AVC et masitinib

Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 21 January 2013
Main ID: EUCTR2010-020603-79-ES
Date of registration: 22/10/2012
Primary sponsor: AB Science
Public title: Evaluation of masitinib in acute ischemic stroke
Scientific title: A prospective, multicentre, randomized, double-blind, placebo-controlled, 2-parallel groups, phase 2 study to evaluate efficacy and safety of 12 weeks treatment with masitinib versus placebo in patients with acute ischemic stroke receiving stroke unit care with or without rt-PA therapy - not applicable
Date of first enrolment: 21/12/2012
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:20 10-020603-79
Study type: Interventional clinical trial of medicinal product
Study design: Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3

Countries of recruitment
Spain
Contacts
Name: Alain Moussy
Address: 3 avanue George V 75008 Paris France
Telephone: 0033 1 47 20 30 08
Email: alain.moussy@ab-science.com
Affiliation: ABScience
Name: Alain Moussy
Address: 3 avanue George V 75008 Paris France
Telephone: 0033 1 47 20 30 08
Email: alain.moussy@ab-science.com
Affiliation: ABScience
Key inclusion & exclusion 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 < 1.
6. Patient fully conscious
7. Patient functionally independent before the stroke (Barthel Index score = 100)
8. Patient whose weight ? 49,9 kg and BMI > 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 < 30 mg/dL. In case of dipstick proteinuria ? 30 mg/dL, 24 hours proteinuria < 1.5g/24 hours.
10. 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
11. Patient able and willing to comply with study procedures as per protocol
12. Patient or her/his representative able to understand, sign, and date the written informed consent form at baseline visit prior to any protocol-specific procedures
13. Patient affiliated to a social security system
14. Patient /representative able to understand the patient card and to follow the patient card procedures in caseof sign or syptoms of severe neutropenia or severe cutaneous toxicity , during the first two months of treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
patients suffering from Acute Ischemic Stroke
MedDRA version: 14.1 Level: LLT Classification code 10023027 Term: Ischaemic stroke NOS System Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

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 descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
INN or Proposed INN: Masitinib mesylate
CAS Number: 790-299-79-5
Current Sponsor code: AB1010
Other descriptive name: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)
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
Primary end point(s): ?Modified Rankin Scale score at week 12 defining success as score value 0-1.
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
Timepoint(s) of evaluation of this end point: week 12
Secondary Outcome(s)
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
Secondary ID(s)
AB08004
Source(s) of Monetary Support