Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEE
NCT05226780 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-07-17
Summary
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).
Conditions
- SCN8A Developmental and Epileptic Encephalopathy Syndrome
Interventions
- DRUG
-
NBI-921352
Administered orally
Sponsors & Collaborators
-
Neurocrine Biosciences
lead INDUSTRY
Principal Investigators
-
Clinical Development Lead · Neurocrine Biosciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-12
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
NCT05364021 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy.
NCT00422422 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
NCT04715646 ·Status: RECRUITING ·Phase: PHASE3
-
A Clinical Trial of PRAX-562 in Subjects With Developmental and Epileptic Encephalopathies (DEE)
NCT05818553 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
NCT05109234 ·Status: COMPLETED ·Phase: PHASE3
-
Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy
NCT05626634 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
NCT06315322 ·Status: RECRUITING ·Phase: PHASE3
-
A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
NCT04666610 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
NCT04639310 ·Status: TERMINATED ·Phase: PHASE3
-
Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
NCT01364597 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Investigate LP352 in Children and Adults With Developmental and Epileptic Encephalopathy (DEE)
NCT06908226 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE3
-
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic Seizures
NCT06425159 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
A Clinical Trial of Elsunersen in Pediatric SCN2A-DEE to Assess Efficacy and Safety
NCT07019922 ·Status: RECRUITING ·Phase: PHASE3
-
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
NCT00150800 ·Status: COMPLETED ·Phase: PHASE3
-
Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies
NCT02239276 ·Status: NO_LONGER_AVAILABLE
-
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
NCT04912856 ·Status: TERMINATED ·Phase: PHASE3
-
A Prospective, Remote Observational Study in Pediatric Participants With Early-Onset SCN2A-Developmental and Epileptic Encephalopathy
NCT05407727 ·Status: COMPLETED
-
Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy Subjects
NCT00918424 ·Status: APPROVED_FOR_MARKETING
-
BMB-101 in Absence Epilepsy and DEE
NCT06401538 ·Status: RECRUITING ·Phase: PHASE2
-
An Open-Label Extension Study of STK-001 for Patients With Dravet Syndrome
NCT04740476 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies
NCT03166215 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
NCT06132893 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
An Open-label Extension Trial of CVL-865 as Adjunctive Therapy in the Treatment of Focal Onset Seizures
NCT04686786 ·Status: TERMINATED ·Phase: PHASE2
-
Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients
NCT00918047 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial for Participants With DEE to Assess Efficacy, Safety, Tolerability, and PK of Relutrigine
NCT07010471 ·Status: RECRUITING ·Phase: PHASE3