Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Olesoxime
TRO19622 · 7 trials · 7 indications
Overall survival was defined from the date of randomization until the date of death (event) or last known alive date (censored). If the death date was after 18 months, the participant was censored at 18 months (548 days). Participants still alive at or after 18 months were censored at 18 months/ 548 days. All data over the 18-month follow-up period after randomization, and participant survival status at the 18-month follow-up visit for participants who withdrew prematurely from the study for reasons other than death were included.
Motor function Measure (MFM) D1+D2 score
safety criteria will be: * Occurrence of AEs, * Physical examination, * Laboratory tests, * Vital signs and ECG,
Cumulative incidence of adverse events/serious adverse events (i.e. total number per patient) as assessed by ongoing monitoring.
| Arm | Type | Description |
|---|---|---|
| Olesoxime | EXPERIMENTAL | 2 Capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzole 50mg bid |
| Placebo Comparator | PLACEBO_COMPARATOR | 2 Capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid |
| Placebo | PLACEBO_COMPARATOR | 50 patients enrolled in this arm. liquid suspension |
| TRO19622 | EXPERIMENTAL | 2 capsules of TRO19622 (330mg) once day with the noon meal |
| Control | PLACEBO_COMPARATOR | 2 capsules of placebo once day with the noon meal |
| olesoxime (TRO19622) | EXPERIMENTAL | olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months. Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit). |
| Name | Type | Description |
|---|---|---|
| Olesoxime | DRUG | 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid |
| Placebo Comparator | DRUG | 2 capsules of Placebo once a day with the noon meal as add-on therapy to riluzole 50mg bid |
| Riluzole | DRUG | Riluzole given as add-on therapy 50mg bid |
| Placebo | DRUG | 0.1ml/kg once a day with food at dinner. |
| TRO19622 | DRUG | 2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid |
| Olesoxime (TRO19622) | DRUG | 2 capsules of TRO19622 (330 mg) once day with the noon meal |
| Placebo Control | DRUG | Placebo Control 2 capsules once day with the noon meal |
Inclusion Criteria: * Patients with sporadic or familial Amyotrophic Lateral Sclerosis * Patients with a clinical diagnosis of laboratory-supported probable, probable, or definite ALS according to the modified El Escorial criteria8. * Have signed an Informed Consent to participate to the trial befo...
TRO19622 is an investigational small molecule being studied for Non-Alcoholic Steatohepatitis (NASH) and Amyotrophic Lateral Sclerosis (ALS). It is developed by Roche Holding AG (ticker: RHHBY) and is currently in Phase 2 clinical development.
TRO19622 is a small molecule therapeutic being developed for neurological and metabolic conditions. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its effects in NASH and ALS.
TRO19622 is being developed by Roche Holding AG, a multinational healthcare company traded under the ticker RHHBY. The drug is currently in Phase 2 clinical trials for Non-Alcoholic Steatohepatitis and Amyotrophic Lateral Sclerosis.
TRO19622 is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Clinical trials have been completed for both Non-Alcoholic Steatohepatitis and Amyotrophic Lateral Sclerosis indications.
TRO19622 has completed two Phase 2 clinical trials. NCT00666016 assessed short-term effects on liver enzymes in 22 patients with NASH in France. NCT01285583 was a safety extension study in 271 ALS patients across Belgium, France, Germany, Spain, and the United Kingdom.
TRO19622 is the primary name used in clinical trial registrations. No alternative names have been documented in the available trial information. The drug is being studied under this identifier in Phase 2 trials for NASH and ALS.