MS Multiple Sclerosis
Conditions
Interventions
* Group 1a: patients will receive masitinib at 4.5 mg/kg/day
* Group 1b: patients will receive masitinib at 4.5 mg/kg/day with a dose
escalation to 6 mg/kg/day after three months of treatment
* Group
Sponsors
AB Science
Eligibility
Age
18 Years to 64 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. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity, during the first 2 months of treatment. 7.Man and woman of childbearing potential (entering the study after a menstrual period, and who have a negative pregnancy test) must agree to use two 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. 8. Patient able and willing to comply with study procedures as per protocol 9. Patient able to understand, sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
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 Major surgery includes all work requiring a general anesthetic. Thus all operations which involve openings into the great cavities of the body; all operations in the course of which hazards of severe hemorrhage are possible; all conditions in which the life of the patient is at stake; all conditions which require for their relief manipulations or for the proper performance of which special anatomical knowledge and manipulative skill are essential. 3. Patient with life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Multiple Sclerosis Functional Composite (MSFC) at week 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| * MSFC at weeks 12, 24, 36, 48, 60, 72 and 84 * Timed 25-foot walk at weeks 12, 24, 36, 48, 60, 72, 84 and 96 * Nine-hole peg test, right and left hands sides (finger dexterity) at weeks 12, 24, 36, 48, 60, 72, 84 and 96 * PASAT 3 at weeks 12, 24, 36, 48, 60, 72, 84 and 96 * Walking speed at weeks 4, 8 and 12 * EDSS at weeks 12, 24, 36, 48, 60, 72, 84 and 96 * Modified Fatigue Impact Scale at weeks 12, 24, 36, 48, 60, 72, 84 and 96 * Hamilton Rating Scale for Depression at weeks 12, 24, 36, 48, 60, 72, 84 and 96 * Disability Impact Profile at weeks 12, 24, 36, 48, 60, 72, 84 and 96 * Health state Visual Analogue Scale (EQ-VAS) at weeks 12, 24, 36, 48, 60, 72, 84 and 96 * Quality of Life assessment: MSQOL-54 at weeks 12, 24, 36,48, 60, 72 and 84 * Quality of Life assessment: MSQOL-54 at week 96 for Marketing Authorization in the European market * Use of corticosteroids for MS * Number of hospitalizations for relapse * Clinical and biological safety profile: occurrence of Adverse Events, potential changes in vital signs, ECG, chest X-ray and biological parameters. | — |
Countries
Argentina, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Czechia, France, Germany, Greece, Hungary, India, Italy, Mexico, Morocco, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Tunisia, Ukraine, United States of America
Outcome results
None listed