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).

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

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004393-62-ES

Enrollment

Registered

2022-01-17

Start date

2022-03-18

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8ADEE) MedDRA version: 20.0 Level: PT Classification code 10077380 Term: Epileptic encephalopathy System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: NBI-921352 Pharmaceutical Form: Granules INN or Proposed INN: NBI-921352 Current Sponsor code: NBI-921352 Concentration unit: mg milligram(s) Concentration type: equal Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Females who are pregnant or currently breastfeeding. 2.Have developed any other disorder for which the treatment takes priority over treatment ofSCN8A-DEE or is likely to interfere with study treatment or impair treatment compliance. 3.The subject or subject’s parent/caregiver is, in the investigator’s opinion, unlikely to comply with the protocol, including the requirement to travel to the study sites for study visits, or is unsuitable for any reason. 4.Have received any other investigational drug within 30 days or 5 half-lives (if known),whichever is longer, of Day -1 or plan to use an investigational drug (other than the study treatment) during the study.

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Percentage change from baseline in 28-day seizure frequency for countable motorseizures during the Treatment Period of the study at Weeks 5, 30, 54, 78, and 104.;Timepoint(s) of evaluation of this end point: Treatment period	—

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety and tolerability of NBI-921352 when administered for up to 106 weeks.;Secondary Objective: To investigate the effect of NBI-921352 on long-term seizure control.;Primary end point(s): •The subject incidence of serious TEAEs, TEAEs leading to discontinuation of studytreatment, and fatal TEAEs.;Timepoint(s) of evaluation of this end point: Treatment period : Day 1 to Week 106.	—

Measure

Time frame

Main Objective: To evaluate the long-term safety and tolerability of NBI-921352 when administered for up to 106 weeks.;Secondary Objective: To investigate the effect of NBI-921352 on long-term seizure control.;Primary end point(s): •The subject incidence of serious TEAEs, TEAEs leading to discontinuation of studytreatment, and fatal TEAEs.;Timepoint(s) of evaluation of this end point: Treatment period : Day 1 to Week 106.

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Countries

Australia, Belgium, Canada, Czechia, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom, United States

Contacts

Public ContactMedical Information Call Center

Neurocrine Biosciences, Inc.

medinfo@neurocrine.com+34653249484

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026