patients suffering from Acute Ischemic Stroke MedDRA version: 14.1 Level: LLT Classification code 10023027 Term: Ischaemic stroke NOS System Organ Class: 100000004852
Conditions
Interventions
Product Name: masitinib
Product Code: AB1010 tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descrip
Sponsors
AB Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male of female patient, age ? 18 years 2. Patient with a clinical diagnosis of acute stroke consistent with acute hemispheric cerebral infarction including hemiparesis and/ or hemiplegia involving the arm, leg, or both 3. Patient with symptom onset of ? 12 hours before the start of treatment and symptoms present for ? 1 hour 4. Patient with NIHSS score ? 8 with at least 2 points from section 5 and 6 (motor) 5. Patient with pre stroke Modified Rankin Scale 18 at the time of informed consent signature 9. Patient with adequate organ functions defined as: ? Absolute neutrophil count (ANC) ? 2.0 x 109/L, ? Hemoglobin ? 10g/dL ? Platelets (PTL) ? 100 x 109/L ? AST/ALT ? 2.5x ULN ? Bilirubin ? 1.5x ULN ? Creatinin clearance > 60 mL/min (Cockcroft and Gault formula) ? Albumin > 1x LLN ? Urea ? 1.5 x ULN ? Dipstick proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Patient with a clinical diagnosis of acute stroke consistent with intracerebral hemorrhage 2. Patient inability to swallow study treatment tablets (tablets cannot be crushed, chewed or divided). 3. Patient with neurological sequellae from previous illness 4. Patient having 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 (atrioventricular 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 5. Patient with severe concurrent illness and/or with life expectancy < 6 months 6. Patient with history of primary malignancy < 5 years, except treated basal cell skin cancer or cervical carcinoma in situ 7. Patient with a known diagnosis of human immunodeficiency virus (HIV) infection 8. Pregant or nursing female 9. Patient with history of poor compliance or history of drug/alcohol abuse, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to compare efficacy and safety of masitinib versus placebo in patients with acute ischemic stroke receiving stroke unit care with or without rt-PA therapy;Secondary Objective: Secondary endpoints · Neurological deficit measured by National Institute of Health Stroke Scale (NIHSS) score at Hour 2, Hour 24, Week 2, Week 4, Week 8 and Week 12 · Modified Rankin Scale score at Week 2 defining success as score value 0-1 · Barthel Index measure of activity of daily living at Week 2 and 12 · Volume of cerebral infarction measured by MRI at baseline, Week 2 and Week 12 · Hemorrhage rate secondary to rt-PA treatment measured by MRI at H24 · Recanalization rate on patients with documented arterial occlusion during W0-W12 period · Survival Rate at Week 12 · Stroke Specific Quality of Life Scale (SS-QOL) score at Week 1, Week 2, Week 4, Week 8 and Week 12 Safety endpoints Adverse events (AEs), laboratory assessments (biochemistry, haematology and urinalysis), physical examination, vital signs and ECGs;Primary end point(s): ?Modified Rankin Scale score at week 12 defining success as score value 0-1.;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints · Neurological deficit measured by National Institute of Health Stroke Scale (NIHSS) score at Hour 2, Hour 24, Week 2, Week 4, Week 8 and Week 12 · Modified Rankin Scale score at Week 2 defining success as score value 0-1 · Barthel Index measure of activity of daily living at Week 2 and 12 · Volume of cerebral infarction measured by MRI at baseline, Week 2 and Week 12 · Hemorrhage rate secondary to rt-PA treatment measured by MRI at H24 · Recanalization rate on patients with documented arterial occlusion during W0-W12 period · Survival Rate at Week 12 · Stroke Specific Quality of Life Scale (SS-QOL) score at Week 1, Week 2, Week 4, Week 8 and Week 12 Safety endpoints Adverse events (AEs), laboratory assessments (biochemistry, haematology and urinalysis), physical examination, vital signs and ECGs;Timepoint(s) of evaluation of this end point: Hour 2, Hour 24, Week 2, Week 4, Week 8 and Week 12 | — |
Countries
Spain
Contacts
Public ContactAlain Moussy
ABScience
Outcome results
None listed