A controlled clinical study to investigate the effectiveness and safety of the medicine called masitinib when used together with a currently available medicine Riluzole when treating the illness called Amyotrophic Lateral Sclerosis (ALS)
- Conditions
- Amyotrophic lateral SclerosisMedDRA version: 18.0Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 18.0Level: PTClassification code 10028003Term: Motor neurone diseaseSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-024423-24-IE
- Lead Sponsor
- AB Science
- 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 (body mass index) 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. Male and 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 (with failure rate < 1%) during the study and for 3 months after the last treatment intake. Acceptable forms of contraception include:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: ?
o oral
o intravaginal
o transferral
- progestogen-only hormonal contraception associated with inhibition of ovulation:
o oral
o inject able hormonal contraception
o implantable hormonal contraception
- placement of an intrauterine device (IUD)
- placement of an intrauterine hormone-releasing system ( IUS)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence
10. Female patient of childbearing potential must have a negative pregnancy test at screening and baseline
11. Patient able and willing to comply with study procedures as per protocol
12. Patient able to understand, and willing to sign, and date the written informed consent form at screening visit prior to any protocol-specific procedures
13. Patient able to understand, and willing to follow the safety procedures mentioned on the patient card in case of signs or symptoms 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 331
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
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 active 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