Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TRI476 · 1 trial · 1 indication
Percent change in partial onset seizure frequency per 28 days during the double-blind phase from the screening phase, was calculated according to the following formula: "Percent change in partial onset seizure frequency per 28 days from the screening phase" = (partial onset seizure frequency per 28 days during the double-blind phase - partial onset seizure frequency per 28 days during the screening phase) / partial onset seizure frequency per 28 days during the double-blind phase x 100 "Partial onset seizure frequency per 28 days" = Number of partial onset seizures during each phase (screening phase or double-blind phase) / number of days during the screening or double-blind phase × 28.
| Arm | Type | Description |
|---|---|---|
| TRI476 | EXPERIMENTAL | Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage. |
| Name | Type | Description |
|---|---|---|
| TRI476 | DRUG | TRI476 oral suspension doses, based on body weight twice daily |
| Placebo to TRI476 | DRUG | Placebo oral suspension, taken twice daily |
| Benzodiazepines | DRUG | Benzodiazepines could be used as needed as rescue medication during the duration of the study. |
Inclusion Criteria: * Male and female outpatients, aged 4 to 14 years (inclusive), with a minimum body weight of 15 kg. * A diagnosis of partial onset seizures, which include the seizure subtypes of simple, complex, and secondarily generalized seizures (based on the International League Against Epi...
TRI476 is an investigational small molecule being developed for the treatment of partial onset seizures. It is being studied in children aged 4 years and older with inadequately controlled partial onset seizures. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
TRI476 is being developed by Novartis AG, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical trials to evaluate the efficacy, safety, and tolerability of TRI476 in pediatric patients with partial onset seizures.
TRI476 is currently in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not received approval from regulatory agencies for any indication.
TRI476 has one completed clinical trial registered under NCT00975715, titled 'Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures.' This Phase 2 study enrolled 99 participants in Japan and was randomized, double-blind, and placebo-controlled.
TRI476 is also known as oxcarbazepine, as indicated in the clinical trial title. The study NCT00975715 evaluates TRI476, which is referred to as oxcarbazepine in the trial name. This suggests that TRI476 is an alternative name for the drug oxcarbazepine, which is being investigated for partial onset seizures in children.