Approval Probability
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Adjusted LOA
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Also known as olesoxime (TRO19622), TRO19622
olesoxime · 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...
Olesoxime is an investigational small molecule developed by Roche Holding AG (ticker RHHBY) for neurological conditions. It has been studied in amyotrophic lateral sclerosis, chemotherapy-induced peripheral neuropathy, spinal muscular atrophy, and relapsing remitting multiple sclerosis. It is not approved and remains in clinical development.
Olesoxime has been studied for amyotrophic lateral sclerosis, chemotherapy-induced peripheral neuropathy, spinal muscular atrophy, and relapsing remitting multiple sclerosis. It is an investigational therapy and has not been approved for any indication. All clinical trials of olesoxime listed to date are completed.
Olesoxime is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical development program for olesoxime across neurological indications including spinal muscular atrophy and multiple sclerosis.
Olesoxime is in Phase 3 development. The overall program includes completed Phase 1 and Phase 2 trials, and the drug has not been approved by the FDA or any regulatory agency. It remains an investigational therapy for the neurological conditions studied.
Olesoxime has been evaluated in completed trials including NCT02628743, a Phase 2 long-term safety and effectiveness study in spinal muscular atrophy; NCT01302600, a Phase 2 safety and efficacy study in SMA patients aged 3 to 25; NCT01808885, a Phase 1 safety study in relapsing remitting multiple sclerosis; and NCT00876538, a Phase 2 study in chemotherapy-induced peripheral neuropathy.
Yes, olesoxime is also known as TRO19622. Both names refer to the same investigational small molecule developed by Roche Holding AG. The alternative designation TRO19622 appears in older trial records and publications.