Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Olesoxime · 6 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
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. |
| 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...
Olesoxime is an investigational small molecule being studied for neurological conditions, including chemotherapy-induced peripheral neuropathy, amyotrophic lateral sclerosis, spinal muscular atrophy type II, and relapsing remitting multiple sclerosis. It has also been evaluated in healthy volunteers for pharmacokinetic studies.
Olesoxime is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is a small molecule in the neurology therapeutic area.
Olesoxime is in Phase 3 clinical development. It is investigational and not yet approved. Clinical trials have been conducted in Phase 1 and Phase 2 as well, with one completed Phase 3 trial.
Olesoxime has been studied in several completed trials, including NCT00876538 for chemotherapy-induced peripheral neuropathy, NCT01808885 for relapsing remitting multiple sclerosis, NCT02628743 for spinal muscular atrophy, and NCT02835976 in healthy volunteers.
Yes, Olesoxime is also known as TRO19622. Clinical trial records refer to the drug by both names, such as in NCT00876538, which studies the effect of TRO19622 in chemotherapy-induced peripheral neuropathy.