An Open-Label Safety Extension Study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.
- Conditions
- Amyotrophic Lateral Sclerosis.MedDRA version: 12.1Level: LLTClassification code 10052889Term: ALS
- Registration Number
- EUCTR2010-021179-10-DE
- Lead Sponsor
- TROPHOS SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Patients must have completed the 18-month safety and efficacy study of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole (Protocol TRO19622 CL E Q 1015-1).
- Both the investigator and the patient will decide based on previous good tolerance and other clinical grounds whether or not to participate to the open-label extension.
- If patients were on anti-vitamin K during the double-blind period, when entering theopen-label extension, coagulation tests should be monitored in exactly the same conditions as if a new anticoagulant treatment was initiated and the dose of anti-vitamin K should be adjusted accordingly.
- Patients enrolling from this prior safety and efficacy study must:
- If female of childbearing age of potential, continue to use adequate birth control
methods and have a negative serum pregnancy test at the preceding double-blind
protocol termination visit,
- Be able to follow the investigator’s instructions and be able to comply with the
visit schedule and visit requirements; and
- Sign a written informed consent.
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
Patients may not participate in this study if they have an ongoing, unresolved, clinically significant medical problem (including patients having experienced serious adverse events or non-serious, but medically significant adverse events during the preceding safety and efficacy study that was assessed to be related to the study medication by the investigator) that in the judgment of the investigator would make it unsafe for the patient to participate in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: The secondary outcome measures will be:<br>• Survival time<br>• Total score of the 48-point ALS Functional Rating Scale Revised<br>• Slow Vital capacity (SVC) as a percentage of predicted SVC only if the SVC is performed by the site in a routine-way during standard ALS visit. This test will not be<br>performed for the sole purpose of the study;Main Objective: To allow patients to be treated by olesoxime (TRO19622) in an open label safety extension following their participation to a randomised study and to provide additional safety data on olesoxime (TRO19622).;Primary end point(s): The primary outcome measure will be the safety assessment. The safety criteria will be:<br>• Occurrence of AEs,<br>• Physical examination,<br>• Laboratory tests,<br>• Vital signs and ECG,
- Secondary Outcome Measures
Name Time Method