Amyotrophic Lateral Sclerosis. MedDRA version: 12.1 Level: LLT Classification code 10052889 Term: ALS
Conditions
Interventions
Product Name: olesoxime
Product Code: TRO19622
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: olesoxime
CAS Number: 2203-87-0
Current Sponsor code: TRO19622
Other descriptive name: 4-choleste
Sponsors
TROPHOS SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary outcome measures will be: • Survival time • Total score of the 48-point ALS Functional Rating Scale Revised • 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 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: • Occurrence of AEs, • Physical examination, • Laboratory tests, • Vital signs and ECG, | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed