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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-004393-62 | EudraCT Number |
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This study was prematurely terminated due to sponsor decision.
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Extension study to evaluate how safe and tolerable the drug NBI-921352 is when used as adjunctive therapy in participants with SCN8A developmental and epileptic encephalopathy syndrome (SCN8A-DEE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NBI-921352 | Experimental | NBI-921352 administered for up to 164 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI-921352 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Serious treatment-emergent adverse events (TEAEs), TEAEs Leading to Discontinuation and Fatal TEAEs | Day 1 to Week 168 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change from Baseline in 28-day Seizure Frequency for Countable Motor Seizures | Baseline, up to Week 162 |
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Key Inclusion Criteria:
For Participants Who Participated in NBI-921352-DEE2012:
For Participants Who did not Participate in NBI-921352-DEE2012:
Key Exclusion Criteria
For Participants Who Participated in NBI-921352-DEE2012:
- Have developed any other disorder for which the treatment takes priority over treatment of SCN8A-DEE or is likely to interfere with study treatment or impair treatment compliance.
For Participants Who did not Participate in NBI-921352-DEE2012:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Lead | Neurocrine Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Medical Center | San Francisco | California | 94143 | United States | ||
| Children's National Hospital |
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| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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