Informations générales (source: ClinicalTrials.gov)
A 96-Week, Prospective, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Efficacy and Safety of Masitinib Dose Titration to 4.5 mg/kg/Day Versus Placebo in the Treatment of Patients With Primary Progressive or Secondary Progressive Multiple Sclerosis Without Relapse (MAXIMS)
Interventional
Phase 3
AB Science (Voir sur ClinicalTrials)
juin 2022
décembre 2025
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Strasbourg - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier intercommunal de Poissy-Saint-Germain-en-Laye - Poissy - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rouen - Rouen - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Nimes - Service de Neurologie - Nîmes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Toulouse - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Hôpital Pasteur - CHU de Nice - Nice - France | Contact (sur clinicalTrials) | ||||
| Hôpital Roger Salengro - Lille - France | Contact (sur clinicalTrials) | ||||
| Le Centre hospitalier universitaire de Poitiers - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Service de Neurologie Hôpital Henri-Mondor - Créteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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