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

Not Applicable

• Conditions: -G35 Multiple sclerosis; Multiple sclerosis; G35

• Registration Number: PER-003-16
• Lead Sponsor: AB Science,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 0

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 < 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. 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified