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Label indication Oxtellar XR is indicated for the treatment of partial-onset seizures in patients 6 years of age and older. Oxtellar XR® is indicated for the treatment of partial-onset seizures in patients 6 years of age and older. ( 1 ) FDA label
Also known as oxcarbazepine extended-release, OXC XR, Oxtellar XR, Oxcarbazepine XR
SPN-804O · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SPN-804O 150mg/Day | EXPERIMENTAL | Subjects who weighed 15.0 to 29.9 kg dosed with SPN-804O 150mg/Day |
| SPN-8040 300mg/Day | EXPERIMENTAL | Subjects who weighed 30.0 to 44.9 kg dosed with SPN-8040 300mg/Day |
| SPN-8040 450mg/Day | EXPERIMENTAL | Subjects who weighed 45.0 to 59.9 kg dosed with SPN-8040 450mg/Day |
| SPN-8040 600mg/Day | EXPERIMENTAL | Subjects who weighed 60.0 kg and above dosed with SPN-8040 600mg/Day |
| Name | Type | Description |
|---|---|---|
| SPN-804O | DRUG | Open Label study |
Inclusion Criteria: 1. Able to provide written informed assent (IAF), as appropriate, with written informed permission (and informed consent (ICF) where required by regional laws or regulations) from the parent or legally-authorized representative (LAR). 2. Male or female aged 4 to 17 years, inclus...
SPN-804O is an investigational small molecule being developed for the treatment of partial epilepsies. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients.
SPN-804O is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN. The company is conducting clinical research to evaluate the drug's potential as a treatment for partial epilepsies.
SPN-804O is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing for partial epilepsies.
SPN-804O has one completed Phase 1 clinical trial, identified as NCT00918047. This study evaluated the pharmacokinetics and safety of oxcarbazepine extended release as adjunctive therapy in pediatric epilepsy patients with partial epilepsies. The trial enrolled 18 participants in the United States.
SPN-804O is a small molecule developed for the treatment of partial epilepsies. The specific molecular target or mechanism of action has not been disclosed in available information, so its precise pharmacological action is not detailed here.