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

Epileptic Encephalopathy Clinical Trial

— Steamboat 2  

Official title:

Long-Term, Open-Label Extension Study to Evaluate the Safety and Tolerability of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05301894
• Other study ID #: NBI-827104-CSWS2025
• Secondary ID: 2021-006788-11
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: June 7, 2022
• Est. completion date: February 2025

Study information

• Verified date: August 2023
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Continuous Spike and Wave During Sleep
• Epilepsy
• Epileptic Encephalopathy

Intervention

Drug:
• NBI-827104
T-type calcium channel blocker.

Locations

Country	Name	City	State
Denmark	Neurocrine Clinical Site	Dianalund
Spain	Neurocrine Clinical Site	Barcelona
Spain	Neurocrine Clinical Site	Madrid
Switzerland	Neurocrine Clinical Site	Zürich
United Kingdom	Neurocrine Clinical Site	London
United States	Neurocrine Clinical Site	Aurora	Colorado
United States	Neurocrine Clinical Site	Cleveland	Ohio
United States	Neurocrine Clinical Site	Durham	North Carolina
United States	Neurocrine Clinical Site	Miami	Florida
United States	Neurocrine Clinical Site	Orange	California
United States	Neurocrine Clinical Site	Rochester	Minnesota
United States	Neurocrine Clinical Site	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

United States,  Denmark,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Occurrence of Serious Treatment-emergent Adverse Events (TEAEs)		Day 1 up to 238 weeks