This study is accepting new patients by invitation only

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

a study on Developmental and Epileptic Encephalopathy Epileptic Encephalopathy SCN8A Epilepsy Brain Diseases Epilepsy

Summary

Eligibility
for people ages 2 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

Extension Study to Evaluate how safe and tolerable the drug NBI-921352 is when used as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE).

Official Title

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)

Keywords

SCN8A Developmental and Epileptic Encephalopathy Syndrome, Epilepsy, Sodium channel, voltage-gated, type VIII, alpha subunit (SCN8A), NaV1.6 inhibitor, Brain Diseases, Syndrome, NBI-921352

Eligibility

You can join if…

Open to people ages 2 years and up

  1. Written or oral pediatric assent from the subject and written informed consent from the subject's parent(s) or legal guardian(s) for subjects<18 years of age and for subjects ≥18 years of age.
  2. Completed 16 weeks of treatment in Study NBI-921352-DEE2012.
  3. Continue to use a nocturnal alerting system or practice consistent with standards of care for the duration of the study.
  4. Have an adequate rescue medication regimen per the investigator's judgment in place for the duration of the study.

You CAN'T join if...

  1. 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.

Locations

  • UCSF Medical Center
    San Francisco California 94143 United States
  • Cook Children's Medical Center
    Fort Worth Texas 76104 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Neurocrine Biosciences
ID
NCT05226780
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 52 study participants
Last Updated