None listed
Conditions
Interventions
This is a prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase III study. Two-parallel groups are defined in each dose level.
A total of 600 patients wil
Group 1a: 200 patients will receive masitinib at 4.5 mg/kg/day
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Group 1b: 200 patients will receive masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after three months of treatment
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Group 2a: 100 patients will receive placebo at 4.5 mg/kg/day
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Group 2b: 100 patients will receive placebo at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after three months of treatment
Patients randomised in group 1b or group 2b will switch after thre
Sponsors
AB Science,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patient suffering from either primary progressive or secondary progressive multiple sclerosis without relapse within 2 years before inclusion according to the revised McDonald’s criteria 2. Patient with EDSS score of [2.0 to 6.0] inclusive at baseline 3. Patient who had an EDSS score progression ≥ 1 point within 2 years before inclusion 4. Patient with normal organ function defined as:  Absolute neutrophils count (ANC) ≥ 2 x 109/L  Hemoglobin ≥ 10 g/dL  Platelets (PTL) ≥ 100 x 109/L  AST/ALT ≤ 3 ULN  Bilirubin ≤ 1.5x ULN  Creatinine clearance > 60 mL/min (Cockcroft and Gault formula)  Albuminemia > 1 x LLN  Proteinuria 50 kg and BMI between 18 and 35 kg/m². 6. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. 7. Male patients must use medically acceptable methods of contraception if your female partner is pregnant, from the time of the first administration of the study drug until three months following administration of the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Patient suffering from a disease other than MS that would better explain the patient’s neurological clinical signs and symptoms and/or MRI lesions 2. Patient who had a major surgery within 2 weeks of study entry 3. Patient with life expectancy < 6 months 4. Patient with history of primary malignancy < 5 years, except treated basal cell skin cancer or cervical carcinoma in situ 5. Patient presenting with cardiac disorders defined by at least one of the following conditions:  Patient with recent cardiac history (within 6 months) of: - Acute coronary syndrome - Acute heart failure (class III or IV of the NYHA classification) - Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)  Patient with cardiac failure class III or IV of the NYHA classification  Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)  Syncope without known aetiology within 3 months  Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension 6. Patient with any severe and/or uncontrolled medical condition 7. Patient with a known diagnosis of human immunodeficiency virus (HIV) infection 8. Patient with known hepatitis B, hepatitis C or tuberculosis 9. Pregnant or nursing female
Countries
Chile, Colombia, Peru
Contacts
Public ContactAracely Galvez
GENEXION PERU S.A.C.
Outcome results
None listed