Extension Study to Evaluate NBI-827104 in Pediatric Participants With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep (Steamboat 2)

Neurocrine Biosciences

Status and phase

Terminated

Phase 2

Conditions

Continuous Spike and Wave During Sleep

Epileptic Encephalopathy

Treatments

Drug: NBI-827104

Study type

Interventional

Funder types

Industry

Identifiers

NCT05301894

2021-006788-11 (EudraCT Number)

NBI-827104-CSWS2025

Details and patient eligibility

About

The primary objective for this study is to evaluate the long-term safety and tolerability of NBI-827104 in pediatric participants with epileptic encephalopathy with continuous spike-and-wave during sleep (EECSWS).

Full description

This study will enroll participants who completed treatment in the Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group Study NBI-827104-CSWS2010 (NCT04625101). Participants who did not participate in Study NBI-827104-CSWS2010 may also be eligible for enrollment.

Enrollment

19 patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:

Completed 12 weeks of treatment in Study NBI-827104-CSWS2010.

For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:

Have diagnosis of EECSWS confirmed by the Diagnosis Confirmation Panel (DCP).

Key Exclusion Criteria:

For participants who enroll directly following the completion of the Study NBI-827104-CSWS2010:

Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.

For Participants Who Do Not Enroll Directly from or Did Not Participate in Study NBI-827104-CSWS2010:

Body weight <15 kg at Day 1.
Clinically relevant findings related to cardiovascular or laboratory parameters at screening as determined by the investigator.
Presence of relevant neurological disorders other than EECSWS and its underlying conditions as judged by the investigator. Symptomatic conditions underlying EECSWS (for example, neonatal strokes) have to be stable for at least 1 year prior to screening.
Planned surgical intervention related to structural abnormalities of the brain from screening through the Week 6 Visit.
Used any active investigational drug other than NBI-827104 in the context of a clinical study within 30 days or 5 half-lives (whichever is longer) before screening or plans to use such an investigational drug (other than NBI-827104) during the study.
Have developed any other disorder for which the treatment takes priority over treatment of EECSWS or is likely to interfere with study treatment or impair treatment compliance.