Evaluation of masitinib in acute ischemic stroke

Phase 1

• Conditions: patients suffering from Acute Ischemic Stroke; MedDRA version: 18.1Level: LLTClassification code 10023027Term: Ischaemic stroke NOSSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020603-79-SK
• Lead Sponsor: AB Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-05
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1.Male or female patient age 18 to 75 years old
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 / representative 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.
4.Patient with symptom onset of = 12 hours before the start of treatment and symptoms present for = 1 hour
5.Patient with NIHSS score = 8 with at least 2 points from section 5 and 6 (motor)
6.Patient with pre-stroke Modified Ranking Scale < 1
7.Patient fully conscious
8.Patient functionally independent before the stroke (Barthel Index score = 100)
9.Patient weighing more than 50 kg and with a Body Mass Index (BMI) between 18 and 35 kg/m²
10.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 = 3x ULN
•Bilirubin = 1.5x ULN
•Creatinin clearance > 60 mL/min (Cockcroft and Gault formula)
•Albuminemia >1 x LLN
•Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is = +1 on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours.
11.twoFemale 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
12.Male patients must use medically acceptable methods of contraception if his 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. 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
13.Patient able and willing to comply with study procedures as per protocol
14.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
15.Patient affiliated to a social security regimen

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified