A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis
- Conditions
- MSMultiple Sclerosis10007951
- Registration Number
- NL-OMON41963
- Lead Sponsor
- AB Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 13
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 < 30 mg/dL (1+) on dipstick; in case of the proteinuria *1+ on the dipstick 24 hours proteinuria must be < 1.5g/24 hours
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.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
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 < 6 months
4. Patient with history of primary malignancy < 5 years except treated basal cell skin cancer or cervical carcinoma
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 active hepatitis B, hepatitis C or tuberculosis
9. Pregnant or nursing female
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Multiple Sclerosis Functional Composite (MSFC) at week 96</p><br>
- Secondary Outcome Measures
Name Time Method