NCT04873869

Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the efficacy, safety, and pharmacokinetics of NBI-921352 as adjunctive therapy for seizures in subjects 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
DRUG	Placebo	Administered orally

Timeline

• Start date: 2022-01-31
• Primary completion: 2023-03-17
• Completion: 2023-03-17
• First posted: 2021-05-05
• Last updated: 2025-10-16
• Results posted: 2025-10-16

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study