Evaluation of masitinib in Amyotrophic Lateral Sclerosis (ALS)
- Conditions
- patients suffering from Amyotrophic Lateral Sclerosis (ALS)MedDRA version: 20.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-024423-24-SK
- Lead Sponsor
- ABScience
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 381
1.Female or male patient aged between 18 and 75 years of age, with a weight > 50 kg and BMI between 18 and 35 kg/m².
2.Familial or sporadic ALS
3.Patient diagnosed with laboratory supported, clinically probable or definite ALS according to the World Federation of Neurology Revised El Escorial criteria (Brooks, 1994)
4.Disease duration from symptoms onset no longer than 36 months at the screening visit
5.Patient treated with a stable dose of riluzole (100 mg/day) for at least 30 days prior to screening
6.Patient with a FVC (Forced Vital Capacity) equal to or more than 60% predicted normal value for gender, height, and age at the screening visit
7.Patient with life expectancy = 6 months
8.Patient with adequate organ function at screening and baseline:
•Absolute Neutrophils Count (ANC) = 2 x 109/L
•Hemoglobin = 10 g/dL
•Platelets (PTL) = 100 x 109/L
•AST/ALT = 3 ULN
•Bilirubin = 1.5 ULN
•Albuminemia > 1 x LLN
•Creatinine clearance > 60 mL/min (Cockcroft and Gault formula)
•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
9.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. Acceptable forms of contraception include:
•A documented placement of an intrauterine device (hormonal/copper) and the use of a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository)
•Documented tubal ligation (female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository) should also be used
•Barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
•and any other contraceptive method with a documented failure rate of <1% per year
•Abstinence only when this is in line with the preferred and usual lifestyle of the subject.
10.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. Acceptable methods include:
• Condom;
•If you have undergone surgical sterilization (vasectomy with documentation of azoospermia) a condom should also be used.
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. The acceptable methods of contraception are as follows:
•Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
•Surgical sterilization (vasectomy with documentation of azoospermia) and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository);
•Your female partner uses oral contraceptives (combination oestrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foa
EXCLUSION CRITERIA
1.Patient with history of hematologic, hepatic, respiratory disorder that is clinically significant for his/her participation in the study
2.Patient who underwent tracheotomy and /or gastrostomy
3.Patient with a diagnosis of cancer or evidence of continued disease within five years before starting study treatment
4.Patient with significant sensory abnormalities, dementia, other neurologic diseases, uncompensated medical illness and psychiatric illness
5.Patient who have participated in a clinical trial within 3 months prior to screening
6.Pregnant, or nursing female patient
7.Patient with a known diagnosis of human immunodeficiency virus (HIV) infection
8.Patient with known hepatitis B, hepatitis C or tuberculosis
9.Patient with any severe and/or uncontrolled medical condition
10.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 (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
11.Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
PREVIOUS TREATMENTS WASH OUT
12.Patient treated with any investigational agent within 3 months prior to screening
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method