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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004265-12 | EudraCT Number |
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The long-term extension study was terminated because the parent study NBI-921352-FOS2021 (NCT05159908) failed to meet its primary endpoint.
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This Phase 2, prospective, interventional, active extension study was designed to evaluate the long-term safety and tolerability of NBI-921352 as adjunctive therapy in adult participants with focal onset seizures who completed 11 weeks of treatment in randomized, double-blind, placebo-controlled Study NBI-921352-FOS2021. Eligible participants may enroll directly following the completion of the Week 11 study visit of Study NBI-921352-FOS2021 or after a gap following completion of that study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBI-921352 Treatment | Experimental | Treatment for up to 107 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-921352 | Drug | Tablets for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of serious treatment-emergent adverse events (TEAEs) | Through Week 111 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Lead | Neurocrine Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Fitzroy | 3065 | Australia | |||
| Neurocrine Clinical Site |
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For participants who enroll directly from Study NBI-921352-FOS2021, the study will include a Blinded Dose Conversion Period (1 week) before proceeding to the Open-Label Treatment Period.
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| Heidelberg |
| 3084 |
| Australia |
| Neurocrine Clinical Site | Melbourne | 3004 | Australia |
| Neurocrine Clinical Site | Brussels | 1070 | Belgium |
| Neurocrine Clinical Site | Ghent | 9000 | Belgium |
| Neurocrine Clinical Site | Leuven | 3000 | Belgium |
| Neurocrine Clinical Site | Brno | 65691 | Czechia |
| Neurocrine Clinical Site | Ostrava | 708 52 | Czechia |
| Neurocrine Clinical Site | Prague | 15006 | Czechia |
| Neurocrine Clinical Site | Prague | 16000 | Czechia |
| Neurocrine Clinical Site | Prague | 18600 | Czechia |
| Neurocrine Clinical Site | Rychnov nad Kněžnou | 51601 | Czechia |
| Neurocrine Clinical Site | Bron | 69677 | France |
| Neurocrine Clinical Site | Lille | 59037 | France |
| Neurocrine Clinical Site | Rennes | 35000 | France |
| Neurocrine Clinical Site | Toulouse | 31059 | France |
| Neurocrine Clinical Site | Budapest | 1145 | Hungary |
| Neurocrine Clinical Site | Budapest | 40320 | Hungary |
| Neurocrine Clinical Site | Pécs | 7623 | Hungary |
| Neurocrine Clinical Site | Bologna | 40139 | Italy |
| Neurocrine Clinical Site | Milan | 20133 | Italy |
| Neurocrine Clinical Site | Pavia | 27100 | Italy |
| Neurocrine Clinical Site | Barcelona | 8035 | Spain |
| Neurocrine Clinical Site | Madrid | 28034 | Spain |
| Neurocrine Clinical Site | Madrid | 28040 | Spain |
| Neurocrine Clinical Site | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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