NCT05226780

Extension Study to Evaluate How Safe and Tolerable NBI-921352 is as an Adjunctive Therapy for Participants With SCN8A-DEE

A Prospective, Long-Term, Interventional, Active Extension Study to Evaluate the Safety and Tolerability of NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 2 Years – 22 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	NBI-921352	Administered orally

Timeline

• Start date: 2022-07-12
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-02-07
• Last updated: 2025-07-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study