SPN-817 Open-Label Extension Study in Adults With Focal Onset Seizures
NCT07141329 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-10-10
Summary
This is a Phase 2b open-label extension study to evaluate the long-term safety and efficacy of SPN-817.
Conditions
Interventions
- DRUG
-
SPN-817
SPN-817 starting at 0.25 mg bid up to 4.00 mg bid
Sponsors & Collaborators
-
Supernus Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Maciej Gasior, MD, PhD · Supernus Pharmaceuticals, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-30
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Open-label Extension to Protocol 1042-0600
NCT00512317 ·Status: COMPLETED ·Phase: PHASE2
-
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
NCT01118962 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures
NCT05533814 ·Status: COMPLETED ·Phase: PHASE4
-
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
NCT06453213 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
An Open-Label Extension Study of the Safety and Tolerability of Carisbamate as Add-On Therapy in Patients With Partial Onset Seizures
NCT00744731 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
NCT05067634 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures
NCT06590896 ·Status: RECRUITING ·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
-
Prospective Open-label Evaluation of Cenobamate Adjunctive Treatment of Adults With Refractory Focal Epilepsy
NCT04879433 ·Status: UNKNOWN
-
Safety and Tolerability of OXC XR as Adjunctive Therapy in Subjects With Refractory Partial Epilepsy
NCT00908349 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
NCT00772603 ·Status: COMPLETED ·Phase: PHASE3
-
Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures
NCT01261325 ·Status: COMPLETED ·Phase: PHASE3
-
Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS
NCT04557085 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study of the Efficacy and Safety of RWJ-333369 as add-on Therapy in the Treatment of Partial Onset Seizures.
NCT00425282 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
NCT06132893 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
NCT02535091 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
NCT01529034 ·Status: TERMINATED ·Phase: PHASE3
-
Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
NCT06309966 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
NCT05301894 ·Status: TERMINATED ·Phase: PHASE2
-
A Study of GWP42006 in People With Focal Seizures - Part A
NCT02369471 ·Status: COMPLETED ·Phase: PHASE2
-
An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
NCT02625090 ·Status: TERMINATED ·Phase: PHASE2
-
An Open-Label Extension Study to Evaluate the Safety and Effectiveness of RWJ 333369 in Patients With Epilepsy
NCT00210652 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures
NCT01191086 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Investigating the Anti-epileptic Efficacy of Afinitor (Everolimus) in Patients With Refractory Seizures Who Have Focal Cortical Dysplasia Type II (FCD II)
NCT03198949 ·Status: COMPLETED ·Phase: PHASE2