Health Condition 1: null- primary progressive or relapse-free secondary progressive multiple sclerosis
Conditions
Interventions
Intervention1: Masitinib: given orally at the dose of 4.5 mg/kg/day with possible dose adjustments twice a day
Control Intervention1: Placebo: given orally at the dose of 4.5 mg/kg/day with possible d
Sponsors
AB Science
Eligibility
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 McDonaldâ??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 - Bilirubin - Creatinine clearance > 60 mL/min (Cockcroft and Gault formula) - Albuminemia > 1 x LLN - Proteinuria =1+ on the dipstick 24 hours proteinuria must be 5. Male or female patient aged between 18 and 75 years old, with a weight > 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. 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. Acceptable forms of contraception include: - A documented placement of an intrauterine device (IUD)or intrauterine system and the use of a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository) - Documented tubal ligation (female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository) should also be used - Double barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository - Any other contraceptive method with a documented failure rate of - Abstinence only when this is in line with the preferred and usual lifestyle of the subject. 8. 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. Acceptable methods include: - Condom; - If you have undergone surgical sterilization (vasectomy with documentation of azoospermia) a condom should also be used. Male patients must 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. The acceptable methods of contraception are as follows: - Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; - Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository); - Your female partner uses oral contraceptives (combination oestrogen/progesterone pill
Exclusion criteria
Exclusion criteria: 1. Patient suffering from a disease other than MS that would better explain the patientâ??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 4. Patient with history of primary malignancy 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 10. Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent 11. Patient with any condition or concurrent medical events, including any clinically significant deviations from reference ranges in laboratory test, that on the opinion of the physician could be detrimental to the subjects 12. Patients requiring medication, which are prohibited in the current protocol, including corticosteroids used other than defined by the protocol, chemotherapies, immunomodulators or immunosuppressors, investigational drugs, live attenuated vaccines, drugs known to be at high risk of Stevens-Johnson syndrome. PREVIOUS TREATMENT WASH OUT 13. Previous treatment with immunomodulators and/or immunosuppressors treatments including azathioprine, cladribine, cyclophosphamide, cyclosporine, methotrexate, mitoxantrone, natalizumab, mycophenolate mofetil, hematopoietic stem cell transplantation, plasma exchange or total lymphoid irradiation within 24 weeks prior to baseline 14. Interferon, glatiramer acetate, IV infusion of immunoglobulins or monthly bolus IV corticosteroids within 12 weeks prior to baseline 15. Treatment with any oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH) within 4 weeks prior to baseline 16. Treatment with any investigational drug within 12 weeks prior to baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint for - Multiple Sclerosis Functional CompositeTimepoint: Week- 12, 24, 36, 48, 60, 72, 84 and 96 | — |
Secondary
| Measure | Time frame |
|---|---|
| Co-primary endpoints: - Multiple Sclerosis Functional Composite (MSFC) - Multiple Sclerosis Quality of Life 54 items (MSQOL-54) at 96 weeks in both MSQOL-54 composite scores for physical health and for mental health 60, Secondary endpoints: - Clinical assessment: - EDSS - Quality of Life assessment: MSQOL-54 - Timed 25-foot walk - Nine-hole peg test, right and left hands sides -PASAT 3 - Modified Fatigue Impact ScaleTimepoint: Week- 12, 24, 36, 48, 60, 72, 84 and 96 | — |
Countries
Argentina, France, Germany, Greece, India, Morocco, Poland, Romania, Slovakia, South Africa, Spain, Tunisia, Ukraine
Contacts
Public ContactJhansi Reddy
Maya Clinicals Drug Development Pvt. Ltd.
Outcome results
None listed