Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole. - Safety and efficacy of TRO19622 in ALS Patients treated with riluzole.
- Conditions
- Disease under investigation : Amyotrophic lateral SclerosisMedDRA version: 9.1 Level: LLT Classification code 10002026 Term: Amyotrophic lateral Sclerosis
- Registration Number
- EUCTR2008-007320-25-GB
- Lead Sponsor
- TROPHOS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 512
Inclusion criteria
1-Patients with sporadic or familial Amyotrophic Lateral Sclerosis
2- Patients with a clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to the modified El Escorial criteria.
3-Have signed an informed consent form to participate to the trial before any study related procedure has taken place.
4-Are aged > 18 and < 80 years.
5-If a female, not lactating, has a negative pregnancy test and agrees to use an effective method of birth control.
6-Onset of ALS Symptoms (weakness) for more than 6 months and less than 36 months.
7-Have slow vital capacity (SVC) , concordant after 3 measures, >70% of that predicted.
8-Are treated with Riluzole at the stable dose of 50 mg bid for at least 30 days before enrolment.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria
1. Tracheostomy, invasive ventilation, or non invasive positive pressure ventilation (NIPPV).
2. Gastrostomy.
3. Evidence of major psychiatric disorder or clinically evident dementia.
4. Diagnosis of a neurodegenerative disease in addition to ALS.
5. Have a current medication that could interfere with TRO19622 pharmacokinetics: tamoxifene
6. Have current medications that could interfere with TRO19622 absorption such as ezetimibe,bile salts chelators,
fibrates, phytosterols, fish oils. Have a current medication of lipid lowering agents other than statins.
7. Known hypersensitivity to any component of the study drug.
8. Patients with known intolerance or contra-indication to riluzole.
9. Have a recent history (within the previous 6 months) or current evidence of alcohol or drug abuse.
10. Have concurrent unstable disease involving any system eg, carcinoma other than basal cell carcinoma, any
cardiac dysrhythmia, myocardial infarction, clinical or ECG signs of myocardial ischemia, cardiac insufficiency,
angina symptoms, current symptoms of Coronary Artery Disease, or any other condition that in the opinion of
the Investigator would make the patient unsuitable for study participation.
11. Having a baseline QTc (Bazett) > 450 msec.
12. Patients with known hepatitis B/C or HIV positive serology.
13. Be pregnant female or lactating.
14. Have renal impairment defined as blood creatinine > 1,5 x upper limit of normal.
15. Have hepatic impairment and/or liver enzymes (ALT or AST) > 3x ULN.
16. Hemostasis disorders or current treatment with oral anticoagulants
17. Be possibly dependent on the Investigator or the Sponsor (eg, including, but not limited to, affiliated
employee).
18. Have participated or are participating in any other investigational drug or therapy study with a non approved medication, within the
previous 3 months.
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