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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001433-39 | EudraCT Number |
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This study will evaluate the safety, pharmacokinetics, and efficacy of three different doses of NBI-921352 versus placebo in adults with focal onset seizures
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo schedule | Placebo Comparator | Participant follows Placebo schedule (13 weeks) |
|
| Dose schedule A | Experimental | Participant follows Dose schedule A (13 weeks) |
|
| Dose schedule B | Experimental | Participant follows Dose schedule B (13 weeks) |
|
| Dose schedule C | Experimental | Participant follows Dose schedule C (13 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-921352 | Drug | Tablets for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Serious Treatment-emergent Adverse Events (TEAEs), TEAEs Leading to Discontinuation of Study Treatment, and Fatal TEAEs | Through Week 15 | |
| NBI-921352 exposure-efficacy response relationship, defined as the slope of the relationship between reduction in monthly focal onset seizure frequency and plasma concentration at steady state | Baseline to Week 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Treatment Period | Baseline and Weeks 1 to 11 | |
| Percent Change from Baseline in Monthly Focal Onset Seizure Frequency During the Maintenance period | Baseline and Weeks 4 to 11 |
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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 | Randwick | New South Wales | 2031 | Australia | ||
| Neurocrine Clinical Site |
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| Placebo | Drug | Matching placebo tablets for oral administration |
|
| Clinical Global Impression of Change (CGIC) Scores at Week 11 | Week 11 |
| Percentage of Participants with a ≥ 50% reduction in monthly (28 days) focal onset seizure frequency during the treatment period | Baseline and Weeks 1 to 11 |
| Ivanhoe |
| Victoria |
| 3079 |
| Australia |
| Neurocrine Clinical Site | Melbourne | Victoria | 3065 | Australia |
| Neurocrine Clinical Site | Parkville | Victoria | 3050 | Australia |
| Neurocrine Clinical Site | Prahran | Victoria | 3181 | Australia |
| Neurocrine Clinical Site | Brussels | 1070 | Belgium |
| Neurocrine Clinical Site | Ghent | 9000 | Belgium |
| Neurocrine Clinical Site | Leuven | 3000 | Belgium |
| Neurocrine Clinical Site | Brno | 656 91 | Czechia |
| Neurocrine Clinical Site | Ostrava | 708 52 | Czechia |
| Neurocrine Clinical Site | Prague | 150 06 | Czechia |
| Neurocrine Clinical Site | Prague | 160 00 | Czechia |
| Neurocrine Clinical Site | Prague | 186 00 | Czechia |
| Neurocrine Clinical Site | Rychnov nad Kněžnou | 516 01 | Czechia |
| Neurocrine Clinical Site | Bron | 69677 | France |
| Neurocrine Clinical Site | Lille | 59037 | France |
| Neurocrine Clinical Site | Rennes | 35033 | France |
| Neurocrine Clinical Site | Toulouse | 31059 | France |
| Neurocrine Clinical Site | Budapest | 1145 | Hungary |
| Neurocrine Clinical Site | Debrecen | 4032 | 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 | 08035 | 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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