain volume lossMultiple 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
Results
Latham BD, Oskin DS, Crouch RD, Vergne MJ, Jackson KD. Cytochromes P450 2C8 and 3A Catalyze the Metabolic Activation of the Tyrosine Kinase Inhibitor Masitinib. Chem Res Toxicol. 2022 Sep 19;35(9):1467-1481. doi: 10.1021/acs.chemrestox.2c00057. Epub 2022 Sep 1.Background
Vermersch P, Brieva-Ruiz L, Fox RJ, Paul F, Ramio-Torrenta L, Schwab M, Moussy A, Mansfield C, Hermine O, Maciejowski M; AB07002 Study Group. Efficacy and Safety of Masitinib in Progressive Forms of Multiple Sclerosis: A Randomized, Phase 3, Clinical Trial. Neurol Neuroimmunol Neuroinflamm. 2022 Feb 21;9(3):e1148. doi: 10.1212/NXI.0000000000001148. Print 2022 May.Background
Vermersch P, Benrabah R, Schmidt N, Zephir H, Clavelou P, Vongsouthi C, Dubreuil P, Moussy A, Hermine O. Masitinib treatment in patients with progressive multiple sclerosis: a randomized pilot study. BMC Neurol. 2012 Jun 12;12:36. doi: 10.1186/1471-2377-12-36.
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History
Started
Jun 2022
Main results due
Dec 2028
Finished
Dec 2028
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